HeartBeam (BEAT) 10-Q 7 Nov 24 2024 Q3 Quarterly report Financial data

Cover Page

Cover Page - shares	9 Months Ended
	Sep. 30, 2024	Nov. 05, 2024
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-41060
Entity Registrant Name	HEARTBEAM, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-4881450
Entity Address, Address Line One	2118 Walsh Avenue
Entity Address, Address Line Two	Suite 210
Entity Address, City or Town	Santa Clara
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	95050
City Area Code	408
Local Phone Number	899-4443
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		26,665,470
Entity Central Index Key	0001779372
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false
Common Stock
Document Information [Line Items]
Title of 12(b) Security	Common Stock
Trading Symbol	BEAT
Security Exchange Name	NASDAQ
Warrants
Document Information [Line Items]
Title of 12(b) Security	Warrants
Trading Symbol	BEATW
Security Exchange Name	NASDAQ

Condensed Balance Sheets (Unaud

Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 5,768	$ 16,189
Prepaid expenses and other current assets	376	636
Total Current Assets	6,144	16,825
Property and equipment, net	457	256
Other assets	56	50
Total Assets	6,657	17,131
Current Liabilities:
Accounts payable and accrued expenses (includes related party $5 and $2, respectively)	1,856	1,194
Total Current Liabilities	1,856	1,194
Total Liabilities	1,856	1,194
Commitments (Note 7)
Stockholders’ Equity
Preferred stock - $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at September 30, 2024 and December 31, 2023	0	0
Common stock - $0.0001 par value 100,000,000 shares authorized; 26,594,928 and 26,329,032 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	3	3
Additional paid in capital	56,164	52,759
Accumulated deficit	(51,366)	(36,825)
Total Stockholders’ Equity	4,801	15,937
Total Liabilities and Stockholders’ Equity	$ 6,657	$ 17,131

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current Liabilities:
Due to related party	$ 1,856	$ 1,194
Stockholders’ Equity
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	26,594,928	26,329,032
Common stock, shares outstanding (in shares)	26,594,928	26,329,032
Related Party
Current Liabilities:
Due to related party	$ 5	$ 2

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Expenses:
General and administrative	$ 2,176	$ 2,114	$ 6,778	$ 6,417
Research and development	2,893	1,623	8,165	4,788
Total operating expenses	5,069	3,737	14,943	11,205
Loss from operations	(5,069)	(3,737)	(14,943)	(11,205)
Other Income and (Expense)
Interest income	96	267	408	445
Other expense	(6)	0	(6)	0
Total other income	90	267	402	445
Loss before provision for income taxes	(4,979)	(3,470)	(14,541)	(10,760)
Income tax provision	0	0	0	0
Net Loss	$ (4,979)	$ (3,470)	$ (14,541)	$ (10,760)
Net loss per share, basic (in dollars per share)	$ (0.19)	$ (0.13)	$ (0.55)	$ (0.59)
Net loss per share, diluted (in dollars per share)	$ (0.19)	$ (0.13)	$ (0.55)	$ (0.59)
Weighted average common shares outstanding, basic (in shares)	26,752,297	26,449,168	26,610,760	18,252,654
Weighted average common shares outstanding, diluted (in shares)	26,752,297	26,449,168	26,610,760	18,252,654

