KORU Medical Systems (KRMD) 10-Q 9 Nov 22 2022 Q3 Quarterly report Financial data

Cover

Cover - $ / shares	9 Months Ended
	Sep. 30, 2022	Nov. 09, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2022
Current Fiscal Year End Date	--12-31
Entity File Number	0-12305
Entity Registrant Name	KORU MEDICAL SYSTEMS, INC.
Entity Central Index Key	0000704440
Entity Tax Identification Number	13-3044880
Entity Incorporation, State or Country Code	NY
Entity Address, Address Line One	100 Corporate Drive
Entity Address, City or Town	Mahwah
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07430
City Area Code	(845)
Local Phone Number	469-2042
Title of 12(b) Security	Common stock, $0.01 par value
Trading Symbol	KRMD
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		45,279,948
Entity Listing, Par Value Per Share	$ 0.01
Treasury stock, common, shares		3,420,502

BALANCE SHEETS (UNAUDITED)

BALANCE SHEETS (UNAUDITED) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
CURRENT ASSETS
Cash and cash equivalents	$ 16,441,268	$ 25,334,889
Accounts receivable less allowance for doubtful accounts of $24,471 for September 30, 2022, and December 31, 2021	5,070,077	3,592,886
Inventory	6,884,156	6,106,338
Other Receivables	686,108	718,220
Prepaid expenses	1,660,655	1,568,821
TOTAL CURRENT ASSETS	30,742,264	37,321,154
Property and equipment, net	3,318,612	1,106,445
Intangible assets, net of accumulated amortization of $310,011 and $263,729 at September 30, 2022 and December 31, 2021, respectively	798,534	808,813
Operating lease right-of-use assets	3,865,370	95,553
Finance lease right -of-use, net accumulated depreciation of $23,671 at September 30, 2022	331,400
Deferred income tax assets, net	3,520,823	1,941,254
Other assets	88,772	19,812
TOTAL ASSETS	42,665,775	41,293,031
CURRENT LIABILITIES
Accounts payable	1,365,610	1,227,533
Accrued expenses	2,568,746	2,709,704
Note Payable	644,733	508,583
Other Liabilities	357,491	90,000
Accrued payroll and related taxes	824,047	160,603
Financing lease liability – current	64,467
Operating lease liability – current	342,399	95,553
TOTAL CURRENT LIABILITIES	6,167,493	4,791,976
Financing lease liability, net of current portion	265,542
Operating lease liability, net of current portion	3,741,015
TOTAL LIABILITIES	10,174,050	4,791,976
STOCKHOLDERS’ EQUITY
Common stock, $0.01 par value, 75,000,000 shares authorized, 48,657,023 and 48,044,162 shares issued 45,236,521 and 44,623,660 shares outstanding at September 30, 2022, and December 31, 2021, respectively	486,570	480,441
Additional paid-in capital	43,443,201	40,774,245
Treasury stock, 3,420,502 shares at September 30, 2022 and December 31, 2021, respectively, at cost	(3,843,562)	(3,843,562)
Retained deficit	(7,594,484)	(910,069)
TOTAL STOCKHOLDERS’ EQUITY	32,491,725	36,501,055
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$ 42,665,775	$ 41,293,031

BALANCE SHEETS (UNAUDITED) (Par

BALANCE SHEETS (UNAUDITED) (Parenthetical) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Accounts receivable, allowance for credit loss, current	$ 24,471	$ 24,471
Finite-lived intangible assets, accumulated amortization	310,011	$ 263,729
Finance Lease, Right-of-Use Asset, Amortization	$ 23,671
Common stock, par or stated value per share	$ 0.01	$ 0.01
Common stock, shares authorized	75,000,000	75,000,000
Common stock, shares, outstanding	48,657,023	48,044,162
Common stock, shares, outstanding	45,236,521	44,623,660
Treasury stock, shares	3,420,502	3,420,502

STATEMENTS OF OPERATIONS (Unaud

STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Statement [Abstract]
NET SALES	$ 7,760,398	$ 6,040,544	$ 20,551,356	$ 16,999,669
Cost of goods sold	3,438,036	2,544,794	9,260,516	7,061,881
Gross Profit	4,322,362	3,495,750	11,290,840	9,937,788
OPERATING EXPENSES
Selling, general and administrative	4,825,349	3,901,830	15,846,584	12,980,604
Research and development	862,148	800,020	3,314,233	1,523,739
Depreciation and amortization	164,344	115,934	399,479	349,822
Total Operating Expenses	5,851,841	4,817,784	19,560,296	14,854,165
Net Operating Loss	(1,529,479)	(1,322,034)	(8,269,456)	(4,916,377)
Non-Operating Income/(Expense)
Loss on currency exchange	(10,057)	(7,283)	(38,897)	(21,761)
Gain on disposal of fixed assets, net		273		1,009
Interest income (expense), net	42,476	(2,838)	44,579	16,883
TOTAL OTHER INCOME/(EXPENSE)	32,419	(9,848)	5,682	(3,869)
LOSS BEFORE INCOME TAXES	(1,497,060)	(1,331,882)	(8,263,774)	(4,920,246)
Income Tax Benefit	271,500	238,104	1,579,359	1,425,781
NET LOSS	$ (1,225,560)	$ (1,093,778)	$ (6,684,415)	$ (3,494,465)
NET LOSS PER SHARE
Basic	$ (0.03)	$ (0.02)	$ (0.15)	$ (0.08)
Diluted	$ (0.03)	$ (0.02)	$ (0.15)	$ (0.08)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
Basic	45,038,181	44,322,335	44,877,366	44,510,021
Diluted	45,038,181	44,322,335	44,877,366	44,510,021

STATEMENTS OF CASH FLOWS (UNAUD

STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss	$ (6,684,415)	$ (3,494,465)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	2,361,085	1,967,632
Depreciation and amortization	399,479	349,822
Deferred income taxes	(1,579,569)	(1,440,060)
Loss on disposal of fixed assets		(1,009)
ROU landlord credit	218,044
Changes in operating assets and liabilities:
Increase in accounts receivable	(1,445,079)	(549,711)
Increase in inventory	(777,818)	(138,160)
Increase in prepaid expenses and other assets	(160,794)	(529,039)
Increase in other Liabilities	267,491
Increase in accounts payable	138,077	760,493
Increase in accrued payroll and related taxes	663,444	45,684
Decrease in accrued expenses	(140,958)	(573,565)
NET CASH USED IN OPERATING ACTIVITIES	(6,741,013)	(3,602,378)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment	(2,541,693)	(301,720)
Proceeds from disposal of property and equipment		9,065
Purchases of intangible assets	(36,003)	(25,838)
NET CASH USED IN INVESTING ACTIVITIES	(2,577,696)	(318,493)
CASH FLOWS FROM FINANCING ACTIVITIES
Borrowings from indebtedness	644,733	924,389
Payments on indebtedness	(508,583)	(251,255)
Proceeds from issuance of equity	314,000	1,230,000
Common stock issuance as settlement for litigation		938,094
Payments on finance lease liability	(25,062)	(2,232)
NET CASH PROVIDED BY FINANCING ACTIVITIES	425,088	2,838,996
NET DECREASE IN CASH AND CASH EQUIVALENTS	(8,893,621)	(1,081,875)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	25,334,889	27,315,286
CASH AND CASH EQUIVALENTS, END OF PERIOD	16,441,268	26,233,411
Cash paid during the periods for:
Interest	15,700	6,194
Income Taxes		850
Schedule of Non-Cash Operating, Investing and Financing Activities:
Issuance of common stock as compensation	355,505	295,947
Issuance of common stock as settlement for litigation		$ 938,094

