(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of the close of business on August ~~9, 2021,~~10, 2022, the registrant had ~~7,029,438~~54,514,828 shares of common stock, par value $0.0001 per share, outstanding.

	June 30, 2021			December 31, 2020			June 30, 2022			December 31, 2021
ASSETS
Current Assets
Cash and cash equivalents	$	20,220		$	23,906		$	11,128		$	15,045
Accounts receivable, net		228			238			17			21
Inventories		2,323			2,218			43			986
Prepaid expenses and other current assets		1,306			1,258			1,144			1,037
Total current assets		24,077			27,620			12,332			17,089
Property and equipment, net		2,661			3,211			38			1,809
Operating lease right-of-use-assets		2,300			2,484
Other non-current assets		121			123
Operating lease right-of-use assets								1,967			2,110
Other long-term assets								36			36
TOTAL ASSETS	$	29,159		$	33,438		$	14,373		$	21,044
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable	$	1,077		$	571		$	487		$	988
Accrued expenses		2,021			4,348			1,970			4,119
Current portion of deferred revenue		1,787			1,801
Current portion of equipment financing		—			265
Current portion of promissory note		—			421
Current portion of operating lease liabilities		320			356
Current portion of operating lease liability								297			283
Total current liabilities		5,205			7,762			2,754			5,390
Deferred revenue		566			686
Promissory note		—			1,579
Operating lease liabilities		2,125			2,264
Operating lease liability								1,828			1,981
Total liabilities		7,896			12,291			4,582			7,371
Commitments and contingencies (Note 13)
Commitments and contingencies (Notes 12-14)
Stockholders’ Equity
Preferred stock, $0.0001 par value, 10,000,000 authorized; NaN issued		—			—
Common stock, $0.0001 par value, 300,000,000 shares authorized; 5,902,612 and 3,188,679 issued and outstanding at June 30, 2021 and December 31, 2020, respectively		7			7
Preferred stock, $0.0001 par value; 10,000 shares authorized; 0 shares issued								—			—
Common stock, $0.0001 par value; 300,000 shares authorized; 32,279 and 7,010 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively								10			8
Additional paid-in capital		186,943			174,342			201,996			191,937
Accumulated deficit		(165,687	)		(153,202	)		(192,215	)		(178,272	)
Total stockholders’ equity		21,263			21,147			9,791			13,673
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	29,159		$	33,438		$	14,373		$	21,044

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

2021

2020

Net revenue

Product sales

$
318

$
154

$
724

$
740

Service and other

687

746

1,399

1,534

Total net revenue

1,005

900

2,123

2,274

Cost of revenue

Product sales

861

624

1,651

1,588

Service and other

627

543

1,210

1,163

Total cost of revenue

1,488

1,167

2,861

2,751

Gross loss

(483
)

(267
)

(738
)

(477
)
Operating expenses

Selling, general and administrative

3,741

7,896

7,855

14,181

Research and development

3,018

1,953

5,834

3,248

Total operating expenses

6,759

9,849

13,689

17,429

Operating loss

(7,242
)

(10,116
)

(14,427
)

(17,906
)
Other income (expense), net

Gain on extinguishment of debt

2,023

—

2,023

—

Interest income

1

10

2

124

Interest expense

(31
)

(15
)

(83
)

(40
)
Total other income (expense), net

1,993

(5
)

1,942

84

Loss before income tax expense

(5,249
)

(10,121
)

(12,485
)

(17,822
)
Income tax expense

—

—

—

—

Net loss

$
(5,249
)

$
(10,121
)

$
(12,485
)

$
(17,822
)
Basic and diluted net loss per share

$
(1.28
)

$
(10.71
)

$
(3.56
)

$
(23.83
)
Basic and diluted weighted average common shares
outstanding

4,089

945

3,506

748

	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Revenues
Product sales	$	5		$	9		$	14		$	13
Cost of revenues
Product sales		11			344			42			608
Service and other		55			176			119			359
Total cost of revenues		66			520			161			967
Gross loss		(61	)		(511	)		(147	)		(954	)
Operating expenses
Selling, general and administrative		2,476			3,398			4,778			7,075
Research and development		2,396			2,829			5,511			5,579
Restructuring and impairment (Note 13)		3,527			—			3,527			—
Total operating expenses		8,399			6,227			13,816			12,654
Operating loss		(8,460	)		(6,738	)		(13,963	)		(13,608	)
Other income, net		12			2,019			20			2,012
Loss from continuing operations before income taxes		(8,448	)		(4,719	)		(13,943	)		(11,596	)
Income taxes		—			—			—			—
Loss from continuing operations		(8,448	)		(4,719	)		(13,943	)		(11,596	)
Discontinued operations
Loss from discontinued operations before income taxes		—			(530	)		—			(889	)
Income taxes		—			—			—			—
Loss from discontinued operations		—			(530	)		—			(889	)
Net loss	$	(8,448	)	$	(5,249	)	$	(13,943	)	$	(12,485	)
Net loss per share, basic and diluted
Continuing operations	$	(0.26	)	$	(1.15	)	$	(0.53	)	$	(3.31	)
Discontinued operations		—			(0.13	)		—			(0.25	)
Total net loss per share, basic and diluted	$	(0.26	)	$	(1.28	)	$	(0.53	)	$	(3.56	)

Weighted average number of shares used in computing net loss per share, basic and diluted		32,162			4,089			26,133			3,506

	Six Months Ended June 30,						Six Months Ended June 30,
	2021			2020			2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES:
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(12,485	)	$	(17,822	)	$	(13,943	)	$	(12,485	)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on extinguishment of debt (promissory note)		(2,023	)		—
Non-cash restructuring and impairment								2,943			—
Depreciation and amortization		881			1,214			322			881
Provision for doubtful accounts		—			25
Stock-based compensation		1,865			2,080			291			1,865
Gain on sale of property and equipment		(493	)		—
Loss (gain) on sales and disposals of property and equipment								44			(493	)
Gain on extinguishment of promissory note								—			(2,023	)
Changes in operating assets and liabilities:
Accounts receivable		10			287			4			10
Inventories		(108	)		33			(57	)		(108	)
Prepaid expenses and other assets		(46	)		650			(502	)		(46	)
Accounts payable		368			107			(501	)		368
Accrued expenses		(2,359	)		1,295			(3,039	)		(2,359	)
Other liabilities								(139	)		(175	)
Deferred revenue		(134	)		(556	)		—			(134	)
Other liabilities		(175	)		(156	)
Net cash used in operating activities		(14,699	)		(12,843	)		(14,577	)		(14,699	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturities of available-for-sale securities		—			16,000
Proceeds from sale of property and equipment		534			—
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sales of property and equipment								—			534
Purchases of property and equipment		(76	)		(49	)		—			(76	)
Net cash provided by investing activities		458			15,951			—			458
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants, net of placement agent fees of $351 and $1,008, respectively		11,022			8,992
Proceeds from issuance of common stock in connection with the exercise of warrants		—			827
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common stock and warrants								12,670			11,022
Payments of offering costs related to the issuance of common stock and warrants								(2,040	)		(228	)
Proceeds from exercise of warrants								25			—
Proceeds from issuance of common stock in connection with the employee stock purchase plan		26			27			5			26
Proceeds from PPP promissory note		—			2,000
Payments on equipment financing		(265	)		(145	)		—			(265	)
Payments of offering costs related to the issuance of common stock and warrants		(228	)		(13	)
Net cash provided by financing activities		10,555			11,688			10,660			10,555
NET CHANGE IN CASH AND CASH EQUIVALENTS		(3,686	)		14,796			(3,917	)		(3,686	)
CASH AND CASH EQUIVALENTS, beginning of period		23,906			14,584			15,045			23,906
CASH AND CASH EQUIVALENTS, end of period	$	20,220		$	29,380		$	11,128		$	20,220

SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Unpaid offering costs	$	84		$	231		$	890		$	84
Transfer from inventories to property and equipment for lasers	$	3		$	40
Unpaid property and equipment	$	109		$	—		$	—		$	109
Transfer of lasers from inventories to property and equipment							$	—		$	3
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash payments for interest	$	2		$	16		$	—		$	2
Cash payments for taxes	$	2		$	—
Cash payments for income taxes							$	—		$	2

Common
Stock
Shares

Common
Stock
Amount

Additional
Paid- in-
Capital

Accumulated
Other
Comprehensive
Income (Loss)

Accumulated
Deficit

Total
Stockholders’
Equity

Balances at December 31, 2020

3,189

$
7

$
174,342

$
—

$
(153,202
)

$
21,147

Common stock issued, net

35

—

65

—

—

65

Stock-based compensation

35

—

1,169

—

—

1,169

Net loss

—

—

—

—

(7,236
)

(7,236
)
Balances at March 31, 2021

3,259

$
7

$
175,576

$
—

$
(160,438
)

$
15,145

Common stock issued, net

2,582

—

10,645

—

—

10,645

Common stock issued pursuant to the vesting of restricted stock units and ESPP

6

—

26

—

—

26

Stock-based compensation

56

—

696

—

—

696

Net loss

—

—

—

—

(5,249
)

(5,249
)
Balances at June 30, 2021

5,903

$
7

$
186,943

$
—

$
(165,687
)

$
21,263

						Additional					Total
	Common Stock					Paid-In		Accumulated			Stockholders'
	Shares			Amount		Capital		Deficit			Equity
Balances at December 31, 2021		7,010		$	8	$	191,937	$	(178,272	)	$	13,673
Common stock and warrants issued, net		25,248			2		9,738		—			9,740
Warrants exercised		50			—		25		—			25
Restricted stock awards cancelled		(7	)		—		—		—			—
Stock-based compensation		—			—		165		—			165
Net loss		—			—		—		(5,495	)		(5,495	)
Balances at March 31, 2022		32,301			10		201,865		(183,767	)		18,108
Common stock issued pursuant to the vesting of restricted stock units and purchases under the employee stock purchase plan		19			—		5		—			5
Restricted stock awards cancelled		(41	)		—		—		—			—
Stock-based compensation		—			—		126		—			126
Net loss		—			—		—		(8,448	)		(8,448	)
Balances at June 30, 2022		32,279		$	10	$	201,996	$	(192,215	)	$	9,791

Common
Stock
Shares

Common
Stock
Amount

Additional
Paid- in-
Capital

Accumulated
Other
Comprehensive
Income (Loss)

Accumulated
Deficit

Total
Stockholders’
Equity

Balances at December 31, 2019

551

$
1

$
150,280

$
26

$
(117,157
)

$
33,150

Common stock issued

5

—

—

—

—

—

Stock-based compensation

—

—

1,047

—

—

1,047

Other comprehensive loss

—

—

—

(22
)

—

(22
)
Net loss

—

—

—

—

(7,701
)

(7,701
)
Balances at March 31, 2020

556

$
1

$
151,327

$
4

$
(124,858
)

$
26,474

Common stock issued, net

889

2

5,282

—

—

5,284

Warrants issued, net

—

—

3,464

—

—

3,464

Exercise of warrants

73

1

826

—

—

827

Common stock issued pursuant to the vesting of restricted stock units and ESPP

9

—

27

—

—

27

Stock-based compensation

—

—

1,033

—

—

1,033

Other comprehensive loss

—

—

—

(4
)

—

(4
)
Net loss

—

—

—

—

(10,121
)

(10,121
)
Balances at June 30, 2020

1,527

$
4

$
161,959

$
—

$
(134,979
)

$
26,984

					Additional					Total
	Common Stock				Paid-In		Accumulated			Stockholders'
	Shares		Amount		Capital		Deficit			Equity
Balances at December 31, 2020		3,189	$	7	$	174,342	$	(153,202	)	$	21,147
Common stock issued, net		35		—		65		—			65
Stock-based compensation		35		—		1,169		—			1,169
Net loss		—		—		—		(7,236	)		(7,236	)
Balances at March 31, 2021		3,259		7		175,576		(160,438	)		15,145
Common stock issued, net		2,582		—		10,645		—			10,645
Common stock issued pursuant to the vesting of restricted stock units and purchases under the employee stock purchase plan		6		—		26		—			26
Stock-based compensation		56		—		696		—			696
Net loss		—		—		—		(5,249	)		(5,249	)
Balances at June 30, 2021		5,903	$	7	$	186,943	$	(165,687	)	$	21,263

Ra Medical Systems, Inc. (the “Company”) is a medical device company that owns intellectual property related to an advanced excimer laser-based platform for use in the treatment of vascular immune-mediated inflammatory diseases. Its excimer laser and single-use catheter system, together referred to as the DABRA Excimer Laser System, (“DABRA”), is used as a tool in the treatment of peripheral artery disease. The Company was formed on September 4, 2002 in the state of California and reincorporated in Delaware on July 14, 2018.

The Company ~~is a medical device company~~previously disclosed that ~~develops and manufactures advanced excimer laser systems for use in the treatment~~its board of vascular and dermatological diseases. The Company’s product development centers around proprietary applications of its advanced excimer laser technology for use as a tool in the treatment of peripheral artery disease (“PAD”) and psoriasis, vitiligo, atopic dermatitis and leukoderma.

~~Reverse Stock Split~~—~~On November 16, 2020, the Company filed a certificate of amendment to the Certificate of Incorporation~~directors was reviewing strategic alternatives with the ~~Secretary~~goal of ~~State of~~maximizing shareholder value. This review was triggered by the State of Delaware to effect a reverse stock split of the Company’s common stock at a ratio of one-for-twenty-five (“Reverse Stock Split”). The Reverse Stock Split became effective as of 4:01 p.m. Eastern time on November 16, 2020,deteriorating macroeconomic environment and the Company’s common stock began trading on the New York Stock Exchange (“NYSE”) on a post-split basis on November 17, 2020. Unless otherwise noted, all share and per share numbers contained in these financial statements are reflected on a post-split basis.

~~COVID-19~~—The global spread of the novel coronavirus (COVID-19) has created significant volatility, uncertainty and economic disruption. The ultimate effects of the COVID-19 on the Company’s business, operations and financial condition are unknown at this time. In the near term, the Company expects that its revenue will continue to be adversely impacted and enrollment in its atherectomy clinical trial will continue to be delayed or slowed, as patients elect to postpone voluntary treatments and many physicians’ offices have been either closed or operating at a reduced capacity. In addition, some customers are requesting more flexible payment terms on a temporary basis. The Company’s manufacturing facility located in Carlsbad, California is currently operational. The Company has experienced delays in receiving shipments of certain parts, which has affected the timing of its key engineering efforts. To date, the delays have not materially impactedconcerns regarding the Company’s ability to ~~support~~continue funding its ~~atherectomy indication~~ clinical ~~trial. However,~~and engineering programs at levels consistent with the ~~extent~~past few years. In conjunction with this review, on June 3, 2022, the board of directors approved a reduction in force (“RIF”) to ~~which COVID-19 impacts~~preserve capital with the goal of maximizing the opportunities available to the Company during the board of directors’ review of strategic alternatives. See further discussion in Note 13. Restructuring and Impairment Charges.

On June 18, 2022, the Company signed a non-binding summary of proposed terms (the “Term Sheet”) with Catheter Precision, Inc. (“Catheter Precision”) to acquire 100% of the outstanding equity interests of Catheter Precision (the “Merger”). Pursuant to the Term Sheet, the Company would acquire Catheter Precision in exchange for shares of the Company. The Merger would give the Company’s shareholders exposure to Catheter Precision’s innovative devices that are designed to improve treatment of cardiac arrhythmias, while allowing the combined company the ability to explore funding its ~~business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning~~strategic initiatives for the ~~severity of COVID-19 and~~Catheter Precision devices through the ~~actions to contain it or treat its impact, among others.~~

~~Going Concern~~ —public capital markets. The Company has ~~experienced~~not entered into a binding agreement with Catheter Precision with respect to the Merger transaction. The Company is currently completing its due diligence review of Catheter Precision and is continuing to negotiate the terms of a definitive merger agreement. Accordingly, the Company cannot provide any assurance that it will effect the Merger or, if it is able to consummate such a transaction, that the terms of any such Merger will be on the terms set forth in the Term Sheet or that the intended benefits of the Merger will be fully realized.

The Company has incurred recurring net losses from operations and negative cash flows from operating activities ~~has a significant accumulated deficit and expects to continue to incur net losses into~~since inception. As of June 30, 2022, the ~~foreseeable future. The~~ Company had an accumulated deficit of ~~$165.7 million at~~$192.2 million. For the six months ended June 30, ~~2021. For the year ended December 31, 2020~~2022, the Company used ~~$28.3~~cash of $14.6 millionin ~~cash for~~ operating activities.

As of June 30, ~~2021,~~2022, the Company had cash and cash equivalents of ~~$20.2~~$11.1 million.

Management ~~expects~~will continue to monitor operating ~~losses~~costs and ~~negative cash flows~~seek to ~~continue for the foreseeable future with~~reduce the Company’s reduced commercial footprint, and as the Company continues to incur costs related to its atherectomy clinical trial, engineering efforts to improve the shelf life of its catheters and develop next generation products and legal costs associated with ongoing litigation. In September 2020, the Company paused commercial sales of DABRA catheters not being used for the atherectomy clinical trial while it conducted further studies on the stability of its shelf life. The Company submitted additional test data with respect to the DABRA catheter shelf life in March 2021, which was cleared by the FDA in July 2021. Although eligible, the Company has not resumed commercial shipments and is evaluating its commercial catheter strategy. The Company also expects the COVID-19 pandemic to have a continued negative impact on its revenue and the timing of enrollment in its atherectomy clinical trial as well ascurrent liabilities. Such actions may impair the Company’s ability to ~~secure additional~~proceed with certain strategic activities, and the Company may be unsuccessful at negotiating existing liabilities, including its operating lease liability, to the Company’s benefit. If these efforts are unsuccessful or the Merger is not completed, the Company’s cash position could be negatively impacted and the Company may, among other things, be required to seek other sources of financing, consummate another strategic transaction or be required to liquidate its assets and dissolve the Company. Because of the significant uncertainty regarding the Company’s future plans, the Company is not able to accurately predict the impact of a potential change in ~~a timely manner or on favorable terms, if at all.~~its business strategy and future funding requirements.

Management believes that, based on the Company’s liquidity resources and the significant uncertainty regarding its future plans, there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. The Company’s independent registered public accounting firm expressed substantial doubt regarding the Company’s ability to continue as a going concern in its report on the Company’s financial statements as of and for the year ended December 31, 2021.

Although the Company ~~bolstered~~improved its liquidity resources through a private placement in ~~2020 and 2021, it has an effective shelf registration statement and an “at the market” offering to allow it to raise additional capital when the opportunities permit~~July 2022, resulting in net proceeds of $5.5 million and may receive additional funds from the exercise of its warrants depending on market conditions, management has concluded that the aforementioned conditions, including the ongoing uncertainty related to the negative

impacts of the COVID-19 pandemic, continue to raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. Management plans to address this uncertainty by raising additional funds, if necessary, through public

or private equity or debt financings as well as by engaging in regular and ongoing reviews of ~~our business model and~~its strategic options to help ensure that the Company is focusing its cash resources on advancing its key corporate initiatives. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

The global effects of COVID-19 have created significant volatility, uncertainty and economic disruption. Although restrictions have been recently eased around the world, the COVID-19 pandemic is still ongoing, and the ultimate effects of COVID-19 on the Company’s business, operations and financial condition are unknown at this time. The Company expects that patient follow-up in its atherectomy clinical trial will continue to be affected by the uncertainty relating to COVID-19, as patients may continue to elect to postpone follow-up visits and physicians’ offices may intermittently close or operate at a reduced capacity in response to COVID-19. The Company’s facility located in Carlsbad, California is currently open. However, the extent to which COVID-19 impacts its business will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain it or treat its impact, among others.

The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and reflect all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed balance sheets, results of operations, cash flows and statements of stockholders’ equity for the periods presented. The results of operations for the three and six months ended June 30, ~~2021~~2022 are not necessarily indicative of the results to be expected for the year ending December 31, ~~2021~~2022 or for any other future annual or interim period. The balance sheet as of December 31, ~~2020~~2021 included herein was derived from the audited financial statements as of that date. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K, filed with the ~~SEC~~Securities and Exchange Commission on March ~~17, 2021.~~24, 2022, and as amended on July 13, 2022.

The preparation of interim unaudited condensed financial statements ~~of the Company have been prepared by management~~ in accordance with generally accepted accounting principles ~~generally accepted~~ in the United States ~~of America.~~ (“GAAP”)~~The preparation of the financial statements~~ requires management to make estimates and assumptions that affect the amounts reported ~~amounts of assets, liabilities and reported disclosures of contingent liabilities at~~in the ~~dates of the~~interim unaudited condensed financial statements and ~~the~~accompanying notes. The amounts reported ~~amounts of revenue and expenses during the reporting periods. Actual results~~ could differ ~~from those estimates. The Company’s financial statements~~under different estimates and assumptions. On an ongoing basis, management evaluates its estimates and judgments, which are based ~~upon a number~~on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of estimates, including but not limited to, allowance for doubtful accounts, evaluation of impairment of assets, reserves for warranty costs including product recalls, evaluation of probable loss contingencies, fair value of stock option awards granteduncertainty and, ~~revenue recognition for multiple performance obligations.~~ as such, actual results may differ from management’s estimates.

Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier value hierarchy is used to identify inputs used in measuring fair value as follows:

Level 1—1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active ~~markets.~~markets;

Level 2—2 – Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

Level 3—3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value.

Cash and cash equivalents, trade accounts receivable, accounts payable, accrued expenses and other current assets and liabilities are reported on the balance sheets at carrying value which approximates fair value due to the short-term ~~investments at fair value.~~maturities of these instruments.

Inventories are stated at the lower of cost ~~(first-in, first-out method)~~ or net realizable value. Cost is determined on a first-in, first-out basis. Cost includes materials, labor and manufacturing overhead related to the purchase and production of inventories. The Company reduces the carrying value of inventories for those items that are potentially excess ~~obsolete~~ or ~~slow-moving~~obsolete based on changes in customer demand, technological developments or other economic factors.

~~Catheters are~~Prior to June 6, 2022, catheters were manufactured in-house, and each catheter iswas tested at various stages of the manufacturing process for adherence to quality standards. Catheters that dodid not meet functionality specification at each test point ~~are~~were destroyed and immediately written ~~off, with the expense recorded in cost of revenue in the statements of operations.~~off. Once manufactured, completed catheters that ~~pass~~passed quality assurance ~~are~~were sent to a third-party for sterilization and sealed in a sterile container. Upon return from the third-party sterilizer, a sample of catheters from each batch ~~are~~was re-tested. If the sample tests ~~are~~were successful, the batch iswas accepted into finished goods ~~inventory and if~~inventory. If the sample tests ~~are~~were unsuccessful, the entire batch iswas written ~~off, with the expense recorded in cost~~off.

~~Revenue~~—The Company ~~generates revenue from~~reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived assets, including its eventual residual values, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values.

The Company operates its business in 1 segment which includes all activities related to the research, development and manufacture of the DABRA system. The chief operating decision-maker reviews the operating results on an aggregate basis and manages the operations as a single operating segment.

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). The new guidance eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance requires that the if-converted method is used in computing diluted earnings per share for all convertible instruments. The update is effective for annual reporting periods, including interim periods, beginning after December 15, 2021. The Company adopted ASU 2020-06 on January 1, 2022 using a modified retrospective approach, and the adoption did not impact its financial statements or per share amounts.

The Company completed the sale of ~~products and services. Product sales consist~~its Pharos dermatology business (the “Dermatology Business”) to STRATA Skin Sciences, Inc. (“Strata”) on August 16, 2021 for net proceeds of $3.7 million, resulting in a gain on the sale of ~~Pharos laser systems,~~ the ~~sale~~Dermatology Business of ~~catheters for use with the DABRA laser, and the sale~~$3.5 million which was included as a component of ~~consumables and replacement parts. The Company’s vascular segment has paused selling commercial product and is only selling catheters for use~~income (loss) from discontinued operations in the ~~Company’s atherectomy clinical trial. The Company’s sales agreements generally do not include right-of-return provisions for any form~~statement of consideration including partial refund or credit against amounts owed to the Company. Services and other revenue primarily consist of sales of extended warranty and billable services, including repair activity and income from rental of lasers.

When engaged in commercial sales, the Company enters into a DABRA laser commercial usage agreement or DABRA laser placement acknowledgement with each customer that is supplied a DABRA laser, collectively the “usage agreement”. The usage agreement provides for specific terms of continued use of DABRA laser, including a nominal periodic fee. The terms of a usage agreement typically allow the Company to place a DABRA laser at a customer’s specified location without a specified contract term. Under the usage agreement terms, the Company retains all ownership rights to the DABRA laser and is permitted to request the return of the equipment within 10 business days of notification. While the laser periodic fees are nominal, the laser usage agreements provide the Company the exclusive rights to supply related single-use catheters to the customer which aggregate the majority of the vascular segment revenue. There are no specified minimum purchase commitmentsoperations for the ~~catheters.~~

year ended December 31, 2021. The Company recognizes revenue associated with the usage agreement and catheter supply arrangements in accordance with Topic 606 as the contract primarily includes variable payments, the catheters are priced at their standalone selling price and the laser equipment is insignificant in the context of the contract. Revenue is recognized when the performance obligation is satisfied, which is generally upon shipment of the catheter.

Sales of laser systems are included in product sales in the statements of operations. The Company recognizes revenue on laser sales at the point in time that control transfers to the customer. Control of the product typically transfers upon shipment.

The Company typically provides a 12-month warranty with the purchase of its laser systems. Customers can extend the warranty period through the purchase of extended warranty service contracts. Extended warranty service contracts are sold with contract terms ranging from 12 to 60 months and cover periods after the end of the initial 12-month warranty period. The warranty provides the customer with maintenance services in addition to the assurance that the laser product complies with agreed-upon specifications. Therefore, the warranty service is treatedDermatology Business was previously disclosed as a separate ~~performance obligation~~reportable segment of the Company.

The results of the Dermatology Business are reported as loss from the laser system. Warranty services are a stand-ready obligation, and the Company recognizes revenue on a straight-line basis over the service contract term. Warranty service revenue is included in service and other revenuediscontinued operations in the condensed statements of ~~operations. Deferred revenue at January 1, 2021~~operations for the three and ~~2020 was $2.5 million and $3.3 million, respectively. Revenue recognized in each of the three~~six months ended June 30, ~~2021~~2021. Certain overhead costs previously allocated to the Dermatology Business for segment reporting purposes did not qualify for classification as discontinued operations and ~~2020 relating~~have been reallocated to ~~amounts previously included~~continuing operations for the three and six months ended June 30, 2021.

The following table summarizes the loss from discontinued operations in ~~deferred revenue~~the condensed statements of operations for the periods presented (in thousands):

Depreciation expense for the Dermatology Business was ~~$0.5~~$0.1 million and ~~$0.6~~$0.2 million ~~respectively. Revenue recognized in each of~~for the three and six months ended June 30, 2021, ~~and 2020 was $1.1 million and $1.3 million,~~ respectively. ~~The deferred revenue greater than one year will be recognized~~There were 0 capital expenditures for the Dermatology Business during the ~~remaining service period through 2024. As of June 30, 2021~~three and ~~2020, deferred revenue greater than one year was $0.5 million and $0.8 million, respectively.~~

In certain markets outside the U.S., the Company sells products and provides services to customers through distributors that specialize in medical device products. The terms of sales transactions through distributors are generally consistent with the terms of direct sales to customers. The Company accounts for these transactions in accordance with the Company’s revenue recognition policy described herein.

The Company capitalizes costs to obtain contracts that are considered incremental and recoverable, such as sales commissions. The capitalized costs are amortized to selling, general and administrative expense over the estimated period of benefit of the asset, which is the contract term. The Company elected to use the practical expedient to expense the costs to obtain a contract

~~when the amortization period is less than one year. The Company has contract costs of $0.2~~ ~~million capitalized at June 30, 2021 and December 31, 2020.~~

The Company also derives income pursuant to product lease agreements for its Pharos laser systems, as operating leases. Consequently, the Company retains title to the equipment and the equipment remains on Company’s balance sheet within property and equipment. Depreciation expense on these leased lasers is recorded to cost of revenues on a straight-line basis. The costs to maintain these leased lasers are charged to cost of revenues as incurred.

These lease arrangements contain one lease component (the laser) and one nonlease component (warranty service) for which the Company elected the practical expedient to not separate the nonlease component from the lease component. The Company accounts for the combined lease component as an operating lease and recognizes lease income on a straight-line basis over the lease term. Rental income from lease arrangements was $0.1 for each of the threesix months ended June 30, ~~2021~~2021.

Stock-based compensation expense for the Dermatology Business was approximately $11,000 and ~~2020.~~ ~~Rental income from lease arrangements~~$30,000 for ~~each of~~ the three and six months ended June 30, 2021, respectively. Stock-based compensation expense of approximately $33,000 and ~~2020~~$71,000 was ~~$0.3 million.~~

capitalized to inventory and property and equipment during the three and six months ended June 30, 2021, respectively.

As of June 30, 2022 and December 31, 2021, cash equivalents of approximately $9.4 million were categorized as Level 1 and consisted of money market funds that were measured at fair value on a recurring ~~basis (in thousands):~~

Due to the RIF and the Company’s decision to discontinue enrollment of patients in its clinical trial, the Company ceased manufacturing activities and disposed of substantially all inventories in July 2022, resulting in a write-down of $1.0 million in its inventories to net realizable value as of June 30, 2022. Such expense is included in restructuring and impairment charges in the condensed statements of operations for the three and six months ended June 30, 2022. See Note 5—13. Restructuring and Impairment Charges.

Depreciation expense was ~~$0.3~~$0.1 million and ~~$0.5~~$0.3 million for the three months ended June 30, 2022 and 2021, respectively, and ~~2020, respectively~~ ~~and $0.7~~$0.2 million and ~~$1.0~~$0.7 million for the six months ended June 30, 2022 and 2021, respectively.

Due to the Company’s decision to discontinue enrollment of patients in its clinical trial and ~~2020, respectively. During~~ the RIF, the Company has ceased manufacturing activities. The Company’s property and equipment was determined to be impaired as of June 30, 2022, resulting in an impairment charge of $1.5 million which was based on the actual cash proceeds received upon the disposal of the property and equipment in July 2022. The impairment charge of $1.5 million is included in restructuring and impairment charges in the condensed statements of operations for the three and six months ended June 30, ~~2021 automobiles were sold for a gain of $0.5 million. The gain is included in selling, general~~2022. See Note 13. Restructuring and ~~administrative expenses in the accompanying condensed statements of operations.~~ Impairment Charges.

~~Activity in the product warranty accrual is included in accrued expenses above and consists of the following (in thousands):~~

~~Warranty expense was $15,000 and $8,000 for the three months ended June 30, 2021 and 2020, respectively~~ ~~and $39,000 and $40,000 for the six months ended June 30, 2021 and 2020, respectively~~.~~The accrued warranty balances at June 30, 2021 and December 31, 2020 each include $0.1 million relating to the voluntary recall~~ ~~of catheters, which occurred in September 2019.~~ ~~Warranty expense is included in cost of revenue in the accompanying condensed statements of operations.~~

In May 2020, the Company entered into a $2.0 million Paycheck Protection Program Promissory Note and Agreement (“PPP Promissory Note”) with a commercial bank under the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. The PPP Promissory Note bore an interest rate of 1.0% per annum. Under the terms of the PPP Promissory Note, payments would have been due monthly beginning November 1, 2020 and the principal amount of the PPP Promissory Note along with any unpaid interest would be due on May 3, 2022. On June 5, 2020, the Paycheck Protection Program Flexibility Act of 2020 (the “PPPFA”) extended the deferral period for all loans to 10 months after the last day of the covered period. Under the revised terms, payments would have been due beginning August 2021 and the principal amount along with unpaid interest would be due in May 2022. The principal and interest may be forgiven if the proceeds are used for forgivable purposes as defined by the terms in the PPP Promissory Note. The Company applied for full forgiveness under the provisions of the CARES Act in March 2021 and received approval by the Small Business Administration on June 24, 2021. Gain on extinguishment of the PPP promissory note is recorded in other income on the condensed statements of operations. Interest expense for the three months ended June 30, 2021 and 2020 was approximately $5,000 and $3,000, respectively. Interest expense for the six months ended June 30, 2021 and 2020 was approximately $10,000 and $3,000, respectively.

The Company has 2an operating ~~leases~~lease for office and manufacturing space which requires it to pay base rent and certain utilities. Monthly rent expense is recognized on a straight-line basis over the ~~terms~~term of the ~~leases,~~lease which ~~expire~~expires in ~~2027 and 2021.~~

2027. At June 30, ~~2021,~~2022, the ~~weighted average~~ remaining lease term was ~~6.5~~5.5 years. The operating ~~leases are~~lease is included in the condensed balance sheets at the present value of the lease payments at a 7% discount rate which approximates ~~using~~ the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term ~~and~~an amount equal to the lease payments in a similar economic environment, as the ~~leases do~~lease does not provide an implicit rate.