Condensed Statement of Changes

Condensed Statement of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022		8,009,743
Beginning balance at Dec. 31, 2022	$ 2,374	$ 1	$ 24,559	$ (22,186)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock based compensation expense	2,021		2,021
Sale of Common Stock under ATM, net of issuance costs (in shares)		17,872,955
Sale of Common Stock under ATM, net of issuance costs	24,764	$ 2	24,762
Stock issuance upon exercise of stock options (in shares)		180,072
Stock issuance upon exercise of stock options	214		214
Stock issuance upon vesting of restricted stock units (in shares)		255,220
Stock issuance upon exercise of warrants (in shares)		7,292
Stock issuance upon exercise of warrants	16		16
Net loss	(10,760)			(10,760)
Ending balance (in shares) at Sep. 30, 2023		26,325,282
Ending balance at Sep. 30, 2023	18,629	$ 3	51,572	(32,946)
Beginning balance (in shares) at Jun. 30, 2023		25,990,516
Beginning balance at Jun. 30, 2023	21,062	$ 3	50,535	(29,476)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock based compensation expense	926		926
Stock issuance upon exercise of stock options (in shares)		92,046
Stock issuance upon exercise of stock options	111		111
Stock issuance upon vesting of restricted stock units (in shares)		242,720
Net loss	(3,470)			(3,470)
Ending balance (in shares) at Sep. 30, 2023		26,325,282
Ending balance at Sep. 30, 2023	$ 18,629	$ 3	51,572	(32,946)
Beginning balance (in shares) at Dec. 31, 2023	26,329,032	26,329,032
Beginning balance at Dec. 31, 2023	$ 15,937	$ 3	52,759	(36,825)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock based compensation expense	3,300		3,300
Sale of Common Stock under ATM, net of issuance costs (in shares)		50,000
Sale of Common Stock under ATM, net of issuance costs	$ 76		76
Stock issuance upon exercise of stock options (in shares)	38,069	38,069
Stock issuance upon exercise of stock options	$ 29		29
Stock issuance upon vesting of restricted stock units (in shares)		177,827
Net loss	$ (14,541)			(14,541)
Ending balance (in shares) at Sep. 30, 2024	26,594,928	26,594,928
Ending balance at Sep. 30, 2024	$ 4,801	$ 3	56,164	(51,366)
Beginning balance (in shares) at Jun. 30, 2024		26,562,111
Beginning balance at Jun. 30, 2024	8,706	$ 3	55,090	(46,387)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock based compensation expense	1,053		1,053
Stock issuance upon exercise of stock options (in shares)		32,817
Stock issuance upon exercise of stock options	21		21
Net loss	$ (4,979)			(4,979)
Ending balance (in shares) at Sep. 30, 2024	26,594,928	26,594,928
Ending balance at Sep. 30, 2024	$ 4,801	$ 3	$ 56,164	$ (51,366)

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Cash Flows From Operating Activities
Net loss	$ (4,979)	$ (3,470)	$ (14,541)	$ (10,760)
Adjustments to reconcile net loss to net cash used in operating activities
Stock based compensation expense			3,300	2,021
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			260	150
Accounts payable and accrued expenses			662	(646)
Net cash used in operating activities			(10,319)	(9,235)
Cash Flows From Investing Activities
Purchase of property and equipment			(201)	(144)
Net cash used in investing activities			(201)	(144)
Cash Flows From Financing Activities
Proceeds from sale of equity, net of issuance costs			76	24,764
Proceeds from exercise of stock options			29	214
Proceeds from exercise of warrants			0	16
Net cash provided by financing activities			105	24,994
Net increase (decrease) in cash and restricted cash			(10,415)	15,615
Cash, cash equivalents and restricted cash – Beginning of period			16,239	3,594
Cash, cash equivalents and restricted cash – Ending of period	5,824	19,209	5,824	19,209
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	5,768	19,184	5,768	19,184
Restricted cash (included in other assets)	56	25	56	25
Total cash, cash equivalents and restricted cash	$ 5,824	$ 19,209	$ 5,824	$ 19,209

ORGANIZATION AND OPERATIONS

ORGANIZATION AND OPERATIONS	9 Months Ended
	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
ORGANIZATION AND OPERATIONS	ORGANIZATION AND OPERATIONS HeartBeam, Inc. (“HeartBeam” or the “Company”) is a cardiac technology company focusing on developing and commercializing higher resolution ambulatory Electrocardiogram (“ECG”) solutions that enable the detection and monitoring of cardiac disease outside a healthcare facility setting. The Company’s ability to develop higher resolution ECG solutions is achieved through the development of the Company’s proprietary and patented Vector Electrocardiography (“VECG”) technology platform. HeartBeam’s VECG is capable of developing three-dimensional (3D) representations of cardiac electrical activity by displaying the spatial locations of ECG waveforms that demonstrated in early studies to deliver diagnostic capability equal or superior to traditional hospital-based ECG systems. The Company has validated this technology and is seeking U.S. Food and Drug Administration (“FDA”) clearance of its initial telehealth products. The Company filed a 510(k) submission in 2023 for its initial product, a patient-held VECG device. With a planned second submission, this product will become an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review. The Company was incorporated in 2015 as a Delaware corporation. The Company operates as one segment and its operations are based in Santa Clara, California.