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Treasury Stock [Member]	Total
Beginning balance, value at Dec. 31, 2020	$ 466,801	$ 35,880,986	$ 3,652,754	$ (3,843,562)	$ 36,156,979
Balance beginning (in shares) at Dec. 31, 2020	46,680,119
Issuance of stock-based compensation	$ 101	56,149			56,250
Issuance of stock-based compensation (in shares)	10,124
Compensation expense related to stock options		677,934			677,934
Litigation settlement share issuance	$ 952	937,142			938,094
Litigation settlement share issuance (in shares)	95,238
Issuance upon options exercised	$ 11,106	1,218,894			1,230,000
Issuance upon options exercised (in shares)	1,110,580
Net loss			(1,276,138)		(1,276,138)
Ending balance, value at Mar. 31, 2021	$ 478,960	38,771,105	2,376,616	(3,843,562)	37,783,119
Balance ending (in shares) at Mar. 31, 2021	47,896,061
Beginning balance, value at Dec. 31, 2020	$ 466,801	35,880,986	3,652,754	(3,843,562)	36,156,979
Balance beginning (in shares) at Dec. 31, 2020	46,680,119
Net loss					(3,494,465)
Ending balance, value at Sep. 30, 2021	$ 479,317	40,004,197	158,289	(3,843,562)	36,798,241
Balance ending (in shares) at Sep. 30, 2021	47,931,664
Beginning balance, value at Mar. 31, 2021	$ 478,960	38,771,105	2,376,616	(3,843,562)	37,783,119
Balance beginning (in shares) at Mar. 31, 2021	47,896,061
Issuance of stock-based compensation	$ 146	97,050			97,196
Issuance of stock-based compensation (in shares)	14,615
Compensation expense related to stock options		441,841			441,841
Compensation expense related to restricted stock awards		66,135			66,135
Net loss			(1,124,549)		(1,124,549)
Ending balance, value at Jun. 30, 2021	$ 479,106	39,376,131	1,252,067	(3,843,562)	37,263,742
Balance ending (in shares) at Jun. 30, 2021	47,910,676
Issuance of stock-based compensation	$ 211	142,290			142,501
Issuance of stock-based compensation (in shares)	20,988
Compensation expense related to stock options		406,414			406,414
Compensation expense related to restricted stock awards		79,362			79,362
Net loss			(1,093,778)		(1,093,778)
Ending balance, value at Sep. 30, 2021	$ 479,317	40,004,197	158,289	(3,843,562)	36,798,241
Balance ending (in shares) at Sep. 30, 2021	47,931,664
Beginning balance, value at Dec. 31, 2021	$ 480,441	40,774,245	(910,069)	(3,843,562)	36,501,055
Balance beginning (in shares) at Dec. 31, 2021	48,044,162
Issuance of stock-based compensation	$ 475	142,025			142,500
Issuance of stock-based compensation (in shares)	47,500
Compensation expense related to stock options		524,670			524,670
Compensation expense related to restricted stock awards		170,386			170,386
Issuance upon options exercised	$ 296	(296)
Issuance upon options exercised (in shares)	29,627
Net loss			(2,537,514)		(2,537,514)
Ending balance, value at Mar. 31, 2022	$ 481,212	41,611,030	(3,447,583)	(3,843,562)	34,801,097
Balance ending (in shares) at Mar. 31, 2022	48,121,289
Beginning balance, value at Dec. 31, 2021	$ 480,441	40,774,245	(910,069)	(3,843,562)	36,501,055
Balance beginning (in shares) at Dec. 31, 2021	48,044,162
Net loss					(6,684,415)
Ending balance, value at Sep. 30, 2022	$ 486,570	43,443,201	(7,594,484)	(3,843,562)	32,491,725
Balance ending (in shares) at Sep. 30, 2022	48,657,023
Beginning balance, value at Mar. 31, 2022	$ 481,212	41,611,030	(3,447,583)	(3,843,562)	34,801,097
Balance beginning (in shares) at Mar. 31, 2022	48,121,289
Issuance of stock-based compensation	$ 697	114,808			115,505
Issuance of stock-based compensation (in shares)	69,707
Compensation expense related to stock options		527,736			527,736
Compensation expense related to restricted stock awards	$ 500	231,011			231,511
Compensation related to restricted stock (in shares)	50,000
Issuance upon options exercised	$ 1,667	(134,825)			(133,158)
Issuance upon options exercised (in shares)	166,623
Net loss			(2,921,341)		(2,921,341)
Ending balance, value at Jun. 30, 2022	$ 484,076	42,349,760	(6,368,924)	(3,843,562)	32,621,350
Balance ending (in shares) at Jun. 30, 2022	48,407,619
Issuance of stock-based compensation	$ 460	97,041			97,501
Issuance of stock-based compensation (in shares)	45,936
Compensation expense related to stock options		514,047			514,047
Compensation expense related to restricted stock awards		170,387			170,387
Issuance upon options exercised	$ 2,034	311,966			314,000
Issuance upon options exercised (in shares)	203,468
Net loss			(1,225,560)		(1,225,560)
Ending balance, value at Sep. 30, 2022	$ 486,570	$ 43,443,201	$ (7,594,484)	$ (3,843,562)	$ 32,491,725
Balance ending (in shares) at Sep. 30, 2022	48,657,023