For each of the three months ended June 30, ~~2021~~2022 and ~~2020,~~2021, operating lease expense and cash paid for leases ~~were $0.1~~was $0.1 million. For ~~each of~~ the six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, operating lease expense and cash paid for leases was $0.2 million and $0.3 ~~million.Operating~~million, respectively. Amortization of operating lease right-of-use assets ~~amortization~~ was $0.1 million for each of the three months ended June 30, 2022 and 2021 and $0.1 million and $0.2 million for ~~each~~ the ~~three and~~ six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively. Variable costs ~~are~~ were de ~~minimis.~~minimis.

~~The following table presents the~~Maturities of operating lease liabilities ~~within the condensed balance sheet, related to the Company’s operating leases~~ as of June 30, ~~2021~~2022 (in thousands):

~~The Company calculates basic~~Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding during the reporting period. A net loss cannot be diluted, so when the Company is in a net loss position, basic and diluted loss per common share are the same. If in the future the Company achieves profitability, the denominator of a diluted earnings per common share calculation will include both the ~~weighted-average~~weighted average number of shares outstanding and the number of common stock equivalents, if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents ~~potentially~~ include warrants, stock options, ~~and~~ non-vested restricted stock ~~awards~~units and ~~units using the treasury~~employee stock ~~method, along with the effect, if any, from outstanding convertible securities.~~purchase plan rights.

The Company’s outstanding warrants to purchase common stock have participation rights to any dividends that may be declared in the future and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, 0 loss is allocated to the participating securities since the holders have no contractual obligation to share in the losses of the Company.

Anti-dilutive ~~common~~share equivalents excluded from the computation of diluted net loss per share at June 30, 2022 consisted of warrants of 56,329,950, stock options of 101,577, restricted stock awards of 79,988 and restricted stock units of 6,818.

Anti-dilutive share equivalents excluded from the computation of diluted net loss per share at June 30, 2021 consisted of warrants of 2,345,033, stock options of 132,477, restricted stock awards of 355,598, restricted stock units of 54,924 ~~restricted stock awards of 355,598~~ and Employee Stock Purchase Plan shares of 10,557.

Anti-dilutive common share equivalents excluded from the computation of diluted net loss per share at June 30, 2020 consisted of warrants of 877,604, stock options of 145,765 and restricted stock units of 7,876, restricted stock awards of 5,000 and Employee Stock Purchase Plan shares of 3,771.

InOn February ~~2021,~~8, 2022, the Company completed ~~an “at the market offering” of 35,768~~a public offering (the “Offering”) in which it issued and sold (i) 9,535,000 shares of common stock, (ii) 24,002,893 warrants to purchase one share of common stock at aan exercise price of ~~$8.3921~~$0.50 that were immediately exercisable and expire one year from the date of issuance, or Series A warrants, and (iii) 24,002,893 warrants to purchase one share of common stock at an exercise price of $0.50 that were immediately exercisable and expire seven years from the date of issuance, or Series B warrants, and (iv) 14,467,893 pre-funded warrants to purchase one share of common stock at an exercise price of $0.0001 per ~~share.~~ share that were immediately exercisable and expire twenty years from the date of issuance. In addition, the Company granted the underwriters of the Offering a 45-day option (the “Overallotment Option”) to purchase up to (i) 3,600,000 additional shares of common stock, (ii) 3,600,000 additional Series A warrants and/or (iii) 3,600,000 additional Series B warrants, solely to cover overallotments.

The Series A warrants and Series B warrants were valued at approximately $11.6 million using the Black-Scholes option pricing model (the “Black-Scholes model”) based on the following assumptions:

In addition, the Company ~~received~~issued 1,245,116 shares of common stock, 3,600,000 Series A warrants and 3,600,000 Series B warrants pursuant to the exercise of the Overallotment Option, resulting in cash proceeds of approximately ~~$0.3~~$0.6 million, in net proceeds, after deducting placement agent’s fees. The Company also incurred $0.2 million in offering and other expenses payable by it in association with filing the related Registration Statement on Form S-3 with the Securities and Exchange Commission.

of underwriting discounts. On various dates in ~~May~~February 2022 and ~~June 2021,~~March 2022, the Company ~~completed “at~~issued 14,467,893 shares of common

stock upon the ~~market offerings”~~exercise of ~~2,582,019~~all of the pre-funded warrants issued in the Offering. In addition, in March 2022, the Company issued 50,000 shares of common stock in connection with the exercise of 50,000 Series A warrants issued in the Offering.

Net proceeds from the Offering were approximately $9.7 million, after deducting underwriter commissions and fees and other offering fees paid or payable by the Company as of June 30, 2022.

At June 30, 2022, the Company had 56,329,950 shares of common stock reserved for issuance pursuant to the warrants issued by the Company at a weighted average exercise price of ~~$4.29 per share.~~ $0.89.

The Company ~~received~~is contractually obligated to pay a former placement agent a cash tail fee equal to 7.5% cash compensation for the gross proceeds raised in the Offering and to issue warrants equal to 7% of the number of shares of common stock sold in the Offering (the “Tail Fees”) to any investor contacted by the former placement agent during the term of its engagement with the Company. Thus, the Company is obligated to pay such placement agent a cash tail fee which it estimates to be approximately ~~$10.7~~$0.9 million and to issue approximately 1.7 million warrants to purchase common stock at an exercise price of $0.625 per share, which represents 125% of the exercise price in ~~net proceeds, after deducting placement agent’s fees.~~the Offering. Such warrants would be immediately exercisable and expire five years from the date of issuance. These warrants were valued at approximately $0.4 million on February 8, 2022, using the Black-Scholes model based on the following assumptions: expected volatility of 93.25%, risk-free interest rate of 1.81%, expected dividend yield of 0% and an expected term of 5 years. The cash tail fees of $0.9 million are included in accrued expenses in the condensed balance sheet as of June 30, 2022. The warrants had not been issued by the Company as of June 30, 2022.

~~A summary of the activity and related information of the stock options issued under the~~ ~~2018 Plan~~ ~~and the~~ ~~Compensation Plan~~ ~~is presented below:~~

~~A summary of the activity and related information of the restricted stock units issued under the 2018 Plan is presented below:~~

A summary of the activity and related ~~information of the restricted stock awards issued~~data by award type under the 2018 Equity Incentive Plan and the 2020 Inducement Equity Incentive Plan (collectively, the “Plans”) for the six months ended June 30, 2022 is ~~presented~~set forth below:

Restricted Stock options issued and outstanding under the 2020 Plan is 18,000 with a weighted average grant date fair value of $25.50 as of December 31, 2020 and June 30, 2021. Stock options aggregating 5,625 were exercisable as of June 30, 2021, under the 2020 Plan.

~~A summary of the activity and related information of the restricted stock awards issued under the 2020 Plan is presented below:~~Units

The following table summarizes stock-based compensation expense for the Plans included in operating expenses for the periods presented (in thousands):

Stock-based compensation expense ~~recorded in operating expenses~~of approximately $3,000 and $27,000 was ~~as follows (in thousands):~~

~~Stock-based compensation amounts of$0.1 million were~~ capitalized to inventory and property and equipment during the three months ended June 30, 2022 and 2021, ~~and 2020.~~respectively. Stock-based compensation expense of ~~$0.1 million~~approximately $6,000 and ~~$0.2 million were~~$67,000 was capitalized to inventory and property and equipment during the six months ended June 30, 2022 and 2021, ~~and 2020,~~ respectively.

Unrecognized stock-based compensation expense ~~for stock options issued as of June 30, 2021 was $0.5 million~~by award type and the remaining weighted average recognition period over which such expense is expected to be recognized ~~over a weighted-average period of 2.0 years. Unrecognized compensation expense for the restricted stock units~~ as of June 30, ~~2021~~2022 was ~~$0.4 million and is expected to be recognized over a weighted-average period of 2.0 years. Unrecognized compensation expense for the restricted stock awards~~ as ~~of June 30, 2021 was $1.3 million and is expected to be recognized over a weighted-average period of 2.2 years.~~follows:

~~Legal~~—In the normal course of business, the Company is at times subject to pending and threatened legal actions. In management’s opinion, any potential loss resulting from the resolution of these matters will not have a material effect on the results of operations, financial position or cash flows of the Company.

the pending motion to dismiss ~~is scheduled~~without prejudice. On May 2, 2022, plaintiffs filed a motion for ~~October 12, 2021.~~ ~~Management intends to vigorously defend the Company against this lawsuit. At this time, the Company cannot predict how a court or jury will rule on the merits~~final approval of the ~~claims and/or~~settlement and plan of allocation, and lead counsel filed a motion for an award of attorneys’ fees and reimbursement of litigation expenses. On June 9, 2022, the ~~scope~~court entered an order continuing the hearing on final approval of the ~~potential loss in~~settlement from June 13, 2022 to August 15, 2022. Should the ~~event~~court not provide final approval of ~~an adverse outcome.~~the proposed settlement or if the proposed settlement otherwise does not become final, the parties will be returned to their litigation postures prior to the execution of the stipulation of settlement. Should the Company ultimately be found liable, the liability could have a material adverse effect on the Company’s financial condition and its results of operations for the period or periods in which itsuch determination is ~~incurred. The Company is unable to predict the ultimate outcome and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from any unfavorable outcome.~~ made.

On October 1, 2019, a shareholder derivative complaint captioned Noel Borg v. Dean Irwin, ~~et.~~et al (Civil Action no. 1:99-cm-09999) was filed in the ~~United States~~U.S. District Court for the District of Delaware against certain current and former officers and directors, purportedly on behalf of the Company, which is named as a nominal defendant in the action. The complaint alleges breaches of fiduciary duty, unjust enrichment, waste, and violations of Section 14(a) of the Securities Exchange Act of 1934. On October 21, 2019, pursuant to the parties’ stipulation, the court stayed the derivative lawsuit until the related class action is resolved. While the Company has obligations to indemnify and/or advance the defendants’ legal fees and costs in connection with this lawsuit, any monetary recovery from the defendants would be to the benefit of the Company. The Company is unable to predict the ultimate outcome and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from any unfavorable outcome.

~~Governmental Investigations~~Settlement Agreements with the Department of Justice and Participating States

As previously announced ~~in the Form 8-K filed~~ on August 12, 2019, the Audit Committee of Ra Medical’s Board of Directors (the “Audit Committee”) conducted an investigation of certain allegations raised by a former employee. The Company announced the Audit Committee’s findings in the Form 8-K filed on October 31, 2019. The primary investigative findings were: (i) the DABRA catheter frequently failed to calibrate and occasionally overheated, posing a risk of injury to physicians and patients; (ii) the Company’s explanations regarding its fourth quarter 2018 and first quarter 2019 sales created a risk of confusion because they did not explicitly reference inconsistent DABRA catheter performance and catheter failures; (iii) the Company failed to timely make at least two Medical Device Reports, or MDRs, to the FDA; (iv) the Company, out of a concern for the DABRA catheters’ performance, engaged in systematic efforts to replace product held by customers, which constituted product recalls, but were not documented as such, (v) the Company lack documentation of sufficient detail and specificity to support certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which could be perceived as an improper attempt to obtain business or to gain special advantage, (vi) while the indication for use in the 510(k) clearance the Company obtained for the DABRA system is not for atherectomy, the Company’s salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes, (vii) the Company’s determinations to direct potentially valuable benefits and opportunities to doctors were informed in part by sales prospects, and (viii) the Company received complaints regarding regulatory or compliance concerns that, because they implicated executive officers, should have been brought to the attention of the Board or the Audit Committee, but were not. ~~The Audit Committee, in reviewing the allegations, identified certain behavior inconsistent with the Company’s Code of Ethics and Conduct and related policies.~~

On December 28, 2020, the Company entered into a Settlement Agreement with the ~~United States of America,~~U.S., acting through the ~~DOJ~~Department of Justice and on behalf of the ~~OIG,~~Office of Inspector General, and other settlement agreements with certain state attorneys general to resolve ~~the pending DOJ investigation~~investigations and a related civil action concerning ~~our~~its marketing of the DABRA laser system and DABRA-related remuneration to certain physicians. In connection with the Settlement Agreement, the Company also has reached agreements with the participating states that resolve previously disclosed related investigations conducted by certain state attorneys general.

The Settlement Agreement recites that a complaint filed by a former employee on behalf of the federal government in the United States District Court for the Eastern District of Michigan, and subsequently amended to assert claims on behalf of certain states, alleged, among other things, that the Company violated the False Claims Act, 31 U.S.C. § 3729, and certain state false claims acts by paying kickbacks to certain physicians in order to induce them to use the DABRA laser system, promoting off-label use of the DABRA laser system, failing to report adverse eventsPursuant to the ~~United States Food and Drug Administration, marketing a device that does not work as advertised, and failing to adhere to Current Good Manufacturing Practices.~~ ~~The complaint, which was settled in connection with the Settlement Agreement, also alleged that we unlawfully retaliated against the former employee.~~ Separate from the former employee’s allegations in the civil action, the United States and the participating states contend that from May 1, 2017 through October 31, 2019, the Company (a) paid illegal remuneration to certain physicians to induce them to use the DABRA laser system in violationterms of the federal anti-kickback statute and (b) marketed the DABRA laser system for off-label use in atherectomy procedures despite product performance issues causing calibration and overheating problems, which posed a risk to physicians and patients (the “Covered Conduct”). The Company denies the allegations in the civil action and those asserted by the United States and the participating states, and the settlement does not constitute an admission of liability or wrongdoing by the Company.

~~Under~~ the Settlement Agreement and the agreements with the participating states, the Company is required to make an initial payment of $2.5 million, of which the Company paid $2.4 million in December 2020 and $0.1 million in April 2021. Pursuant to the terms of the Settlement Agreement, (a) if ~~its~~the Company’s revenue exceeds $10 million in any of ~~the next four~~ fiscal years ~~(2021-2024), it~~2021-2024, the Company also is required to pay ~~an additional amount in settlement~~ for the corresponding year: $500,000 for 2021, $750,000 for 2022, $1 million for 2023, and $1.25 million for 2024; (b) if itthe Company is acquired or is otherwise involved in a change in control transaction inbefore the ~~years 2020 through~~end of 2024, itthe Company is required to pay an additional settlement amount of $5 million, plus 4% of the value attributed to the Company in the transaction, so long as the attributed value is in excess of $100 million, with the total change in control payment never to exceed $28 million; and (c) if ~~its~~the Company’s obligations under the Settlement Agreement are avoided by bankruptcy, the ~~United States~~U.S. may rescind the releases and bring an action against the Company in which the Company agrees is not subject to an automatic stay, is not subject to any statute of limitations, estoppel or laches defense, and is a valid claim in the amount of $56 million, minus any prior change in control payments. ~~Under~~

In the ~~Settlement Agreement,~~normal course of business, the Company ~~also paid~~is at times subject to pending and threatened legal actions. In management’s opinion, any potential loss resulting from the ~~former employee’s reasonable expenses, costs~~resolution of these matters will not have a material effect on the results of operations, financial position or cash flows of the Company.

Note 13. Restructuring and ~~attorneys’ fees, which amount to $0.2 million.~~ ~~The Company has expensed $2.7 million during the year ended December 31, 2020 and all amounts have been paid.~~Impairment Charges

During the three months ended June 30, 2022, the Company incurred restructuring and impairment charges of approximately $3.5 million as set forth below:

The ~~OIG has agreed, conditioned upon full payment of amounts owed in the Settlement Agreement,~~RIF was effective on June 6, 2022 and ~~in consideration~~impacted approximately 65% of the Company’s ~~obligations under~~full-time employees, resulting in one-time severance payments of $0.6 million. Certain non-terminated employees were offered conditional retention arrangements for a ~~Corporate Integrity Agreement,~~period of approximately 60-120 days to ~~release its permissive exclusion rights~~allow for evaluation and ~~refrain from instituting any administrative action seeking to exclude it from participating in Medicare, Medicaid, or other federal health care programs as a result~~monitoring of the ~~Covered Conduct. The Corporate Integrity Agreement has a five-year term~~Company’s near-term personnel needs based in part on its financial status and ~~imposes monitoring, reporting, certification, documentation, oversight, screening, and training obligations on~~the board of directors’ review of strategic alternatives. In addition, the Company ~~including~~decided to discontinue enrollment of patients in its clinical trial, cease manufacturing activities, sell or dispose of substantially all of its property and equipment, inventories and research and development supplies, resulting in impairment and inventory obsolescence charges and the ~~hiring~~write-off of ~~a compliance officer~~research and ~~independent review organization.~~development supplies totaling $2.9 million.

~~Pursuant~~As of June 30, 2022, the accrued liability balance related to severance expense was $0.1 million and is included in accrued expenses in the accompanying condensed balance sheet at June 30, 2022. The Company expects to terminate certain employees who accepted retention arrangements under the RIF in August 2022, resulting in additional severance expense of approximately $0.2 million. The restructuring charges related to prepaid expenses are for supplies that would have been expensed when used for research and development.

As of the date of this filing, the terms of the ~~Settlement Agreement,~~Merger with Catheter Precision are under negotiation. The Company cannot provide any assurance that it will effect the ~~United States~~Merger or, even if it is able to consummate such a Merger, that the terms of any such Merger will be on the terms set forth in the Term Sheet or that the intended benefits of the Merger will be fully realized. The consummation of the Merger will also be subject to specified conditions precedent to closing that must be satisfied or waived, including certain conditions to closing that are subject to the approval or consent of third parties. The Company cannot provide any assurance that all of the conditions to closing will be satisfied or waived or that it will receive any of the required third party consents or approvals or be able to satisfy or waive all the conditions precedent to closing necessary to consummate the Merger. If the conditions precedent to closing are not satisfied or waived in a timely manner or at all, the Merger may not occur or may be delayed, and the ~~former employee have dismissed~~Company may lose some or all of the ~~complaint against~~intended benefits of the Merger with Catheter Precision.

On July 22, 2022, the Company ~~with prejudice~~reduced the exercise price of all outstanding warrants, consisting of Series A warrants and ~~have released~~Series B warrants, that were issued in the February 2022 public offering from $0.50 per share to $0.28 per share (the “Warrant Repricing”). Following the Warrant Repricing, the Company ~~from any civil or administrative monetary liability arising under~~entered into warrant inducement offer letters (the “Inducement Letters”) with certain investors to immediately exercise all of the ~~Covered Conduct. The Settlement Agreement does not include a release for any conduct other than the Covered Conduct or any criminal liability related~~Series A warrants and Series B warrants held by such investors. In response to the ~~Covered Conduct.~~Inducement Letters, investors exercised approximately 22.2 million Series A warrants and 0 Series B warrants. Investors who exercised their Series A warrants received Series C warrants to purchase 100% of the shares exercised pursuant to the Series A warrants with an exercise price of $0.28 and a term of five years. The ~~Settlement Agreement does~~Company received net proceeds of approximately $5.5 million, after issuance costs of approximately $0.7 million, from the exercises of the Series A warrants. The Series C warrants and the shares underlying the Series C warrants are unregistered and were issued in a private placement pursuant to Section 4(a)(2) of the Securities Act.

The Warrant Repricing resulted in an immediate and incremental increase of approximately $2.3 million in the estimated fair value of the Series A warrants and Series B warrants which will be reported in the statement of stockholders’ equity for the three months ended September 30, 2022. Based on the Black-Scholes model, the Company estimated the fair value of the Series C warrants issued to be approximately $2.3 million.

The Company may be obligated to pay a former placement agent Tail Fees on the proceeds received from the Series A warrant exercises and the issuance of the Series C warrants. As a result, the Company may be obligated to pay a cash fee of approximately $0.5 million and issue approximately 1.6 million warrants to purchase common stock at an exercise price of $0.35 per share which represents 125% of the exercise price of the Series C warrants. Such warrants were valued at approximately $0.2 million on the issuance date of the Series C warrants and would be immediately exercisable and expire five years from their issuance date. These warrants had not ~~release any claims under investigation~~been issued by the ~~SEC.~~Company as of the date of this filing.

~~As also previously announced, the Company voluntarily contacted the~~ ~~SEC’s~~ ~~Enforcement Division regarding the Audit Committee’s investigation. On November 13, 2019, the~~ ~~SEC~~ ~~notified the Company that it was conducting an investigation. The Company cooperated fully with the SEC in this investigation.~~ 510(k) Clearance

On ~~August 3, 2021~~July 5, 2022, the Company received ~~notice that the SEC has concluded~~U.S. Food and Drug Administration 510(k) clearance for its ~~investigation and does not intend to recommend an enforcement action by the SEC against the Company.~~

~~On November 21, 2019, the Company became aware that the Criminal Division, Fraud Section~~DABRA 2.0 catheter as part of the ~~DOJ has an open investigation related~~DABRA Excimer Laser System. This next-generation DABRA catheter features enhancements, including a braided over jacket design that’s intended to ~~the Company. At this time, it is unclear if the Company is~~improve deliverability and kink resistance when navigating tortuous anatomy, as well as a ~~target in this investigation.~~ ~~The Company has been, and intends to continue, cooperating with the DOJ in its~~ ~~active and ongoing~~ ~~investigation.~~ ~~The Company is unable to predict the ultimate outcome and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from any unfavorable outcome.~~

~~The Company has organized its business into 2 operating segments based on the product specialties: the vascular segment and the dermatology segment.~~

In deciding how to allocate resources and assess performance, the Company’s chief operating decision maker regularly evaluates the sales and gross profit of these segments. Amounts included within selling, general and administrative expense and research and development expense are not evaluated by the Company’s chief operating decision maker on a segmented basis.

Generally, all assets are common assets, except for lasers placed with customers, which are a subset of property and equipment. The net book value of the lasers in the vascular segment was $1.5 million and $1.9 million as of June 30, 2021 and December 31, 2020, respectively. The net book value of the lasers in the dermatology segment was $0.4 million and $0.7 million as of June 30, 2021 and December 31, 2020, respectively.

No sales to an individual customer or country other than the United States accounted for more than 10% of revenue for the three and six months ended June 30, 2021 and 2020. Net revenue, classified by the major geographic areas in which our customers are located, was as follows (in thousands):

~~On August 3, 2021 the Company received notice that the SEC has concluded its investigation and does not intend to recommend an enforcement action by the SEC against the Company.~~

Between July 1, 2021 and August 2, 2021, the Company completed “at the market offerings” of 1,139,306 shares of common stock and received approximately $4.4 million in net proceeds, after deducting placement agent’s fees.

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available. This section should be read in conjunction with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report. The statements contained in this Quarterly Report ~~on Form 10-Q~~ that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

Forward-looking statements can be identified by words such as “believe,” “anticipate,” “may,” “might,” “can,” “could,” “continue,” “depends,” “expect,” “expand,” “forecast,” “intend,” “predict,” “plan,” “rely,” “should,” “will,” “may,” “seek,” or the negative of these terms or and other similar expressions, although not all forward-looking statements contain these words. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements.

These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including, but not limited to, those described in ~~“Risk Factors”~~Risk Factors. These forward-looking statements reflect our beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report ~~on Form 10-Q~~ and are subject to risks and uncertainties. We discuss many of these risks in greater detail in the section entitled “Risk Factors” included in Part II, Item 1A and elsewhere in this Quarterly ~~Report on Form 10-Q.~~Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We qualify all of the forward-looking statements in this Quarterly Report ~~on Form 10-Q~~ by these cautionary statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events or otherwise.

This Quarterly Report ~~on Form 10-Q~~ also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

References to “we”, “us”, “our”, “Ra” and “the Company” refer to Ra Medical Systems, Inc.

Ra Medical Systems, Inc. is a ~~commercial-stage~~ medical device company ~~leveraging our~~that owns intellectual property related to an advanced excimer laser-based platform for use in the treatment of vascular ~~and dermatological~~ immune-mediated inflammatory diseases. We believe our products enhance patients’ quality of life by restoring ~~blood-flow~~blood flow in ~~arteries and clearing chronic skin conditions.~~arteries.

The DABRA laser and single-use catheter, together referred to as the DABRA Excimer Laser System, or DABRA, is used as a tool in the treatment of peripheral artery disease, or PAD, which commonly occurs in the legs. DABRA is cleared by the U.S. Food and Drug Administration, or FDA, as a device for crossing chronic total occlusions ~~or CTOs,~~ in patients with symptomatic infrainguinal lower extremity vascular disease and with an intended use for ablating a channel in occlusive peripheral vascular disease. DABRA was also granted CE mark approval in Europe in September 2016 for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions.

Our ~~vascular~~ business strategy ishas been focused on ~~multiple engineering efforts to improve~~improving our catheter offering and exploring new markets, as well as conducting a clinical study to obtain an atherectomy “indication for use” in the United States. ~~Key~~

We previously disclosed that our board of directors was reviewing strategic alternatives with the goal of maximizing shareholder value. This review was triggered by the deteriorating macroeconomic environment and concerns regarding our ability to continue funding our clinical and engineering programs at levels consistent with the past few years. In conjunction with this review, on June 3, 2022, the board of directors approved a reduction in force, or RIF, under which approximately 65%

of our full-time employees were terminated, effective June 6, 2022, and provided one-time severance payments of $0.6 million. Non-terminated employees were offered conditional retention arrangements for a period of approximately 60-120 days to allow for evaluation and monitoring of our near-term personnel needs based in part on our financial status and the board of directors’ review of strategic alternatives. The purpose of the RIF was to preserve capital with the goal of maximizing the opportunities available to us during the board of directors’ review of strategic alternatives.

As a result of the RIF and the board of directors’ review of strategic alternatives, we have paused all engineering activities, including the development of a version of the DABRA catheter ~~engineering efforts~~that is compatible with a standard interventional guidewire as well as research to prove the feasibility of using a DABRA-derived catheter technology to fracture calcium in arteries in a procedure known as lithotripsy. On July 5, 2022, we announced the receipt of FDA 510(k) clearance for the DABRA 2.0 catheter as part of the DABRA Excimer Laser System. This catheter includes a braided over jacket to make the catheter more robust and more kink-resistant when navigating tortuous anatomy. This catheter also has a six-month shelf life as a result of multiple design and manufacturing remediations implemented to address prior limitations. We currently ~~underway include projects to:~~have no plans to commercialize the DABRA 2.0.

As stated, we are currently pursuing an atherectomy indication for use, which the FDA defines to include a prespecified improvement in luminal patency. ~~To satisfy the FDA’s data requirements to support an atherectomy indication, we are performing a pivotal study designed to allow the FDA to evaluate the use of DABRA in atherectomy procedures.~~ We received an Investigational Device Exemption, or IDE, approval in January 2020, and the study iswas approved for up to 10 clinical sites and 100 subjects. In January 2022, primarily due to subject fallout for follow-up visits due to COVID-19, we filed a protocol amendment with the FDA to add up to an additional 25 subjects to the study. The protocol amendment was approved by the FDA in February 2022, raising the enrollment limit from a maximum of 100 subjects to 125 subjects.

We enrolled the first subject in the atherectomy clinical study in February 2020. Throughout much of ~~2020~~2021 and ~~2021,~~2020, the COVID-19 pandemic substantially impacted our ability to activate new sites and enroll additional subjects. Many sites or potential sites have been or are currently operating at a reduced capacity, and some have been closed from time to time. ~~In addition, potential~~

On June 6, 2022, we made the decision to stop enrollment at 108 subjects in the atherectomy clinical study, ~~subjects may voluntarily opt to postpone their procedures due to COVID-19 concerns. As of August 2, 2021,~~and we believe we have ~~enrolled 69 subjects. Four sites are currently cleared~~enough subjects to ~~enroll subjects and~~eventually satisfy the ~~fifth site, previously cleared, has moved locations and is in the process of being reactivated. Due~~FDA’s data requirements to ~~the unpredictable impact~~support an atherectomy indication. Although the COVID-19 pandemic has had and will continue to have an unpredictable impact on ~~enrollment~~subject follow-up in this study, we currently aim to complete the six-month follow-up in early 2023.

As a result of discontinuing enrollment in the clinical study, the previously discussed RIF and the board of directors’ ongoing review of strategic alternatives, we have ceased manufacturing activities and are no longer supplying catheters to any sites.

On June 18, 2022, we signed a non-binding summary of proposed terms, or the Term Sheet, with Catheter Precision, Inc., or Catheter Precision, to acquire 100% of the outstanding equity interests of Catheter Precision, or the Merger. Pursuant to the Term Sheet, we would acquire Catheter Precision in exchange for shares of the Company. The Merger would give our shareholders exposure to Catheter Precision’s innovative devices that are designed to improve treatment of cardiac arrhythmias, while allowing the combined company the ability to explore funding its strategic initiatives for the Catheter Precision devices through the public capital markets.

As of the date of this Quarterly Report, the terms of the Merger with Catheter Precision are under negotiation. We cannot ~~estimate when enrollment~~provide any assurance that we will effect the Merger or, if we are able to consummate such a Merger, that the terms of any such Merger will be ~~completed.~~on the terms set forth in the Term Sheet or that the intended benefits of the Merger will be fully realized. The consummation of the Merger will also be subject to specified conditions precedent to closing that must be satisfied or waived, including certain conditions to closing that are subject to the approval or consent of third parties. We cannot provide any assurance that all of the conditions to closing will be satisfied or waived or that we will receive any of the third party consents or approvals or be able to satisfy or waive all the conditions precedent to closing necessary to consummate the Merger. If the conditions precedent to closing are not satisfied or waived in a timely manner or at all, the Merger may not occur or may be delayed, and we may lose some or all of the intended benefits of the Merger with Catheter Precision.

Although consummating the Merger with Catheter Precision is our strategic priority, our board of directors continues to review strategic alternatives that could result in changes to our business strategy and future operations with a goal of maximizing shareholder value.

We cannot provide any commitment as to the timing of our determination or the strategy we may adopt if we are ~~continuing~~unable to ~~supply catheters~~consummate the Merger and may be required to ~~those sites involved~~dissolve the Company or pursue other strategic transactions. Because of the

significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our ~~atherectomy clinical study.~~business strategy and future funding requirements.

On July 22, 2022, we reduced the exercise price of all outstanding warrants, consisting of Series A and Series B warrants that were issued in the February 2022 public offering, from $0.50 per share to $0.28 per share, or the Warrant Repricing. Following the Warrant Repricing, we entered into warrant inducement offer letters, or the Inducement Letters, with certain investors to immediately exercise all of the Series A and Series B warrants held by such investors. In response to the Inducement Letters, investors exercised approximately 22.2 million Series A warrants and no Series B warrants. Investors who exercised their Series A warrants received Series C warrants to purchase 100% of the shares exercised pursuant to the Series A warrants with an exercise price of $0.28 per share and a term of five years. We ~~paused shipments~~received net proceeds of ~~catheters~~approximately $5.5 million, after issuance costs of $0.7 million, from the exercises of the Series A warrants. The Series C warrants and the shares underlying the Series C warrants are unregistered and were issued in a private placement pursuant to ~~commercial sites while we conducted further studies~~Section 4(a)(2) of the Securities Act of 1933, or the Securities Act.

The Warrant Repricing resulted in an immediate and incremental increase of approximately $2.3 million in the estimated fair value of the Series A warrants and Series B warrants. Based on the ~~stability~~Black-Scholes valuation model, we estimated the fair value of ~~our shelf life.~~ the Series C warrants issued to be approximately $2.3 million.

We ~~submitted additional test data with respect~~may be obligated to pay a former placement agent tail fees on the proceeds received from the Series A warrant exercises and the issuance of the Series C warrants. The tail fees are comprised of cash tail fees equal to 7.5% cash compensation for the gross proceeds raised in the exercises of the Series A warrants in response to the ~~DABRA catheter shelf life in a traditional 510(k) in March 2021, which was cleared~~Inducement Letters and the issuance of warrants equal to 7% of the number of shares of common stock issued, or the Tail Fees, to any investor contacted by the ~~FDA~~former placement agent during the term of its engagement with us. Therefore, the Tail Fees we may be obligated to pay related to the exercises of the Series A warrants in ~~July 2021. Although eligible,~~response to the Inducement Letters are comprised of a cash fee of approximately $0.5 million and the issuance of approximately 1.6 million warrants to purchase common stock at an exercise price of $0.35 per share which represents 125% of the exercise price of the Series C warrants. The warrants were valued at approximately $0.2 million on the issuance date of the Series C warrants and would be immediately exercisable and expire five years from their issuance date. These warrants had not been issued by the Company as of the date of this Quarterly Report.