GOING CONCERN AND OTHER UNCERTA

GOING CONCERN AND OTHER UNCERTAINTIES	9 Months Ended
	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
GOING CONCERN AND OTHER UNCERTAINTIES	GOING CONCERN AND OTHER UNCERTAINTIES The Company is subject to a number of risks similar to those of early stage medical device companies, including dependence on key individuals and products, the inherent uncertainties with regulatory approvals, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital, competition from larger companies, other technology companies and other technologies. The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024 the Company has a cash and cash equivalents balance of approximately $5.8 million. Based on its current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. The Company expects no material commercial revenue in 2024. The Company continues to maintain strong financial discipline as it achieves critical R&D, clinical and regulatory milestones in advance of commercialization. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements. On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. There were 50,000 shares issued under the At The Market (“ATM”) during the nine months ended September 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BASIS OF PRESENTATION The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 20, 2024 (“2023 Annual Report”). CASH, CASH EQUIVALENTS AND RESTRICTED CASH The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2024 and December 31, 2023. The Company has made a deposit to the bank for their credit cards in the amount of $56,000 and $50,000 and is classified as restricted cash included in other assets as of September 30, 2024, and December 31, 2023, respectively. USE OF ESTIMATES The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates. PROPERTY AND EQUIPMENT, NET Property and equipment are stated at cost less accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The Company regularly evaluates the estimated remaining useful lives of the Company’s property and equipment, net, to determine whether events or changes in circumstances warrant a revision to the remaining period of depreciation. Maintenance and repairs are expensed as incurred. During the three months ended September 30, 2024, the Company has capitalized tools amounting to $52,200, which is being depreciated based on useful life of 7 years. Depreciation and amortization expense for the three months ended September 30, 2024 was nominal. As of September 30, 2024, property and equipment, net represents machinery and equipment of $51,600 and construction-in-progress related to tooling development that has not been placed into service is amounting to $405,000 and $256,000 as of September 30, 2024, and December 31, 2023, respectively. Construction-in-progress amounts are not subject to depreciation as such assets are not yet available for their intended use. NET LOSS PER COMMON SHARE Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding. Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of 178,533 and 176,105 have been included in the calculation of weighted average basic and diluted earnings per share for the three and nine months ended September 30, 2024 and September 30, 2023, respectively. The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares: Three and Nine months ended 2024 2023 Stock options (excluding exercisable penny stock options) 7,244,175 4,782,020 Restricted stock units 283,411 221,631 Warrants 5,152,397 5,152,397 Total 12,679,983 10,156,048 RECENTLY ISSUED ACCOUNTING STANDARDS Not Yet Adopted as of September 30, 2024: In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures. In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures. In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.

STOCKHOLDERS_ EQUITY

STOCKHOLDERS’ EQUITY	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
STOCKHOLDERS’ EQUITY	STOCKHOLDERS’ EQUITY WARRANTS The following is a summary of warrant activity during the nine months ended September 30, 2024: Number of Weighted Weighted Aggregate Outstanding and exercisable - December 31, 2023 5,152,397 $ 4.71 3.35 $ 792 Exercised — — — — Expired — — — — Outstanding and exercisable – September 30, 2024 5,152,397 $ 4.71 2.59 $ 742