NATURE OF OPERATIONS AND SUMMAR

NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES NATURE OF OPERATIONS KORU MEDICAL SYSTEMS, INC. (the “Company,” “KORU Medical,” “we,” “us” or “our”) designs, manufactures and markets proprietary portable and innovative medical devices primarily for the subcutaneous drug delivery market as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality system management. The Company operates as one BASIS OF PRESENTATION The accompanying financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2021 (“Annual Report”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted from the accompanying financial statements. The accompanying year-end balance sheet was derived from the audited financial statements included in the Annual Report. The accompanying interim financial statements are unaudited and reflect all adjustments which are in the opinion of management necessary for a fair statement of the Company’s financial position, results of operations, and cash flows for the periods presented. All such adjustments are of a normal, recurring nature. The Company’s results of operations and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods. CASH AND CASH EQUIVALENTS For purposes of the statement of cash flows, the Company considers all short-term investments with an original maturity of three months or less to be cash equivalents. The Company holds cash in excess of $ 250,000 INVENTORY Inventories of raw materials are stated at the lower of standard cost, which approximates average cost, or market value including allocable overhead. Work-in-process and finished goods are stated at the lower of standard cost or market value and include direct labor and allocable overhead. PATENTS Costs incurred in obtaining patents have been capitalized and are being amortized over the legal life of the patents. INCOME TAXES Deferred income taxes are provided using the liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. The Company believes that it has no uncertain tax positions requiring disclosure or adjustment. Generally, tax years starting with 2019 are subject to examination by income tax authorities. PROPERTY, EQUIPMENT, AND DEPRECIATION Property and equipment is stated at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets. STOCK-BASED COMPENSATION The Company maintains a stock option plan and an omnibus equity incentive plan under which it grants stock options to certain executives, key employees and consultants. The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model. All options are charged against income at their fair value. The entire compensation expense of the award is recognized over the vesting period. The Company also maintains a non-employee director compensation plan. Shares of stock granted for director fees are recorded at the fair value of the shares at the grant date. The Company issues restricted stock awards. Restricted stock awards are equity classified and measured at the fair market value of the underlying stock at the grant date. The fair value of restricted stock awards vesting at certain market capitalization thresholds were estimated on the date of grant using the Brownian Motion Monte Carlo lattice model. The fair value of restricted stock awards with time-based vesting were estimated on the date of grant at the current stock price. We recognize restricted stock expense using the straight-line attribution method over the requisite service period and account for forfeitures as they occur. NET LOSS PER COMMON SHARE Basic earnings per share are computed on the weighted average of common shares outstanding during each year. Diluted earnings per share include only an increase in the weighted average shares by the common shares issuable upon exercise of employee and consultant stock options. See “NOTE 4 — STOCK-BASED COMPENSATION” for further detail. Schedule of net loss per common share Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Net loss $ (1,225,560 ) $ (1,093,778 ) $ (6,684,415 ) $ (3,494,465 ) Weighted Average Outstanding Shares: Outstanding shares 45,038,181 44,322,335 44,877,366 44,510,021 Option shares includable — (a) — (a) — (a) — (a) Total 45,038,181 44,322,335 44,877,366 44,510,021 Net loss per share Basic $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) Diluted $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) __________ (a) For the three months ended September 30, 2022, and 2021, option shares of 72,347 296,504 81,723 244,422 For the three months ended September 30, 2022 and 2021, restricted shares of 950,000 1,000,000 950,000 1,000,000 USE OF ESTIMATES IN THE FINANCIAL STATEMENTS The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Important estimates include but are not limited to asset lives, valuation allowances, inventory valuation, and accruals. REVENUE RECOGNITION Our revenues are derived from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies. Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“Product Revenue”) for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use. For Product Revenues, we recognize revenues when shipment occurs, and at which point the customer obtains control and ownership of the goods. Shipping costs generally are billed to customers and are included in sales. The Company generally does not accept return of goods shipped unless it is a Company error. The only credits provided to customers are for defective merchandise. The Company warrants the syringe driver from defects in materials and workmanship under normal use and the warranty does not include a performance obligation. The costs under the warranty are expensed as incurred. Rebates are provided to distributors for the difference in selling price to distributor and pricing specified to select customers. In addition, rebates are provided to customers for meeting growth targets. Provisions for both distributor pricing and customer growth rebates are variable consideration and are recorded as a reduction of revenue in the same period the related sales are recorded or when it is probable the growth target will be achieved. Our novel therapies revenues can fluctuate and may not be consistent from period to period. Engineering work performed on our product may be specialized and tailored to the specific needs of each independent clinical trial and not uniform in nature. The clinical trial size and scope of protocols may also range greatly from customer to customer, and there is no expectation of repeat customers on a consistent basis compared to our core business. We recognize NRE revenue under an input method, which recognizes revenue on the basis of our efforts or inputs (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the satisfaction of a performance obligation relative to the total expected inputs to the satisfaction of that performance obligation (ie completion milestone). The input method that we use is based on costs incurred. The following table summarizes net sales by geography for the three and nine months ended September 30, 2022, and 2021: Schedule of net sales by geography Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Sales Domestic $ 6,661,196 $ 5,254,336 $ 17,475,083 $ 14,346,895 International 1,099,202 786,208 3,076,273 2,652,774 Total $ 7,760,398 $ 6,040,544 $ 20,551,356 $ 16,999,669 LEASES In February 2016, the FASB issued a standard related to leases to increase transparency and comparability among organizations by requiring the recognition of right-of-use (“ROU”) assets and lease liabilities on the balance sheet. Most prominent among the changes in the standard is the recognition of ROU assets and lease liabilities by the Company for those leases classified as operating leases under current GAAP, while our accounting for capital leases remains substantially unchanged. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The standard became effective for us on January 1, 2019. The standard had a material impact on our balance sheets but did not have a material impact on our statements of operations. See “NOTE 6 — ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments The Company considers the applicability and impact of all recently issued accounting pronouncements. Recent accounting pronouncements not specifically identified in our disclosures are either not applicable to the Company or are not expected to have a material effect on our financial condition or results of operations. FAIR VALUE MEASUREMENTS Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. Valuation techniques used to measure fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable: • Level 1 – Quoted prices in active markets for identical assets or liabilities. • Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means. • Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and includes instruments for which the determination of fair value requires significant judgment or estimation. The carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses are considered to be representative of their fair values because of the short-term nature of those instruments. There were no transfers between levels in the fair value hierarchy during the nine months ended September 30, 2022. IMPAIRMENT OF LONG-LIVED ASSETS The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value. No impairment losses have been recorded through September 30, 2022. RECLASSIFICATION Certain reclassifications have been made to conform prior period data to the current presentation. These reclassifications had no effect on reported net income.