As of the date of this Quarterly Report, we ~~have not resumed commercial shipments and are evaluating~~concluded that there is substantial doubt regarding our ~~commercial catheter strategy.~~

~~Our Pharos laser is a medical device that we have marketed since October 2004~~ability to continue as a ~~tool~~going concern for the ~~treatment~~twelve months from the date of ~~proliferative skin conditions including psoriasis, vitiligo, atopic dermatitis,~~filing of this Quarterly Report. Substantial doubt about a company’s ability to continue as a going concern is generally viewed unfavorably by current and ~~leukoderma. The COVID-19 pandemic~~prospective investors, as well as by analysts and creditors and potential strategic partners. As a result, it may be more difficult for us to consummate any strategic transactions and/or raise the additional financing necessary to continue to operate our business. If the Merger is ~~negatively impacting~~not consummated, we may be forced to refocus or rebuild around a different core or strategic technology, consummate another strategic transaction or be required to liquidate our assets and dissolve the dermatology business as many customers delay the acquisition or purchase of capital equipment such as our PHAROS laser. Because this business does not have a disposables component and we augment our capital equipment sales with recurring revenue derived from service and/or rental or lease agreements, we are experiencing less of an impact than business models that rely solely on capital equipment and/or disposables sales. We are evaluating multiple strategic options for the dermatology business, including, but not limited to, investments in the commercial organization, additional improvements to the Pharos laser system, commercial partnerships and alliances, or a divestiture of the business.Company.

The global ~~spread~~effects of ~~the novel coronavirus (COVID-19) has~~COVID-19 have created significant volatility, uncertainty and economic disruption. ~~The~~Although restrictions have been recently eased around the world, the COVID-19 pandemic is still ongoing, and the ultimate effects of ~~the~~ COVID-19 on our business, operations and financial condition are unknown at this time. ~~In the near term, we~~We expect that ~~our revenue will continue to be adversely impacted and enrollment~~patient follow-up in our atherectomy clinical trial will continue to be ~~delayed or slowed,~~affected by the uncertainty relating to COVID-19, as patients may continue to elect to postpone ~~voluntary treatments~~follow-up visits and physicians’ offices ~~are either closed~~may intermittently close or ~~operating~~operate at a reduced ~~capacity. In addition, some customers are requesting more flexible payment terms on a temporary basis. We also may not be able~~capacity in response to secure additional financing in a timely manner or on favorable terms, if at all. Our manufacturing facility located in Carlsbad, California is currently operational. We have experienced delays in receiving shipments of certain parts, which has affected the timing of our key engineering efforts. To date, the shipment delays have not had a material impact on our ability to support our atherectomy indication trial.COVID-19. However, the extent to which COVID-19 impacts our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain it or treat its impact, among others.

Product sales consist of the ~~sale of Pharos lasers, the sale~~sales of catheters for use with the DABRA ~~laser and the sale of consumables and replacement parts. The Company’s vascular segment is~~laser. We are currently not selling commercial product and isare only selling catheters for use in ~~the Company’s~~our atherectomy clinical trial.

Service and other revenue consists primarily of sales of extended warranties, which we recognize over the contract period and billable services, including repair activity, which is recognized when the service is provided. It also includes revenue from the rental of our lasers.

We currently use our commercial team to service the U.S. dermatology market, and we utilize distributors outside the U.S. in markets where we have received regulatory approval. We expect to continue to seek regulatory approvals for our products in additional strategic markets.

Cost of revenue for product sales consists primarily of costs of components for use in our products, the labor that ~~are~~is used to produce our products, and the manufacturing overhead that support production.

Cost of revenue for service and other ~~includes the cost~~consists primarily of ~~maintaining and servicing the warranties on our products, including the~~ depreciation on the lasers we own.

~~We expect cost of revenue to increase to the extent our total revenue grows.~~

~~We calculate gross profit (loss) as revenue less cost of revenue. Our gross profit (loss) has been~~Selling, General and will continue to be affected by a variety of factors, primarily production volumes, the cost of direct materials, discounting practices, manufacturing costs, product yields, headcount and cost-reduction strategies. Our gross loss would be reduced if our production volume increased and certain costs remain fixed or increased at a slower rate. We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing processes, which we believe will reduce costs.

~~Research and development, or R&D, expenses consist of applicable personnel, clinical trial expenses, materials and consulting. R&D expenses include:~~

We expense R&D costs as incurred. In the future, we expect R&D expenses to increase if we continue to develop new products, enhance existing products and technologies or perform activities related to obtaining additional regulatory approval. However, we expect R&D expenses as a percentage of total expenses to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trials and studies and other related activities.

Selling, general and administrative, or SG&A, expenses primarily consist of employee-related expenses, including salaries, benefits ~~travel expense, sales commissions~~ and stock-based compensation expense. Other SG&A expenses ~~primarily~~ include professional services fees, including legal, audit and tax fees, insurance costs, general corporate expenses ~~facilities-related~~and facility related expenses.

Research and development, or R&D, expenses primarily consist of employee-related expenses, including salaries, benefits and ~~shipping~~stock-based compensation expense. Other R&D expenses include the cost of clinical studies and ~~handling costs. We expect continued legal costs associated~~trials, supplies used for internal R&D and clinical activities and the cost of outside consultants who assist with ~~ongoing litigation~~technology development and ~~government investigation.~~clinical affairs.

The following table ~~shows~~sets forth our results of continuing operations for the periods presented (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

Change $

2021

2020

Change $

Statements of operations data:

Net revenue

Product sales

$
318

$
154

$
164

$
724

$
740

$
(16
)
Service and other

687

746

(59
)

1,399

1,534

(135
)
Total net revenue

1,005

900

105

2,123

2,274

(151
)
Cost of revenue

Product

861

624

237

1,651

1,588

63

Service and other

627

543

84

1,210

1,163

47

Total cost of revenue

1,488

1,167

321

2,861

2,751

110

Gross loss

(483
)

(267
)

(216
)

(738
)

(477
)

(261
)
Operating expenses:

Selling, general and administrative

3,741

7,896

(4,155
)

7,855

14,181

(6,326
)
Research and development

3,018

1,953

1,065

5,834

3,248

2,586

Total operating expenses

6,759

9,849

(3,090
)

13,689

17,429

(3,740
)
Operating loss

(7,242
)

(10,116
)

2,874

(14,427
)

(17,906
)

3,479

Other income (expense), net

1,993

(5
)

1,998

1,942

84

1,858

Loss before income taxes

(5,249
)

(10,121
)

4,872

(12,485
)

(17,822
)

5,337

Income tax expense

—

—

—

—

—

—

Net loss

$
(5,249
)

$
(10,121
)

$
4,872

$
(12,485
)

$
(17,822
)

$
5,337

	Three Months Ended June 30,							Six Months Ended June 30,
	2022		2021		Change			2022		2021		Change
Net revenue	$	5	$	9	$	(4	)	$	14	$	13	$	1
Cost of revenue		66		520		(454	)		161		967		(806	)
Selling, general and administrative expenses		2,476		3,398		(922	)		4,778		7,075		(2,297	)
Research and development expenses		2,396		2,829		(433	)		5,511		5,579		(68	)
Restructuring and impairment charges		3,527		—		3,527			3,527		—		3,527
Other income, net		12		2,019		(2,007	)		20		2,012		(1,992	)

We organize our business into two operating segments based on the product specialties: the vascular segment and the dermatology segment. In deciding how to allocate resources and assess performance, we regularly evaluate the net revenue and gross profit (loss) of these segments. Amounts included within selling, general and administrative expense and research and development expense are not evaluated by us on a segmented basis. Additional information on our reportable segments is contained in Note 14 to the interim condensed financial statements included in Part I, Item 1 in this Quarterly Report on Form 10-Q.

~~The following table shows our net revenue from our two segments (in thousands):~~

Net revenue was $9,000 and $0.1 million for the three months ended June 30, 2021 and 2020, respectively. The $0.1 million decrease was due to decreased catheter unit sales as a result of pausing commercial shipments in 2021 while we conducted further studies on the stability of the catheter’s shelf life. However, we continue to supply catheters to clinical trial sites.Revenue

Net revenue was ~~$13,000 and $0.2 million~~relatively flat for the three and six months ended June 30, ~~2021 and 2020, respectively. The $0.2 million decrease was due~~2022 as compared to ~~decreased catheter unit sales as a result of pausing commercial shipments~~the corresponding periods in ~~2021~~ ~~while~~the prior year since we ~~conducted further studies on the stability of the catheter’s shelf life. However, we continue to supply~~ were only selling catheters to clinical trial ~~sites.~~

~~We do not expect our net revenue to increase in the near term~~sites while we ~~supply catheters only to a limited number of U.S. accounts involved in,~~focused our ~~atherectomy clinical study and as we focus~~efforts on remedying the inconsistencies in our DABRA catheter performance and obtaining an atherectomy indication. ~~In addition, we expect net~~

The decreases in cost of revenue ~~to continue to be negatively impacted by~~of $0.5 million and $0.8 million for the ~~COVID-19 pandemic,~~three and six months ended June 30, 2022, respectively, as ~~patients elect to postpone voluntary treatments and physicians’ offices are either closed or operating at a reduced capacity. Over the longer term, we believe that we will be able to increase our vascular revenue if we can extend the catheter’s shelf life, introduce design changes~~compared to the ~~catheter~~corresponding periods in the prior year were primarily due to decreases in labor and ~~obtain an atherectomy indication.~~overhead costs as a result of certain cost savings initiatives implemented in mid-2021, including a reduction in headcount, and the Company directing its resources to focus on engineering efforts and clinical trial initiatives.

~~Net revenue was $1.0 million and $0.8~~The decrease in SG&A expenses of $0.9 million for the three months ended June 30, ~~2021 and 2020, respectively. The increase~~2022 as compared to the corresponding period in the prior year was due to decreases of ~~approximately~~$0.5 million in stock-based compensation expense, $0.1 million in legal expenses, $0.2 million ~~was due primarily to an increase~~ in ~~direct unit product sales.~~personnel expenses and $0.1 million in other costs.

~~Net revenue was $2.1~~The decrease in SG&A expenses of $2.3 million for ~~each of~~ the six months ended June 30, ~~2021~~2022 as compared to the corresponding period in the prior year was due to decreases of $1.3 million in stock-based compensation expense, $0.9 million in legal expenses, $0.4 million in personnel expenses and ~~2020.~~ $0.2 million in other costs, partially offset by a decrease in gain on sale of assets of $0.5 million.

~~We expect net revenue to continue to be negatively impacted by the COVID-19 pandemic,~~ ~~as patients elect to postpone voluntary treatments~~Research and ~~physicians’ offices are either closed or operating at a reduced capacity~~.

The ~~following table shows our cost~~decrease in R&D expenses of ~~revenue from our two segments (in thousands):~~

~~Cost of revenue was $0.5 million and~~ $0.4 million for the three months ended June 30, ~~2021 and 2020, respectively. The increase of $49,000~~2022 as compared to the corresponding period in the prior year was primarily due to ~~increased costs~~the decrease in personnel and consulting expenses of ~~repairs~~$0.5 million

due to the decrease in research and ~~maintenance of catheter manufacturing equipment.~~

~~Cost of revenue was $0.9 million and $1.1 million for the six months ended June 30, 2021 and 2020, respectively. The $0.2 million decrease was due~~ ~~to decrease in~~ ~~catheter unit sales, partially offset by increased costs of repairs and maintenance of catheter manufacturing equipment.~~

~~Cost of revenue was $1.0 million and $0.8 million for~~development activity during the three months ended June 30, ~~2021 and 2020, respectively. The increase of approximately $0.3 million was primarily due~~2022 as compared to ~~an increase in direct unit product sales and an increase~~the corresponding period in the ~~number of service calls and travel.~~

Cost of revenue was $2.0 million and $1.7 million for the six months ended June 30, 2021 and 2020, respectively. The increase of approximately $0.3 million was primarily due to an increase in direct unit product sales and an increase in the number of service calls and travel.prior year.

The ~~following table shows our gross profit (loss) from our two segments (in thousands):~~

Gross loss was $0.5 million and $0.3 million for the three months ended June 30, 2021 and 2020, respectively. The $0.2 million increase in gross loss was primarily due to decreased unit sales and increased costs of repairs and maintenance of catheter manufacturing equipment.

~~Gross loss was $0.9 million for each ofthe six months ended June 30, 2021 and 2020.~~

We expect our gross loss to be negatively impacted in the short term while we supply catheters only to a limited number of U.S. accounts involved in our atherectomy clinical study and as we continue efforts to remedy the ~~inconsistencies in our DABRA catheter performance~~. ~~In addition, we expect the gross loss to continue to be negatively impacted by the COVID-19 pandemic,~~ ~~as patients elect to postpone voluntary treatments and physicians’ offices are either closed or operating at a reduced capacity~~.

Gross loss was $26,000 for the three months ended June 30, 2021 compared to gross profit $0.1 million for the three months ended June 30, 2020. The decrease of $0.1 million was primarily due to an increase in service costs as a result of an increase in service calls and travel.

~~Gross profit was $0.1 million and $0.4 million for the six months ended June 30, 2021 and 2020, respectively. The decrease of $0.3 million was primarily due to increased~~ ~~overhead as we are operating under capacity~~ ~~and increase in service costs as a result of an increase in service calls and travel.~~

We expect the gross profit to continue to be negatively impacted by the COVID-19 pandemic, as patients elect to postpone voluntary treatments and physicians’ offices are either closed or operating at a reduced capacity.

~~SG&A expenses were $3.7 million and $7.9 million for the three months ended June 30, 2021 and 2020, respectively. The $4.2 million decrease was primarily related to decreases of (i)~~ ~~$2.6 million in legal expense due to a~~ decrease in ~~legal services and legal settlement expenses,~~ ~~(ii) $0.7 million in salary, benefits, recruiting expenses and other personnel-related costs~~ ~~primarily due to continued cost reduction efforts, (iii~~) $0.3 million in insurance expenses due to a reduction in premiums, (iv) $0.3 million in stock-based compensation expense, (v) $0.2 million in public company expenses, (vi) $0.3 million in in other costs including sales related costs, travel and trade shows, marketing, and provisions for doubtful accounts, partially offset by a $0.2 million increase in consulting and professional expenses.

~~SG&A expenses were $7.9 million and $14.2 million for the six months ended June 30, 2021 and 2020, respectively. The $6.3 million decrease was~~ ~~to primarily related to decreases of (i)~~ ~~$3.6 million in legal expense due to a decrease in legal services and legal settlement expenses,~~ ~~(ii) $1.0 million in salary, benefits, recruiting expenses and other personnel-related costs primarily due to continued cost reduction efforts,~~ ~~(iii)~~ ~~$0.6~~ ~~in insurance expenses due to a reduction in premiums, (iv)~~ ~~$0.5 million due to gain on sale of vehicles that were purchased for the sales force to transport our laser equipment, (v) $0.4 million in public company expenses,~~ ~~(vi) $0.3 million in sales related costs, travel, trade shows and marketing costs~~, ~~(vii) $0.4 million in other costs including provisions for doubtful accounts, (viii) $0.2 million in stock-based compensation expense, partially~~ ~~offset by a $0.6 million increase in consulting and professional expenses.~~

R&D expenses ~~were $3.0 million and $2.0 million for the three months ended June 30, 2021 and 2020, respectively. The $1.0 million increase was due to increases~~ of $0.6 million in personnel and consulting expenses, $0.3 million in supplies, and $0.1 in clinical study and other expenses. These increases are due to engineering efforts on our next-generation catheters, including increased shelf life and improved deliverability, and also progress on the atherectomy clinical study.

R&D expenses were $5.8 million and $3.2 million for the six months ended June 30, 2021 and 2020, respectively. The $2.6 million increase was primarily due to increases of $1.2 million in personnel and consulting expenses, $1.1 million in supplies, $0.1 million in clinical study expenses, $0.1 million in other expenses, and $0.1 million in stock-based compensation expense. ~~These increases are due to engineering efforts on our next-generation catheters, including increased shelf life and improved deliverability, and also progress on the atherectomy clinical study.~~

Other income, net was $2.0 million for the three months ended June 30, 2021 and de minimis for the three months ended June 30, 2020, respectively. The increase of $2.0 million is due to the gain on forgiveness of the PPP loan.

~~Other income, net was $2.0 million and~~ $0.1 million for the six months ended June 30, ~~2021 and 2020, respectively. The increase of $1.9 million is~~2022 as compared to the corresponding period in the prior year was primarily due to decreases of $0.5 million in personnel costs and $0.2 million in stock-based compensation expense, partially offset by increases of $0.2 million in R&D supplies, $0.2 million in clinical study expenses and $0.2 million in other expenses due to engineering efforts on our next-generation catheters and progress on the atherectomy clinical study.

Restructuring and impairment charges of $3.5 million for the three and six months ended June 30, 2022 represent the expenses incurred in June 2022 due to the RIF, resulting in one-time severance payments, and our decision to discontinue enrollment of patients in our clinical trial, cease manufacturing activities, sell or dispose of substantially all of our property and equipment, inventories and R&D supplies, resulting in impairment of property and equipment, inventory obsolescence charges and the write-off of R&D supplies.

The decrease in other income, net of $2.0 million ~~gain from~~for the three and six months ended June 30, 2022 as compared to the corresponding periods in the prior year was primarily due to the forgiveness of the ~~PPP loan, offset by $0.1 million~~ ~~decrease~~Paycheck Protection Plan promissory note in ~~interest expense related to the significant financing component for multi-year warranty service contracts.~~ 2021.

EBITDA and Adjusted EBITDA are performance measures that provide supplemental information we believe is useful to analysts and investors to evaluate our ongoing results of operations, when considered alongside other GAAP measures. These non-GAAP ~~Measures~~measures exclude the financial impact of items management does not consider in assessing our ongoing operating performance, and thereby facilitate review of our operating performance on a period-to-period basis.

We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with ~~U.S.~~ GAAP. Some of these limitations are that:

In addition, other companies, including companies in our industry, may calculate ~~similarly-titled~~similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison.

A reconciliation for each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with ~~U.S.~~ GAAP is included below. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business. We define Adjusted EBITDA as our GAAP ~~net~~ loss from continuing operations as adjusted to exclude depreciation and amortization, interest income, interest expense, income tax expense, stock-based compensation, gain on ~~sale~~extinguishment of promissory note, restructuring and impairment charges and loss (gain) on sales and disposals of property and ~~equipment and gain on extinguishment of debt.~~equipment.

The following is a reconciliation of ~~Net~~ loss from continuing operations to Adjusted ~~EBITDA:~~EBITDA (in thousands):

	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended June 30,						Six Months Ended June 30,
	2021			2020			2021			2020			2022			2021			2022			2021
Statement of Operations Data:
Net loss	$	(5,249	)	$	(10,121	)	$	(12,485	)	$	(17,822	)
Loss from continuing operations													$	(8,448	)	$	(4,719	)	$	(13,943	)	$	(11,596	)
Depreciation and amortization		426			636			881			1,214			136			321			322			655
Interest income		(1	)		(10	)		(2	)		(124	)		(16	)		(18	)		(17	)		(19	)
Interest expense		31			15			83			40			—			(1	)		—			7
Income tax expense		—			—			—			—
EBITDA		(4,793	)		(9,480	)		(11,523	)		(16,692	)		(8,328	)		(4,417	)		(13,638	)		(10,953	)
Stock-based compensation		696			1,033			1,865			2,080			123			625			285			1,697
Gain on extinguishment of PPP promissory note		(2,023	)		—			(2,023	)		—
Loss (gain) on sale of property and equipment		8			—			(493	)		—
Restructuring and impairment														3,527			—			3,527			—
Loss (gain) on sales and disposals of property and equipment														8			8			44			(493	)
Gain on extinguishment of promissory note														—			(2,023	)		—			(2,023	)
Adjusted EBITDA	$	(6,112	)	$	(8,447	)	$	(12,174	)	$	(14,612	)	$	(4,670	)	$	(5,807	)	$	(9,782	)	$	(11,772	)

The decreases in negative Adjusted EBITDA ~~was negative $6.1~~of $1.1 million ~~compared to negative $8.4~~and $2.0 million for the three ~~months ended June 30, 2021~~ and ~~2020, respectively~~ ~~and a negative $12.2 million compared to a negative $14.6 million for the~~ six months ended June 30, ~~2021~~2022, respectively, as compared to the corresponding periods in the prior year were primarily due to the decreases in SG&A expenses due to lower legal expenses related to the securities litigation and ~~2020, respectively.~~ ~~The change in Adjusted EBITDA primarily reflects decreased selling, general~~prior investigation and ~~administrative costs, including legal expense. The decreased costs were partially offset by an increase in research and development.~~lower personnel expenses.

As of June 30, ~~2021,~~2022, we had cash and cash equivalents of ~~$20.2 million and accumulated deficit of $165.7~~$11.1 million. Our primary sources of capital have been from the sale of our products and services, the net proceeds of $67.3 million from our initial public offering, the net proceeds of $19.1 million from our 2020 public offerings, $11.0 million proceeds, net of placement agent fees, received from our “at the market” offering, $2.0 million received in the form of a Paycheck Protection Program loan under the CARES Act and, to a lesser extent, private placements of common stock and equipment financing arrangements.

~~Management expects operating losses and negative cash flows to continue for the foreseeable future with our reduced commercial footprint, and as we~~We will continue to ~~incur~~monitor our operating costs ~~related~~and seek to our atherectomy clinical trial, engineering efforts to improve the shelf life of our catheters, development of our next generation products and legal costs associated with ongoing litigation. We also expect the COVID-19 pandemic to have a continued negative impact on our revenue and the timing of enrollment in our atherectomy clinical trial as well as our ability to secure additional financing in a timely manner or on favorable terms, if at all. In the third quarter of 2019, we began implementing certain operational efficiency and cost savings initiatives intended to align our resources with our product strategy, reduce our operating expenses, and manage our cash flows. These cost efficiency initiatives included targeted workforce reductions of our sales and marketing teams. We continue to analyze opportunities for cost reductions. In addition, we may need to decrease or defer capital expenditures and development activities to further optimize our operations.current liabilities. Such ~~measures~~actions may impair our ability to ~~invest~~proceed with certain strategic activities, and we may be unsuccessful at negotiating existing liabilities, including our operating lease liability, to our benefit. If these efforts are unsuccessful or the Merger is not completed, our cash position could be negatively impacted and we may, among other things, be required to seek other sources of financing, consummate another strategic transaction or be required to liquidate our assets and dissolve the Company. Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in ~~developing, marketing~~our business strategy and ~~selling new~~future funding requirements.

Management believes that, based on the Company’s liquidity resources and ~~existing products.~~

Asthe significant uncertainty regarding its future plans, there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. The Company’s independent registered public ~~company, we incur and will~~accounting firm expressed substantial doubt regarding the Company’s ability to continue ~~to incur significant legal, accounting, insurance, and other expenses. We expect legal and related expenses to remain high~~as a going concern in its report on the ~~near term in connection with the legal proceedings discussed in~~ ~~Note 13, "Commitments and Contingencies," in the notes to the condensed~~Company’s financial statements. as of and for the year ended December 31, 2021.

Although we ~~bolstered~~improved our liquidity resources through a private placement in ~~2020 and 2021, have an effective shelf registration statement and an “at the market” offering to allow us to raise additional capital when the opportunities permit,~~July 2022, resulting in net proceeds of $5.5 million and may receive additional funds from the exercise of ~~our~~its warrants depending on market conditions, management has concluded that the aforementioned conditions, including the ongoing uncertainty related to the negative impacts of the COVID-19 pandemic, continue to raise substantial doubt about ~~our~~the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. ~~We plan~~Management plans to address this uncertainty by raising additional funds, if necessary, through public or private equity or debt financings as well as by engaging in regular and ongoing reviews of ~~our business model and~~its strategic options to help ensure that ~~we are~~the Company is focusing ~~our~~its cash resources on advancing ~~our~~its key corporate initiatives. However, wethe Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if ~~we issue~~the Company issues equity securities to raise additional funds, ~~our~~its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of ~~our~~the Company’s existing stockholders.

Our condensed financial statements include explanatory disclosures regarding substantial doubt about our ability to continue as a going concern. Future reports on our financial statements may also include explanatory disclosures with respectFurther, SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our ~~ability~~effective shelf registration statement on Form S-3. We are currently subject to ~~continue~~General Instruction I.B.6 to Form S-3, or the Baby Shelf Rule, and the amount of funds we can raise through primary public offerings of securities in any 12-month period using our registration statement on Form S-3 is limited to one-third of the aggregate market value of the voting and non-voting common equity held by non-affiliates. We are currently limited by the Baby Shelf Rule as ~~a going concern. Our condensed financial statements do not include any adjustments relating to~~of the ~~recoverability~~filing of this Quarterly Report, until such time as our public float exceeds $75 million.

The following information reflects cash flows for continuing operations and ~~classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.~~

Net cash used in operating activities ~~was~~of $14.6 million for the six months ended June 30, 2022 consisted of a net loss of $13.9 million and non-cash adjustments of $3.6 million, consisting primarily of non-cash restructuring and impairment charges of $2.9 million and stock-based compensation and depreciation and amortization of $0.3 million each. In addition, we experienced changes in operating assets and liabilities of $4.3 million.

Net cash used in operating activities of $14.7 million for the six months ended June 30, 2021 ~~consisting~~consisted of a net loss of $12.5 million and ~~an increase~~non-cash adjustments of $0.2 million, consisting of gain on extinguishment of promissory note of $2.0 million, stock-based compensation of $1.9 million, depreciation and amortization of $0.9 million and gain on sale of property and equipment of $0.5 million. In addition, we experienced changes in ~~net~~ operating assets and liabilities of $2.4 million partially offset by non-cash charges of $0.2 million consisting of primarily stock-based compensation expense, and depreciation and amortization, partially offset by gain on sale of property and equipment ~~and gain on extinguishment of the PPP promissory note.~~

We did not have any cash ~~used in operating~~flows related to investing activities ~~was $12.8 million~~ for the six months ended June 30, 2020, consisting of a net loss of $17.8 million and a decrease in net operating assets and liabilities of $1.7 million, and non-cash charges of $3.3 million consisting of primarily stock-based compensation expense and depreciation and amortization.

2022. Net cash provided by investing activities ~~was~~of $0.5 million for the six months ended June 30, 2021 ~~consisting~~consisted primarily of ~~$0.5 million from~~ proceeds from ~~sale~~sales of property and equipment.

Net cash provided by ~~investing~~financing activities ~~was $16.0~~of $10.7 million for the six months ended June 30, ~~2020, consisting~~2022 primarily consisted of ~~$16.0 million~~net cash proceeds from ~~proceeds of maturities of investments.~~

Net cash provided by financing activities ~~was~~of $10.6 million for the six months ended June 30, 2021 ~~was~~ primarily ~~from $11.0 million~~consisted of ~~proceeds,~~ net ~~of placement agent fees, received~~proceeds from our “at the market” offering proceeds of $0.1 million from the purchase of shares under our 2018 Employee Stock Purchase Plan, or ESPP, offset by payments on our financed equipment of $0.3 million. We also paid $0.2 million of offering costs for the Registration Statement on Form S-3 and the “at the market” offerings filed with the Securities and Exchange Commission.

Net cash provided by financing activities was $11.7 million for the six months ended June 30, 2020 was primarily due to $9.0 million of proceeds, net of placement agent fees, received from our May 2020 public offering, $2.0 million proceeds under the PPP Promissory Note and $0.8 million proceeds from the exercise of warrants associated with the May 2020 public

~~offering.~~ ~~The remaining $0.2 million offering costs associated with our May 2020 public financing were paid in July 2020.~~ ~~These proceeds were partially offset by payments on our financed equipment.~~ATM financing.

The discussion and analysis of our financial position and results of operations is based on our interim unaudited ~~interim~~ condensed financial statements included elsewhere in this Quarterly Report, ~~on Form 10-Q,~~ which have been prepared in accordance with accounting principles generally accepted in the ~~United States,~~U.S., or GAAP. We believe certain of our accounting policies are critical to understanding our financial position and results of operations. There have been no significant changes to our critical accounting judgments, policies and estimates as described in our Annual Report on Form 10-K for the year ended December 31, ~~2020~~2021 filed with the Securities and Exchange Commission, or SEC, on March ~~17, 2021.~~24, 2022, or Annual Report, and as amended on July 13, 2022, other than the change in the estimated useful life of our lasers which was changed to eight years effective January 1, 2022, as more fully described in Note 2. Summary of Significant Accounting Policies in our Annual Report.

The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

We do not engage in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, as a part of our ongoing business. Accordingly, we did not have any off-balance sheet arrangements during any of the periods presented.

During the six months ended June 30, 2021, there have been no material changes outside the ordinary course of business to our contractual obligations disclosed in our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form 10-K for the year ended December 31, 2020.

We are exposed to market risks in the ordinary course of our business, including the effects of interest rate changes and foreign currency fluctuations. Information relating to quantitative and qualitative disclosures about these market risks is described below.

We had cash and cash equivalents of ~~$20.2~~$11.1 million as of June 30, ~~2021.~~2022. The goals of our investment policy are liquidity and capital preservation; we do not enter into investments for trading or speculative purposes. We believe that we do not have any material exposure to changes in the fair value of these assets as a result of changes in interest rates due to the ~~short term~~short-term nature of our cash and cash equivalents. A hypothetical 10% relative change in interest rates during any of the periods presented would not have had a material impact on our financial statements.

Our revenue is denominated in U.S. dollars. Our expenses are generally denominated in the currencies in which our operations are located, which is in the United States. As of June 30, 2021, the effect of a 10% adverse change in exchange rates on foreign denominated cash, receivables and payables would not have been material for the periods presented. If our operations in countries outside of the United States grow, our results of operations and cash flows may be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. To date, we have not entered into any material foreign currency hedging contracts although we may do so in the future.

We do not believe that inflation has had a material effect on our business, results of operations, or financial condition. Nonetheless, if our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs. Our inability or failure to do so could harm our business, results of operations and/or financial condition.

Our management, with the participation of our Chief Executive Officer and interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of June 30, ~~2021.~~2022. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and interim Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based upon our evaluation, our Chief Executive Officer and interim Chief Financial Officer concluded that, as of June 30, ~~2021,~~2022, our disclosure controls and procedures were effective at the reasonable assurance level.

There were no changes in our internal control over financial reporting during the three months ended June 30, ~~2021~~2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

The former Chief Financial Officer of the Company resigned effective May 25, 2022. On July 8, 2022, the board of directors appointed the Company’s Chief Executive Officer to act as the interim Chief Financial Officer effective immediately. On July 14, 2022, the board of directors appointed a new interim Chief Financial Officer effective immediately. These changes in personnel, along with the changes in personnel resulting from the Company’s RIF, did not necessitate material changes in internal control process design or operation.

Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

On June 7, 2019, a putative securities class action complaint captioned Derr v. Ra Medical Systems, Inc., ~~et. al.,~~et al, (Civil Action no. 19CV1079 LAB NLS) was filed in the ~~United States~~U.S. District Court for the Southern District of California against ~~us,~~the Company, certain current and former officers and directors, and certain underwriters of ~~our IPO.~~the Company’s initial public offering. Following the appointment of a lead plaintiff and the filing of a subsequent amended complaint, the lawsuit alleges that the defendants made material misstatements or omissions in ~~our~~the Company’s registration statement in violation of Sections 11 and 15 of the Securities Act of 1933, ~~(the “Securities Act”)~~or the Securities Act, and between September 27, 2018 and November 27, 2019, inclusive, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, ~~(the “Exchange Act”).~~or the Exchange Act. On March 11, 2020, lead plaintiffs voluntarily dismissed the underwriter defendants without prejudice. On March 13, 2020, defendants filed a motion to dismiss the amended complaint. On March 24, 2021, the court issued an order granting defendants’ motion to dismiss claims under the Securities Act in full and certain claims under the Exchange Act and denying defendants’ motion to dismiss certain Exchange Act claims. Plaintiffs filed their second amended complaint on April 19, 2021, realleging the Securities Act claims and certain of the previously dismissed Exchange Act claims. On June 10, 2021, defendants moved to dismiss the second amended complaint. AOn November 12, 2021, following a private settlement mediation with the lead plaintiffs, the parties executed a stipulation of settlement that resolved the claims asserted in the securities class action. The settlement provides for a payment to the plaintiff class of $10.0 million. On March 18, 2022, the Company paid approximately $0.6 million towards the settlement to satisfy its self-insured retention/deductible. The Company’s insurers paid the remainder of the settlement. The proposed settlement requires both preliminary and final approval by the court. On February 11, 2022, the court granted preliminary approval of the settlement, scheduled a hearing on final approval of the settlement for June 13, 2022, and denied the pending motion to dismiss ~~is scheduled~~without prejudice. On May 2, 2022, plaintiffs filed a motion for ~~October 12, 2021.~~ ~~Management intends to vigorously defend against this lawsuit. At this time, we cannot predict how a court or jury will rule on the merits~~final approval of the ~~claims and/or~~settlement and plan of allocation, and lead counsel filed a motion for an award of attorneys’ fees and reimbursement of litigation expenses. On June 9, 2022, the ~~scope~~court entered an order continuing the hearing on final approval of the ~~potential loss in~~settlement from June 13, 2022 to August 15, 2022. Should the ~~event~~court not provide final approval of ~~an adverse outcome.~~the proposed settlement or if the proposed settlement otherwise does not become final, the parties will be returned to their litigation postures prior to the execution of the stipulation of settlement. Should wethe Company ultimately be found liable, the liability could have a material adverse effect on ~~our~~the Company’s financial condition and ~~our~~its results of operations for the period or periods in which itsuch determination is ~~incurred.~~made.