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION	9 Months Ended
	Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]
STOCK-BASED COMPENSATION	STOCK-BASED COMPENSATION At the June 2024 annual stockholders’ meeting the 2022 Equity Incentive Plan was amended to increase the number of authorized shares from 5,900,000 shares to 8,900,000. STOCK OPTIONS The following is a summary of stock option activity during the nine months ended September 30, 2024: Number of Weighted Average Aggregate Outstanding – December 31, 2023 6,092,525 $ 2.22 8.7 $ 2,945 Options granted 1,435,000 2.32 Options exercised (38,069) 0.77 Options cancelled (66,748) 3.54 Outstanding – September 30, 2024 7,422,708 $ 2.24 8.6 $ 2,826 Exercisable – September 30, 2024 2,147,402 $ 1.96 7.5 $ 1,534 The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant. For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows: Nine Months ended September 30, 2024 2023 Weighted-average Black-Scholes option pricing model assumptions: Volatility 125.33% - 128.85% 110.23% - 110.64% Expected term (in years) 6.00 - 7.00 5.85 - 6.07 Risk-free rate 3.59% - 4.60% 3.54% - 3.95% Expected dividend yield $ — $ — Weighted average grant date fair value per share $1.81 - $2.48 $1.75 - $3.38 RESTRICTED STOCK UNITS The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024: Nine Months ended September 30, 2024 Numbers of Shares Weighted Average Grant Date Fair value Non-Vested at beginning of period 217,881 $ 3.12 Shares granted 243,357 2.26 Shares vested (177,827) 3.13 Non-vested at the end of period 283,411 $ 2.38 STOCK BASED COMPENSATION The following is a summary of stock-based compensation expense (rounded): Three months ended September 30, Nine Months ended September 30, 2024 2023 2024 2023 General and administrative Stock options 560,000 589,500 1,898,000 1,352,100 RSU’s 149,000 153,000 433,000 323,000 Total general and administrative 709,000 742,500 2,331,000 1,675,100 Research and development Stock options 334,000 173,600 941,000 336,100 RSU’s 10,000 10,200 28,000 10,200 Total research and development 344,000 183,800 969,000 346,300 Total 1,053,000 926,300 3,300,000 2,021,400 During the nine months ended 2023, the Company granted 2,208,000 options to various executives and employees. Sixty percent (60%) of these options vest based on FDA Clearance for marketing of HeartBeam’s synthesized 12L product and the remaining forty percent (40%) vest monthly over a period of 48 months. The Company calculated the fair value for each of these grants using the Black-Scholes option pricing model and the performance-based options are expensed beginning from date of grant to the expected FDA clearance, which is based on management’s probability assessment performed on a quarterly basis. As of September 30, 2024, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $8.3 million and $0.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.9 years and 0.85 years, respectively.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Sep. 30, 2024
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	RELATED PARTY TRANSACTIONS During the course of business, the Company obtains accounting services from CTRLCFO, a firm in which a prior executive of the Company had significant influence. On December 29, 2023, this executive, informed the Company of his plans to retire from his position as of February 1, 2024 and as such ceased to be a related party as of February 1, 2024. The Company had balances due to this firm amounting to approximately $2,000 as of December 31, 2023. During April 2024, the Company entered into consulting agreement with one of the independent Board of Directors to provide business development consulting services. For these consulting services, the Company agreed to pay $5,000 per month as remuneration and granted 70,000 options to vest during over a period of 36 months. During the three and nine months ended September 30, 2024, the Company recognized $25,700 and $50,200, respectively related to these consulting services, which includes stock based compensation expense of $10,700 and $20,200, respectively.

COMMITMENTS

COMMITMENTS	9 Months Ended
	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS	COMMITMENTS Lease Obligations Prior to February 1, 2024, the Company was in a month-to-month lease agreement for its headquarters. The agreement was for an undefined term that could be cancelled at any time, given one month’s notice by either party. The Company’s monthly rent expense associated with this agreement was approximately $1,800. This headquarters lease was in the name of the Company’s Chief Executive Officer, and the cost was reimbursed monthly to CEO until January 31, 2024 when the Company terminated the month-to-month lease, and entered into a new lease in name of the Company with the same landlord. The new lease commenced on February 1, 2024, for initial period of 3 years. The Company performed an assessment and concluded that amount of operating lease right-of-use, or ROU assets was below the Company’s capitalization thresholds set in accordance with ASC 842. For the three and nine months ended September 30, 2024 rent was approximately $5,400 and $15,840, respectively. For the three and nine months ended September 30, 2023, rent expense was approximately $4,000 and $12,000, respectively. Professional Services Agreement In March 2022, the Company entered into a professional services agreement with Triple Ring Technologies, Inc. (“TRT”), a co-development company, to assist in the design and development of the Company’s telehealth complete solution 3D vector ECG collection device for remote heart attack or MI monitoring. This agreement was followed by several amendments. The agreement with TRT includes a commitment totaling $1.7 million. For the three and nine months ended September 30, 2024, the Company has expensed approximately $0.1 million and $0.3 million, respectively. For the three and nine months ended September 30, 2023, the Company has expensed approximately $0.3 million and $0.8 million, respectively. As of September 30, 2024, the Company has a remaining commitment of $0.1 million. Clinical Research Organization On March 8, 2024, the Company has entered into an agreement with Clinical Research Organization (CRO) to perform certain services related to project set up, clinical trial management and monitoring during next six months. As per terms of the agreement, the Company will pay CRO approximately $0.5 million for these services. Additionally, the Company has signed a Clinical Study Agreement with first of five sites to carry out the clinical study for which CRO will act as Company sponsor in relation to payment for these services. The total cost of the clinical trial including the CRO cost is expected to approximate $0.9 million. For the three months and nine months ended September 30, 2024, the Company has expensed $0.1 million and $0.7 million based on actual services performed by the CRO and clinical sites, of which $0.1 million was accrued as of September 30, 2024. As of September 30, 2024, the Company has a remaining commitment of $0.1 million.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
BASIS OF PRESENTATION	BASIS OF PRESENTATION
CASH, CASH EQUIVALENTS AND RESTRICTED CASH	CASH, CASH EQUIVALENTS AND RESTRICTED CASH
USE OF ESTIMATES	USE OF ESTIMATES The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.
PROPERTY AND EQUIPMENT, NET	PROPERTY AND EQUIPMENT, NET
NET LOSS PER COMMON SHARE	NET LOSS PER COMMON SHARE Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding. Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
RECENTLY ISSUED ACCOUNTING STANDARDS	RECENTLY ISSUED ACCOUNTING STANDARDS Not Yet Adopted as of September 30, 2024: In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures. In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures. In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share	The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares: Three and Nine months ended 2024 2023 Stock options (excluding exercisable penny stock options) 7,244,175 4,782,020 Restricted stock units 283,411 221,631 Warrants 5,152,397 5,152,397 Total 12,679,983 10,156,048