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT	9 Months Ended
	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
PROPERTY AND EQUIPMENT	NOTE 2 — PROPERTY AND EQUIPMENT Property and equipment consists of the following at: Schedule of property and equipment September 30, 2022 December 31, 2021 Furniture and office equipment $ 896,655 $ 818,897 Construction in progress 803,931 — Leasehold improvements 1,598,037 556,907 Manufacturing equipment and tooling 2,646,962 2,042,675 Total property and equipment 5,945,585 3,418,479 Less: accumulated depreciation and amortization (2,626,973 ) (2,312,034 ) Property and equipment, net $ 3,318,612 $ 1,106,445 Construction in progress and leasehold improvement increases of $ 0.8 1.0 Depreciation expense was $ 130,882 100,502 329,526 301,469

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 3 — COMMITMENTS AND CONTINGENCIES LEGAL PROCEEDINGS The Company has been and may again become involved in legal proceedings, claims and litigation arising in the ordinary course of business. KORU Medical is not presently a party to any litigation or other legal proceeding that is believed to be material to its financial condition.

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
STOCK-BASED COMPENSATION	NOTE 4 — STOCK-BASED COMPENSATION The Company has three equity incentive plans: the 2015 Stock Option Plan, as amended (the “2015 Plan”), the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”), and the Non-Employee Director Compensation Plan. The Company has also issued restricted stock as employment inducement awards to its Chief Executive Officer. As of September 30, 2022, there were options to purchase 2,650,000 zero 295,000 6,000,000 The 2021 Plan provides for the grant of up to 1,000,000 zero 97,100 475,000 20,988 Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor were eligible to receive of $ 75,000 to be paid quarterly $12,500 in cash and $6,250 in common stock. 100,000 to be paid quarterly $12,500 in cash and $12,500 in common stock. 110,000 to be paid quarterly $12,500 in cash and $15,000 in common stock. 140,000 to be paid quarterly $12,500 in cash and $22,500 in common stock. 2015 STOCK OPTION PLAN, as amended Time Based Stock Options The per share weighted average fair value of stock options granted during the nine months ended September 30, 2022 and September 30, 2021 was $2.10 and $2.93, respectively. The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the nine months ended September 30, 2022 and September 30, 2021. Historical information was the primary basis for the selection of the expected volatility, expected dividend yield and the expected lives of the options. The risk-free interest rate was selected based upon yields of the U.S. Treasury issues with a term equal to the expected life of the option being valued. We have recognized tax benefits associated with stock-based compensation of $ 151,736 56,102 Schedule of time based stock options September 30, 2022 2021 Dividend yield 0.00 0.00 Expected Volatility 65.9 77.5 74.01 76.77 Weighted-average volatility — — Expected dividends — — Expected term (in years) 10 10 Risk-free rate 1.81 2.99 1.20 1.62 The following table summarizes the status of the 2015 Plan with respect to time based stock options: Schedule of status of time based stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 3,672,500 $ 3.42 2,922,494 $ 2.46 Granted 295,000 $ 2.70 1,650,000 $ 3.75 Exercised 831,250 $ 1.57 1,000,000 $ 1.23 Forfeited 486,250 $ 2.73 187,494 $ 3.36 Outstanding at September 30 2,650,000 $ 4.05 3,385,000 $ 3.39 Options exercisable at September 30 825,000 $ 4.41 1,005,625 $ 2.65 Weighted average fair value of options granted during the period — $ 2.10 — $ 2.93 Stock-based compensation expense — $ 1,465,567 — $ 1,934,935 Total stock-based compensation expense was $ 1,465,567 1,934,935 314,000 1,230,000 The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2022, and 2021 was $ 0.6 4.8 831,250 1.0 The following table presents information pertaining to options outstanding at September 30, 2022: Schedule of information pertaining to options outstanding Range of Exercise Price Number Weighted Weighted Number Weighted $1.57-$9.49 2,650,000 8.1 $ 4.05 825,000 $ 4.41 As of September 30, 2022, there was $ 4,581,923 2,679,152 1,909,141 Performance Based Stock Options There were no performance based stock options granted during the nine months ended September 30, 2022, and 2021. The following table summarizes the status of the 2015 Plan with respect to performance based stock options: Schedule of performance base stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 — $ — 1,000,000 $ 1.70 Granted — $ — — $ — Exercised — $ — — $ — Forfeited — $ — — $ — Outstanding at September 30 — $ — 1,000,000 $ 1.70 Options exercisable at September 30 — $ — — $ — Weighted average fair value of options granted during the period — $ — — $ — Stock-based compensation expense — $ — — $ (408,747 ) Total performance stock-based compensation expense totaled zero and ($408,747) for the nine months ended September 30, 2022, and 2021, respectively. All performance based stock options were forfeited as of September 30, 2021, and there was no unrecognized compensation cost remaining. 2021 STOCK OPTION PLAN, as amended Time Based Stock Options The per share weighted average fair value of stock options granted during the nine months ended September 30, 2022 and September 30, 2021 was $1.99 and $0 respectively. The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the nine months ended September 30, 2022 and September 30, 2021. Historical information was the primary basis for the selection of the expected volatility, expected dividend yield and the expected lives of the options. The risk-free interest rate was selected based upon yields of the U.S. Treasury issues with a term equal to the expected life of the option being valued. We have recognized tax benefits associated with stock-based compensation of $ 20,677 0 Schedule of time based stock options September 30, 2022 2021 Dividend yield 0.00 0.00 Expected Volatility 65.9 0 0 Weighted-average volatility — — Expected dividends — — Expected term (in years) 10 0 Risk-free rate 2.99 0 0 The following table summarizes the status of the 2021 Plan with respect to time based stock options: Schedule of status of time based stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 0 $ 0 — $ — Granted 475,000 $ 2.67 — $ — Exercised 0 $ — — $ — Forfeited 0 $ — — $ — Outstanding at September 30 475,000 $ 2.67 — $ — Options exercisable at September 30 0 $ — — $ — Weighted average fair value of options granted during the period — $ 1.99 — $ — Stock-based compensation expense — $ 98,460 — $ — Total stock-based compensation expense was $98,460 and $0 for the nine months ended September 30, 2022, and 2021, respectively. There were no options exercised during the nine months ended September 30, 2022 and September 30, 2021. The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2022, and 2021 was $0.95 million and $0 million, respectively. There were zero options exercised during the nine months ended September 30, 2022, and September 30, 2021. The following table presents information pertaining to options outstanding at September 30, 2022: Schedule of information pertaining to options outstanding Range of Exercise Price Number Weighted Weighted Number Weighted $2.67 475,000 9.6 $ 2.67 0 $ 0 As of September 30, 2022, there was $ 846,755 zero zero RESTRICTED STOCK AWARDS The following table summarizes the activities for our restricted stock awards for the nine months ended September 30, 2022, and 2021. Schedule of activities for restricted stock awards Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Unvested at January 1 — $ — — $ — Granted 1,000,000 $ 3.01 1,000,000 $ 3.01 Vested 50,000 $ 3.31 — $ — Forfeited/canceled — $ — — $ — Unvested at September 30 950,000 $ 2.99 1,000,000 $ 3.01 As of September 30, 2022, and 2021, there was $ 1,788,565 2,379,089 107,344 30,554