On October 1, 2019, a shareholder derivative complaint captioned Noel Borg v. Dean Irwin, et. al (Civil Action no. 1:99-cm-09999) was filed in the ~~United States~~U.S. District Court for the District of Delaware against certain current and former officers and directors, purportedly on behalf of the Company, which is named as a nominal defendant in the action. The complaint alleges breaches of fiduciary duty, unjust enrichment, waste, and violations of Section 14(a) of the Securities Exchange Act of 1934. On October 21, 2019, pursuant to the parties’ stipulation, the court stayed the derivative lawsuit until the related class action is resolved. While we have obligations to indemnify and/or advance the defendants’ legal fees and costs in connection with this lawsuit, any monetary recovery from the defendants would be to the benefit of us.

~~Governmental Investigations~~Settlement Agreements with the Department of Justice and Participating States

As previously announced ~~in the Form 8-K filed~~ on August 12, 2019, the Audit Committee of Ra Medical’s Board of Directors (the “Audit Committee”) conducted an investigation of certain allegations raised by a former employee. We announced the Audit Committee’s findings in the Form 8-K filed on October 31, 2019. The primary investigative findings were: (i) the DABRA catheter frequently failed to calibrate and occasionally overheated, posing a risk of injury to physicians and patients; (ii) our explanations regarding our fourth quarter 2018 and first quarter 2019 sales created a risk of confusion because they did not explicitly reference inconsistent DABRA catheter performance and catheter failures; (iii) we failed to timely make at least two Medical Device Reports, or MDRs, to the FDA; (iv) we, out of a concern for the DABRA catheters’ performance, engaged in systematic efforts to replace product held by customers, which constituted product recalls, but were not documented as such, (v) we lack documentation of sufficient detail and specificity to support certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which could be perceived as an improper attempt to obtain business or to gain special advantage, (vi) while the indication for use in the 510(k) clearance we obtained for the DABRA system is not for atherectomy, our salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes, (vii) our determinations to direct potentially valuable benefits and opportunities to doctors were informed in part by sales prospects, and (viii) we received complaints regarding regulatory or compliance concerns that, because they implicated executive officers, should have been brought to the attention of the Board or the Audit Committee, but were not. The Audit Committee, in reviewing the allegations, identified certain behavior inconsistent with our Code of Ethics and Conduct and related policies.

On December 28, 2020, we entered into a Settlement Agreement with the United States of America, acting through the DOJ and on behalf of the OIG, and other settlement agreements with certain state attorneys general to resolve ~~the pending DOJ investigation~~investigations and a related civil action concerning our marketing of the DABRA laser system and DABRA-related remuneration to certain physicians. ~~In connection with the Settlement Agreement, we also have reached agreements that resolve previously disclosed related investigations conducted by certain state attorneys general.~~

label use of the DABRA laser system, failing to report adverse events to the United States Food and Drug Administration, marketing a device that does not work as advertised, and failing to adhere to Current Good Manufacturing Practices. ~~The complaint, which was settled in connection with the Settlement Agreement, also alleged that we unlawfully retaliated against the former employee.~~ Separate from the former employee’s allegations in the civil action, the United States and the participating states contend that from May 1, 2017 through October 31, 2019, we (a) paid illegal remuneration to certain physicians to induce them to use the DABRA laser system in violation of the federal anti-kickback statute and (b) marketed the DABRA laser system for off-label use in atherectomy procedures despite product performance issues causing calibration and overheating problems, which posed a risk to physicians and patients (the “Covered Conduct”). We deny the allegations in the civil action and those asserted by the United States and the participating states, and the settlement does not constitute an admission of liability or wrongdoing by us.

Under the Settlement Agreement, and the agreements with the participating states, we are required to make an initial payment of $2.5 million, of which we paid $2.4 million in December 2020 and $0.1 million in April 2021. Pursuant to the terms of the Settlement Agreement and the agreement with the participating states, (a) if our revenue exceeds $10 million in ~~any of the next four~~ fiscal years ~~(2021-2024),~~2021-2024, we also are required to pay an additional amount in settlement for the corresponding year: $500,000 for 2021, $750,000 for 2022, $1 million for 2023, and $1.25 million for 2024; (b) if we are acquired or are otherwise involved in a change in control transaction inbefore the ~~years 2020 through~~end of 2024, we are required to pay an additional settlement amount of $5 million, plus 4% of the value attributed to us in the transaction, so long as the attributed value is in excess of $100 million, with the total change in control payment never to exceed $28 million; and (c) if our obligations under the Settlement Agreement are avoided by bankruptcy, the ~~United States~~U.S. may rescind the releases and bring an action against us in which we agree is not subject to an automatic stay, is not subject to any statute of limitations, estoppel or laches defense, and is a valid claim in the amount of $56 million, minus any prior change in control payments. ~~Under the Settlement Agreement, we also paid the former employee’s reasonable expenses, costs and attorneys’ fees, which amount to $0.2 million.~~

The OIG has agreed, conditioned upon our full payment of amounts owed in the Settlement Agreement, and in consideration of our obligations under a Corporate Integrity Agreement, to release our permissive exclusion rights and refrain from instituting any administrative action seeking to exclude us from participating in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct. The Corporate Integrity Agreement has a five-year term and imposes monitoring, reporting, certification, documentation, oversight, screening, and training obligations on us, including the hiring of a compliance officer and independent review organization.

Pursuant to the terms of the Settlement Agreement, the United States and the former employee have dismissed the complaint against us with prejudice and have released us from any civil or administrative monetary liability arising under the Covered Conduct. The Settlement Agreement does not include a release for any conduct other than the Covered Conduct or any criminal liability related to the Covered Conduct. The Settlement Agreement does not release any claims under investigation by the SEC.

As also previously announced, we voluntarily contacted the SEC’s Enforcement Division regarding the Audit Committee’s investigation. On November 13, 2019, the SEC notified us that it was conducting an investigation. We cooperated fully with the SEC in its investigation. ~~On August 3, 2021 we received notice that the SEC has concluded its investigation and does not intend to recommend an enforcement action by the SEC against us.~~

On November 21, 2019, we became aware that the Criminal Division, Fraud Section of the U.S. Department of Justice has an open investigation related to us. At this time, it is unclear if we are a target in this investigation. We have been, and intend to continue, cooperating with the DOJ in its active and ongoing investigation. We are unable to predict the ultimate outcome and are unable to make a meaningful estimate of the amount or range of loss, if any, that could result from any unfavorable outcome.

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this Quarterly Report, ~~on Form 10-Q,~~ before making an investment decision. The risks and uncertainties described below may not be the only ones we face. If any of the risks actually occur, our business, financial condition, operating results, cash flows and prospects could be materially and adversely affected. In that event, the market price of our common stock could decline, and you could lose part or all of your investment.

Risks Related to Our ~~Business~~Financial Position and ~~Products~~Need for Additional Capital

On June 18, 2022, we entered into the non-binding Term Sheet with Catheter Precision, a private medical device company focused on cardiovascular diseases, including heart arrythmias. The purpose of the Term Sheet is to effect a Merger with Catheter Precision. We cannot provide any assurance that we will effect the Merger with Catheter Precision or, if we are able to consummate such a transaction, that the intended benefits of the Merger will be fully realized. Even if the Merger is approved by the stockholders of the Company and Catheter Precision, specified conditions to closing must be satisfied or waived to complete the Merger, including conditions that are subject to the approval or consent of third parties. We cannot assure you that all of the conditions to closing will be satisfied or waived or that we will receive any of the required third party consents or approvals. If the conditions to closing are not satisfied or waived in a timely manner or at all, the Merger may not occur or will be delayed, and we may lose some or all of the intended benefits of the Merger.

If we are unable to consummate the Merger, then we anticipate that we will continue conducting a review of our strategic alternatives and/or seek additional financing. If we are unable to consummate one or more strategic transactions or secure additional financing, then we may also be required to liquidate our assets and dissolve the Company.

If we are unable to consummate the Merger, then we anticipate that we will continue conducting a review of our strategic alternatives and/or seek additional financing. However, no assurance can be provided that we will be able to consummate a strategic transaction or obtain additional financing on a timely basis or on commercially reasonable terms, if at all. Our ~~Business~~failure to raise capital or consummate a strategic transaction would have a material adverse effect on our financial condition and ~~Products~~we may be unable to continue as a going concern and may be required to liquidate our assets and dissolve the Company.

If we were to dissolve the Company and liquidate our assets, we would be required to pay all of our debts and contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurance as to the amount or timing of available cash left to distribute to our stockholders after paying our debts and other obligations and setting aside funds for potential future claims.

We may require additional capital to consummate the Merger, which may not be available to us on acceptable terms or at all.

We may be required to raise additional capital in order to consummate the Merger. The terms of such additional capital may not be on favorable terms to the Company, or at all. Obtaining financing would require expending a significant amount of management’s time and resources, and a failure to obtain the additional financing could affect our ability to consummate the Merger or its terms. The impact of a financing could result in substantial dilution to our stockholders.

Future sales or issuances of substantial amounts of our common stock, including potentially, as a result of the Merger with Catheter Precision, could result in significant dilution.

In the event that the Merger with Catheter Precision is completed and subject to receipt of stockholder approval, we would expect to issue a significant number of shares of our common stock to the stockholders of Catheter Precision. Additionally, we may elect to raise additional capital due to market conditions or strategic considerations as a result of the Merger. If additional shares are issued in connection with the proposed merger transaction or additional capital is raised through the sale of equity or convertible debt securities, the issuance of those securities could result in further dilution to investors.

If the Merger is consummated, the market price of our common stock following the Merger may decline as a result of the Merger.

The market price of our common stock may decline as a result of the Merger for a number of reasons including, but not limited to, if:

We may be targeted by securities class action and derivative lawsuits that could result in substantial costs and may delay or prevent the Merger from being completed.

Securities class action lawsuits and derivative lawsuits are often brought against public companies that have entered into merger agreements. Even if the lawsuits are without merit, defending against these claims can result in substantial costs and divert management time and resources. An adverse judgment could result in monetary damages, which could have a negative impact on our liquidity and financial condition. In addition, if a plaintiff is successful in obtaining an injunction prohibiting completion of the Merger, then that injunction may delay or prevent the Merger from being completed, or from being completed within the expected timeframe, which may adversely affect our and Catheter Precision’s respective businesses, financial positions and results of operation. Currently, neither we nor Catheter Precision is aware of any securities class action lawsuits or derivative lawsuits having been filed in connection with the Merger.

Litigation against us and Catheter Precision, or the members of the board of directors of the Company or Catheter Precision, could prevent or delay the completion of the Merger or result in the payment of damages following completion of the Merger.

While we and Catheter Precision believe that any claims that may be asserted by purported shareholder or stockholder plaintiffs related to the Merger would be without merit, the results of any such potential legal proceedings are difficult to predict and could delay or prevent the Merger from becoming effective in a timely manner. The existence of litigation related to the Merger could affect the likelihood of obtaining any approvals that are required from our stockholders or Catheter Precision’s stockholders. Moreover, any litigation could be time consuming and expensive, could divert our and Catheter Precision’s management’s attention away from their regular business and, if any lawsuit is adversely resolved against either us, Catheter Precision or members of the respective board of directors of the Company or Catheter Precision (each of whom we or Catheter Precision are respectively required to indemnify pursuant to indemnification agreements), could have a material adverse effect on our or Catheter Precision’s financial condition.

Our and Catheter Precision’s equity holders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

The post-Merger public company may not be able to realize the full strategic and financial benefits currently anticipated from the Merger and if such benefits are not fully realized as a result of the Merger, then our and Catheter Precision’s equity holders will have experienced dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the post-Merger public company.

During the pendency of the Merger, we and Catheter Precision may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

The Term Sheet impedes the ability of us and Catheter Precision to make acquisitions, subject to certain exceptions relating to fiduciaries duties, as set forth below, or complete other transactions that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets or other business combination outside the ordinary course of business, with any third party, subject to certain exceptions described below. These restrictions apply even if such transactions could be favorable to such party’s equity holders.

The Term Sheet may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.

The Term Sheet prohibits each of us and Catheter Precision from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when such party’s board of directors determines in good faith, after consultation with its independent financial advisor, if any, and outside counsel, that an unsolicited competing proposal constitutes, or would reasonably be expected to result in, a superior competing proposal and that failure to take such action would result in a breach of the fiduciary duties of the board of directors.

Some Ra and Catheter executive officers and directors have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

Some officers and directors of Ra and Catheter are parties to arrangements that provide them with interests in the Merger that are different from the respective stockholders of Ra and Catheter, including, among others, service as an officer or director of the post-Merger public company following the closing of the Merger, severance and retention benefits, the acceleration of equity award vesting, and continued indemnification.

Ra and Catheter security holders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the post-Merger public company following the closing of the Merger as compared to their current ownership and voting interest in the respective companies.

After the completion of the Merger, the current security holders of Ra and Catheter will own a smaller percentage of the post-Merger public company than their ownership in their respective companies prior to the Merger.

Because the lack of a public market for Catheter’s capital stock makes it difficult to evaluate the fairness of the Merger, the shareholders of Catheter may receive consideration in the Merger that is less than the fair market value of Catheter’s capital stock and/or Ra may pay more than the fair market value of Catheter’s capital stock.

The outstanding capital stock of Catheter is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Catheter’s capital stock. Because the Ra equity to be issued to Catheter stockholders will be determined based on negotiations between the parties, it is possible that the value of the Ra capital stock to be received by Catheter stockholders will be less than the fair market value of Catheter’s capital stock, or Ra may pay more than the aggregate fair market value for Catheter’s capital stock.

If the Merger does not qualify as a tax-free reorganization, the receipt of Ra Common Stock pursuant to the Merger could be fully taxable to all Catheter stockholders.

Both Ra and Catheter intend the Merger to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended and the Treasury Regulations promulgated thereunder. However, completion of the Merger is not conditioned upon receipt of an opinion from counsel dated as of the closing date that the Merger qualifies as a reorganization. The tax opinions received by Catheter and Ra will be based on representation letters by Catheter and Ra pertaining to factual matters and on certain factual assumptions, including with respect to the number of Catheter shares held by, and the amount of consideration payable to, Catheter stockholders, if any, that exercise dissenters’ rights. If any of these assumptions or representations proves incorrect, for example, if there is a change in applicable law or if consideration paid to Catheter stockholders exercising dissenters’ rights is significant, the Merger could be fully taxable to all Catheter stockholders. If the transactions were to fail to so qualify, then each holder of Catheter common stock generally would recognize gain or loss, as applicable, equal to the difference between (1) the sum of the fair market value of the shares of Ra common stock received by such U.S. holder of Catheter stock in the Merger and the amount of cash received for fractional shares by such U.S. holder

of Catheter stock in the Merger and (2) its adjusted tax basis in the shares of Catheter common stock surrendered in exchange therefor. The consequences of the Merger to any particular Catheter stockholder will depend on that stockholder’s particular situation. We strongly urge you to consult your own tax advisor to determine the particular tax consequences of the Merger to you.

Because the Merger may result in an ownership change under Section 382 of the Code for Ra, Ra’s pre-Merger net operating loss carryforwards and certain other tax attributes may be subject to limitation. The net operating loss carryforwards and certain other tax attributes of the post-Merger public company may also be subject to limitations as a result of ownership changes.

If a corporation undergoes an “ownership change” within the meaning of Section 382 of the Code, the corporation’s net operating loss carryforwards and certain other tax attributes arising from before the ownership change are subject to limitations on use after the ownership change. In general, an ownership change occurs if there is a cumulative change in the corporation’s equity ownership by certain stockholders that exceeds fifty percentage points over a rolling three-year period. Similar rules may apply under state tax laws. The Merger will may result in an ownership change for Ra and, accordingly, Ra’s net operating loss carryforwards and certain other tax attributes will be subject to limitations on their use after the Merger. Additional ownership changes in the future could result in additional limitations on Ra’s and the post-Merger public company’s net operating loss carryforwards. Consequently, even if the post-Merger public company achieves profitability, it may not be able to utilize a material portion of Ra’s or the post-Merger public company’s net operating loss carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results of operations.

Ra’s and Catheter’s equity holders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

The post-Merger public company may not be able to realize the full strategic and financial benefits currently anticipated from the Merger and if such benefits are not fully realized as a result of the Merger, then Ra’s and Catheter’s equity holders will have experienced dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the post-Merger public company.

We requireadditionalcapitalto financeour operations,which maynot be availableto us on acceptableterms or at all.

Although management believes the Company has adequate resources to operate as a going concern, our current cash resources may not ultimately be sufficient to fund operations at the expected level of activity beyond the twelve months from the date of this Quarterly Report. We will need additional capital to continue operations at the current level and to continue our atherectomy indication trial and engineering efforts.

Our operations have consumed substantial amounts of cash since inception, primarily due to our research and development and commercialization efforts. As of June 30, 2022, we had cash and cash equivalents of $11.1 million and an accumulated deficit of $192.2 million. For the six months ended June 30, 2022, we used cash of $14.6 million in operating activities. We have experienced recurring net losses from operations, negative cash flows from operating activities, and a significant accumulated deficit and expect to continue to incur net losses into the foreseeable future. As a result, our financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.

In the near term, we expect our recurring operational costs to decrease as a result of our cost savings initiatives. On June 6, 2022, we initiated a RIF, in which approximately 65% of our full-time employees were immediately terminated and the non-terminated employees were offered conditional retention arrangements pursuant to which it was expected that they would continue to provide services into the third quarter of 2022. We have suspended sales of DABRA catheters. We sold or disposed of most of our inventories and property and equipment, including lasers. We are in the process of attempting to renegotiate our building lease. Although we are continuing the follow-up for our atherectomy clinical trial, we stopped enrollment in June 2022. We have decreased or deferred capital expenditures, development and engineering activities and implemented further operating expense reduction measures. Such measures are likely to impair our ability to invest in developing, marketing and selling new and existing products. Until we are able to generate sufficient revenue to support our level of operating expenses, we will continue to incur operating and net losses and negative cash flow from operations. Additionally, we anticipate additional legal and other costs related to the securities class action and derivative lawsuits, as well as compliance with, and payments under, the terms of our Settlement Agreement and Corporate Integrity Agreement associated with our settlements with the DOJ and the participating states. Because of the numerous risks and uncertainties associated with our commercialization efforts and future product development and these lawsuits and the government investigation, we are unable to predict when we will become profitable, and we may never become profitable.

The amount and timing of any expenditures needed to implement our commercial strategy will depend on numerous factors, including:

If we raise additional capital or develop and/or commercialize our products with third parties through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements, we may have to develop our products on a slower timeline or relinquish certain valuable rights to our products, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. If we are unable to obtain adequate financing on commercially reasonable terms when needed, we may have to continue to delay, reduce the scope of our future sales and marketing efforts, which would have a material adverse effect on our business, financial condition, and results of operations. We also expect the continuing economic uncertainty resulting from the effects of the COVID-19 pandemic and Russia’s invasion of Ukraine to have a negative impact on our ability to secure additional financing in a timely manner or on favorable terms, if at all.

We are continuing to conduct a review of our strategic alternatives, including evaluating potential paths forward for our core and strategic technologies that could significantly impact our future operations and financial position.

We have entered into a non-binding summary of proposed terms for a proposed Merger with Catheter Precision. However, we have not entered into a binding agreement with Catheter Precision with respect to the Merger transaction. We cannot be certain that the Merger will be consummated or that all of the conditions precedent will be satisfied or waived in a timely manner or at all. Our board of directors has therefore continued its review of strategic alternatives that could result in changes to our business strategy and future operations. As part of this process, which is being conducted in parallel with our efforts in furtherance of the proposed Merger and a review of the development and commercialization options, as well as associated costs, for our core and strategic technologies, our board of directors is reviewing alternatives with the goal of maximizing stockholder value. Such options may result in a financing to continue our atherectomy indication trial and development of our catheter or refocusing and rebuilding the Company around the lithotripsy asset, or a business combination including a company sale, merger, asset sale, in-license, out-license, or other business transaction. If we determine to pursue an alternate strategy or engage in a strategic transaction, our future business, prospects, financial position and operating results could be significantly different than those in historical periods or projected by our management. Any decision to change our strategic direction could result in us limiting our research and development activities to manage our cash position. The proposed Merger is uncertain, and we cannot provide any commitment as to the timing of our determination or the strategy we may adopt

and may be required to liquidate our assets and dissolve the Company if we are unable to secure additional financing or consummate one or more strategic transactions. If we do not consummate the Merger and determine to continue our atherectomy indication trial and the development of our catheter or refocusing and rebuilding the Company around the lithotripsy asset, we will need to obtain substantial additional funding. Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements.

We have determined that there is substantial doubt about our ability to continue as a going concern, and we will need ~~additional financings~~to develop a business plan for the combined company to execute ~~our~~following the Merger, should it be consummated. We may require additional capital in order to execute the business plan and fund the operations of the combined company or, if the Merger is not consummated, in order to ~~fund~~continue the operations of our current business as a standalone company. We may not be able to obtain such funding on a timely basis, or on commercially reasonable terms, or at all. Any capital-raising transaction we are able to complete may result in substantial dilution to our existing stockholders, require us to relinquish significant rights, or restrict our operations.

We do not yet generate sufficient revenues from our operations to fund our activities and are therefore dependent upon external sources for financing our operations. We have concluded and disclosed in the footnotes to our condensed financial statements, included elsewhere within this Quarterly Report, that we do not have sufficient cash to fund our operations through 12 months from the date of issuance of the most recent financial statements. As a result, our financial statements include disclosures expressing substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of the uncertainty regarding our ability to continue as a going concern. This disclosure with respect to our ability to continue as a going concern could materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise. If we do not consummate the Merger and are unable to successfully raise additional funds, then we may have to refocus or rebuild around a different core or strategic technology, consummate another strategic transaction or be required to liquidate our assets and dissolve the Company. Future reports on our financial statements may continue to include such disclosures. If we cannot continue as a going concern, our stockholders may lose their entire investment in our common stock.

~~Historically,~~We are developing a business plan for the combined company to execute should we ~~have financed~~consummate the proposed Merger. Management currently believes that it will be necessary for us to raise additional funding in the form of an equity financing from the sale of common stock or the issuance of debt or to pursue and consummate one or more strategic transactions, whether related or unrelated. There can be no guarantee that we will successfully raise all the funding we require or be able to consummate any strategic transaction and, even if so, that we would be able to continue as a going concern. However, substantial doubt about a company’s ability to continue as a going concern is generally viewed unfavorably by current and prospective investors, as well as by analysts and creditors. As a result, it may be more difficult for us to raise the additional financing necessary to continue to operate our business, and we may be forced to significantly alter our business strategy, substantially curtail our current operations, ~~through private~~or liquidate and ~~public placement~~cease operations altogether.

If our board of ~~equity securities.~~ directors decides to dissolve the Company and liquidate its assets, we would be required to pay all of our debts and contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurance as to the amount or timing of available cash left to distribute to our stockholders after paying our debts and other obligations and setting aside funds for potential future claims.

If we are unable to raise capital when needed, we may be forced to significantly alter our business strategy, substantially curtail our current operations, or liquidate and cease operations altogether.

We expect our expenses to increase in parallel with our ongoing activities, particularly as we incur expenses relating to the exploration of strategic options intended to maximize shareholder value, seek to continue our atherectomy indication trial and the development of our catheter, develop our lithotripsy asset and potentially seek other strategic transactions such as a company sale, merger, asset sale, in-license, out-license, or other business transaction, or in the absence of any of the foregoing, be required to liquidate our assets and dissolve the Company. If we are unable to raise capital when needed or on attractive terms, we may be forced to significantly alter our business strategy, substantially curtail our current operations, or liquidate and cease operations altogether.

Our ability to ~~obtain financing~~continue as a standalone company and to successfully conduct our business is ~~subject~~highly dependent upon us attracting and retaining highly qualified personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to ~~multiple risks, many~~successfully implement our business strategy.

Our ability to compete in the highly competitive medical devices industry depends upon our ability to attract and retain highly qualified managerial, scientific, sales and medical personnel. Our success as a standalone company and to successfully conduct our current business is highly dependent on attracting and retaining a highly qualified management team. Will McGuire, our Chief Executive Officer, has been diagnosed with a serious illness not caused by COVID-19 and has been undergoing treatment for his illness. He continues to fulfill all of ~~which are beyond~~his duties and responsibilities and has stated his desire to continue in such roles. We do not expect our ~~control. We have~~Chief Executive Officer to relinquish any of his responsibilities or duties in the short term as a result of this diagnosis, however, his condition may change and prevent him from doing so. The Board has discussed a plan of succession and will continue ~~seeking~~ to ~~reduce~~evaluate and monitor our ~~recurring operation costs by engaging~~options on an ongoing basis should Mr. McGuire need to relinquish any of his responsibilities or duties at any time as a result of his illness or otherwise.

We face intense competition for executive-level talent from a variety of sources, including from current and potential competitors in ~~regular~~the medical device and ~~ongoing reviews of~~healthcare industries. Our continued success is dependent, in part, upon our ~~business model~~ability to attract and ~~strategic options~~retain superior executive officers.

Competition for skilled personnel in our market is intense and may limit our ability to ~~help ensure that we are focusing our cash resources~~hire and retain highly qualified personnel on advancing our key corporate initiatives. We also intend to raise additional capital in order to fund our operations and grow our business and have an effective shelf registration statement and “at the market” offering. However, no assurance can be provided that we will be able to do so on commercially reasonableacceptable terms or at all. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued stock options and restricted stock units that vest over time. The value to employees of stock options and restricted stock units that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies. The decline in our stock price may create additional challenges by reducing the ~~extent~~retention value of our equity awards to these employees. Members of our management, scientific and development teams have and may continue to terminate their employment with us, either as a result of further reductions in force initiated by us or voluntarily on their own. Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave, and have left, our employment at any time, with or without notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel. If we are ~~unable to do so, we may need to curtail or cease~~not successful in attracting and retaining highly qualified personnel, it would have a material adverse effect on our ~~operations~~business, financial condition, and ~~implement a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further~~results of operations.

We may be unable to successfully ~~remedy the performance, shelf life and calibration issues associated with our DABRA catheters,~~ achieve market acceptance of DABRA or achieve revenue growth.

Our ability to grow our revenue in future periods will depend on our ability to successfully ~~remedy the inconsistencies in our DABRA catheter performance,~~ penetrate our target markets and increase sales of our products and any new product indications that we introduce, which will, in turn, depend in part on our success in growing our installed unit base and driving continued use of our systems, including long-term adoption by physicians. During the fourth quarter of 2018 and into 2019, we saw an increase in calibration issues experienced by physicians. In addition, in reviewing the performance inconsistencies, we found that our catheters occasionally overheated, which could cause a risk of injury to patients and physicians. These higher than anticipated rates of non-calibration resulted in customer dissatisfaction with the product, resulting in what we believe to be fewer purchases by our customers. In the third quarter of 2019, we determined that catheters that were more than two months from sterilization had a significantly higher rate of non-calibration than catheters that were within two months of sterilization. A~~s a result, in September 2019, we initiated a voluntary recall of our catheters to replace 12-month shelf life labeled catheters with two-month shelf life labeled catheters.~~ Accordingly, we reduced the number of sales and marketing personnel in order to conserve cash and focus our efforts on key territories and accounts. We also initiated a voluntary recall of our DABRA catheters to replace 12-month shelf life labeled catheters with two-month shelf life labeled catheters and have paused commercial sales not related to our atherectomy clinical trial. These actions will likely make it more difficult in the near term to achieve significant revenue growth. In addition, new product indications will also need to be approved or cleared by the FDA and comparable non-U.S. regulatory agencies to help drive revenue growth. If we cannot achieve revenue growth, it would have a material adverse effect on our business, financial condition, and results of operations.

Our success depends in large part on DABRA. If we are unable to successfully manufacture, market and sell DABRA, our business prospects will be significantly harmed.

Our future financial success will depend substantially on our ability to effectively and profitably manufacture, market and sell DABRA. We have recently significantly reduced the component of our workforce that was responsible for the manufacturing, marketing and sales of DABRA. The commercial success of DABRA will depend on a number of factors, including the following:

If we fail to successfully market, manufacture and sell DABRA, we may not be able to achieve or maintain profitability, which will have a material adverse effect on our business, financial condition, and results of operations.

Our ability to successfully complete our atherectomy trial may continue to be hindered or delayed by the effects of the COVID-19 ~~pandemic and DABRA catheter performance limitations that are currently being addressed by various engineering efforts.~~pandemic.

The ~~current~~effects of the COVID-19 pandemic and the DABRA catheter performance limitations ~~may impact~~have impacted our ability to complete our atherectomy study in a timely manner. For example, ~~enrollment in~~follow up with our atherectomy clinical trial, and patients’ completion of our atherectomy trial, may be further delayed or slowed by ~~continuing~~any increases in COVID-19 cases or other effects of the COVID-19 pandemic, as patients elect, or are asked, to postpone voluntary treatments and physicians’ offices are either closed or only performing procedures on patients with a more advanced disease ~~state that may not meet the enrollment criteria for our atherectomy clinical trial.~~ ~~In addition,~~ inconsistencies or limitations in our DABRA catheter performance, including a current two-month shelf life and a history of non-calibrations, may deter some clinical sites from participating in our atherectomy study.Other limitations in our DABRA catheter performance, such as the potential for kinking during certain clinical scenarios or the lack of a guidewire-compatible version of our DABRA catheter, may limit the number of cases in which the DABRA catheter will be used during the trial. ~~We have recently experienced delays in our efforts to develop these design enhancements to the DABRA catheter as a result of delays in obtaining materials from a key supplier.~~ state. Accordingly, we cannot predict whether or when we will be able to successfully complete our atherectomy indication ~~trial.~~trial follow-up. Any inability to complete our atherectomy indication trial could have an adverse impact on our ability to successfully manufacture, market and sell DABRA, which in turn could adversely impact our business, financial condition and results of operations.

~~We anticipate requiring additional capital to finance our operations, which may not be available to us on acceptable terms or at all.~~

Our operations have consumed substantial amounts of cash since inception, primarily due to our research and development and commercialization efforts. As of June 30, 2021, we had cash and cash equivalents of $20.2 million and an accumulated deficit of $165.7 million. For the years ended December 31, 2020 and 2019, we used $28.3 million and $33.2 million in cash for operating activities, respectively. We have experienced recurring net losses from operations, negative cash flows from operating activities, and a significant accumulated deficit and expect to continue to incur net losses into the foreseeable future. As a result, our financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.

In the near term, we expect our recurring operational costs to decrease as a result of our cost savings initiatives. In the third quarter of 2019, we began implementing certain operational efficiency and cost savings initiatives intended to align our resources with our product strategy, reduce our operating expenses, and manage our cash flows. These cost efficiency initiatives included targeted workforce reductions of our sales and marketing teams. We have suspended sales of DABRA catheters not related to our atherectomy clinical trial. We submitted additional test data with respect to the DABRA catheter shelf life in March 2021, which was cleared by the FDA in July 2021. Further such actions may be required on an ongoing basis to optimize our organization. For example, we may need to decrease or defer capital expenditures and development activities or implement further operating expense reduction measures. Such measures may impair our ability to invest in developing, marketing and selling new and existing products. Until we are able to generate sufficient revenue to support our level of operating expenses, we will continue to incur operating and net losses and negative cash flow from operations. Additionally, we anticipate additional legal and other costs related to our completed Audit Committee investigation, including the pending securities class action and derivative lawsuits and a pending DOJ criminal investigation as well as compliance with, and payments under, the terms of our Settlement Agreement and Corporate Integrity Agreement associated with our settlement of a DOJ civil investigation. Because of the numerous risks and uncertainties associated with our commercialization efforts and future product development and these lawsuits and ongoing government investigation, we are unable to predict when we will become profitable, and we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase our profitability.