STOCKHOLDERS_ EQUITY (Tables)

STOCKHOLDERS’ EQUITY (Tables)	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
Schedule of Warrant Activity	The following is a summary of warrant activity during the nine months ended September 30, 2024: Number of Weighted Weighted Aggregate Outstanding and exercisable - December 31, 2023 5,152,397 $ 4.71 3.35 $ 792 Exercised — — — — Expired — — — — Outstanding and exercisable – September 30, 2024 5,152,397 $ 4.71 2.59 $ 742

STOCK-BASED COMPENSATION (Table

STOCK-BASED COMPENSATION (Tables)	9 Months Ended
	Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]
Schedule of Stock Option, Activity	The following is a summary of stock option activity during the nine months ended September 30, 2024: Number of Weighted Average Aggregate Outstanding – December 31, 2023 6,092,525 $ 2.22 8.7 $ 2,945 Options granted 1,435,000 2.32 Options exercised (38,069) 0.77 Options cancelled (66,748) 3.54 Outstanding – September 30, 2024 7,422,708 $ 2.24 8.6 $ 2,826 Exercisable – September 30, 2024 2,147,402 $ 1.96 7.5 $ 1,534
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions	For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows: Nine Months ended September 30, 2024 2023 Weighted-average Black-Scholes option pricing model assumptions: Volatility 125.33% - 128.85% 110.23% - 110.64% Expected term (in years) 6.00 - 7.00 5.85 - 6.07 Risk-free rate 3.59% - 4.60% 3.54% - 3.95% Expected dividend yield $ — $ — Weighted average grant date fair value per share $1.81 - $2.48 $1.75 - $3.38
Schedule of Nonvested Restricted Stock Units Activity	The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024: Nine Months ended September 30, 2024 Numbers of Shares Weighted Average Grant Date Fair value Non-Vested at beginning of period 217,881 $ 3.12 Shares granted 243,357 2.26 Shares vested (177,827) 3.13 Non-vested at the end of period 283,411 $ 2.38
Schedule of Stock-Based Compensation	The following is a summary of stock-based compensation expense (rounded): Three months ended September 30, Nine Months ended September 30, 2024 2023 2024 2023 General and administrative Stock options 560,000 589,500 1,898,000 1,352,100 RSU’s 149,000 153,000 433,000 323,000 Total general and administrative 709,000 742,500 2,331,000 1,675,100 Research and development Stock options 334,000 173,600 941,000 336,100 RSU’s 10,000 10,200 28,000 10,200 Total research and development 344,000 183,800 969,000 346,300 Total 1,053,000 926,300 3,300,000 2,021,400

ORGANIZATION AND OPERATIONS (De

ORGANIZATION AND OPERATIONS (Details)	9 Months Ended
	Sep. 30, 2024 segment
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of operating segments	1

GOING CONCERN AND OTHER UNCER_2

GOING CONCERN AND OTHER UNCERTAINTIES (Details) - USD ($) shares in Thousands, $ in Thousands	9 Months Ended
	Sep. 30, 2024	May 02, 2024	Dec. 31, 2023	Sep. 30, 2023
Liquidity, Going Concern, and Other Uncertainties [Line Items]
Cash and cash equivalents	$ 5,768		$ 16,189	$ 19,184
Public Ventures, LLC | Private Placement
Liquidity, Going Concern, and Other Uncertainties [Line Items]
Sale of stock, maximum amount authorized		$ 17,000
Shares issued in at the market (ATM) (in shares)	50
Sale of stock, available for issuance under the ATM	$ 16,900