DEBT OBLIGATIONS

DEBT OBLIGATIONS	9 Months Ended
	Sep. 30, 2022
Debt Disclosure [Abstract]
DEBT OBLIGATIONS	NOTE 5 — DEBT OBLIGATIONS On June 29, 2022, the Company entered into a Loan Modification Extension Agreement (the “Modification Agreement”) with Keybank National Association (“Lender”) to modify its revolving line of credit with Lender in the amount of $ 3,500,000 (i) extends the maturity date of the Loan from June 1, 2022 to June 1, 2023; (ii) changes the interest rate applicable to the Loan from Prime – 1.50% to Prime + 0%; (iii) releases the Company from its obligations under a certain security agreement dated June 24, 2021 pursuant to which the Company had previously granted the Lender a first priority security interest in all equipment, inventory, accounts, instruments, chattel paper and general intangibles of the Company (the “Security Agreement”); and (iv) replaces the Security Agreement with a new pledge security agreement dated June 29, 2022 by and between the Company On August 5, 2022, the Company entered into a commercial insurance premium finance and security agreement with AON Premium Finance, LLC in the aggregate principal amount of $ 0.8 6.5 Monthly payments were due on the first of each month beginning August 1, 2022 through June 1, 2023

LEASES

LEASES	9 Months Ended
	Sep. 30, 2022
Leases [Abstract]
LEASES	NOTE 6 — LEASES We have finance and operating leases for our corporate office and certain office and computer equipment. Our two operating leases have remaining lease terms of ten years and 6 months, respectively. On September 29, 2022, we extended our existing lease in Chester NY through March 31, 2023 with the same payment terms. Our finance lease, which was entered into in June 2022 has a remaining lease term of 5 years. The components of lease expense were as follows: Schedule of components of lease expense Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Operating lease cost $ 157,076 $ 37,093 $ 396,658 $ 112,383 Short-term lease cost 18,300 35,960 96,588 104,396 Total lease cost $ 175,376 $ 73,053 $ 493,246 $ 216,779 Finance lease cost: Amortization of right-of-use assets $ 17,754 $ 597 $ 23,672 $ 2,188 Interest on lease liabilities 1,381 10 1,381 57 Total finance lease cost $ 19,135 $ 607 $ 25,053 $ 2,245 Supplemental cash flow information related to leases was as follows: Schedule of cash flow information related to leases Nine Months Ended September 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 301,150 $ 105,618 Financing cash flows from finance leases 26,443 2,232 Supplemental balance sheet information related to leases was as follows: Schedule of balance sheet information related to leases September 30, December 31, Operating Leases Operating lease right-of-use assets $ 3,865,370 $ 95,553 Operating lease current liabilities 342,399 95,553 Operating lease long term liabilities 3,741,015 — Total operating lease liabilities $ 4,083,414 $ 95,553 Finance Leases Property and equipment, at cost $ 355,071 $ 12,725 Accumulated depreciation 23,671 (12,725 ) Property and equipment, net $ 331,400 $ — Finance lease current liabilities 64,467 — Finance lease long term liabilities 265,542 — Total finance lease liabilities $ 330,009 $ — September 30, December 31, Weighted Average Remaining Lease Term Operating leases 10.1 0.6 Finance leases 4.9 0 Weighted Average Discount Rate Operating leases 4.02 4.75 Finance leases 4.25 4.75 Maturities of lease liabilities are as follows: Schedule of maturities of lease liabilities Year Ending December 31, Operating Leases Finance Leases 2022 (excluding the nine months ended September 30, 2022) 124,876 19,832 2023 499,503 79,329 2024 499,503 79,329 2025 499,503 79,329 2026 499,503 79,329 Thereafter 2,830,519 33,052 Total undiscounted lease payments 4,953,407 370,200 Less: imputed interest (869,993 ) (40,191 ) Total lease liabilities $ 4,083,414 $ 330,009