~~The amount and timing of any expenditures needed to implement our commercial strategy will depend on numerous factors, including:~~

If we raise additional capital or develop and/or commercialize our products with third parties through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements, we may have to develop our products on a slower timeline or relinquish certain valuable rights to our products, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. If we are unable to obtain adequate financing on commercially reasonable terms when needed, we may have to delay, reduce the scope of or suspend our sales and marketing efforts, which would have a material adverse effect on our business, financial condition, and results of operations. We also expect the continuing economic uncertainty resulting from the COVID-19 pandemic to have a negative impact on our ability to secure additional financing in a timely manner or on favorable terms, if at all.

We are required to devote significant resources to complying with the terms and conditions of our Corporate Integrity Agreement and, if we fail to comply, we could be subject to penalties or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.

On December 28, 2020, we entered into a five-year Corporate Integrity Agreement with the Office of Inspector General, or OIG. The Corporate Integrity Agreement requires that we maintain our existing compliance programs, as well as expanding compliance-related requirements during the term of the Corporate Integrity Agreement. The Corporate Integrity Agreement requires us to establish specific procedures and requirements regarding consulting activities, marketing activities and other interactions with healthcare professionals and healthcare institutions and the sale and marketing of our products; ongoing monitoring, reporting, certification and training obligations; and the engagement of an independent review organization to perform certain auditing and reviews and prepare certain reports regarding our compliance with federal health care programs. Developing and maintaining these processes, policies and procedures necessary to comply with the Corporate Integrity Agreement will require a significant portion of management’s attention and the application of significant resources. In addition, while we have developed and instituted a corporate compliance program, we cannot guarantee that we, our employees, our consultants or our contractors are or will be in compliance with all potentially applicable U.S. federal and state regulations and/or laws, all potentially applicable foreign regulations and/or laws and/or all requirements of the Corporate Integrity Agreement. If we breach the Corporate Integrity Agreement, we could become liable for payment of certain stipulated penalties or could be excluded from participation in federal health care programs. The costs associated with compliance with the Corporate Integrity Agreement, or any liability or consequences associated with its breach, could have an adverse effect on our ~~business.~~business or any potential strategic transaction, such as a sale of one or more of our assets, a license to our technology, a business combination or other partnership transaction.

Physicians and staff may not commit enough time to sufficiently learn how to use our products.

In order for physicians and staff to learn to use our products and familiarize themselves with our technology, we encourage physicians to attend structured training sessions. There are many nuances to successfully using our products. For example, the DABRA catheter is fragile and may be prone to bending, a problem known as kinking. In addition, the DABRA laser needs to be calibrated correctly for each use. During the fourth quarter of 2018 and into 2019, we saw an increase in calibration issues experienced by physicians. In addition, in reviewing the performance inconsistencies, we found that our

catheters occasionally overheated, which could cause a risk of injury to patients and physicians. Although we are instituting measures intended to improve calibration and decrease kinking in the future, physiciansPhysicians and their staff must utilize the technology on a regular basis to ensure they maintain the skill set necessary to use our products. This will depend on their willingness to attend training sessions or sufficiently familiarize themselves with DABRA. An inability to train a sufficient number of physicians to generate adequate demand for our products could have a material adverse effect on our business, financial condition, and results of operations.

Our products may not gain or maintain market acceptance among physicians and patients and others in the medical community.

Our success will depend, in part, on the acceptance of our products as safe, useful and, with respect to physicians, cost effective and easy to use. We cannot predict how quickly, if at all, catheterization laboratories and physicians will accept our products or, if accepted, how frequently they will be used. Patients and their care providers must believe our products offer benefits over alternative treatment methods. Additional factors that will influence whether our products gain and maintain market acceptance, include:

If we do not adequately educate physicians about ~~peripheral artery disease, or~~ PAD and the existence and proper use of our products, DABRA may not gain market acceptance, as many physicians do not routinely screen for PAD while screening for coronary artery disease, or CAD. Additionally, even if our products achieve market acceptance, they may not maintain that market acceptance over time if competing products or technologies are introduced that are received more favorably or are more

cost effective. Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition, and results of operations.

The continuing development of our products depends upon our developing and maintaining strong working relationships with physicians.

The research, development, marketing and sale of our current products and any potential new and improved products or future product indications for which we receive regulatory clearance or approval depend upon our maintaining working relationships with physicians. We rely on these professionals to provide us with considerable knowledge and experience regarding the development, marketing and sale of our products. Physicians assist us as researchers, marketing and product consultants and public speakers. If we cannot maintain our strong working relationships with these professionals and continue to receive their advice and input, the development and marketing of our products could suffer, which could have a material adverse effect on our business, financial condition, and results of operations. At the same time, companies in the medical device industry are under continued scrutiny by the OIG and the DOJ, for improper relationships with physicians. For example, on December 28, 2020, we entered into a Settlement Agreement and a related Corporate Integrity Agreement related to a resolution of a DOJ civil investigation concerning, among other things, whether we paid improper remuneration to physicians and other healthcare providers in violation of the Anti-Kickback Statute, 42 U.S.C. §1320a-7b. Our failure to comply with the Corporate Integrity Agreement or requirements governing the industry’s relationships with physicians, including the reporting of certain payments to physicians under the National Physician Payment Transparency Program (Open Payments) or the reputational harm or negative publicity resulting from the settlement of the ~~pending~~ government investigation could impact physicians’ willingness to conduct business with us, which would have a material adverse effect on our business, financial condition, and results of operations.

We have experienced inconsistencies in our DABRA catheter performance. This and any other development or manufacturing problems or delays could limit the potential growth of our revenue or increase our losses.

Beginning in the fourth quarter of 2018, we started experiencing inconsistencies in our DABRA catheter performance. We believed at the time that these inconsistencies were related to controlling the temperature of the oven used in the manufacturing process, which we had previously referred to as production limitations. These inconsistencies led to an increase in the number of catheters that failed to calibrate at customer sites, despite calibrating successfully during our quality assurance steps. During that same period, our sales team noted higher rates of non-calibration of catheters at customer physician offices. The higher than anticipated rates of non-calibration resulted in customer dissatisfaction with the product, resulting in what we believe to be fewer purchases by our customers and therefore lower revenue during the fourth quarter of 2018 and into 2019, however, the decrease in purchases and the impact of such decrease on our revenues is not determinable. In response, we upgraded our temperature control regulator and made certain changes in our production flow and validated the changes that we believed corrected the production limitations. After manufacturing several well-performing lots with this upgraded process, the percentage of catheters that failed to calibrate at customer sites began to increase after decreasing during April and May 2019. After collecting field data and performing internal testing, we observed that while catheters can perform satisfactorily up to one year, catheters that were more than two months from sterilization had a significantly higher rate of non-calibration than catheters that were within two months from sterilization. As a result, in September 2019, we initiated a voluntary recall of our catheters to replace 12-month shelf life labeled catheters with two-month shelf life labeled catheters. At the FDA’s request, we engaged in additional shelf life testing as part of a special 510(k) and suspended commercial sales of catheters in order to remedy the shelf life issues. The FDA subsequently decided not to clear the special 510(k) and requested to see additional test data to confirm the stability of the shelf life before permitting us to resume commercial shipments. We submitted this additional test data with respect to the DABRA shelf life in March 2021 in a traditional 510(k) and received clearance by the FDA in July 2021.

There can be no assurance that we will be able to timely correct the performance issues related to the DABRA catheters or that a premarket FDA submission would not be required for such changes. In addition, the manufacture of our products is subject to strict regulatory requirements as described in the risk factor entitled “Our medical device operations are subject to pervasive and continuing FDA regulatory requirements.” Problems can arise during the manufacturing process for a number of reasons, including equipment malfunction, failure to maintain or follow necessary protocols and procedures, raw material problems or human error. If we are unable to timely remedy our ~~inconsistencies in our DABRA catheter performance~~ or if we otherwise fail to meet our internal quality standards or the quality system regulations enforced by the FDA or other applicable regulatory bodies, which include detailed manufacturing and quality obligations, our reputation could be damaged, we could be required to issue a safety alert to our customer or initiate a recall, we could incur product liability and other costs, product approvals could be delayed, suspended or revoked, enforcement action could be initiated by regulatory authorities, we could be required to cease commercialization of DABRA and our business could otherwise be adversely affected.

In addition, our production processes and assembly methods may require additional changes to accommodate any significant expansion of our manufacturing capacity, which may increase our manufacturing costs, delay production of our products, reduce our product margin, be subject to FDA approval and adversely impact our business. Conversely, if demand for our products shifts such that a manufacturing facility is operated below its capacity for an extended period, we may adjust our manufacturing operations to reduce fixed costs, which could lead to uncertainty and delays in manufacturing times and quality during any transition period.

Additionally, since our products are manufactured at our sole manufacturing facility in Carlsbad, California, any contamination of the controlled environment, equipment malfunction, or failure to strictly follow procedures can significantly reduce our yield. A drop in yield can increase our cost to manufacture our products or, in more severe cases, require us to halt the manufacture of our products until the problem is resolved. Identifying and resolving the cause of a drop in yield can require substantial time and resources.

If our manufacturing activities are adversely impacted, our revenue could be impaired, market acceptance for our products could be adversely affected and our customers might instead purchase our competitors’ ~~products, which would have a material adverse effect on our business, financial condition, and results of operations.~~

We may face additional issues associated with the voluntary recall of our DABRA catheters if we are unable to show that we initiated a timely recall and improved calibration rates in the use of our DABRA catheters.

In the third quarter of 2019 we initiated a voluntary recall of our DABRA catheters to replace 12-month shelf life labeled catheters with two-month shelf life labeled catheters, as we observed through field data and internal testing that catheters more than two months from sterilization have a significantly higher rate of non-calibration. While the newly labeled DABRA catheters showed a significant decrease in non-calibrations, we have paused commercial sales of DABRA catheters not being used for the atherectomy clinical trial while we continue our engineering efforts to improve the shelf life of our catheters.

~~We have~~ incurred losses in recent periods and may be unable to achieve profitability in the future.

We incurred ~~net~~ losses from continuing operations of ~~$36.0~~$8.4 million and ~~$57.0~~$13.9 million for the ~~years~~three and six months ended ~~December 31, 2020 and 2019,~~June 30, 2022, respectively. As of June 30, ~~2021,~~2022, we had an accumulated deficit of ~~$165.7~~$192.2 million. We expect to continue to incur significant manufacturing, product development, regulatory and other expenses ~~as we continue to remedy the~~ ~~inconsistencies in our DABRA catheter performance,~~ to obtain regulatory clearances or approvals for our products in additional jurisdictions and for additional indications, to develop new products or add new features to our existing products, and to defend, cooperate and resolve pending lawsuits and government investigation, as applicable. In addition, our general and administrative expenses have increased ~~following our initial public offering~~due to legal proceedings, and we expect these costs to continue due to the additional costs associated with being a public company. The ~~net~~ losses that we incur may fluctuate significantly from period to period. We will need to generate significant additional revenue in order to achieve and sustain profitability and, even if we achieve profitability, we cannot be sure that we will remain profitable for an extended period of time. Our failure to achieve or maintain profitability would have a material adverse effect on our business, financial condition, and results of operations and could negatively impact the value of our common stock.

Matters relating to or arising from our completed Audit Committee investigation, including an active and ongoing government investigation and proceedings, litigation matters and potential additional expenses, may adversely affect our business and results of operations.

As previously disclosed in our public filings, the Audit Committee completed its internal investigation. In connection with the Audit Committee investigation, we voluntarily contacted the Enforcement Division of the SEC in August 2019 to advise them of the investigation and on November 13, 2019, the SEC notified us that it was conducting an investigation. On March 11, 2020, the SEC served us with document subpoenas. We cooperated fully with the SEC’s investigation. On August 3, 2021 we received notice that the SEC has concluded its investigation and does not intend to recommend an enforcement action by the SEC against us. ~~In November 2019, we learned that the DOJ opened a criminal investigation relating to us.~~ ~~We have been, and intend to continue, cooperating in the DOJ’s investigation.~~

As disclosed above, on December 28, 2020, we entered into a Settlement Agreement with the DOJ to resolve a civil False Claims Act investigation and a related civil action, and in connection with the Settlement Agreement, reached agreements that resolve previously disclosed related civil investigations conducted by certain state attorneys general. Under the Settlement Agreement, and the agreements with the participating states, we are required to make an initial payment of $2.5 million, of which we paid $2.4 million in December 2020 and $0.1 million in April 2021. In addition, if our revenue exceeds $10 million in any of the next four fiscal years, we also are required to pay an additional amount in settlement for the corresponding year: $500,000 for 2021, $750,000 for 2022, $1 million for 2023, and $1.25 million for 2024. If we are acquired or are otherwise involved in a change-in-control transaction prior to December 31, 2024, we also are required to pay an additional settlement amount of $5 million, plus 4% of the value of the transaction if the value of the transaction is in excess of $100 million, with

the total change-in-control payment not to exceed $28 million. Under the Settlement Agreement, we also paid the former employee’s reasonable expenses, costs and attorneys’ fees, which amounted to $0.2 million. We also have additional obligations under a related Corporate Integrity Agreement, which has a five-year term and imposes monitoring, reporting, certification, documentation, oversight, screening, and training obligations on us, including the hiring of a compliance officer and independent review organization.

If one or more government agencies, including those conducting the pending investigation identified above, commences legal action and we are found to have violated state or federal laws or regulations, we may be subject to criminal damages, penalties, fines, disgorgement, injunctions, cease and desist orders, other equitable remedies, exclusion from governmental health care programs, and the curtailment or restructuring of our operations, any of which would have a material adverse effect on our business, financial condition, and results of operations for years. Regardless of whether actions are commenced, if we were to settle with one or more government agencies or state governments, including those conducting the ongoing investigation identified above, such settlements could include an agreement to pay civil or criminal damages, deferred prosecution agreements, or other equitable remedies, exclusion form governmental health care programs, and the curtailment or restructuring of our operations, any of which would have a material adverse effect on our business, financial condition and results of operations for years after any settlement is reached. In light of the ongoing nature of the investigation, whether actions will be commenced, whether this investigation can be settled before or after actions are commenced, and the terms on which this investigation can be resolved is not certain.

We have incurred, and may continue to incur, significant expenses related to legal, accounting, and other professional services in connection with the completed Audit Committee investigation and related legal matters, including the securities class action, shareholder derivative lawsuit, and government investigation, as well as costs related to compliance under, and payments made pursuant to, the Settlement Agreement and Corporate Integrity Agreement. These expenses and the diversion of the attention of the management team that has occurred, and is expected to continue, has adversely affected, and could continue to adversely affect, our ~~business, financial condition, and results of operations.~~

As a result of the matters reported above, we are exposed to greater risks associated with litigation, regulatory proceedings and government enforcement actions. Any future investigations or additional lawsuits could have a material adverse effect on our business, financial condition, and results of operations.

If our sole manufacturing facility becomes damaged or inoperable, or we are required to vacate the facility, our ability to manufacture and sell our products and to pursue our research and development efforts may be jeopardized.

We currently manufacture and assemble our products in our sole manufacturing facility in Carlsbad, California. Our products consist of components sourced from a variety of suppliers, with final assembly completed at our facility. Our facility and equipment, or those of our suppliers, could be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, fires, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, extreme weather conditions, medical epidemics, and other natural or man-made disasters, pandemics, epidemics, or other business interruptions, for which we are predominantly self-insured. Any of these may render it difficult or impossible for us to manufacture products for an extended period of time. If our facility is inoperable for even a short period of time, the inability to manufacture our current products, and the interruption in research and development of any future products, may result in harm to our reputation, increased costs, lower revenue and the loss of customers, which would have a material adverse effect on our business, financial condition, and results of operations. Furthermore, it could be costly and time-consuming to repair or replace our ~~facilities~~facility and the equipment we use to perform our research and development work and manufacture our products. We also rely on third-party component suppliers, and our ability to obtain commercial supplies of our products could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption, which would have a material adverse effect on our business, financial condition, and results of operations.

The emergence and effects related to a pandemic, epidemic or outbreak of an infectious disease, including the ~~current~~recent COVID-19 pandemic could adversely affect our operations.

If a disaster such as a pandemic, epidemic, outbreak of an infectious disease or other public health crisis were to occur in an area in which we operate, our operations could be adversely affected. For example, COVID-19 ~~has now been~~was characterized as a global pandemic and how long and how extensive the economic effects will last, has not been determined. The extent to which the effects of COVID-19 ~~impacts~~impact our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge ~~concerning the severity of~~regarding COVID-19 and the actions to contain it or treat its impact, among others.A further spread of the pandemic could cause include the temporary closure of our manufacturing facilities and those used in our supply chain processes, restrictions on the export or shipment of our products, business closures in impacted areas, and further restrictions on our employees’ and consultants’ ability to travel and to meet with customers. The pandemic has, and will likely continue, to cause delays in enrollment in our atherectomy indication trial. In

~~addition, we~~ We have experienced ~~minor~~ delays in receiving shipments of parts which has ~~not~~ had ~~a material~~an impact on the timing of our key engineering efforts ~~nor~~but has not affected our ability to support our atherectomy indication clinical trial. The effects of the

pandemic could also adversely affect our ability to secure additional financing in a timely manner or on favorable terms, if at all.

We are involved in securities litigation, and an adverse resolution of such litigation may adversely affect our business, financial condition, results of operations and cash flows.

In June 2019, we became the subject of a lawsuit alleging securities law violations based on alleged misstatements or omissions in the Registration Statement for our IPO and in subsequent public statements. This type of litigation can be expensive and disruptive to normal business operations, and the outcome can be difficult to predict regardless of the facts involved. An unfavorable outcome with respect to this lawsuit could have a material adverse effect on our business, financial condition, results of operations or cash flows. For additional information regarding this lawsuit, see Note ~~13, "Commitments~~12. Commitments and Contingencies" in the notes to the unaudited condensed financial statements included elsewhere in this Quarterly ~~Report on Form 10-Q.~~Report.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our products and could result in recalls, delayed shipments and rejection of our products and damage to our reputation and could expose us to regulatory or other legal action.

We face an inherent risk of product liability as a result of the marketing and sale of our products. For example, we may be sued if our products cause or are perceived to cause injury or are found to be otherwise unsuitable during manufacturing, marketing or sale. For example, in connection with the review of our performance inconsistencies, our catheters were found to occasionally overheat. Any product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or breach of warranty. In addition, we may be subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on physicians in connection with the use of our products on patients. If these physicians are not properly trained, including on the intended use, or are negligent, the capabilities of our products may be diminished, or the patient may suffer critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies.

There can be no assurance that we will be able to detect, remedy and report all defects in the products that we sell, including successfully remedying the issues with our catheters’ performance. These issues with performance could result in the rejection of our products by physicians, damage to our reputation, lost sales, diverted development resources and increased customer service and support costs and warranty claims. Individuals could sustain injuries from our products, and we may be subject to claims or lawsuits resulting from such injuries. There is a risk that these claims or liabilities may exceed, or fall outside the scope of, our insurance coverage. Moreover, we may not be able to retain adequate liability insurance in the future.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit, delay or halt commercialization of our products. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

We believe our product liability insurance is customary for similarly situated companies, but it may not be adequate to cover all liabilities that we may incur. We may not be able to maintain or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise, if at all. Our insurance policy contains various exclusions, and we may be

subject to a product liability claim for which we have no coverage. The potential inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the marketing and sale of products we develop. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts, which would have a material adverse effect on our business, financial condition, and results of operations.

We face substantial competition, which may result in others discovering, developing or commercializing products more successfully than us.

The medical device industry is intensely competitive and subject to rapid and significant technological change. Many of our competitors have significantly greater financial, technical and human resources. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our competitors may also develop products that are more effective, more convenient, more widely used, less costly, have higher reimbursement coverage or have a better safety profile than our products and these competitors may also be more successful than us in manufacturing and marketing their products.

Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, our programs. Competition for these people in the medical device industry is intense and we may face challenges in retaining and recruiting such individuals if, for example, other companies may provide more generous compensation and benefits, more diverse opportunities, and better chances for career advancement than we do. Some of these advantages may be more appealing to high-quality candidates and employees than those we have to offer. In addition, the decline in our stock price has created additional challenges by reducing the retention value of our equity awards. Because of the complex and technical nature of our systems and the dynamic market in which we compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our ability to develop and commercialize our technology, which would have a material adverse effect on our business, financial condition, and results of operations.

We may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do.

The healthcare industry is highly competitive. There are numerous approved products for treating vascular ~~and dermatological~~ diseases in the indications in which we have received clearance or approval and those that we may pursue in the future. Many of these cleared or approved products are well-established and are widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may encourage the use of competitors’ products. In addition, many companies are developing products, and we cannot predict what the standard of care will be in the future.

Our primary competitors for DABRA include Medtronic plc, Cardiovascular Systems Inc., Boston Scientific Corp., Avinger, Inc., Koninklijke Philips N.V., including Volcano Corporation and Spectranetics Corporation, Becton Dickinson and Company, including products from the C.R. Bard acquisition, AngioDynamics and Abbott Laboratories. These companies are manufacturers of products used in competing therapies within the peripheral arterial disease market such as:

We also face competition from pharmaceutical companies that produce drugs which aim to destroy plaque or remove blockages in the bloodstream.

Our primary competitors for Pharos are The Daavlin Company, National Biological Corp., STRATA Skin Sciences and large pharmaceutical companies producing biologicals used in the treatment of chronic skin conditions.

Many of our competitors have substantially greater financial, manufacturing, commercial, and technical resources than we do. There has been consolidation in the industry, and we expect that to continue. Larger competitors may have substantially larger sales and marketing operations than we do. This may allow those competitors to spend more time with current and

potential customers and to focus on a larger number of current and potential customers, which gives them a significant advantage over our sales and marketing team and our international distributors in making sales. In addition, we are often selling

to customers who already utilize our competitors’ products and who have established relationships with our competitors’ sales representatives and familiarity with our competitors’ products.

Larger competitors may also have broader product lines, which enables them to offer customers bundled purchase contracts and quantity discounts. These competitors may have more experience than we have in research and development, marketing, manufacturing, preclinical testing, conducting clinical trials, obtaining FDA and non-U.S. regulatory clearances or approvals and marketing cleared or approved products. Our competitors may discover technologies and techniques, or enter into partnerships and collaborations, to develop competing products that are more effective or less costly than our products or the products we may develop. For example, our competitors with laser-based products may develop upgrades to their lasers that make them easier to use, more efficient or more functional and they may more quickly obtain necessary FDA and non-U.S. regulatory clearances and approvals for such improvements. This may render our technology or products obsolete or noncompetitive. Our competitors may also be better equipped than we are to respond to competitive pressures. If we are unable to compete successfully in our industry, it would have a material adverse effect on our business, financial condition, and results of operations.

If DABRA ~~and Pharos are~~is not cleared or approved for new indications, our commercial opportunity will be limited.

We market and sell DABRA for use as a tool in the treatment of vascular blockages resulting from lower extremity vascular ~~disease and Pharos for use in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.~~disease. Although physicians, in the practice of medicine, may prescribe or use marketed products for uncleared or unapproved indications, manufacturers may promote their products only for the cleared or approved indications and in accordance with the provisions of the cleared or approved label. However, one of our strategies in the future is to pursue additional vascular indications for ~~DABRA and additional dermatological indications for Pharos.~~DABRA. Submitting the required applications for additional indications ~~may~~will require substantial additional funding beyond our cash and cash equivalents as of June 30, ~~2021.~~2022. We cannot assure you that we will be able to successfully obtain clearance or approval for any of these additional product indications through the application process or that a premarket FDA submission may not be necessary.

Even if we obtain FDA clearance or approval to market our products for additional indications in the U.S., we cannot assure you that any such indications will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. If we are unable to successfully develop our products for additional indications, our commercial opportunity will be limited, which would have a material adverse effect on our business, financial condition, and results of operations.

If we make acquisitions or divestitures, we could encounter difficulties that harm our business.

To date, the growth of our business has been organic, and we have no experience in acquiring other businesses, products or technologies. We may acquire companies, products or technologies that we believe to be complementary to the present or future direction of our ~~business.~~business, or may be of a strategic nature with a focus on a new direction focused on the combined company and the business that we may acquire. If we engage in such acquisitions, we may have difficulty integrating the acquired personnel, financials, operations, products or technologies. Acquisitions may dilute our earnings per share, disrupt our ongoing business, distract our management and employees, increase our expenses, subject us to liabilities, and increase our risk of litigation, all of which could harm our business. If we use cash to acquire companies, products or technologies, it may divert resources otherwise available for other purposes. If we use our common stock to acquire companies, products or technologies, our stockholders may experience substantial dilution.

Technological change may adversely affect sales of our products and may cause our products to become obsolete.

The medical device market is characterized by extensive research and development and rapid technological change. Technological progress or new developments in our industry could adversely affect sales of our products. Our products could be rendered obsolete because of future innovations by our competitors or others in the treatment of vascular diseases, ~~and dermatological diseases,~~ which would have a material adverse effect on our business, financial condition, and results of operations.

Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.

Many medical device industry companies are consolidating to create new companies with greater market power. ~~For example, the Spectranetics Corporation was acquired by Koninklijke Philips N.V in 2017.~~ As the medical device industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for medical devices that incorporate components produced by us. If we reduce our prices because of consolidation in the healthcare

industry, our revenue would decrease and our earnings, financial condition, or cash flows would suffer, which would have a material adverse effect on our business, financial condition, and results of operations.

We may be subject to enforcement actions, competitor lawsuits, or other claims if we engage or are found to have engaged in the off-label promotion of our products.

Our promotional materials and training methods must comply with FDA regulations and other applicable laws, including restraints and prohibitions on the promotion of off-label, or uncleared use, of our products. Physicians may use our products for off-label use without regard to these prohibitions, as FDA regulations do not restrict or regulate a physician’s choice of treatment within the practice of medicine. Although our policy is to follow published FDA guidance in order to avoid promoting our products improperly, the FDA or other regulatory agencies or third parties could disagree and conclude that we have engaged in off-label promotion. For example, our DABRA Laser System has been cleared by the FDA for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease. We have not received FDA clearance or approval to market DABRA for an atherectomy indication, and we may not promote DABRA for an atherectomy indication. As previously disclosed, the DOJ served us with a Civil Investigative Demand seeking information with respect to a False Claims Act investigation concerning, among other things, whether we marketed and promoted DABRA devices for unapproved uses that were not covered by federal healthcare programs. Without admitting any liability or wrongdoing, on December 28, 2020, we entered into a Settlement Agreement with the DOJ, other settlement agreements with certain state attorneys general and a related Corporate Integrity Agreement that resolved ~~this~~ civil ~~investigation.~~investigations and a related civil lawsuit. Our pivotal clinical study of the DABRA Laser System completed in 2017 would not be sufficient to expand our FDA-cleared indication for use to an atherectomy indication for use, which the FDA currently defines to include a prespecified improvement in luminal patency, or prespecified increase in the openness of the artery at a pre-defined time point, such as ~~six~~nine months following a DABRA procedure, using a consistent assessment tool. As discussed above, we are currently conducting a clinical study intended to support our FDA regulatory application for the atherectomy indication for use.

We cannot predict the extent to which our competitors may be successful in dissuading physicians from using the DABRA system out of concerns regarding reimbursement. Furthermore, we may incur additional liability from claims initiated under the Lanham Act or other federal and state unfair competition laws with respect to how our products have been marketed and promoted.

In addition, we operate in an industry characterized by extensive litigation. However, the scope of potential liability with respect to any such claims, enforcement actions, or lawsuits is uncertain, and we cannot assure you that we will not receive claims from competitors or other third parties or be subject to enforcement actions in the future from regulatory agencies. For example, the FDA, FTC, the Office of the Inspector General of the Department of Health and Human Services, or HHS, the DOJ and various state ~~Attorneys General~~attorneys general actively enforce laws and regulations that prohibit the promotion of off-label uses. As disclosed above, on December 28, 2020, we entered into a Settlement Agreement and the related Corporate Integrity Agreement to resolve a DOJ civil investigation into, among other things, whether we marketed and promoted DABRA devices for unapproved uses that were not covered by federal healthcare programs, and in connection with the Settlement Agreement, we also have reached agreements ~~that resolve previously disclosed related investigations conducted by~~with certain state attorneys general. ~~The Settlement Agreement does not include a release for any conduct other than the Covered Conduct or any criminal liability related to the Covered Conduct.~~ ~~We have been, and intend to continue, cooperating with the DOJ’s ongoing criminal investigation.~~

The False Claims Act prohibits, among other things, making a fraudulent claim for payment of federal funds, causing such a fraudulent claim to be made, or making a false statement to get a false claim paid. The government may assert that a claim resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim under the False Claims Act. Many companies have faced government investigations or lawsuits by whistleblowers who bring a qui tam action under the False Claims Act on behalf of themselves and the government for a variety of alleged improper marketing activities, including providing free product to customers expecting that the customers would bill federal programs for the product, providing consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe the company’s products, and inflating prices reported to private price publication services, which are used to set drug reimbursement rates under government healthcare programs. In addition, the government and private whistleblowers have pursued False Claims Act cases against medical device companies for causing false claims to be submitted as a result of the marketing of their products for unapproved uses. Medical device and other healthcare companies also are subject to other federal false claim laws,

including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. If we are found to have improperly promoted off-label uses, we may be subject to significant liability, including civil fines, criminal fines and penalties, civil damages, exclusion from federal funded healthcare programs and potential liability under the federal False Claims Act and any applicable state false claims act. Due to the Settlement Agreement and the Corporate Integrity Agreement and the previously disclosed and concluded SEC ~~investigation and ongoing DOJ criminal~~ investigation, we have incurred, and will continue to incur, substantial legal costs, including settlement costs, costs of compliance with such agreements, and payments made pursuant to such agreements, and business disruption, including from ongoing and future compliance with such agreements. In the future, if we are found to have violated the False Claims Act, it may result in significant financial penalties, on a per claim or statement basis, treble damages and exclusion from participation in federal health care programs. In addition, if the FDA determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or

promotional materials, which could negatively impact our marketing and decrease demand for our products. Conduct giving rise to such liability could also form the basis for private civil litigation by third-party payers, competitors, or other persons claiming to be harmed by such conduct.

The FDA, HHS, DOJ, and/or state ~~Attorneys General,~~attorneys general, competitors, and other third parties may take the position that we have violated or are not in compliance with such guidelines, and if such non-compliance is proven, it could harm our reputation, financial condition or divert financial and management resources from our core business and would have a material adverse effect on our business, financial condition and results of operations. Moreover, threatened or actual government enforcement actions or lawsuits by third parties have and could continue to generate adverse publicity, which could decrease demand for our products and require that we devote substantial resources that could be used productively on other aspects of our business.

Regardless of whether actions are commenced, if we were to settle with one or more government agencies, ~~including those conducting the ongoing and unresolved investigation identified above,~~ such settlements could include an agreement to pay civil or criminal damages, injunctions, cease and desist orders, deferred prosecution agreements, or other equitable remedies, exclusion from governmental health care programs, and the curtailment or restructuring of our operations, any of which would have a material adverse effect on our business, financial condition and results of operations for years after any settlement is reached. ~~In light of the ongoing nature of the investigation, whether~~Whether actions will be commenced, whether ~~this~~an investigation can be settled before or after actions are commenced, and the terms on which ~~this~~any investigation can be resolved is not certain.

From time to time we are involved in and may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action, and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. For example, we are currently a party to securities class action and shareholder derivative litigation and other litigation as set forth in ~~the “Legal Proceedings.”~~Legal Proceedings. Litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition, and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for our products, even if the regulatory or legal action is unfounded or not material to our operations.

We must indemnify or advance reasonable legal expenses for officers and directors, including, in certain circumstances, former employees and directors, in their defense against legal proceedings, unless certain conditions apply. A prolonged uninsured expense and indemnification obligation could have a material adverse effect on our business, financial condition, and results of operations.

We are subject to numerous laws and regulations related to healthcare fraud and abuse, false claims, anti-bribery and anti-corruption laws, such as the U.S. Anti-Kickback Statute and Foreign Corrupt Practices Act of 1977, in which violations of these laws could result in substantial penalties, exclusion and prosecution.

In the ~~United States,~~U.S., we are subject to various state and federal fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act. There are similar laws in other countries. These laws may impact, among other things, the sales, marketing and education programs for our products. The federal Anti-Kickback Statute prohibits persons from knowingly and willingly soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program. The federal False Claims Act prohibits persons from knowingly

filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from the federal government. Any allegation, investigation, or violation of domestic healthcare fraud and abuse laws could result in government or internal investigations, significant diversion of resources, exclusion from government healthcare programs and the curtailment or restructuring of our operations, significant fines, penalties, or other financial consequences, any of which may ultimately have a material adverse effect on our business, financial condition, and results of operations. For example, our Audit Committee identified potential healthcare compliance risk areas relating to the previous sales, marketing and education programs for our products. In particular, the Audit Committee found that we lacked documentation of sufficient detail and specificity regarding certain payments to physicians, ostensibly for training and consulting services, and did not accurately reflect the purpose and nature of approximately $300,000 of payments to three physicians, which could be perceived as an improper attempt to obtain business or to gain special advantage. The Audit Committee also found that our salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes.