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Restricted cash (included in other assets)	$ 56,000	$ 25,000	$ 56,000	$ 25,000	$ 50,000
Property and equipment, net	$ 457,000		$ 457,000		256,000
Incremental common shares attributable to dilutive effect of equity forward agreements (in shares)	178,533	176,105	178,533	176,105
Tools, Dies and Molds
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Capitalized tools	$ 52,200		$ 52,200
Depreciated based on useful life	7 years		7 years
Machinery and Equipment
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Property and equipment, net	$ 51,600		$ 51,600
Construction in Progress
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Property and equipment, net	$ 405,000		$ 405,000		$ 256,000

SUMMARY OF SIGNIFICANT ACCOUN_5

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	12,679,983	10,156,048	12,679,983	10,156,048
Stock options (excluding exercisable penny stock options)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,244,175	4,782,020	7,244,175	4,782,020
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	283,411	221,631	283,411	221,631
Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	5,152,397	5,152,397	5,152,397	5,152,397

STOCKHOLDERS_ EQUITY - Schedule

STOCKHOLDERS’ EQUITY - Schedule of Warrant Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of shares
Outstanding, beginning balance (in shares)	5,152,397
Exercisable beginning balance (in shares)	5,152,397
Exercised (in shares)	0
Expired (in shares)	0
Outstanding, ending balance (in shares)	5,152,397	5,152,397
Exercisable ending balance (in shares)	5,152,397	5,152,397
Weighted average exercise price
Outstanding, beginning balance (in dollars per share)	$ 4.71
Exercisable beginning balance ( in dollars per share)	4.71
Exercised (in dollars per share)	0
Expired (in dollars per share)	0
Outstanding, ending balance (in dollars per share)	4.71	$ 4.71
Exercisable ending balance ( in dollars per share)	$ 4.71	$ 4.71
Weighted average remaining life (years)
Outstanding	2 years 7 months 2 days	3 years 4 months 6 days
Exercisable	2 years 7 months 2 days	3 years 4 months 6 days
Aggregate intrinsic value (in thousands)
Outstanding	$ 742	$ 792
Exercisable	$ 742	$ 792

STOCK-BASED COMPENSATION - Narr

STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Jun. 30, 2024	May 31, 2024
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Cost not yet recognized, options, amount	$ 8.3
Cost not yet recognized, excluding options, amount	$ 0.5
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Cost not yet recognized, period of recognition (in years)	2 years 10 months 24 days
RSU’s
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Cost not yet recognized, period of recognition (in years)	10 months 6 days
Executives And Employees
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of options granted (in shares)		2,208,000
Executives And Employees | Share-Based Payment Arrangement, Tranche Two
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Percentage of share-based compensation arrangement vesting (as a percent)		40%
Vesting period		48 months
Executives And Employees | Stock options | Share-Based Payment Arrangement, Tranche One
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Percentage of share-based compensation arrangement vesting (as a percent)		60%
2022 Equity Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized for issuance (in shares)			8,900,000	5,900,000

STOCK-BASED COMPENSATION - Sche

STOCK-BASED COMPENSATION - Schedule of Stock Option, Activity (Details) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares
Number of options outstanding
Beginning balance (in shares) | shares	6,092,525
Options granted (in shares) | shares	1,435,000
Options exercised (in shares) | shares	(38,069)
Options cancelled (in shares) | shares	(66,748)
Ending balance (in shares) | shares	7,422,708	6,092,525
Weighted average exercise price
Beginning balance (in dollars per share) | $ / shares	$ 2.22
Options granted (in dollars per share) | $ / shares	2.32
Options exercised (in dollars per share) | $ / shares	0.77
Options cancelled (in dollars per share) | $ / shares	3.54
Ending balance (in dollars per share) | $ / shares	$ 2.24	$ 2.22
Stock Options Additional Disclosures
Average remaining contractual life	8 years 7 months 6 days	8 years 8 months 12 days
Aggregate intrinsic value, outstanding | $	$ 2,826	$ 2,945
Exercisable (in shares) | shares	2,147,402
Exercisable, Weighted average exercise price (in dollars per share) | $ / shares	$ 1.96
Exercisable, Average remaining contractual life	7 years 6 months
Exercisable, Aggregate intrinsic value | $	$ 1,534