NATURE OF OPERATIONS AND SUMM_2

NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
NATURE OF OPERATIONS	NATURE OF OPERATIONS KORU MEDICAL SYSTEMS, INC. (the “Company,” “KORU Medical,” “we,” “us” or “our”) designs, manufactures and markets proprietary portable and innovative medical devices primarily for the subcutaneous drug delivery market as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality system management. The Company operates as one
BASIS OF PRESENTATION	BASIS OF PRESENTATION The accompanying financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2021 (“Annual Report”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted from the accompanying financial statements. The accompanying year-end balance sheet was derived from the audited financial statements included in the Annual Report. The accompanying interim financial statements are unaudited and reflect all adjustments which are in the opinion of management necessary for a fair statement of the Company’s financial position, results of operations, and cash flows for the periods presented. All such adjustments are of a normal, recurring nature. The Company’s results of operations and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods.
CASH AND CASH EQUIVALENTS	CASH AND CASH EQUIVALENTS For purposes of the statement of cash flows, the Company considers all short-term investments with an original maturity of three months or less to be cash equivalents. The Company holds cash in excess of $ 250,000
INVENTORY	INVENTORY Inventories of raw materials are stated at the lower of standard cost, which approximates average cost, or market value including allocable overhead. Work-in-process and finished goods are stated at the lower of standard cost or market value and include direct labor and allocable overhead.
PATENTS	PATENTS Costs incurred in obtaining patents have been capitalized and are being amortized over the legal life of the patents.
INCOME TAXES	INCOME TAXES Deferred income taxes are provided using the liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. The Company believes that it has no uncertain tax positions requiring disclosure or adjustment. Generally, tax years starting with 2019 are subject to examination by income tax authorities.
PROPERTY, EQUIPMENT, AND DEPRECIATION	PROPERTY, EQUIPMENT, AND DEPRECIATION Property and equipment is stated at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets.
STOCK-BASED COMPENSATION	STOCK-BASED COMPENSATION The Company maintains a stock option plan and an omnibus equity incentive plan under which it grants stock options to certain executives, key employees and consultants. The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model. All options are charged against income at their fair value. The entire compensation expense of the award is recognized over the vesting period. The Company also maintains a non-employee director compensation plan. Shares of stock granted for director fees are recorded at the fair value of the shares at the grant date. The Company issues restricted stock awards. Restricted stock awards are equity classified and measured at the fair market value of the underlying stock at the grant date. The fair value of restricted stock awards vesting at certain market capitalization thresholds were estimated on the date of grant using the Brownian Motion Monte Carlo lattice model. The fair value of restricted stock awards with time-based vesting were estimated on the date of grant at the current stock price. We recognize restricted stock expense using the straight-line attribution method over the requisite service period and account for forfeitures as they occur.
NET LOSS PER COMMON SHARE	NET LOSS PER COMMON SHARE Basic earnings per share are computed on the weighted average of common shares outstanding during each year. Diluted earnings per share include only an increase in the weighted average shares by the common shares issuable upon exercise of employee and consultant stock options. See “NOTE 4 — STOCK-BASED COMPENSATION” for further detail. Schedule of net loss per common share Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Net loss $ (1,225,560 ) $ (1,093,778 ) $ (6,684,415 ) $ (3,494,465 ) Weighted Average Outstanding Shares: Outstanding shares 45,038,181 44,322,335 44,877,366 44,510,021 Option shares includable — (a) — (a) — (a) — (a) Total 45,038,181 44,322,335 44,877,366 44,510,021 Net loss per share Basic $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) Diluted $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) __________ (a) For the three months ended September 30, 2022, and 2021, option shares of 72,347 296,504 81,723 244,422 For the three months ended September 30, 2022 and 2021, restricted shares of 950,000 1,000,000 950,000 1,000,000
USE OF ESTIMATES IN THE FINANCIAL STATEMENTS	USE OF ESTIMATES IN THE FINANCIAL STATEMENTS The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Important estimates include but are not limited to asset lives, valuation allowances, inventory valuation, and accruals.
REVENUE RECOGNITION	REVENUE RECOGNITION Our revenues are derived from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies. Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“Product Revenue”) for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use. For Product Revenues, we recognize revenues when shipment occurs, and at which point the customer obtains control and ownership of the goods. Shipping costs generally are billed to customers and are included in sales. The Company generally does not accept return of goods shipped unless it is a Company error. The only credits provided to customers are for defective merchandise. The Company warrants the syringe driver from defects in materials and workmanship under normal use and the warranty does not include a performance obligation. The costs under the warranty are expensed as incurred. Rebates are provided to distributors for the difference in selling price to distributor and pricing specified to select customers. In addition, rebates are provided to customers for meeting growth targets. Provisions for both distributor pricing and customer growth rebates are variable consideration and are recorded as a reduction of revenue in the same period the related sales are recorded or when it is probable the growth target will be achieved. Our novel therapies revenues can fluctuate and may not be consistent from period to period. Engineering work performed on our product may be specialized and tailored to the specific needs of each independent clinical trial and not uniform in nature. The clinical trial size and scope of protocols may also range greatly from customer to customer, and there is no expectation of repeat customers on a consistent basis compared to our core business. We recognize NRE revenue under an input method, which recognizes revenue on the basis of our efforts or inputs (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the satisfaction of a performance obligation relative to the total expected inputs to the satisfaction of that performance obligation (ie completion milestone). The input method that we use is based on costs incurred. The following table summarizes net sales by geography for the three and nine months ended September 30, 2022, and 2021: Schedule of net sales by geography Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Sales Domestic $ 6,661,196 $ 5,254,336 $ 17,475,083 $ 14,346,895 International 1,099,202 786,208 3,076,273 2,652,774 Total $ 7,760,398 $ 6,040,544 $ 20,551,356 $ 16,999,669
LEASES	LEASES In February 2016, the FASB issued a standard related to leases to increase transparency and comparability among organizations by requiring the recognition of right-of-use (“ROU”) assets and lease liabilities on the balance sheet. Most prominent among the changes in the standard is the recognition of ROU assets and lease liabilities by the Company for those leases classified as operating leases under current GAAP, while our accounting for capital leases remains substantially unchanged. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The standard became effective for us on January 1, 2019. The standard had a material impact on our balance sheets but did not have a material impact on our statements of operations. See “NOTE 6 —
ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED	ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED	ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments The Company considers the applicability and impact of all recently issued accounting pronouncements. Recent accounting pronouncements not specifically identified in our disclosures are either not applicable to the Company or are not expected to have a material effect on our financial condition or results of operations.
FAIR VALUE MEASUREMENTS	FAIR VALUE MEASUREMENTS Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. Valuation techniques used to measure fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable: • Level 1 – Quoted prices in active markets for identical assets or liabilities. • Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means. • Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and includes instruments for which the determination of fair value requires significant judgment or estimation. The carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses are considered to be representative of their fair values because of the short-term nature of those instruments. There were no transfers between levels in the fair value hierarchy during the nine months ended September 30, 2022.
IMPAIRMENT OF LONG-LIVED ASSETS	IMPAIRMENT OF LONG-LIVED ASSETS The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value. No impairment losses have been recorded through September 30, 2022.
RECLASSIFICATION	RECLASSIFICATION Certain reclassifications have been made to conform prior period data to the current presentation. These reclassifications had no effect on reported net income.

NATURE OF OPERATIONS AND SUMM_3

NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
Schedule of net loss per common share	Basic earnings per share are computed on the weighted average of common shares outstanding during each year. Diluted earnings per share include only an increase in the weighted average shares by the common shares issuable upon exercise of employee and consultant stock options. See “NOTE 4 — STOCK-BASED COMPENSATION” for further detail. Schedule of net loss per common share Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Net loss $ (1,225,560 ) $ (1,093,778 ) $ (6,684,415 ) $ (3,494,465 ) Weighted Average Outstanding Shares: Outstanding shares 45,038,181 44,322,335 44,877,366 44,510,021 Option shares includable — (a) — (a) — (a) — (a) Total 45,038,181 44,322,335 44,877,366 44,510,021 Net loss per share Basic $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) Diluted $ (0.03 ) $ (0.02 ) $ (0.15 ) $ (0.08 ) __________ (a) For the three months ended September 30, 2022, and 2021, option shares of 72,347 296,504 81,723 244,422 For the three months ended September 30, 2022 and 2021, restricted shares of 950,000 1,000,000 950,000 1,000,000
Schedule of net sales by geography	The following table summarizes net sales by geography for the three and nine months ended September 30, 2022, and 2021: Schedule of net sales by geography Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Sales Domestic $ 6,661,196 $ 5,254,336 $ 17,475,083 $ 14,346,895 International 1,099,202 786,208 3,076,273 2,652,774 Total $ 7,760,398 $ 6,040,544 $ 20,551,356 $ 16,999,669

PROPERTY AND EQUIPMENT (Tables)

PROPERTY AND EQUIPMENT (Tables)	9 Months Ended
	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
Schedule of property and equipment	Property and equipment consists of the following at: Schedule of property and equipment September 30, 2022 December 31, 2021 Furniture and office equipment $ 896,655 $ 818,897 Construction in progress 803,931 — Leasehold improvements 1,598,037 556,907 Manufacturing equipment and tooling 2,646,962 2,042,675 Total property and equipment 5,945,585 3,418,479 Less: accumulated depreciation and amortization (2,626,973 ) (2,312,034 ) Property and equipment, net $ 3,318,612 $ 1,106,445