In November 2019, we learned that the DOJ opened a criminal investigation relating to us. We have been, and intend to continue, cooperating with the DOJ in its ongoing investigation described above. On December 28, 2020, we entered into a Settlement Agreement and a related Corporate Integrity Agreement that resolved a DOJ civil investigation and related lawsuit that concerned, among other things whether we paid improper remuneration to physicians and other healthcare providers in violation of the Anti-Kickback Statute, 42 U.S.C. §1320a-7b.

For our sales and operations outside the ~~United States,~~U.S., we are similarly subject to various ~~heavily-enforced~~heavily enforced anti-bribery and anti-corruption laws, such as the U.S. Foreign Corrupt Practices Act of 1977, as amended, or FCPA, U.K. Bribery Act, and similar laws around the world. These laws generally prohibit U.S. companies and their employees and intermediaries from offering, promising, authorizing or making improper payments to foreign government officials for the purpose of obtaining or retaining business or gaining any advantage. We face significant risks if we, which includes our third parties, fail to comply with the FCPA and other anti-corruption and anti-bribery laws.

We leverage various third parties to sell our products and conduct our business abroad, including to government owned universities and hospitals. We, our distributors and channel partners, and our other third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities (such as in the context of obtaining government approvals, registrations, or licenses or sales to government owned or controlled healthcare facilities, universities, institutes, clinics, etc.) and may be held liable for the corrupt or other illegal activities of these third-party business partners and intermediaries, our employees, representatives, contractors, partners, and agents, even if we do not explicitly authorize such activities. In many foreign countries, particularly in countries with developing economies, it may be a local custom that businesses engage in practices that are prohibited by the FCPA or other applicable laws and regulations. To that end, while we have adopted and implemented internal control policies and procedures and employee training and compliance programs to deter prohibited practices, such compliance measures ultimately may not be effective in prohibiting our employees, contractors, third parties, intermediaries or agents from violating or circumventing our policies and/or the law.

Responding to any enforcement action or related ~~investigation, such as the currently ongoing DOJ~~ investigation may result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees. Any violation of the FCPA, other applicable anti-bribery, anti-corruption laws, healthcare laws, and anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, loss of export privileges, severe criminal or civil sanctions and, in the case of the FCPA, suspension or debarment from U.S. government contracts, which could have a material and adverse effect on our reputation, business, financial condition, and results of operations for years after these investigations are resolved.

Governmental export or import controls could limit our ability to compete in foreign markets and subject us to liability if we violate them.

Our products may be subject to U.S. export controls. Governmental regulation of the import or export of our products, or our failure to obtain any required import or export authorization for our products, when applicable, could harm our international sales and adversely affect our revenue. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments, and persons targeted by U.S. sanctions. If we fail to comply with export and import regulations and such economic sanctions, we may be fined or other penalties could be imposed, including a denial of certain export privileges. Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or technologies targeted by such regulations, could result in decreased use of our products by, or in our decreased ability to export our products to existing or potential customers with international operations. Any decreased use of our products or limitation on our ability to export or sell access to our products would likely materially and adversely affect our business, financial condition, and results of operations.

A variety of risks associated with marketing our products internationally could materially adversely affect our business.

In addition to selling our products in the U.S., we ~~sell Pharos, and in the past~~ have sold DABRA outside of the U.S. in the past. We are subject to additional risks related to operating in foreign countries, including:

These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition, and results of operations.

~~We face additional credit and compliance risks related to our international sales using foreign distributors.~~

~~We have partnered with distributors for DABRA and Pharos in select geographies outside~~The impact of the ~~U.S. For~~military action in Ukraine, and the ~~six months ended June 30, 2021, approximately 3%~~actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our ~~sales were outside of~~supply chain.

On February 24, 2022, Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the ~~U.S. We are not currently distributing DABRA outside~~region is possible. The impact to Ukraine, as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the U.S. and ~~will likely not be able~~other countries and companies and organizations against officials, individuals, regions and industries in Russia and Ukraine, and actions taken by Russia in response to ~~do so until we extend the shelf life of the DABRA catheter. We may not be able~~such sanctions, and each country’s potential response to collect all of the funds owed to us by our foreign distributors. Some foreign distributors may experience financial difficulties, including bankruptcy, which may hinder our collection of accounts receivable. Where we extend credit terms to distributors, we periodically review the collectabilitysuch sanctions, tensions and ~~creditworthiness when determining the payment terms for such distributors. If our uncollectible accounts exceed our expectations, this~~military actions could adversely impact our operating results. In addition, failure by our foreign distributors to comply with the Foreign Corrupt Practices Act or similar laws, insurance requirements, or other contract terms could have a negative impact on our business. Failure to manage the risks related to our foreign distributors would have a material adverse effect on our ~~business,~~operations. Any such material adverse effect from the conflict and enhanced sanctions activity may disrupt our supply chains and affect the delivery of our products and services or impair our ability to complete financial ~~condition,~~or banking transactions.

We also cannot predict the impact of any heightened geopolitical instability or the results that may follow, including reductions in consumer confidence, heightened inflation, cyber disruptions or attacks, higher natural gas costs, higher manufacturing costs and higher supply chain costs. The impact of Russia’s invasion of Ukraine could cause our results ~~of operations.~~to differ materially from the outlook presented in this Quarterly Report.

Changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products. Increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results.

~~The~~In addition to current and proposed economic sanctions on Russia, which may increase or continue for an indefinite period of time as a result of Russia’s invasion of Ukraine, the U.S. has imposed or proposed new or higher tariffs on certain products exported by a number of U.S. trading partners, including China, Europe, Canada, and Mexico. In response, many of those trading partners, including China, have imposed or proposed new or higher tariffs on American products. Continuing changes in government trade policies create a heightened risk of further increased tariffs that impose barriers to international trade. ~~For the six months ended June 30, 2021. approximately 3% of our revenue came from international markets.~~

Tariffs on our customers’ products may adversely affect our gross profit margins in the future due to the potential for increased pressure on our selling prices by customers seeking to offset the impact of tariffs on their own products. We believe that increases in tariffs on imported goods or the failure to resolve current international trade disputes could have a material adverse effect on our business and operating results.

~~We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.~~

Our ability to compete in the highly competitive medical devices industry depends upon our ability to attract and retain highly qualified managerial, scientific, sales and medical personnel. We are highly dependent on our senior management team. The loss of the services of any of our executive officers and other key employees, and our inability to find suitable replacements could result in delays in product development and harm our business.

~~We face intense competition for executive-level talent from a variety of sources, including from current and potential competitors in the medical device and healthcare industries.~~ ~~Our continued success is dependent, in part, upon our ability to attract and retain superior executive officers.~~

Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued stock options and restricted stock units that vest over time. The value to employees of stock options and restricted stock units that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies. The decline in our stock price may create additional challenges by reducing the retention value of our equity awards to these employees. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice. Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. We do not maintain “~~key man~~” insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel. If we are not successful in attracting and retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition, and results of operations.

If we experience significant disruptions in our information technology systems, our business may be adversely affected.

We depend on our information technology systems for the efficient functioning of our business, including the manufacture, distribution and maintenance of DABRA, ~~and Pharos,~~ as well as for accounting, financial reporting, data storage, compliance, purchasing and inventory management. We do not have redundant information technology systems at this time. Our information technology systems may be subject to computer viruses, ransomware or other malware, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, telecommunication failures and user errors, among other malfunctions. In addition, a variety of our software systems are cloud-based data management applications hosted by third-party service providers whose security and information technology systems are subject to similar risks. Technological interruptions would impact our business operations would disrupt our operations, including our ability to timely ship and track product orders, project inventory requirements, manage our supply chain and otherwise adequately service our customers or disrupt our customers’ ability use our products for treatments. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our business, financial condition, and results of operations. Currently, we carry business interruption coverage to mitigate certain potential losses, but this insurance is limited in amount, subject to deductibles, and we cannot be certain that such potential losses will not exceed our policy limits. We are increasingly dependent on complex information technology to manage our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance our existing systems. Failure to maintain or protect our information systems and data integrity effectively could have a material adverse effect on our business, financial condition, and results of operations.

Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. As an “emerging growth company,” we will avail ourselves of the exemption from the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404. However, we may no longer avail ourselves of this exemption when we cease to be an “emerging growth company” unless at that time we are still a “smaller reporting company.” When our independent registered public accounting firm is required to undertake an assessment of our internal control over financial reporting, the cost of our compliance with Section 404 will correspondingly increase. Our compliance with applicable provisions of Section 404 will require that we incur substantial accounting expense and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. Moreover, if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

~~In reviewing the allegations and findings from an Audit Committee investigation related to an initially anonymous complaint~~As previously disclosed, in 2019, ~~as well as additional matters discovered during the course of the investigation,~~ we identified material weaknesses in our internal control over financial reporting. A material weakness is a significant deficiency, or a combination of significant deficiencies, in internal control over financial reporting such that it is reasonably possible that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. The material weaknesses that we identified related to the aggregation of control deficiencies in our control environment, in particular an inappropriate “tone at the top” set by certain members of senior management, a failure to promote adherence to our Code of Ethics and Conduct, and the lack of sufficient competent resources in key roles at the organization.

The material weaknesses discussed were remediated as of December 31, 2019. We incurred significant costs to remediate those weaknesses, primarily personnel costs, external consulting and legal fees, system implementation costs, and related indirect costs including the use of facilities and technology. However, completion of remediation does not provide assurance that our controls will operate properly or that our financial statements will be free from error, which may undermine our ability to provide accurate, timely and reliable reports on our financial and operating results. There may be additional undetected material weaknesses in our internal control over financial reporting, as a result of which we may not detect financial statement errors on a timely basis. Further, to the extent we identify additional material weaknesses, we will not be able to fully assess whether corrective measures will remediate the material weakness in our internal control over financial reporting until we have completed our implementation efforts and sufficient time passes in order to evaluate their effectiveness. In addition, if we identify additional errors that result in material weaknesses in our internal control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. Moreover, in the future we may engage in

business transactions, such as acquisitions, reorganizations or implementation of new information systems that could negatively affect our internal control over financial reporting and result in material weaknesses.

If we identify additional material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 in a timely manner, if we are unable to assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, we may be late with the filing of our periodic reports, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be negatively affected. As a result of such failures, we could also become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation, financial condition or divert financial and management resources from our core business and would have a material adverse effect on our business, financial condition and results of operations.

In order to increase our revenue over the longer term, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.

At June 30, ~~2021,~~2022, we had 8622 full-time employees. In the second quarter of 2022, we initiated a reduction in force, in which approximately 65% of our full-time employees were immediately terminated and the non-terminated employees were offered conditional retention arrangements pursuant to which it was expected that they would continue to provide services through the third quarter of 2019, we began implementing certain operational efficiency and cost savings initiatives intended to align our resources with our product strategy, reduce our operating expenses, and manage our cash flows. These cost efficiency initiatives include targeted workforce reductions of our sales and marketing teams.2022.

Over the longer term, we intend to hire and train additional skilled sales personnel. At such time, we would expect to need additional managerial, operational, sales, marketing, financial, and other personnel. Future growth would impose significant added responsibilities on members of management, including:

Our future financial performance and our ability to successfully market and sell our products will depend, in part, on our ability to hire and retain qualified personnel and to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our products and, accordingly, may not achieve our research, sales and marketing goals, which would have a material adverse effect on our business, financial condition, and results of operations.

We actively employ social media as part of our marketing strategy, which could give rise to regulatory violations, liability, fines, breaches of data security or reputational damage.

Despite our efforts to monitor evolving social media communication guidelines and comply with applicable rules, there is risk that the use of social media by us, our employees or our customers to communicate about our products or business may cause us to be found in violation of applicable requirements, including requirements of regulatory bodies such as the FDA and Federal Trade Commission. For example, promotional communications and endorsements on social media that, among other things, promote our products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label uses”), do not contain a fair balance of information about risks associated with using our products, make comparative or other claims about our products that are not supported by sufficient evidence, and/or do not contain required disclosures could result in an enforcement actions against us. In addition, adverse events, product complaints, off-label usage by physicians, unapproved marketing or other unintended messages posted on social media could require an active response from us, which may not be completed in a timely manner and could result in regulatory action by a governing body. Further, our employees may knowingly or inadvertently make use of social media in ways that may not comply with our corporate policies or other legal or contractual requirements, which may give rise to liability, lead to the loss of trade secrets or other intellectual property or result in public exposure of personal information of our employees, clinical trial patients, customers and others. Furthermore, negative posts or comments about us or our products in social media could seriously damage our reputation, brand image and goodwill, which would have a material adverse effect on our business, financial condition, and results of operations.

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.

In the ordinary course of our business, we may become exposed to, or collect and store sensitive data, including procedure-based information and legally protected health information, credit card, and other financial information, insurance information, and other potentially personally identifiable information. We also store sensitive intellectual property and other proprietary business information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology, or IT, and infrastructure, and that of our third-party billing and collections provider and other technology partners, may be vulnerable to cyber-attacks by hackers or viruses or breached due to employee error,

malfeasance or other disruptions. We rely extensively on IT systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided and/or used by third-parties or their vendors, to assist in conducting our business. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations. The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination or intentional destruction of confidential information stored in our or our third-party providers’ systems, portable media or storage devices. We could also experience a business interruption, theft of confidential information or reputational damage from industrial espionage attacks, malware or other cyber-attacks, which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party providers. Although the aggregate impact on our operations and financial condition has not been material to date, we have been the target of events of this nature and expect them to continue as cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry. We are investing in protections and monitoring practices of our data and IT to reduce these risks and continue to monitor our systems on an ongoing basis for any current or potential threats. There can be no assurance, however, that our efforts will prevent breakdowns or breaches to our or our third-party providers’ databases or systems that could adversely affect our business.

Regulatory compliance is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.

The FDA and similar agencies regulate our products as medical devices. Complying with these regulations is costly, time consuming, complex and uncertain. FDA regulations and regulations of similar agencies are wide-ranging and include, among other things, oversight of:

Our current products are subject to extensive regulation by the FDA and non-U.S. regulatory agencies. Further, all of our potential products and improvements of our current products will be subject to extensive regulation and will likely require permission from regulatory agencies and ethics boards to conduct clinical trials, and clearance or approval from the FDA and non-U.S. regulatory agencies prior to commercial sale and distribution. Failure to comply with applicable U.S. requirements may subject us to a variety of administrative or judicial actions and sanctions, such as Form 483 observations, warning letters, untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution. The FDA can also refuse to clear or approve pending applications. Any enforcement action by the FDA and other comparable non-U.S. regulatory agencies could have a material adverse effect on our business, financial condition, and results of operations.

Our medical device operations are subject to pervasive and continuing FDA regulatory requirements.

Medical devices regulated by the FDA are subject to “general controls” which include:

As previously disclosed, the Audit Committee found, among other things, that we, out of a concern for the DABRA catheters’ performance, engaged in efforts to replace product held by customers, which constituted product recalls, but were not documented as such. As disclosed above, we have entered ~~to a~~into the Settlement Agreement, and the agreements with the participating states, resolving a DOJ civil investigation concerning certain Covered Conduct (as defined in the Settlement Agreement), and the OIG has agreed, conditioned upon our full payment of amounts owed in the Settlement Agreement, and in consideration of our obligations under a Corporate Integrity Agreement, to release our permissive exclusion rights and refrain from instituting any administrative action seeking to exclude us from participating in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct. The Corporate Integrity Agreement has a five-year term and imposes monitoring, reporting, certification, documentation, oversight, screening, and training obligations on us, including the hiring of a compliance officer and independent review organization.

Some devices known as “510(k)-exempt” devices can be marketed without prior marketing clearance or approval from the FDA. In addition to the “general controls,” ~~some~~ Class II medical devices are also subject to “special controls,” including, in many cases, adherence to a particular guidance document and compliance with the performance standard. As Class II, 510(k)-cleared devices, our products are subject to both general and special controls. Instead of obtaining 510(k) clearance, most Class III devices are subject to premarket approval, or PMA. We do not believe any of our current products are Class III devices, but future products could be, which would subject them to the PMA process.

Many medical devices, such as medical lasers, are also regulated by the FDA as “electronic products.” In general, manufacturers and marketers of “electronic products” are subject to certain FDA regulatory requirements intended to ensure the radiological safety of the products. These requirements include, but are not limited to, filing certain reports with the FDA about the products and defects/safety issues related to the products as well as complying with radiological performance standards.

In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting, or MDR, requirements, including the reporting of adverse events and malfunctions related to our products. We are required to file MDRs if our products may have caused or contributed to a serious injury or death or malfunctioned in a way that could likely cause or contribute to a serious injury or death if it were to recur. Any such MDR that reports a significant adverse event could result in negative publicity, which could harm our reputation and future sales. ~~For example, the Audit Committee found that~~ ~~we failed to timely make at least two MDRs to the FDA which have since been reported.~~ Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory clearances or approvals, product seizures, injunctions or the imposition of civil or criminal penalties which may have a material adverse effect on our business, financial condition, and results of operations.

The medical device industry is now experiencing greater scrutiny and regulation by federal, state and foreign governmental authorities. Companies in our industry are subject to more frequent and more intensive reviews and investigations, often involving the marketing, business practices, and product quality management. For example, as discussed above, on December 28, 2020, we entered into a Settlement Agreement with the DOJ to resolve a civil False Claims Act investigation and related civil action, and in connection with the Settlement Agreement, we also have reached agreements that resolve previously disclosed related investigations conducted by certain state attorneys general. Under the Settlement Agreement, and the agreements with the participating states, we are required to make an initial payment of $2.5 million, of which we paid $2.4 million in December 2020 and $0.1 million in April 2021. We also may be required to make additional payments in the future upon the achievement of revenue targets or consummating a change-in-control transaction. We also

entered into a 5-year Corporate Integrity Agreement with the OIG. The Settlement Agreement does not include a release for any conduct other than the Covered Conduct or any criminal liability related to the Covered Conduct. ~~The Settlement Agreement does not release any claims that were~~This settlement and our ongoing obligations under ~~investigation by~~ the U.S. Securities and Exchange Commission. The DOJ criminal investigation is ongoing, and we are cooperating with that investigation. These investigations may result in criminal proceedings; the imposition of substantial fines and penalties; the receipt of warning letters, untitled letters, demands for recalls or the seizure of our products; fines and penalties for violation of our Corporate Integrity Agreement ~~stipulated~~

~~judgments or other administrative remedies, and result in our incurring substantial unanticipated costs and the diversion of key personnel and management~~’~~s attention from their regular duties, any of which may have an adverse effect on our financial condition, results of operations and liquidity, and~~ may result in greater and continuing governmental scrutiny of our business in the future.

Additionally, federal, state and foreign governments and entities have enacted laws and issued regulations and other standards requiring increased visibility and transparency of our interactions with healthcare providers. For example, the U.S. Physician Payment Sunshine Act, now known as Open Payments, requires us to report to the Centers for Medicare & Medicaid Services, or CMS, payments and other transfers of value to all U.S. physicians and U.S. teaching hospitals, with the reported information made publicly available on a searchable website. ~~As previously disclosed, the Audit Committee found that~~On December 28, 2020, we lacked documentation of sufficient detail and specificity regarding certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which that could be perceived as an improper attempt to obtain business or to gain special advantage, and we subsequently entered into the Settlement Agreement with the DOJ relating to claims under the civil False Claims Act investigation concerning, among other things, whether we marketed and promoted DABRA devices for unapproved uses that were not covered by federal healthcare programs, and whether we paid improper remuneration to physicians and other healthcare providers in violation of the Anti-Kickback Statute. Effective January 2022, we ~~will~~are also be required to collect and report information on payments or transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives. Failure to comply with these legal and regulatory requirements could impact our business, and we have had and will continue to spend substantial time and financial resources to develop and implement enhanced structures, policies, systems and processes to comply with these legal and regulatory requirements, which may also impact our business and which could have a material adverse effect on our business, financial condition, and results of operations for years after any resolution of these investigations and any resulting claims are resolved.

Under FDA regulations, unless exempt, a new medical device may only be commercially distributed after it has received 510(k) clearance, is authorized through the de novo classification process, or is the subject of an approved PMA. The FDA will clear marketing of a medical device through the 510(k) process if it is demonstrated that the new product is substantially equivalent to another legally marketed product not subject to a PMA. Sometimes, a 510(k) clearance must be supported by preclinical and clinical data. Our ability to enroll patients in clinical trials, including our atherectomy indication trial, could be impacted by the COVID-19 outbreak, as many patients are electing or being asked to delay procedures at this time.

The PMA process typically is more costly, lengthy and stringent than the 510(k) process. Unlike a 510(k) review which determines “substantial equivalence,” a PMA requires that the applicant demonstrate reasonable assurance that the device is safe and effective by producing valid scientific evidence, including data from preclinical studies and human clinical trials. Therefore, to obtain regulatory clearance or approvals, we typically must, among other requirements, provide the FDA and similar foreign regulatory authorities with preclinical and clinical data that demonstrate to their satisfaction that our products satisfy the criteria for approval. Preclinical testing and clinical trials must comply with the regulations of the FDA and other government authorities in the U.S. and similar agencies in other countries.

We may be required to obtain PMAs, PMA supplements or additional 510(k) premarket clearances to market modifications to our existing products. The FDA requires device manufacturers to make and document a determination of whether a device modification requires approval or clearance; however, the FDA can review a manufacturer’s decision. The FDA may not agree with our decisions not to seek approvals or clearances for particular device modifications. If the FDA requires us to obtain PMAs, PMA supplements or premarket clearances for any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing the modified device and perhaps also to recall such modified device until we obtain FDA clearance or approval. We may also be subject to significant regulatory fines or penalties.

The FDA may not approve ~~our current or~~ future PMA applications or supplements or clear our 510(k) applications on a timely basis or at all. For example, the COVID-19 outbreak could affect the FDA’s ability to review applications or supplements. Such delays or refusals could have a material adverse effect on our business, financial condition, and results of operations.

The FDA may also change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our products under development or impact our ability to modify our currently approved or cleared products on a timely basis. Any of these actions could have a material adverse effect on our business, financial condition, and results of operations.

International regulatory approval processes may take more or less time than the FDA clearance or approval process. If we fail to comply with applicable FDA and comparable non-U.S. regulatory requirements, we may not receive regulatory clearances or approvals or may be subject to FDA or comparable non-U.S. enforcement actions. We may be unable to obtain future regulatory clearance or approval in a timely manner, or at all, especially if existing regulations are changed or new regulations are adopted. For example, the FDA clearance or approval process can take longer than anticipated due to requests for additional clinical data and changes in regulatory requirements. A failure or delay in obtaining necessary regulatory clearances or approvals would materially adversely affect our business, financial condition, and results of operations.

Although we have obtained regulatory clearance for our products in the U.S. and certain non-U.S. jurisdictions, they will remain subject to extensive regulatory scrutiny.

Although our products have obtained regulatory clearance in the U.S. and certain non-U.S. jurisdictions, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, effectiveness, and other post-market information, including both federal and state requirements in the U.S. and requirements of comparable non-U.S. regulatory authorities.

Our manufacturing facility is required to comply with extensive requirements imposed by the FDA and comparable foreign regulatory authorities, including ensuring that quality control and manufacturing procedures conform to the QSR or similar regulations set by foreign regulatory authorities. Following our voluntary recalls, ~~and given our Audit Committee findings,~~ we have a heightened potential for an FDA inspection. As such, we will be subject to continual review and inspections to assess compliance with the QSR and adherence to commitments made in any 510(k) application. Accordingly, we continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any regulatory clearances or approvals that we have received for our products will be subject to limitations on the cleared or approved indicated uses for which the product may be marketed and promoted or to the conditions of approval or contain requirements for potentially costly post-marketing testing. We are required to report certain adverse events and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing product safety issues could result in increased costs to assure compliance. The FDA and other agencies, including the DOJ, closely regulate and monitor the post-clearance or approval marketing and promotion of products to ensure that they are marketed and distributed only for the cleared or approved indications and in accordance with the provisions of the cleared or approved labeling. For example, the DOJ served us with a Civil Investigative Demand seeking information with respect to a False Claims Act investigation concerning whether we fraudulently obtained 510(k) marketing clearance for our ablation devices marketed under the trade name DABRA, whether we marketed and promoted DABRA devices for unapproved uses that were not covered by federal healthcare programs, and whether we paid improper remuneration to physicians and other healthcare providers in violation of the Anti-Kickback Statute, 42 U.S.C. §1320a-7b.

Promotional communications with respect to devices are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s cleared or approved labeling. As such, we may not promote our products for indications or uses for which they do not have clearance or approval. However, physicians can use their independent and professional judgment and use our products for off-label purposes, as FDA regulations do not restrict a physician’s choice of treatment with the practice of medicine. Prior to making certain changes to a cleared product, including certain changes to product labeling, the holder of a cleared 510(k) application may be required to submit a new premarket application and obtain clearance or approval.

If a regulatory agency discovers previously unknown problems with our products, such as adverse events of unanticipated severity or frequency, or problems with our facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of our products, such regulatory agency or enforcement authority may impose restrictions on that product or us, including requiring withdrawal of the product from the market. In addition to this type of penalty for failing to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

In addition, violations of the Federal Food, Drug, and Cosmetic Act, or FDCA, relating to the promotion of approved products may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws. As disclosed previously, we settled a DOJ civil False Claims Act investigation concerning, among other things, whether we marketed and promoted DABRA devices for unapproved uses that were not covered by federal healthcare programs.

Any government adverse finding, regulatory sanction or investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory clearance or approval is withdrawn, it would have a material adverse effect on our business, financial condition, and results of operations.

Our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business.

The FDA and similar foreign governmental authorities have the authority to order the recall of our products because of any failure to comply with applicable laws and regulations, or defects in design or manufacture. A government mandated or voluntary product recall by us could occur because of, for example, component failures, device malfunctions, or other adverse events, such as serious injuries or deaths, or quality-related issues such as manufacturing errors or design or labeling defects.

For example, we have conducted four recent recalls related to our DABRA and Pharos products. In August 2018, we initiated a voluntary recall of our Pharos laser due to the potential for the laser to calibrate with the iris closed. This recall was classified as a Class II recall by FDA (a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote). The four affected lasers were corrected, and the recall has been terminated by the FDA. In August 2019, we initiated a voluntary recall of a limited number of Pharos lasers due to a software error that caused the device to fail at low doses. This recall was classified as a Class II recall by the FDA. The software was revised, and the affected lasers were corrected. The FDA classified this recall as complete.product. In September 2019, we initiated a voluntary recall of our DABRA catheters to replace 12-month shelf life labeled catheters with two-month shelf life labeled catheters, which we believe will significantly reduce the number of catheters that fail to calibrate. We submitted a request for termination to the FDA in February 2020, and as of July 2020, 98% of the affected product has been returned to us. ~~Finally, a~~A voluntary recall of DABRA lasers was initiated in January 2020 to correct a software issue that could result in user or patient injury or may adversely impact laser performance. This recall was classified as a Class II recall by the FDA. The ~~Company considers~~FDA terminated this recall ~~complete and submitted to the FDA a final status report in July 2020 requesting termination of this field correction.~~on November 1, 2021. In addition, in July 2020 we initiated a voluntary recall of our DABRA lasers to replace the wheels with lower profile wheels that were cleared by the FDA in the DABRA 510(k). We formally notified the FDA of this recall in accordance with applicable ~~law and expect it will be classified by the FDA in due course.~~law. This field correction was completed in March 2021. The Company considers this recall complete and submitted to the FDA a final status report in March 2021 requesting termination of this field correction. In October 2020 we initiated a voluntary recall of our DABRA lasers to replace the footswitch with a footswitch that meets specification for protection from ingress of solids or liquids. We formally notified the FDA of this recall in accordance with applicable law. This recall was classified as a Class II recall by the FDA. This field correction was completed in October 2021, and the Company received notice in February 2022 that the FDA has terminated this field correction. Any government-mandated recall or additional voluntary recall by us could occur as a result of component failures, manufacturing errors, design or labeling defects or other issues. These voluntary recalls and any future recalls of our products could divert managerial and financial resources, harm our reputation and adversely affect our business.

In addition, the FDA conducted an unannounced facility inspection in December 2019. The FDA issued to us a Form 483 that included observations that schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established, a device master record index was not current, and document control procedures have not been fully established. We responded to the FDA with the corrective measures we are taking and to address the issued identified in the Form 483 and based on this information, the FDA issued to us an Establishment Inspection Report, or EIR, closing out the inspection. All actions are complete, and the final Form 483 report was sent to the FDA on September 25, 2020.

Also, we have been engaged in additional shelf life testing at the FDA’s request as part of a special 510(k). Due to recent variations noted in the shelf life of the catheter during our testing procedures, we have paused commercial sales of DABRA catheters not being used for the atherectomy clinical trial. We submitted additional test data in March 2021 related to the DABRA catheter shelf life in a traditional 510(k), which was cleared by the FDA in July 2021.

Depending on the corrective action we take to address a product’s deficiencies or defects, the FDA may require, or we may voluntarily decide, that we will need to seek and obtain new approvals or clearances for the device before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including adverse inspection findings, FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fines. We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our products in the future.

As part of our investigation into the DABRA device performance, we conducted an internal audit of the clinical study that was used to support the device’s 510(k) application. The audit consisted of review of clinical study documentation that was retained by the study sponsor and found adequate evidence to support the safety and efficacy reported in the clinical study report submitted with the 510(k) application. The other observations identified by the audit were found to not have a major impact on the reported results of the study. If FDA were to disagree with the outcome of the audit and take the position that the issues with the clinical trial were reportable to the FDA, we could be required to issue a safety alert to our customers or initiate a recall, we could incur product liability and other costs, product clearances or approvals could be delayed, suspended or revoked, enforcement action could be initiated by regulatory authorities, we could be required to cease commercialization of DABRA and our business could otherwise be adversely affected.

In addition, we are subject to medical device reporting regulations that require us to report to the FDA or similar foreign governmental authorities if one of our products may have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction recurred. After a May 2018 inspection, the FDA issued to us a Form 483 that included observations for failure to properly evaluate whether certain complaints related to ~~Pharos and~~ DABRA that we have received rose to a level required to be reported to the FDA. At that time, in response, we informed the FDA that we have modified our complaint review procedures and we completed a retrospective evaluation and have not found any complaints which require a submission to the FDA. We have not requested, and the FDA has not issued, an EIR related to this inspection. ~~In connection with our Audit Committee investigation, the Audit Committee also found failures~~

The failure by us to properly identify reportable events or to file timely reports ~~as well as failure to address each of~~with the ~~May 2018 observations to~~ FDA’~~s satisfaction. Although we have since identified and made the appropriate reports to the FDA, these prior failures~~ can subject us to sanctions and penalties, including warning letters and recalls. Physicians, hospitals and other healthcare providers may make similar reports to regulatory authorities. Any such reports may trigger an investigation by the FDA or similar foreign regulatory bodies, which could divert managerial and financial resources, harm our reputation and have a material adverse effect on our business, financial condition, and results of operations.

Material modifications to our devices may require new 510(k) clearances or premarket approvals or may require us to recall or cease marketing our devices until clearances or approvals are obtained.

Material modifications to the intended use or technological characteristics of our devices will require new 510(k) clearances or premarket approvals or require us to recall or cease marketing the modified devices until these clearances or approvals are obtained. Based on FDA published guidelines, the FDA requires device manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement, or clearance; however, the FDA can review a manufacturer’s decision. Any modification to an FDA-cleared device that would significantly affect its safety or efficacy or that would constitute a major change in its intended use would constitute a material modification and would require a new 510(k) clearance or possibly a premarket approval. If required, we may not be able to obtain additional 510(k) clearances or premarket approvals for new devices or for modifications to, or additional indications for, our devices in a timely fashion, or at all. Delays in obtaining required future clearances would harm our ability to introduce new or enhanced devices in a timely manner, which in turn would harm our future growth. We have made modifications to our devices in the past and will make additional modifications in the future that we believe do not or will not require additional clearances or approvals. If the FDA disagrees and requires new clearances or approvals for the modifications, we may be required to recall and to stop selling or marketing our devices as modified, which could harm our operating results and require us to redesign our platform devices. In these circumstances, we may also be subject to significant enforcement actions such as significant regulatory fines or penalties. Furthermore, the FDA’s ongoing review of the 510(k) program may make it more difficult for us to modify our previously cleared products, either by imposing stricter requirements on when a new 510(k) for a modification to a previously cleared product must be submitted or applying more onerous review criteria to such submissions.