STOCK-BASED COMPENSATION - Sc_2

STOCK-BASED COMPENSATION - Schedule of Assumptions (Details) - Stock options - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free rate, minimum	3.59%	3.54%
Risk-free rate, maximum	4.60%	3.95%
Expected dividend yield	$ 0	$ 0
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Volatility	125.33%	110.23%
Expected term (in years)	6 years	5 years 10 months 6 days
Weighted average grant date fair value per share (in dollars per share)	$ 1.81	$ 1.75
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Volatility	128.85%	110.64%
Expected term (in years)	7 years	6 years 25 days
Weighted average grant date fair value per share (in dollars per share)	$ 2.48	$ 3.38

STOCK-BASED COMPENSATION - Sc_3

STOCK-BASED COMPENSATION - Schedule of Nonvested Restricted Stock Units Activity (Details) - RSU’s	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Numbers of Shares
Non-vested, beginning balance (in shares) | shares	217,881
Shares granted (in shares) | shares	243,357
Shares vested (in shares) | shares	(177,827)
Non-vested, ending balance (in shares) | shares	283,411
Weighted Average Grant Date Fair value
Non-Vested, beginning balance (in dollars per share) | $ / shares	$ 3.12
Shares granted (in dollars per share) | $ / shares	2.26
Shares vested (in dollars per share) | $ / shares	3.13
Non-vested, ending balance (in dollars per share) | $ / shares	$ 2.38

STOCK-BASED COMPENSATION - Sc_4

STOCK-BASED COMPENSATION - Schedule of Stock-Based Compensation (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	$ 1,053,000	$ 926,300	$ 3,300,000	$ 2,021,400
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	709,000	742,500	2,331,000	1,675,100
General and administrative | Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	560,000	589,500	1,898,000	1,352,100
General and administrative | RSU’s
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	149,000	153,000	433,000	323,000
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	344,000	183,800	969,000	346,300
Research and development | Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	334,000	173,600	941,000	336,100
Research and development | RSU’s
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total	$ 10,000	$ 10,200	$ 28,000	$ 10,200

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details)	1 Months Ended	3 Months Ended		9 Months Ended
	Apr. 30, 2024 USD ($) director shares	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)
Related Party Transaction [Line Items]
Due to related party		$ 1,856,000		$ 1,856,000		$ 1,194,000
Number of independent board of directors members | director	1
Monthly payment	$ 5,000
Options granted (in shares) | shares				1,435,000
Consulting service fees		2,176,000	$ 2,114,000	$ 6,778,000	$ 6,417,000
Stock based compensation expense		1,053,000	$ 926,300	3,300,000	$ 2,021,400
Related Party
Related Party Transaction [Line Items]
Due to related party		5,000		5,000		$ 2,000
Options granted (in shares) | shares	70,000
Consulting service fees		25,700		50,200
Stock based compensation expense		$ 10,700		$ 20,200
Related Party | Stock options
Related Party Transaction [Line Items]
Vesting period	36 months

COMMITMENTS (Details)

COMMITMENTS (Details)		3 Months Ended		9 Months Ended
	Jan. 31, 2024 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Mar. 08, 2024 USD ($) site	Feb. 01, 2024	Dec. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)
Long-term Purchase Commitment [Line Items]
Operating lease, prior notice for cancellation	1 month
Monthly rent expense	$ 1,800
Lease commenced, initial period							3 years
Rent expense		$ 5,400	$ 4,000	$ 15,840	$ 12,000
Research and development		2,893,000	1,623,000	8,165,000	4,788,000
Accrued liabilities		1,856,000		1,856,000				$ 1,194,000
Triple Ring Technologies
Long-term Purchase Commitment [Line Items]
Purchase commitments									$ 1,700,000
Research and development		100,000	$ 300,000	300,000	$ 800,000
Remaining commitment		100,000		100,000
Clinical Research Organization
Long-term Purchase Commitment [Line Items]
Research and development		100,000		700,000
Remaining commitment		100,000		100,000
Amount to be paid to clinical research organization (CRO)						$ 500,000
Number of planned sites to carrying out the clinical study | site						5
Research and development expense, expected cost						$ 900,000
Accrued liabilities		$ 100,000		$ 100,000