STOCK-BASED COMPENSATION (Table

STOCK-BASED COMPENSATION (Tables)	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
Schedule of time based stock options	Schedule of time based stock options September 30, 2022 2021 Dividend yield 0.00 0.00 Expected Volatility 65.9 77.5 74.01 76.77 Weighted-average volatility — — Expected dividends — — Expected term (in years) 10 10 Risk-free rate 1.81 2.99 1.20 1.62
Schedule of status of time based stock options	The following table summarizes the status of the 2015 Plan with respect to time based stock options: Schedule of status of time based stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 3,672,500 $ 3.42 2,922,494 $ 2.46 Granted 295,000 $ 2.70 1,650,000 $ 3.75 Exercised 831,250 $ 1.57 1,000,000 $ 1.23 Forfeited 486,250 $ 2.73 187,494 $ 3.36 Outstanding at September 30 2,650,000 $ 4.05 3,385,000 $ 3.39 Options exercisable at September 30 825,000 $ 4.41 1,005,625 $ 2.65 Weighted average fair value of options granted during the period — $ 2.10 — $ 2.93 Stock-based compensation expense — $ 1,465,567 — $ 1,934,935
Schedule of information pertaining to options outstanding	The following table presents information pertaining to options outstanding at September 30, 2022: Schedule of information pertaining to options outstanding Range of Exercise Price Number Weighted Weighted Number Weighted $1.57-$9.49 2,650,000 8.1 $ 4.05 825,000 $ 4.41
Schedule of performance base stock options	The following table summarizes the status of the 2015 Plan with respect to performance based stock options: Schedule of performance base stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 — $ — 1,000,000 $ 1.70 Granted — $ — — $ — Exercised — $ — — $ — Forfeited — $ — — $ — Outstanding at September 30 — $ — 1,000,000 $ 1.70 Options exercisable at September 30 — $ — — $ — Weighted average fair value of options granted during the period — $ — — $ — Stock-based compensation expense — $ — — $ (408,747 )
Schedule of time based stock options	Schedule of time based stock options September 30, 2022 2021 Dividend yield 0.00 0.00 Expected Volatility 65.9 0 0 Weighted-average volatility — — Expected dividends — — Expected term (in years) 10 0 Risk-free rate 2.99 0 0
Schedule of status of time based stock options	The following table summarizes the status of the 2021 Plan with respect to time based stock options: Schedule of status of time based stock options Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Outstanding at January 1 0 $ 0 — $ — Granted 475,000 $ 2.67 — $ — Exercised 0 $ — — $ — Forfeited 0 $ — — $ — Outstanding at September 30 475,000 $ 2.67 — $ — Options exercisable at September 30 0 $ — — $ — Weighted average fair value of options granted during the period — $ 1.99 — $ — Stock-based compensation expense — $ 98,460 — $ —
Schedule of information pertaining to options outstanding	The following table presents information pertaining to options outstanding at September 30, 2022: Schedule of information pertaining to options outstanding Range of Exercise Price Number Weighted Weighted Number Weighted $2.67 475,000 9.6 $ 2.67 0 $ 0
Schedule of activities for restricted stock awards	The following table summarizes the activities for our restricted stock awards for the nine months ended September 30, 2022, and 2021. Schedule of activities for restricted stock awards Nine Months Ended September 30, 2022 2021 Shares Weighted Shares Weighted Unvested at January 1 — $ — — $ — Granted 1,000,000 $ 3.01 1,000,000 $ 3.01 Vested 50,000 $ 3.31 — $ — Forfeited/canceled — $ — — $ — Unvested at September 30 950,000 $ 2.99 1,000,000 $ 3.01

LEASES (Tables)

LEASES (Tables)	9 Months Ended
	Sep. 30, 2022
Leases [Abstract]
Schedule of components of lease expense	The components of lease expense were as follows: Schedule of components of lease expense Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Operating lease cost $ 157,076 $ 37,093 $ 396,658 $ 112,383 Short-term lease cost 18,300 35,960 96,588 104,396 Total lease cost $ 175,376 $ 73,053 $ 493,246 $ 216,779 Finance lease cost: Amortization of right-of-use assets $ 17,754 $ 597 $ 23,672 $ 2,188 Interest on lease liabilities 1,381 10 1,381 57 Total finance lease cost $ 19,135 $ 607 $ 25,053 $ 2,245
Schedule of cash flow information related to leases	Supplemental cash flow information related to leases was as follows: Schedule of cash flow information related to leases Nine Months Ended September 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 301,150 $ 105,618 Financing cash flows from finance leases 26,443 2,232
Schedule of balance sheet information related to leases	Supplemental balance sheet information related to leases was as follows: Schedule of balance sheet information related to leases September 30, December 31, Operating Leases Operating lease right-of-use assets $ 3,865,370 $ 95,553 Operating lease current liabilities 342,399 95,553 Operating lease long term liabilities 3,741,015 — Total operating lease liabilities $ 4,083,414 $ 95,553 Finance Leases Property and equipment, at cost $ 355,071 $ 12,725 Accumulated depreciation 23,671 (12,725 ) Property and equipment, net $ 331,400 $ — Finance lease current liabilities 64,467 — Finance lease long term liabilities 265,542 — Total finance lease liabilities $ 330,009 $ — September 30, December 31, Weighted Average Remaining Lease Term Operating leases 10.1 0.6 Finance leases 4.9 0 Weighted Average Discount Rate Operating leases 4.02 4.75 Finance leases 4.25 4.75
Schedule of maturities of lease liabilities	Maturities of lease liabilities are as follows: Schedule of maturities of lease liabilities Year Ending December 31, Operating Leases Finance Leases 2022 (excluding the nine months ended September 30, 2022) 124,876 19,832 2023 499,503 79,329 2024 499,503 79,329 2025 499,503 79,329 2026 499,503 79,329 Thereafter 2,830,519 33,052 Total undiscounted lease payments 4,953,407 370,200 Less: imputed interest (869,993 ) (40,191 ) Total lease liabilities $ 4,083,414 $ 330,009