If we or our suppliers fail to comply with the FDA’s Quality System Regulation or any applicable state equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer.

We and our suppliers are required to comply with the ~~FDA~~’sFDA’s QSR, which delineates, among other things, the design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product requirements, corrective and preventive action requirements, labeling and packaging controls, handling, storage, distribution and installation requirements, complaint handling, records requirements, servicing requirements, and statistical techniques potentially applicable to the production of our medical devices. We and our suppliers are also subject to the regulations of foreign jurisdictions regarding the manufacturing process if we market products overseas. The FDA enforces the QSR through periodic and announced or unannounced inspections of manufacturing facilities. Our ~~facilities have~~facility has been inspected by the FDA and other regulatory authorities, and weanticipate that we and certain of our third-party component suppliers will be subject to additional future inspections. If our ~~facilities~~facility or manufacturing processes or our suppliers’ facilities or manufacturing processes are found to be in non-compliance or fail to take satisfactory corrective action in response

to adverse QSR inspectional findings, the FDA could take legal or regulatory enforcement actions against us and/or our products, including but not limited to the cessation of sales or the initiation of a recall of distributed products, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our ~~customers~~’customers’ demands. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits.

Current regulations depend heavily on administrative interpretation. If the FDA does not believe that we are in compliance with applicable FDA regulations, the agency could take legal or regulatory enforcement actions against us and/or our products. We are also subject to periodic inspections by the FDA, other governmental regulatory agencies, as well as certain third-party regulatory groups. Future interpretations made by the FDA or other regulatory bodies made during the course of these inspections may vary from current interpretations and may adversely affect our business and prospects. The ~~FDA~~’sFDA’s and other comparable non-U.S. regulatory ~~agencies~~’agencies’ statutes, regulations, or policies may change, and additional government regulation or statutes may be enacted, which could increase post-approval regulatory requirements, or delay, suspend, prevent marketing of any cleared or approved products or necessitate the recall of distributed products. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

The medical device industry has been under heightened FDA scrutiny as the subject of government investigations and enforcement actions. If our operations and activities are found to be in violation of any FDA laws or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and other legal and/or agency enforcement actions. Any penalties, damages, fines, or curtailment or restructuring of our operations or activities could adversely affect our ability to operate our business and our financial results. The risk of us being found in violation of FDA laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend ourselves against that action and its underlying allegations, could cause us to incur significant legal expenses and divert ~~management~~’smanagement’s attention from the operation of our business. Where there is a dispute with a federal or state governmental agency that cannot be resolved to the mutual satisfaction of all relevant parties, we may determine that the costs, both real and contingent, are not justified by the commercial returns to us from maintaining the dispute or the product.

Various claims, design features or performance characteristics of our medical devices, that we regarded as permitted by the FDA without new marketing clearance or approval, may be challenged by the FDA or state or foreign regulators. The FDA or state or foreign regulatory authorities may find that certain claims, design features or performance characteristics, in order to be made or included in the products, may have to be supported by further clinical studies and marketing clearances or approvals, which could be lengthy, costly and possibly unobtainable.

If any of our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

Under the FDA medical device reporting regulations, or MDR regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. For example, ~~in 2015 we submitted to the FDA an MDR~~ for ~~an event that involved a patient who experienced significant erythema, or skin reddening, and transient blistering after treatment with Pharos. The patient was treatedwith topical antibiotics and subsequently continued treatment. For~~ DABRA the most frequent complication reported to us as a result of post-market surveillance is clinically non-significant vessel perforation. In connection with an internal audit of our regulatory reporting systems, ~~and our Audit Committee investigation,~~ we have revised and continue to monitor our internal

operating procedures for complaint handling and adverse event classifications. We reviewed all adverse medical events that ~~were~~have been reported to us ~~prior to and during the Audit Committee investigation~~ and retrospectively filed three MDRs with the FDA.

If we fail to report events required to be reported to the FDA within the required timeframes, or at all, the FDA could take enforcement action against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require our time and capital, distract management from operating our business, and may harm our reputation and have a material adverse effect on our business, financial condition, and results of operations.

Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.

There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increasing costs of healthcare and, more generally, to reform the U.S. healthcare system.

Certain of these proposals could limit the prices we are able to charge for our products or the coverage and reimbursement available for our products and could limit the acceptance and availability of our products on the market. The adoption of proposals to control costs could have a material adverse effect on our business, financial condition, and results of operations.

For example, in the U.S., in March 2010, the PPACA was passed. The PPACA was intended to make significant changes to the way healthcare is financed by both federal and state governments and private insurers, with direct impacts to the medical device industry. Among other provisions, the PPACA imposed, with limited exceptions, a deductible excise tax of 2.3% on sales of medical devices by entities, including us, that manufacture or import certain medical devices offered for sale in the U.S., including many of our products. The Consolidated Appropriations Act, 2016 (Pub. L. 114-113), signed into law in December 2015, included a two-year moratorium on the medical device excise tax. A second two-year moratorium on the medical device excise tax was signed into law in January 2018 as part of the Extension of Continuing Appropriations Act, 2018 (Pub. L. 115-120), extending the moratorium through December 31, 2019. On December 20, 2019, President Trump signed into law a permanent repeal of the medical device tax under the PPACA, but there is no guarantee that Congress or the President will not reverse course in the future. If such an excise tax on sales of certain of our products in the ~~United States~~U.S. is enacted, it could have a material adverse effect on our business, financial condition, and results of operations.

In addition, the PPACA and the Medicare Access and CHIP Reauthorization Act of 2015 substantially changed the way healthcare is delivered and financed by both governmental and private insurers. These changes included the creation of demonstration programs and other value-based purchasing initiatives that provide financial incentives for physicians and hospitals to reduce costs, including incentives for furnishing low-cost therapies for chronic wounds even if those therapies are less effective than our products. Under the Trump Administration, there were ongoing efforts to modify or repeal all or part of PPACA or take executive action that affects its implementation. Tax reform legislation was passed that includes provisions that impact healthcare insurance coverage and payment such as the elimination of the tax penalty for individuals who do not maintain health insurance coverage (the so-called “individual mandate”). Such actions or similar actions could have a negative effect on the utilization of our products. ~~We are uncertain as to the extent such efforts will continue under the Biden administration and to what extent there will be additional reform proposals at federal and state levels.~~

On December 18, 2019, the ~~United States~~U.S. Court of Appeals for the Fifth Circuit upheld a lower court’s determination in Texas v. Azar,, 4:18-cv-00167, that the individual mandate was unconstitutional and remanded the case to the lower court for further analysis as to whether PPACA as a whole is unconstitutional because the individual mandate is not severable from other provisions of the law. In ~~November 2020,~~June 2021, the ~~United States~~U.S. Supreme Court held ~~oral arguments~~that Texas and other challengers had no legal standing to challenge the PPACA, dismissing the case on procedural grounds without specifically ruling on the ~~Fifth Circuit United States Court~~constitutionality of ~~Appeals decision~~the PPACA. Thus, the PPACA will remain in effect in its current form. Further, legislative and regulatory changes under the PPACA remain possible, although the new federal administration under President Biden has signaled that ~~held that~~it plans to build on the ~~individual mandate is unconstitutional.~~PPACA and expand the number of people who are eligible for health insurance under it. It is ~~uncertain~~unclear how ~~the United States Supreme Court will rule on this case or how~~future litigation and healthcare measures ofpromulgated by the Biden administration will impact the implementation of the PPACA and our ~~business. Litigation~~business, financial condition and results of operations. Complying with any new legislation ~~over~~or reversing changes implemented under the PPACA ~~are likely to continue, with unpredictable~~could be time-intensive and ~~uncertain results. We cannot predict the ultimate results of the~~ ~~Texas~~ ~~case or whether additional legislative reform proposals will be adopted, when they will be adopted, or what impact they may have on us, but any such proposals could have~~expensive, resulting in a ~~negative impact~~material adverse effect on our ~~business and provide incentives for hospitals and physicians to not use our products.~~business.

Other healthcare reform legislative changes have also been proposed and adopted in the U.S. since the PPACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, led to aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect in April 2013, which, due to subsequent legislative amendments, will stay in effect through ~~2030,~~2031, with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through March 31, ~~2021,~~2022, unless additional congressional action is taken. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of the sequester. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced

Medicare payments to several types of providers, including hospitals, imaging centersand cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Further, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed, and enacted federal legislation designed to bring transparency to product pricing and reduce the cost of products and services under government healthcare programs. ~~Congress~~As a result of reform of the U.S. healthcare system, changes in reimbursement policies or healthcare cost containment initiatives may limit or restrict coverage and ~~the Trump administration have each indicated that it will continue~~reimbursement for procedures using our products and cause our revenue to ~~seek new legislative and/or administrative measures to control product costs.~~decline. Additionally, individual states in the U.S. have also become increasingly active in passing legislation and implementing regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. Moreover, Medicare, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what products to purchase, and which suppliers will be included in their healthcare programs. Adoption of price controls and other ~~cost-containment~~cost-

containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures may prevent or limit our ability to generate revenue, attain profitability.

Various new healthcare reform proposals are emerging at the federal and state level. Any new federal and state healthcare initiatives that may be adopted could limit the amounts that federal and state governments will pay for healthcare products and services and could have a material adverse effect on our business, financial condition, and results of operations.

Healthcare cost containment pressures and legislative or administrative reforms resulting in restrictive coverage and reimbursement practices of third-party payors could decrease the demand for our products and the number of procedures performed using our devices, which could have an adverse effect on our business.

Our products are purchased principally by physician office-based labs, which typically bill various third-party payors, including governmental programs, such as Medicare and Medicaid, private insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of our customers to obtain reimbursement for procedures that are performed using our products from government and private third-party payors is critical to our success. The availability of coverage and reimbursement for procedures performed using our products affects which products customers purchase and the prices they are able to pay to us.

Reimbursement can vary based on geographical location, type of provider/customer, and third-party payor and can significantly influence the acceptance of new products and services. Third-party payors may view some procedures performed using our products as experimental and may not provide coverage. Third-party payors may not cover and reimburse our customers for certain procedures performed using our products in whole or in part in the future, or payment rates may decline and not be adequate, or both. Further, coverage and reimbursement by third-party payors to our customers is also related to billing codes to describe procedures performed using our products. Hospitals and physicians use several billing codes to bill for such procedures. Third-party payors may not continue to recognize the current procedural technology, or CPT, codes available for use by our customers. The CPT codes may change undermining our ~~customer~~’scustomer’s ability to use those codes and reimbursement may be interrupted. Furthermore, some payors may not accept these new or revised codes for payment. If payors do not cover atherectomy, physicians may not perform as many DABRA treatments as they otherwise would perform. Consequently, we may not be able to sell as many catheters for DABRA treatments as projected.

Reimbursement rates are unpredictable, and we cannot project how our business may be affected by future legislative and regulatory developments. Future legislation or regulation, or changing payment methodologies, may have a material adverse effect on our business, financial condition, and results of operations, and reimbursement may not be adequate for all customers. From time to time, typically on an annual basis, payment amounts are updated and revised by third-party payors. Because the cost of our products generally is recovered by the healthcare provider as part of the payment for performing a procedure and not separately reimbursed, these updates, especially lower payments could directly impact the demand for our products. For example, in July 2013, the Centers for Medicare and Medicaid Services, or CMS, proposed reimbursement changes that would have decreased reimbursement for procedures in an outpatient-based facility, such as a catheterization lab. Although CMS chose not to implement those changes in 2013, we cannot assure you that CMS will not take similar actions in the future.

After we develop new products or seek to market our products for new approved or cleared indications, we may find limited demand for the product unless government and private third-party payors provide adequate coverage and reimbursement to our customers. Obtaining codes and reimbursement for new products may require an extended, multi-year effort. Even with reimbursement approval and coverage by government and private payors, providers submitting reimbursement claims for new products or existing products with new approved or cleared indications may face delay in payment if there is confusion by providers or payors regarding the appropriate codes to use in seeking reimbursement. Such delays may create an unfavorable impression within the marketplace regarding the level of reimbursement or coverage available for our products.

Demand for our products or new approved indications for our existing products may fluctuate over time if federal or state legislative or administrative policy changes affect coverage or reimbursement levels for our products or the services related to our products. In the U.S., there have been, and we expect there will continue to be legislative and regulatory proposals to change the healthcare system, such as the potential repeal of the PPACA, some of which could significantly affect our business. It is uncertain what impact the current U.S. presidential administration will have on healthcare spending. If enacted and implemented, any measures to restrict healthcare spending could result in decreased revenue from the sale of our products and decreased potential returns from our research and development initiatives. Other legislative or administrative reforms to the U.S. or international reimbursement systems in a manner that significantly reduces reimbursement for procedures performed using our products or denies coverage for those procedures could have a material adverse effect on our business, financial condition, and results of operations.

Our sales into foreign markets expose us to risks associated with international sales and operations.

We ~~are currently selling~~have historically sold into foreign markets and plan to ~~expand such sales.~~continue to do so if we re-commercialize DABRA. Conducting international operations subjects us to risks that could be different than those faced by us in the ~~United States.~~U.S. The sale and shipment of our products across international borders, as well as the purchase of components and products from international sources, subject us to extensive U.S. and foreign governmental trade, import and export and customs regulations and laws, including but not limited to, the Export Administration Regulations and trade sanctions against embargoed countries, which are administered by the Office of Foreign Assets Control within the Department of the Treasury, as well as the laws and regulations administered by the Department of Commerce. These regulations limit our ability to market, sell, distribute or otherwise transfer our products or technology to prohibited countries or persons.

Compliance with these regulations and laws is costly, and failure to comply with applicable legal and regulatory obligations could adversely affect us in a variety of ways that include, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export privileges, seizure of shipments and restrictions on certain business activities. Also, the failure to comply with applicable legal and regulatory obligations could result in the disruption of our distribution and sales activities.

These risks may limit or disrupt our expansion, restrict the movement of funds or result in the deprivation of contractual rights or the taking of property by nationalization or expropriation without fair compensation. Operating in international markets also requires significant management attention and financial resources.

Our employees, independent contractors, consultants, commercial partners, distributors, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, consultants, commercial partners, distributors, and vendors and other individuals or entities with whom we have arrangements may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws of the FDA and other similar foreign regulatory bodies, including those laws requiring the reporting of true, complete and accurate information to such regulators; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the U.S. and similar foreign fraudulent misconduct laws; or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales, marketing, and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, waste, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

We have adopted a code of ethics and business conduct, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or

lawsuits stemming from a failure to be in compliance with such laws or regulations. For example, ~~the Audit Committee investigation identified certain behavior inconsistent with the Company’s Code of Ethics and Conduct and related policies. In addition,~~ as discussed above, we entered into to a Settlement Agreement with the DOJ to resolve a civil investigation and related civil action, and in connection with the Settlement Agreement, entered into a 5-year Corporate Integrity Agreement with the OIG. We have incurred, and will continue to incur, costs related to compliance under, and payments made pursuant to, the Settlement Agreement and Corporate Integrity Agreement. These expenses and the diversion of the attention of the management team that has occurred, and is expected to continue, has adversely affected, and could continue to adversely affect, our business, financial condition, and results of operations. ~~In addition, as disclosed above, there is an ongoing DOJ criminal investigation.~~ If such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in government investigations, civil and criminal proceedings, the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. In the future, whether or not we are successful in defending against such further actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition, and results of operations.

Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations.

Federal, state, local and foreign laws regarding environmental protection, hazardous substances and human health and safety may adversely affect our business. Using hazardous substances in our operations exposes us to the risk of accidental injury, contamination or other liability from the use, storage, importation, handling, or disposal of hazardous materials. If our or our suppliers’ operations result in the contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and fines, and any liability could significantly exceed our insurance coverage and have a material adverse effect on our on our business, financial condition, and results of operations. Future changes to environmental and health and safety laws could cause us to incur additional expenses or restrict our operations, which could have a material adverse effect on our business, financial condition, and results of operations.

Our operations and relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers and third-party payors play a primary role in the recommendation of our cleared devices and any future cleared or approved devices. Our current and future arrangements with providers, third-party payors and customers may be materially limited because of broadly applicable fraud and abuse and other healthcare laws and regulations. The business or financial arrangements and relationships through which we market, sell and distribute our cleared devices could also be constrained.

Restrictions under applicable U.S. federal and state healthcare laws and regulations may include the following:

Some state laws require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require medical device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. In addition, we may be subject to state and non-U.S. laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Our Audit Committee identified certain conduct that may implicate healthcare laws and FDA regulatory requirements, including a failure to timely make at least two MDRs to the FDA, replacement of product held by customers, which constituted product recalls, but were not documented as such, a lack of sufficient documentation to support certain payments to physicians, and as to three physicians did not accurately reflect the purpose and nature of the payments, instructions to salespeople to characterize DABRA as performing atherectomy and encouragement to doctors to seek reimbursement using atherectomy codes, and direction of potentially valuable benefits and opportunities to doctors that were informed in part by sales prospects. As disclosed above, we entered into a Settlement Agreement with the DOJ to resolve a civil investigation and related civil complaint concerning Covered Conduct. Also as disclosed above, the DOJ is conducting a criminal investigation. We are cooperating with that investigation.

We have undertaken efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations. Such efforts may involve substantial costs. As disclosed above, we entered into a Settlement Agreement with the DOJ to resolve a civil investigation and related civil complaint concerning Covered Conduct. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of product candidates from government-funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. If any of the above occurs, it could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government-funded healthcare programs, which could have a material adverse effect on our business, financial condition, and results of operations.

If a breach of our measures protecting personal data covered by HIPAA, the HITECH Act, or the CCPA occurs, we may incur significant liabilities.

~~The Health Insurance Portability and Accountability Act of 1996, or~~ HIPAA, as amended by the HITECH Act, and the regulations that have been issued under it, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of protected health information. The requirements and restrictions apply to “covered entities” (which include health care providers and insurers) as well as to their business associates that receive protected health information from them in order to provide services to or perform certain activities on their behalf. The statute and regulations also impose notification obligations on covered entities and their business associates in the event of a breach of the privacy or security of protected health information. We occasionally receive protected health information from our customers in the course of our business. As such, we believe that we are business associates and therefore subject to HIPAA’s requirements and restrictions with respect to handling such protected health information and have executed business associate agreements with certain customers.

In addition, California has enacted the California Consumer Privacy Act, or CCPA, which came into effect on January 1, 2020. Pursuant to the CCPA, certain businesses are required, among other things, to make certain enhanced disclosures related to California residents regarding the use or disclosure of their personal information, allow California residents to opt-out of certain uses and disclosures of their personal information without penalty, provide Californians with other choices related to personal data in our possession, and obtain opt-in consent before engaging in certain uses of personal information relating to Californians under the age of 16. The California Attorney General may seek substantial monetary penalties and injunctive relief in the event of our non-compliance with the CCPA. The CCPA also allows for private lawsuits from Californians in the event of certain data breaches. Aspects of the CCPA remain uncertain, and we may be required to make modifications to our policies or practices in order to comply.

It is possible the data protection laws may be interpreted and applied in a manner that is inconsistent with our practices. If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. In addition, these privacy regulations may differ from country to country and state to state and may vary based on whether testing is performed in the ~~United States~~U.S. or in the local country. Complying with these various laws and regulations could cause

us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Further, compliance with data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. We can provide no assurance that we are or will remain in compliance with diverse privacy and security requirements in all of the jurisdictions in which we do business. If we fail to comply or are deemed to have failed to comply with applicable privacy protection laws and regulations such failure could result in government enforcement actions and create liability for us, which could include substantial civil and/or criminal penalties, as well as private litigation and/or adverse publicity that could negatively affect our operating results and business.

If we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our existing products and any products we may develop, and our technology may be adversely affected.

As with other medical device companies, our ability to maintain and solidify a proprietary position for our products will depend upon our success in obtaining effective patent claims that cover such products, their manufacturing processes and their intended methods of use, and enforcing those claims once granted. Furthermore, in some cases, we may not be able to obtain issued claims covering DABRA, ~~and Pharos,~~ as well as other technologies that are important to our business, which are sufficient to prevent third parties, such as our competitors, from utilizing our technology. Any failure to obtain or maintain patent protection with respect to DABRA ~~and Pharos~~ could have a material adverse effect on our business, financial condition, and results of operations.

Changes in either the patent laws or their interpretation in the U.S. and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our issued patents. Additionally, we cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors or other third parties.

The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, suppliers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable over the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in any of our pending patent applications, or that we were the first to file for patent protection of such inventions. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from or license to third parties and are therefore reliant on our licensors or licensees. Therefore, these and any of our patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example, with respect to proper priority claims, inventorship, and the like, although we are unaware of any such defects that we believe are of material importance. If we or any future licensors or licensees, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If any future licensors or licensees are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation or prosecution of our patents or patent applications, such patents or applications may be invalid and unenforceable. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

In addition, if any patents are issued in the future, they may not provide us with any competitive advantages, or may be successfully challenged by third parties. Agreement terms that address non-competition are difficult to enforce in many jurisdictions and may not be enforceable in any particular case. To the extent that our intellectual property and other proprietary rights are not adequately protected, third parties might gain access to our proprietary information, develop and market products or services similar to ours, or use trademarks similar to ours, each of which could materially harm our business. Existing ~~United States~~U.S. federal and state intellectual property laws offer only limited protection. Moreover, the laws of other countries in which we

now, or may in the future, conduct operations or contract for services may afford little or no effective protection of our intellectual property. The failure to adequately protect our intellectual property and other proprietary rights could materially harm our business.

The strength of patent rights involves complex legal and scientific questions and can be uncertain. This uncertainty includes changes to the patent laws through either legislative action to change statutory patent law or court action that may reinterpret existing law or rules in ways affecting the scope or validity of issued patents. The patent applications that we own may fail to result in issued patents in the ~~United States~~U.S. or foreign countries with claims that cover our products or services. Even if patents do successfully issue from the patent applications that we own, third parties may challenge the validity, enforceability or scope of such patents, which may result in such patents being narrowed, invalidated or held unenforceable. Any successful challenge to our patents could deprive us of exclusive rights necessary for the successful commercialization of our products and services. Furthermore, even if they are unchallenged, our patents may not adequately protect our products and services, provide exclusivity for our products and services, or prevent others from designing around our claims. If the breadth or strength of protection provided by the patents we hold or pursue with respect to our products and services is challenged, it could dissuade companies from collaborating with us to develop, or threaten our ability to commercialize, our products and services.

Patents have a limited lifespan. In the ~~United States,~~U.S., the natural expiration of a utility patent is generally 20 years after its effective filing date and the natural expiration of a design patent is generally 14 years after its issue date, unless the filing date occurred on or after May 13, 2015, in which case the natural expiration of a design patent is generally 15 years after its issue date. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our products and services, we may be open to competition. Further, if we encounter delays in our development efforts, the period of time during which we could market our products and services under patent protection would be reduced.

In addition to the protection afforded by patents, we also rely on trade secret protection to protect proprietary know-how that may not be patentable or that we elect not to patent, processes for which patents may be difficult to obtain or enforce, and any other elements of our products and services that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. If the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating any trade secrets. Misappropriation or unauthorized disclosure of our trade secrets could significantly affect our competitive position and may have a material adverse effect on our business. Furthermore, trade secret protection does not prevent competitors from independently developing substantially equivalent.

If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and products would be adversely affected.

The patent position of medical device companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our products or which effectively prevent others from commercializing competitive technologies and products.

Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether DABRA ~~and Pharos~~ will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition, results of operations and prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our patents may be challenged in the courts or patent offices in the U.S. and abroad. We may be subject to a third-party preissuance submission of prior art to the ~~United States~~U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings or other similar proceedings challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our priority of invention or other features of patentability with respect to our patents and patent applications. Such challenges may result in

loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of ~~DABRA and Pharos.~~DABRA. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us, which would have a material adverse effect on our business, financial condition, and results of operations.

Obtaining and maintaining our patent protection depends on compliance with various procedural measures, document submissions, fee payments and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and applications will be due to be paid to the USPTO and various government patent agencies outside of the U.S. over the lifetime of our patents and applications. The USPTO and various non-U.S. government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, and results of operations.

We may not be able to protect our intellectual property and proprietary rights throughout the world.

Third parties may attempt to commercialize competitive products or services in foreign countries where we do not have any patents or patent applications where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations.

Filing, prosecuting, and defending patents on our products in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

Changes in either the patent laws or interpretation of the patent laws in the U.S. could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Assuming that other requirements for patentability are met, prior to March 2013, in the U.S., the first to invent the claimed invention was entitled to the patent, while outside the U.S., the first to file a patent application was entitled to the patent. After March 2013, under the

Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 2011, the U.S. transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Since patent applications in the U.S. and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we were the first to either (i) file any patent application related to our products or (ii) invent any of the inventions claimed in our patents or patent applications.

The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, and results of operations.

Issued patents covering our products could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.

If we initiated legal proceedings against a third party to enforce a patent covering our products, the defendant could counterclaim that such patent is invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise claims challenging the validity or enforceability of our patents before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products. Such a loss of patent protection would have a material adverse effect on our business, financial condition, and results of operations.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for our products, we rely upon unpatented trade secrets, know-how and continuing technological innovation to develop and maintain a competitive position. We seek to protect our proprietary information, in part, through confidentiality agreements with our employees, collaborators, contractors, advisors, consultants, and other third parties, and invention assignment agreements with our employees. We also have agreements with some of our consultants that require them to assign to us any inventions created as a result of their working with us. The confidentiality agreements are designed to protect our proprietary information and, in the case of agreements or clauses requiring invention assignment, to grant us ownership of technologies that are developed through a relationship with a third party.

Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the U.S. are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely

harmed. Furthermore, we expect these trade secrets, know-how and proprietary information to over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to industry scientific positions.

We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions, which could have a material adverse effect on our business, financial condition, and results of operations.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our products. Litigation may be necessary to defend against these and other claims challenging inventorship or our patents, trade secrets or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our products. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, and results of operations.

We may become involved in intellectual property litigation either due to claims by others that we are infringing their intellectual property rights or due to our own assertions that others are infringing upon our intellectual property rights.

The medical device industry in general has been characterized by extensive litigation and administrative proceedings regarding patent infringement and intellectual property rights. Our competitors hold a significant number of patents relating to medical laser technology. From time to time, we may commence litigation to enforce our intellectual property rights. An adverse decision in these actions or in any other legal action could limit our ability to assert our intellectual property rights, limit the value of our technology or otherwise negatively impact our business, financial condition and results of operations.

Monitoring unauthorized use of our intellectual property is difficult and costly. Unauthorized use of our intellectual property may have occurred or may occur in the future. Although we have taken steps to minimize the risk of this occurring, any such failure to identify unauthorized use and otherwise adequately protect our intellectual property would adversely affect our business. Moreover, if we are required to commence litigation, whether as a plaintiff or defendant, not only will this be time-consuming, but we will also be forced to incur significant costs and divert our attention and efforts of our employees, which could, in turn, result in lower revenue and higher expenses.

We cannot provide assurance that our products or methods do not infringe the patents or other intellectual property rights of third parties. Additionally, if our business is successful, the possibility may increase that others will assert infringement claims against us.

Determining whether a product infringes a patent involves complex legal and factual issues, and the outcome of a patent litigation action is often uncertain. We have not conducted an extensive search of patents issued or assigned to other parties, including our competitors, and no assurance can be given that patents containing claims covering our products, parts of our products, technology or methods do not exist, have not been filed or could not be filed or issued. Because of the number of patents issued and patent applications filed in our technical areas, our competitors or other parties may assert that our products and the methods we employ in the use of our products are covered by U.S. or foreign patents held by them. In addition, because patent applications can take many years to issue and because publication schedules for pending applications vary by jurisdiction, there may be applications now pending of which we are unaware, and which may result in issued patents which our current or future products infringe. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that we infringe. There could also be existing patents that one or more of our products or parts may infringe and of which we are unaware. As the number of competitors in the market for medical lasers and as the number of patents issued in this area grows, the possibility of patent infringement claims against us increases. In certain situations, we may determine that it is in our best interests or their best interests to voluntarily challenge a party’s products or patents in litigation or other proceedings, including patent interferences or re-examinations. As a result, we may become involved in unwanted litigation that could be costly, result in diversion of management’s attention, require us to pay damages and force us to discontinue selling our products.

Infringement and other intellectual property claims and proceedings brought against us, whether successful or not, could result in substantial costs and harm to our reputation. Such claims and proceedings can also distract and divert management and key personnel from other tasks important to the success of the business. We cannot be certain that we will successfully defend against allegations of infringement of patents and intellectual property rights of others. In the event that we become subject to a patent infringement or other intellectual property lawsuit and if the other party’s patents or other intellectual property were upheld as valid and enforceable and we were found to infringe the other party’s patents or violate the terms of a license to which we are a party, we could be required to do one or more of the following:

Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the sale and marketing of our products.

The medical devices industry is highly competitive and dynamic. Due to the focused research and development that is taking place by several companies, including us and our competitors, in this field, the intellectual property landscape is in flux, and it may remain uncertain in the future. As such, there may be significant intellectual property related litigation and proceedings relating to our, and other third party, intellectual property, and proprietary rights in the future.

Our commercial success depends in part on our and any potential future collaborators’ ability to avoid infringing, misappropriating and otherwise violating the patents and other intellectual property rights of third parties. It is uncertain whether the issuance of any third-party patent would require us or any licensee to alter our development or commercial strategies, obtain licenses, or cease certain activities. The medical device industry is characterized by extensive litigation regarding patents and other intellectual property rights, as well as administrative proceedings for challenging patents, including interference, derivation and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. As discussed above, recently, due to changes in U.S. law referred to as patent reform, new procedures including inter partes review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of challenge to our patents in the future.

Third parties may currently have patents or obtain patents in the future and claim that the manufacture, use or sale of our products infringes upon these patents. In the event that any third-party claims that we infringe their patents or that we are otherwise employing their proprietary technology without authorization and initiates litigation against us, even if we believe such claims are without merit, a court of competent jurisdiction could hold that such patents are valid, enforceable and infringed by our products. In this case, the holders of such patents may be able to block our ability to commercialize the applicable products or technology unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be held invalid or unenforceable. Such a license may not be available on commercially reasonable terms or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, we may be unable to commercialize our products, or such commercialization efforts may be significantly delayed, which could in turn significantly harm our business.

For example, in December 2017, we were contacted by a third party suggesting that we should consider licensing three U.S. patents directed to the treatment of vitiligo, U.S. Pat. No. 6,979,327, (or the “’327 patent,”), U.S. Pat. No. 7,261,729, (or the “’729 patent,”), and U.S. Pat. No. 8,387,621, (or the “’621 ~~patent~~”).patent. In addition, we were also previously contacted in 2006 by the same third party suggesting that we should consider licensing the ’327‘~~327~~ patent as well as the then pending application that became the ’‘729 patent. We believe that we will be meritorious if a claim of infringement of the ’‘327 patent, the ’‘729 patent, or the ’‘621 patent is asserted against us in a legal proceeding by this or any other third party. However, although we believe that we do not infringe the claims of the ’‘327 patent, the ’‘729 patent, or the ’‘621 patent, nor do we believe that we need a license to the ’‘327 patent, the ’‘729 patent, or the ’‘621 patent in order to freely commercialize our products, there is a possibility that a suit claiming infringement of the ’‘327 patent, the ’‘729 patent, or the ’‘621 patent will be brought against us, and we cannot assure

that a court or an administrative agency will agree with our assessment with regard to non-infringement of the ‘’327 patent, the ‘’729 patent, or the ‘’621 patent. If it was necessary to obtain a license to the ‘’327 patent, the ‘’729 patent, or the ‘’621 patent and a license was not available on commercially reasonable terms or available at all, that could affect our ability to commercialize our products and materially and adversely affect our business.

If a third party commences a patent infringement action against us it could consume significant financial and management resources, regardless of the merit of the claims or the outcome of the litigation. Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, and may impact our reputation. In the event of a successful claim of infringement against us, we may be enjoined from further developing or commercializing our infringing products. In addition, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties and/or redesign our infringing products or technologies, which may be impossible or require substantial time and monetary expenditure. In that event, we would be unable to further develop and commercialize our products, which could harm our business significantly.

Engaging in litigation to defend against third parties alleging that we have infringed their patents or other intellectual property rights is very expensive, particularly for a company of our size, and time-consuming. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we can because they may have greater financial resources. Patent litigation and other proceedings may also consume significant management time. Uncertainties resulting from the initiation or continuation of patent litigation or other proceedings against us could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition or results of operations.

We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents, or we may be required to defend against claims of infringement. In addition, our patents also may become involved in inventorship, priority or validity disputes. To counter or defend against such claims can be expensive and time consuming. In an infringement proceeding, a court may decide that a patent owned by us is invalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on our common stock price. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

We may be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.

Many of our employees, consultants and scientific advisors are currently or were previously employed at universities or healthcare companies, including our competitors and potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we have been and may in the future become subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. If we fail in defending any such claims, it could have a material adverse effect on our business, financial condition, and results of operations. Even if we are successful in defending against such claims, litigation could result in substantial costs to us and be a distraction to management.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, and results of operations.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be violating or infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement or dilution claims brought by owners of other trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, and results of operations.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these events occur, they could have a material adverse effect on our business, financial condition, and results of operations.

We depend on third-party suppliers for key components and sub-assemblies used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate components and sub-assemblies could harm our business.

We ~~are currently experiencing~~have experienced inconsistencies in our DABRA catheter performance, as more fully described in the risk factor ~~entitled “—~~titled We ~~are experiencing~~have experienced inconsistencies in our DABRA catheter ~~performance, including shelf life and non-calibrations.~~performance. This and any other development or manufacturing problems or delays ~~that~~ could limit the potential growth of our revenue or increase our losses.” In addition to the inconsistencies and risks described in the foregoing risk factor, we may encounter unforeseen situations that would result in delays or shortfalls in ~~manufacturing.~~manufacturing, including as a result of the ongoing military conflict between Russia and Ukraine. Key components and sub-assemblies of DABRA ~~and Pharos are currently~~would be provided by a limited number of suppliers, and we domay not maintain large inventory levels of these components and sub-assemblies. For example, we would rely on a limited number of suppliers for the Thyratron used to manufacture our lasers. If we experience a shortage in any of these components or sub-assemblies, we would need to identify and qualify new supply sources, which could increase our costs, result in manufacturing delays, and cause delays in the delivery of our products. ~~We may also experience a delay in completing validation and verification testing or sterility audits for controlled-environment rooms at our manufacturing facility.~~

We also depend on limited source suppliers for some of our product components and sub-assemblies, and if any of those suppliers are unable or unwilling to produce these components or sub-assemblies or supply them in the quantities that we need, and at acceptable prices, we would experience manufacturing delays and may not be able to deliver our products on a timely or cost-effective basis to our customers, or at all, which could reduce our product sales, increase our costs, and harm our business. While we believe that we could obtain replacement components from alternative suppliers, we may be unable to do so. Losing any of these suppliers could cause a disruption in our production. Our suppliers may encounter problems during manufacturing due to a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction and environmental factors. Establishing additional or replacement suppliers for these materials may take significant time, as certain of these suppliers must be approved by regulatory authorities, which could disrupt our production. As a result, we could experience significant delays in manufacturing and delivering our products to customers. We cannot assure you we can continue obtaining required materials, components, and sub-assemblies that are in short supply within the time frames we require at an affordable cost, if at all. If we cannot secure on a timely basis sufficient quantities of the materials we depend on to manufacture our products, if we encounter delays or contractual or other difficulties in our relationships with these suppliers, or if we cannot find replacement suppliers at an acceptable cost, then manufacturing our products may be disrupted, which could increase our costs, prevent or impair our development or commercialization efforts, and have a material adverse effect on our business, financial condition, and results of operations.

Our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms.

Because we ~~currently obtain~~have historically obtained certain components globally, some of which are uniquely customized, from limited sources, we are subject to significant supply and pricing risks and exposed to multiple potential sources of component shortages. Many components, including those that are available from multiple sources, are at times subject to industry-wide shortages and significant commodity pricing fluctuations that could materially adversely affect our financial condition and operating results. We ~~are sourcing~~have sourced alternative parts to mitigate the challenges caused by these shortages, but there is no guarantee we may be able to continually do so as we scale production to meet our growth targets. The unavailability of any component or supplier could result in production delays, idle manufacturing facilities, product design changes and loss of access to important technology and tools for producing and supporting our products, as well as impact our capacity production. Our suppliers may not be willing or able to sustainably meet our timelines or our cost, quality and volume needs, or to do so may cost us more, which may require us to replace them with other sources. If our supply of components for a new or existing product continues to be delayed or constrained for any reason, including if an outsourcing partner delayed shipments of completed products to us or additional time is required to obtain sufficient quantities from the original source, or if we have to identify and obtain sufficient quantities from an alternative source, then our financial condition and operating results could be materially adversely affected. In addition, the continued availability of these components at acceptable prices, or at all, can be affected for any number of reasons,

including if suppliers decide to concentrate on the production of common components or components for other customers instead of components customized to meet our requirements. While we have entered into agreements for the supply of many components, there can be no assurance that we will be able to extend or renew these agreements on similar terms, or at all. Component suppliers may suffer from poor financial conditions, which can lead to business failure for the supplier or consolidation within a particular industry, further limiting our ability to obtain sufficient quantities of components on commercially reasonable terms. While we believe that we will be able to secure additional or

alternate sources or develop our own replacements for most of our components, there is no assurance that we will be able to do so quickly or at all. Additionally, we may be unsuccessful in our continuous efforts to negotiate with existing suppliers to obtain cost reductions and avoid unfavorable changes to terms, source less expensive suppliers for certain parts and redesign certain parts to make them less expensive to produce. Any of these occurrences may harm our business, prospects, financial condition and operating results.

We and our component suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations.

As a medical device manufacturer, we must register with the FDA and non-U.S. regulatory agencies, and we are subject to periodic inspection by the FDA and foreign regulatory agencies, for compliance with certain good manufacturing practices, including design controls, product validation and verification, in process testing, quality control and documentation procedures. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA and foreign regulatory agencies. Our component suppliers are also required to meet certain standards applicable to their manufacturing processes.

We cannot assure you that we or our component suppliers comply or can continue to comply with all regulatory requirements. A failure by us or one of our component suppliers to achieve or maintain compliance with these requirements or quality standards may disrupt our ability to supply products sufficient to meet demand until compliance is achieved or, with a component supplier, until a new supplier has been identified and evaluated. Our or any of our component ~~supplier~~’ssuppliers’ failure to comply with applicable regulations could cause sanctions to be imposed on us, including warning letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals or clearances, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, which could harm our business. We cannot assure you that if we need to engage new suppliers to satisfy our business requirements, we will be able to locate new suppliers in compliance with regulatory requirements at a reasonable cost and in an acceptable timeframe. Our failure to do so could have a material adverse effect on our business, financial condition, and results of operations.

In the European Union, we must maintain certain International Organization for Standardization, or ISO, certifications to sell our products and must undergo periodic inspections by notified bodies, including the British Standards Institution, to obtain and maintain these certifications. If we fail these inspections or fail to meet these regulatory standards, it could have a material adverse effect on our business, financial condition, and results of operations.

We may form or seek strategic alliances or enter into licensing arrangements in the future, and we may not realize the benefits or costs of such alliances or licensing arrangements.

We may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our sales and marketing efforts with respect to our products and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our products. If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new strategic partnership agreements related to our products could delay the commercialization of our products in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

We relyon thirdpartiesto conduct our clinicaltrialsand thosethirdpartiesmaynot performsatisfactorily, includingfailingto meetdeadlinesforthe completionof such trials,researchand studies,or failingto comply with regulatoryrequirements.

We do not have the ability to independently conduct our clinical trials. We currently rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct clinical trials and we would expect to continue to rely upon third parties to conduct clinical trials of our investigational products. Third parties have a significant role in the conduct of our clinical trials and the subsequent collection and analysis of data. These third parties are not our employees, and except for remedies available to us under our agreements with such third parties, we have limited ability to control the amount or timing of resources that any such third party will devote to our clinical trials. The third parties we rely on for these services may also have relationships with other entities, some of which may be our competitors. Some of these third

parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements with a third party, it would delay our development activities.

Our reliance on these third parties for such medical device development activities will reduce our control over these activities but will not relieve us of our regulatory responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with GCP standards, regulations for conducting, recording and reporting the results of clinical trials to assure that data and reported results are reliable and accurate and that the rights, integrity and confidentiality of trial participants are protected. If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials substantially comply with GCP regulations. In addition, our clinical trials must be conducted with product produced under current cGMP or quality system regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the marketing authorization process.

Misconduct by our CROs or other third-party contractors could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by third parties we contract with, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant penalties, damages, reputational harm, and the curtailment or restructuring of our operations, among others.

The price of our stock may be volatile, which could result in substantial losses for investors. Further, an active, liquid and orderly trading market for our common stock may not be sustained and we do not know what the market price of our common stock will be, and as a result it may be difficult for you to sell your shares of our common stock.

Prior to our listing on the ~~NYSE~~New York Stock Exchange in September 2018, there was no public market for shares of our common stock. Although our common stock is listed on the NYSE American, the market for our shares has demonstrated varying levels of trading activity. Furthermore, an active trading market for our shares may not be sustained in the future. You may not be able to sell your shares quickly or at the market price if trading in shares of our common stock is not active. Further, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using shares of our common stock as consideration, which could have a material adverse effect on our business, financial condition, and results of operations. In addition, the trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk ~~Factors”~~Factors section and elsewhere in this report, these factors include:

In addition, the stock market in general, and medical device companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which could have a material adverse effect on our business, financial condition, and results of operations.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.

Our quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future operating results. Our operating results may fluctuate due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:

In addition, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award, and recognize the cost as an expense over the employee’s requisite service period. As the

variables that we use as a basis for valuing these awards change over time, including our underlying stock price and stock price volatility, the magnitude of the expense that we must recognize may vary significantly.

From time to time, we may also enter into license or collaboration agreements with other companies that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source of our revenue. Accordingly, our revenue may depend in part on any potential future license and collaboration agreements and sales of our products. These upfront and milestone payments may vary significantly from period to period and any such variance could cause a significant fluctuation in our operating results from one period to the next.

The cumulative effect of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated revenue and/or earnings guidance we may provide.

As of December 31, ~~2020,~~2021, we had net operating loss carryforwards, or NOLs, of approximately ~~$14.3~~$39.2 million for federal income tax purposes, and ~~$13.4~~$41.2 million for state income tax purposes. ~~The federal net operating loss can be carried forward indefinitely and the state net operating losses begin expiring in 2032.~~ Utilization of these NOLs depends on many factors, including our future income, which cannot be assured. These NOLs could expire unused and be unavailable to offset our future income tax liabilities. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership by 5% stockholders over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change income may be limited. We have completed an IRC Section 382 analysis regarding the limitation of net operating losses through December 31, 2020 and determined that an ownership change occurred in May 2020. The effect of the ownership change is reflected in the NOL balances as of December 31, 2020. The Company calculated the limitation on net operating losses and other tax attributes and reduced the value of the deferred tax assets resulting in a tax expense impact of ~~$20.8M.~~$20.8 million. The tax expense was offset by a tax benefit recorded on the reduction in valuation allowance recorded for the deferred tax assets for the year ended December 31, 2020. We may experience ownership changes in the future as a result of subsequent changes in our stock ownership, some of which may be outside of our control. Ownership changes that materially limit our use of our historical NOLs could harm our future operating results by effectively increasing our future U.S federal income tax and state income tax obligations. In addition, as a result of the Tax Cuts and Jobs Act of 2017, as modified by the ~~recently enacted~~ Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, federal NOLs incurred in 2018 and in future years may be carried forward indefinitely, ~~and deductibility of federal NOLs generally may be limited in future years.~~

~~Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.~~

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could affect the tax treatment of our domestic and foreign earnings. Any new taxes could adversely affect our domestic and international business operations, and our business and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, on December 22, 2017, President Trump signed tax legislation into law, commonly referred to as the Tax Cuts and Jobs Act of 2017, that contains many significant changes to the U.S. tax laws, the consequences of which have not yet been fully determined. Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings, andhowever, the deductibility of ~~expenses contained~~our federal NOLs generated in ~~the Tax Cuts and Jobs Act~~such years will be limited to 80% of ~~2017 or other tax reform legislation could have a material impact on the value of our deferred tax assets, could result~~taxable income if utilized in ~~significant one-time charges in the current or future~~ taxable years ~~and could increase our future U.S. tax expense. The foregoing items could have~~beginning after December 31, 2020. Federal net operating losses incurred in years beginning before January 1, 2018 are subject to a ~~material adverse effect on our business, cash flow, financial condition or results~~twenty-year carryforward but are not limited to 80% of operations. In addition, it is uncertain if and to what extent various states will conform to the newly enacted federal tax legislation. The impact of this tax legislation on holders of our common stock is also uncertain and could be adverse. We urge our stockholders and investors to consult with their own legal and tax advisors with respect to this legislation and the potential tax consequences of investing in or holding our common stock.taxable income.

We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

We are an emerging growth company, as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growth company for up to five years following the year in which we completed our ~~initial public offering,~~IPO, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of our ~~initial public offering,~~IPO, (b) in which we have total annual gross revenue of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company” which may allow us to take advantage of many of the same exemptions from disclosure requirements including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to avail ourselves of this exemption and, therefore, we are not subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, changes in rules of U.S. generally accepted accounting principles, or GAAP, or their interpretation, the adoption of new guidance or the application of existing guidance to changes in our business could significantly affect our financial position and results of operations.

We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management has devoted and will continue to devote substantial time to new compliance initiatives, including maintaining an effective system of internal controls over financing reporting.

As a public company, we have incurred and will continue to incur significant legal, accounting, insurance, and other expenses that we did not incur as a private company. We are subject to the reporting requirements of the Exchange Act, which

require, among other things, that we file with the SEC, annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and the NYSE American to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Emerging growth companies are permitted to implement many of these requirements over a longer period and up to five years from the completion of our ~~initial public offering.~~IPO. We intend to take advantage of this legislation but cannot guarantee that we will not be required to implement these requirements sooner than anticipated or planned and thereby incur unexpected expenses. Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.

These rules and regulations applicable to public companies have increased and will continue to substantially increase our legal and financial compliance costs and to make some activities more time consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition, and results of operations. The increased costs will decrease our net income or increase our net loss and may require us to reduce costs in other areas of our business or increase the prices of our products or services. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

Future sales and issuances of a substantial number of shares of our common stock or rights to purchase common stock by our stockholders in the public market could result in additional dilution of the percentage ownership of our stockholders and cause our stock price to fall.

If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline. As of June 30, ~~2021,~~2022, we had outstanding ~~5,902,612~~32,278,914 shares of our common stock.

In connection with our ~~May 2020~~February 2022 equity offering and ~~August~~our 2020 equity offerings, we issued warrants to investors and our placement ~~agent,~~agents and, in connection with the sale of the Dermatology Business in 2021, we issued a warrant to the broker. We had an aggregate ~~of 2,345,033~~56,329,950 warrants ~~are~~ outstanding as of June 30, ~~2021.~~2022. We have an effective shelf registration statement and had an ~~“at~~effective ATM offering thereunder until January 18, 2022. During the ~~market” offering (“ATM”). In the first six months of~~year ended December 31, 2021, we ~~completed ATM offerings of 2,617,787~~sold 3,811,170 shares of common ~~stock.~~stock under the ATM offering. No shares were sold under the ATM offering during 2022. In addition, pursuant to our 2018 Equity Incentive Plan, or 2018 Plan, equity incentive awards representing up to an aggregate of ~~71,679~~353,868 shares of our common stock were available for issuance to our employees, directors and consultants as of June 30, ~~2021.~~2022. The 2018 Plan includes an annual increase in the number of shares available for future grant each year pursuant to the “~~evergreen~~”“evergreen” provision of our 2018 Plan. Additionally, pursuant to our 2018 Employee Stock Purchase Plan, or ESPP, ~~a total of 26,510~~no shares were available for sale under our ESPP as of June 30, ~~2021.~~2022. As such, the ESPP was paused after the end of the contribution period in May 2022. The ESPP ~~also~~ includes an annual increase in the number of shares available for sale under our ESPP each year pursuant to the “~~evergreen~~”“evergreen” provision of our ESPP. In addition to the increase in shares available to grant in ~~2020~~2022 due to the “evergreen” provisions contained in the 2018 Plan and the ESPP, in the first quarter of 2020 we adopted the 2020 Inducement Equity Incentive Plan ~~(or, the 2020 Plan)~~ for the purpose of attracting, retaining and incentivizing employees in furtherance of our success. On adoption, 32,000 shares of common stock were reserved solely for the granting of inducement stock options, restricted stock, restricted stock units and other awards and 9,000 shares were available for issuance as of June 30, ~~2021.~~ 2022. If these additional shares of common stock are issued and sold, or if it is perceived that they will be sold, in the public market, this could result in additional dilution and the trading price of our common stock could decline.

Further, SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3. We are currently subject to General Instruction I.B.6 to Form S-3, or the Baby Shelf Rule, and the amount of funds we can raise through primary public offerings of securities in any 12-month period using our registration statement on Form S-3 is limited to one-third of the aggregate market value of the voting and non-voting common equity held by non-affiliates. We are currently limited by the Baby Shelf Rule as of the filing of this Quarterly Report, until such time as our public float exceeds $75 million. If we are required to file a new registration statement on another form, we may incur additional costs and be subject to delays due to review by SEC staff.

Further, additional capital may be needed in the future to continue our planned operations, including commercialization efforts, expanded research and development activities and costs associated with operating a public company. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner, we determine from time to time. If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business.

If one or more of the analysts covering us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price may decline. In addition, if one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove members of our board of directors or our current management and may adversely affect the market price of our common stock.

Our certificate of incorporation and bylaws contain provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:

In addition, because we are now incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeover provisions and other provisions in our certificate of incorporation and bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our company. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the ~~United States~~U.S. are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising under the Delaware General Corporation Law, our certificate of incorporation or our bylaws; any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; and any action asserting a claim against us that is governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction.

Our certificate of incorporation further provides that the federal district courts of the ~~United States~~U.S. is the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. The enforceability of similar exclusive federal forum provisions in other companies’ organizational documents has been challenged in legal proceedings, and while the Delaware Supreme Court has ruled that this type of exclusive federal forum provision is facially valid under Delaware law, there is uncertainty as to whether other courts would enforce such provisions and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to find either exclusive forum provision in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material adverse effect on our business, financial condition, and results of operations.

If we fail to comply with the continued listing standards of the NYSE American, our common stock could be delisted. If it is delisted, the market value and the liquidity of our common stock would be impacted.

~~We recently transferred the listing of our common stock from the NYSE to the NYSE American.~~ The continued listing of our common stock on the NYSE American is contingent on our continued compliance with a number of listing standards. The NYSE American retains substantial discretion to, at any time and without notice, suspend dealings in or remove any security from listing. In order to maintain this listing, we must maintain certain share prices, financial and share distribution targets, including maintaining a minimum amount of shareholders’ equity and a minimum number of public shareholders. In addition to these objective standards, the NYSE American may delist the securities of any issuer: (i) if, in its opinion, the issuer’s financial condition and/or operating results appear unsatisfactory; (ii) if it appears that the extent of public distribution or the aggregate market value of the security has become so reduced as to make continued listing on the NYSE American inadvisable; (iii) if the issuer sells or disposes of principal operating assets or ceases to be an operating company; (iv) if an issuer fails to comply with the NYSE American’s listing requirements; (v) if an issuer’s common stock sells at what the NYSE American considers a “low selling price” and the issuer fails to correct this via a reverse split of shares after notification by the NYSE American; or (vi) if any other event occurs or any condition exists which makes continued listing on the NYSE American, in its opinion, inadvisable. There is no assurance that we will remain in compliance with these standards. For example, the NYSE American will consider suspending dealings in, or delisting, securities of an issuer that has stockholders’ equity of less than $6 million if that issuer has sustained losses from continuing operations and/or net losses in its five most recent fiscal years. We have had a loss from operations and net loss in each of our five most recent fiscal years. As of June 30, 2022, our stockholders’ equity was $9.8 million. If our stockholders’ equity falls below $6 million, the NYSE American may determine that we are no longer suitable for listing and may commence delisting proceedings pursuant Section 1003(a)(iii) of the NYSE MKT Company Guide.

Delisting from the NYSE American would adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities and negatively affect the value

and liquidity of our common stock. Delisting also could limit our strategic alternatives and attractiveness to potential counterparties and have other negative results, including the potential loss of employee confidence, decreased analyst coverage of our securities, the loss of institutional investors or interest in business development opportunities. Moreover, we committed in connection with the sale of securities to use commercially reasonable efforts to maintain the listing of our common stock during such time that certain warrants are outstanding.

We may be required to raise additional financing by issuing new securities, which may have terms or rights superior to those of our shares of common stock, which could adversely affect the market price of our shares of common stock and our business.

We will require additional financing to fund research, development and commercialization of our technology, to obtain and maintain patents and other intellectual property rights in our technology, and for working capital and other purposes. We may not be able to obtain financing on favorable terms, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our then-current shareholders will be reduced. Further, we may have to offer new investors in our equity securities rights that are superior to the holders of common stock, which could adversely affect the market price and the voting power of shares of our common stock. If we raise additional funds by issuing debt securities, the holders of these debt securities would similarly have some rights senior to those of the holders of shares of common stock, and the terms of these debt securities could impose restrictions on operations and create a significant interest expense for us which could have a materially adverse effect on our business.

We have not paid dividends in the past and have no immediate plans to pay dividends.

We plan to reinvest all of our earnings, to the extent we have earnings, in order to market our products and to cover operating costs and to otherwise become and remain competitive. We do not plan to pay any cash dividends with respect to our securities in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our common stock as a dividend.

~~None.~~On July 22, 2022, we reduced the exercise price of all Series A Common Stock Purchase Warrants and Series B Common Stock Purchase Warrants, or the Existing Warrants, that were issued in our February 2022 underwritten public offering from $0.50 per share to $0.28, or the Warrant Repricing. Following the Warrant Repricing, we entered into warrant inducement offer letters, or the Inducement Letters, with certain investors to immediately exercise up to approximately 22.2 million of the Existing Warrants held by such investors, or the Inducement Offer. In consideration for exercising the Existing Warrants, pursuant to the terms of the Inducement Letters, we issued to the investors a new Series C Common Stock Purchase Warrant, or the Series C Warrant, if the investor exercised a Series A Warrant or a new Series D Common Stock Purchase Warrant, or the Series D Warrant, and together with the Series C Warrants, collectively the New Warrants, if the investor exercised a Series B Warrant, in each case, to purchase up to a number of shares of common stock equal to 100% of the number of shares of common stock issued pursuant to the immediate exercise of the corresponding Series A Warrants and Series B Warrants, as applicable. The Series C Warrants have an exercise price of $0.28 and a term of five years, and the Series D Warrants have an exercise price of $0.28 and a term of seven years. We received aggregate gross proceeds of approximately $6.2 million from the exercise of the Series A Warrants which resulted in the issuance of an aggregate of 22,202,503 shares of common stock, together with the corresponding issuance of Series C Warrants exercisable for 22,202,503 shares of common stock. None of the Series B Warrants were exercised pursuant to the Inducement Offer. The New Warrants and the shares underlying the New Warrants were issued in a private placement pursuant to Section 4(a)(2) of the Securities Act and were unregistered at the time of issuance.

The terms of the Warrant Repricing, the Inducement Offer and the New Warrants are complex and are only briefly summarized above. For further information regarding these agreements and the financing, please refer to our Current Report on Form 8-K filed with the SEC on July 22, 2022. The discussion herein is qualified in its entirety by reference to such filed transaction documents.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Delaware		38-3661826
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

2070 Las Palmas Drive Carlsbad, California		92011
(Address of principal executive offices)		(Zip Code)

PART I. FINANCIAL INFORMATION		Page
Item 1.	Financial Statements:	3
	Condensed Balance Sheets ~~(unaudited)~~(Unaudited)	3
	Condensed Statements of Operations ~~(unaudited)~~(Unaudited)	4
	Condensed Statements of ~~Comprehensive Loss (unaudited)~~Cash Flows (Unaudited)	5
	Condensed Statements of ~~Cash Flows (unaudited)~~Stockholders’ Equity (Unaudited)	6
	Notes to Unaudited Condensed Financial Statements ~~of Stockholders’ Equity (unaudited)~~	7
	~~Notes to Condensed Financial Statements (unaudited)~~	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1917
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	2824
Item 4.	Controls and Procedures	2925
PART II. OTHER INFORMATION		3026
Item 1.	Legal Proceedings	3026
Item 1A.	Risk Factors	3227
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	8078
Item 3.	Defaults Upon Senior Securities	8079
Item 4.	Mine Safety Disclosures	8079
Item 5.	Other Information	8079
Item 6.	Exhibits	8180
SIGNATURES		8281

	Total Fair Value		Quoted Market Prices for Identical Assets (Level 1)		Other Observable Inputs (Level 2)		Unobservable Inputs (Level 3)
As of June 30, 2021
Money market funds	$	9,395	$	9,395	$	—	$	—
As of December 31, 2020
Money market funds	$	18,394	$	18,394	$	—	$	—

	June 30, 2022		December 31, 2021
Offering costs	$	890	$	—
Compensation and related benefits		318		2,004
Warranty expenses		192		195
Restructuring charges		117		—
Legal expenses		110		1,345
Other accrued expenses		343		575
Total accrued expenses	$	1,970	$	4,119

	Six Months Ended June 30, 2021			Year Ended December 31, 2020
Balance at beginning of period	$	242		$	338
Increase in warranty accrual		39			87
Change in liability for pre-existing warranties		—			(2	)
Claims satisfied		(44	)		(181	)
Accrued warranty	$	237		$	242

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

	Common Stock Shares		Common Stock Amount		Additional Paid- in- Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit			Total Stockholders’ Equity
Balances at December 31, 2020		3,189	$	7	$	174,342	$	—	$	(153,202	)	$	21,147
Common stock issued, net		35		—		65		—		—			65
Stock-based compensation		35		—		1,169		—		—			1,169
Net loss		—		—		—		—		(7,236	)		(7,236	)
Balances at March 31, 2021		3,259	$	7	$	175,576	$	—	$	(160,438	)	$	15,145
Common stock issued, net		2,582		—		10,645		—		—			10,645
Common stock issued pursuant to the vesting of restricted stock units and ESPP		6		—		26		—		—			26
Stock-based compensation		56		—		696		—		—			696
Net loss		—		—		—		—		(5,249	)		(5,249	)
Balances at June 30, 2021		5,903	$	7	$	186,943	$	—	$	(165,687	)	$	21,263

	Three Months Ended			Six Months Ended
	June 30, 2021
Revenues	$	996		$	2,109
Cost of revenues		967			1,894
Gross income		29			215
Operating expenses		532			1,034
Operating loss from discontinued operations		(503	)		(819	)
Other expense, net		(27	)		(70	)
Net loss from discontinued operations	$	(530	)	$	(889	)

Years Ending December 31,					��
2021 (remaining six months)	$	264
2022		432
2022 (remaining six months)				$	216
2023		445			445
2024		459			459
2025		472			472
2026		486			486
Thereafter		501			501
Total operating lease payments	$	3,059			2,579
Less: imputed interest		(614	)		(454	)
Total operating lease liabilities	$	2,445
Total operating lease liability				$	2,125

	Series A			Series B
Risk-free interest rate		0.91	%		1.93	%
Volatility		131.07	%		85.38	%
Expected dividend yield		0.00	%		0.00	%
Expected life (in years)		1.0			7.0

	Stock Options			Weighted Average Exercise Price		Weighted Average Remaining Life (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2020		124,171		$	363.31		6.42	$	—
Forfeited		(9,694	)		82.61
Outstanding at June 30, 2021		114,477		$	387.08		5.85	$	—
Exercisable at June 30, 2021		95,116		$	459.60		5.50	$	—
Vested and expected to vest at June 30, 2021		114,477		$	387.08		5.85	$	—

	Restricted Stock Units			Weighted Average Grant Date Fair Value
Outstanding at December 31, 2020		33,548		$	21.93
Granted		29,614			3.99
Vested and released		(1,845	)		64.80
Forfeited		(6,393	)		15.40
Outstanding at June 30, 2021		54,924		$	11.58

	Restricted Stock Awards (in shares)			Weighted Average Grant Date Fair Value
Outstanding at December 31, 2020		286,161		$	4.77
Granted		103,939			4.82
Forfeited		(13,531	)		6.40
Vested		(24,721	)		6.92
Outstanding at June 30, 2021		351,848		$	4.57

	Restricted Stock Units			Weighted Average Grant Date Fair Value
Outstanding at December 31, 2021		70,025		$	4.37
Vested		(5,864	)	$	12.17
Canceled/forfeited		(57,343	)	$	3.04
Outstanding at June 30, 2022		6,818		$	8.88

	Restricted Stock Awards			Weighted Average Grant Date Fair Value
Outstanding at December 31, 2021		179,334		$	4.71
Vested		(63,284	)	$	4.78
Canceled/forfeited		(36,062	)	$	4.31
Outstanding at June 30, 2022		79,988

	Unrecognized Expense (in thousands)		Remaining Weighted Average Recognition Period (in years)
Stock options	$	190		1.5
Restricted stock awards	$	321		1.7
Restricted stock units	$	50		1.4

Impairment of property and equipment	$	1,548
Inventory obsolescence		1,000
Severance expense		584
Prepaid expenses		395
Total restructuring and impairment charges	$	3,527


•		our ability to develop a larger diameter catheter to facilitate treatment of larger vessels more commonly seen in above-the-knee procedures;
•		the timing for completing follow-up in our clinical trial for an atherectomy indication for use;
•		our ability to achieve sufficient market acceptance, the ability for our customers to get coverage and adequate reimbursement from third-party payors and our ability to achieve acceptable market share for DABRA;
•		the cost to establish, maintain, expand, and defend the scope of our intellectual property portfolio, as well as any other action required in connection with licensing, preparing, filing, prosecuting, defending, and enforcing any patents or other intellectual property rights;
•		the emergence of competing technologies and other adverse market developments;
•		the costs associated with manufacturing, selling, and marketing DABRA for its cleared or approved indications or any other indications for use for which we receive regulatory clearance or approval, including the cost and timing of expanding our manufacturing capabilities, as well as establishing our sales and marketing capabilities;
•		our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
•		the timing, receipt, and amount of license fees and sales of, or royalties on, our future products or future improvements on our existing products, if any; and
•		the time and cost necessary to complete post-marketing studies that could be required by regulatory authorities or other studies required to obtain clearance for additional indications.

Exhibit Number		Exhibit Title

~~3.1~~4.1		~~Amended and Restated Certificate~~Form of ~~Incorporation of the Registrant~~Series A Warrant offered in February 2022 (incorporated by reference to Exhibit ~~3.1~~4.8 of Company’s Amendment No. 3 to the ~~Registrant's Current Report~~Registration Statement on Form ~~8-K~~S-1 filed on ~~October 1, 2018~~February 3, 2022 (File No. ~~001-38677)~~333-262195)).

~~3.2~~4.2		~~Amended and Restated Bylaws~~Form of ~~the Registrant~~Series B Warrant offered in February 2022 (incorporated by reference to Exhibit ~~3.1~~4.9 of Company’s Amendment No. 3 to the ~~Registrant's Current Report~~Registration Statement on Form S-1 filed on February 3, 2022 (File No. 333-262195)).

4.3		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.10 of Company’s Amendment No. 3 to the Registration Statement on Form S-1 filed on February 3, 2022 (File No. 333-262195)).

4.4		Warrant Agency Agreement dated February 8, 2022, by and between the Registrant and American Stock & Trust Company LLC (incorporated by reference to Exhibit 4.4 of Company’s Form 8-K filed on ~~November 17, 2020 (File~~February 8, 2022).

4.5		Form of Series C Warrant offered in July 2022 (incorporated by reference to Exhibit 4.1 of Company’s Form 8-K filed on July 22, 2022).

4.6		Form of Series D Warrant offered in July 2022 (incorporated by reference to Exhibit 4.2 of Company’s Form 8-K filed on July 22, 2022).

4.7		Amendment No. ~~001-38677))~~1 to Warrant Agency Agreement dated July 22, 2022, by and between the Company and American Stock Transfer & Trust Company, LLC.

4.8		Form of Warrant Inducement Offer Letter Form (incorporated by reference to Exhibit 10.1 of Company's Form 8-K filed on July 22, 2022).

4.9		Non-Binding Summary of Proposed Terms by and between Ra Medical Systems, Inc. and Catheter Precision, Inc. dated as of July 18, 2022 (incorporated by reference to Exhibit 10.2 of Company’s Form 8-K filed on July 22, 2022).

4.10		Amendment to Letter Agreement by and between the Company and Brian Conn dated as of August 10, 2022 (incorporated by reference to Exhibit 10.1 of Company’s Form 8-K filed on August 12, 2022).

31.1		Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1(*)		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2(*)		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

Date: August ~~11, 2021~~15, 2022	By:	/s/ ~~Andrew Jackson~~Brian Conn
		~~Andrew Jackson~~Brian Conn
		Chief Financial Officer