Schedule of net loss per common

Schedule of net loss per common share (Details) - USD ($)		3 Months Ended						9 Months Ended
		Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Net loss		$ (1,225,560)	$ (2,921,341)	$ (2,537,514)	$ (1,093,778)	$ (1,124,549)	$ (1,276,138)	$ (6,684,415)	$ (3,494,465)
Weighted Average Outstanding Shares:
Outstanding shares		45,038,181			44,322,335			44,877,366	44,510,021
Option shares includable	[1]	0			0			0	0
Total		45,038,181			44,322,335			44,877,366	44,510,021
Net loss per share
Basic		$ (0.03)			$ (0.02)			$ (0.15)	$ (0.08)
Diluted		$ (0.03)			$ (0.02)			$ (0.15)	$ (0.08)
Restricted Stock [Member]
Net loss per share
Antidilutive Securities excluded from computation of earnings per share, amount		950,000			1,000,000			950,000	1,000,000
Employee Stock [Member]
Net loss per share
Antidilutive Securities excluded from computation of earnings per share, amount		72,347			296,504			81,723	244,422
Common Stock [Member]
Net loss
Weighted Average Outstanding Shares:
Outstanding shares		45,038,181			44,322,335			44,877,366	44,510,021
[1]For the three months ended September 30, 2022, and 2021, option shares of 72,347 296,504 81,723 244,422

Schedule of net sales by geogra

Schedule of net sales by geography (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenues	$ 7,760,398	$ 6,040,544	$ 20,551,356	$ 16,999,669
UNITED STATES
Revenues	6,661,196	5,254,336	17,475,083	14,346,895
Non-US [Member]
Revenues	$ 1,099,202	$ 786,208	$ 3,076,273	$ 2,652,774

NATURE OF OPERATIONS AND SUMM_4

NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Sep. 30, 2022 USD ($) Number
Accounting Policies [Abstract]
Number of segments | Number	1
FDIC cash uninsured amount | $	$ 250,000

Schedule of property and equipm

Schedule of property and equipment (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 5,945,585	$ 3,418,479
Less: accumulated depreciation and amortization	(2,626,973)	(2,312,034)
Property and equipment, net	3,318,612	1,106,445
Furniture And Office Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	896,655	818,897
Construction in Progress [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	803,931
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	1,598,037	556,907
Manufacturing Equipment And Tooling [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 2,646,962	$ 2,042,675

PROPERTY AND EQUIPMENT (Details

PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Abstract]
Construction in progress gross	$ 800,000		$ 800,000
Leasehold improvements gross	1,000,000		1,000,000
Depreciation expense	$ 130,882	$ 100,502	$ 329,526	$ 301,469

Schedule of time based stock op

Schedule of time based stock options (Details) - Time Based Shares Options [Member] - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Stock Option Plan 2015 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Dividend yield	0%	0%
Weighted-average volatility
Expected dividends
Expected term (in years)	10 years	10 years
Stock Option Plan 2015 [Member] | Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected Volatility	65.90%	74.01%
Risk-free rate	1.81%	1.20%
Stock Option Plan 2015 [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected Volatility	77.50%	76.77%
Risk-free rate	2.99%	1.62%
Stock Option Plan 2021 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected Volatility	65.90%
Weighted-average volatility
Expected dividends
Expected term (in years)	10 years	10 years
Risk-free rate	2.99%
Dividend yield	0%	0%
Stock Option Plan 2021 [Member] | Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected Volatility		0%
Risk-free rate		0%
Stock Option Plan 2021 [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected Volatility		0%
Risk-free rate		0%

Schedule of status of time base

Schedule of status of time based stock options (Details)	9 Months Ended
	Sep. 30, 2022 USD ($) $ / shares shares	Sep. 30, 2021 USD ($) $ / shares shares
Stock Option Plan 2015 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding at beginning | shares	3,672,500	2,922,494
Outstanding at beginning	$ 3.42	$ 2.46
Granted | shares	295,000	1,650,000
Granted	$ 2.70	$ 3.75
Exercised | shares	831,250	1,000,000
Exercised	$ 1.57	$ 1.23
Forfeited | shares	486,250	187,494
Forfeited	$ 2.73	$ 3.36
Outstanding at ending | shares	2,650,000	3,385,000
Outstanding at ending	$ 4.05	$ 3.39
Options exercisable at ending | shares	825,000	1,005,625
Options exercisable	$ 4.41	$ 2.65
Weighted average fair value of options granted during the period	$ 2.10	$ 2.93
Stock-based compensation expense | $	$ 1,465,567	$ 1,934,935
Stock Option Plan 2021 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Options exercisable at ending | shares	0
Outstanding at beginning | shares	0
Outstanding at beginning	$ 0
Granted | shares	475,000
Granted	$ 2.67
Exercised | shares	0
Exercised
Forfeited | shares	0
Forfeited
Outstanding at ending | shares	475,000
Outstanding at ending	$ 2.67
Options exercisable at ending
Weighted average fair value of options granted during the period	$ 1.99
Stock-based compensation expense | $	$ 98,460

Schedule of information pertain

Schedule of information pertaining to options outstanding (Details) - Time Based Shares Options [Member] - Exercise Price1 [Member]	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Stock Option Plan 2015 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number outstanding | shares	2,650,000
Weighted average remaining contractual life	8 years 1 month 6 days
Weighted average exercise price | $ / shares	$ 4.05
Number exercisable | shares	825,000
Weighted average exercise price | $ / shares	$ 4.41
Stock Option Plan 2021 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number outstanding | shares	475,000
Weighted average remaining contractual life	9 years 7 months 6 days
Weighted average exercise price | $ / shares	$ 2.67
Number exercisable | shares	0
Weighted average exercise price | $ / shares	$ 0

Schedule of performance base st

Schedule of performance base stock options (Details) - Performance Shares [Member] - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding at beginning		1,000,000
Outstanding at beginning		$ 1.70
Options exercisable at ending
Granted
Exercised
Exercised
Forfeited
Forfeited
Outstanding at ending		1,000,000
Outstanding at ending		$ 1.70
Options exercisable at ending
Weighted average fair value of options granted during the period
Weighted average fair value of options granted during the period
Stock-based compensation expense		$ (408,747)

Schedule of activities for rest

Schedule of activities for restricted stock awards (Details) - Restricted Stock Awards [Member] - Stock Option Plan 2021 [Member] - $ / shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding at beginning
Outstanding at beginning
Granted	1,000,000	1,000,000
Granted	$ 3.01	$ 3.01
Vested	50,000
Vested	$ 3.31
Forfeited/canceled
Forfeited/canceled
Outstanding at ending	950,000	1,000,000
Outstanding at ending	$ 2.99	$ 3.01

STOCK-BASED COMPENSATION (Detai

STOCK-BASED COMPENSATION (Details Narrative) - USD ($)			3 Months Ended						9 Months Ended
	May 18, 2021	Jan. 01, 2021	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock issued during period			0						295,000
Stock Issued			0						97,100
Non-employee director compensation		75,000
stock-based compensation expense			$ 97,501	$ 115,505	$ 142,500	$ 142,501	$ 97,196	$ 56,250
Chief Executive Officer Linda Tharby [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Non-employee director compensation		100,000
Non Employee Director And Board Advisor [Member[
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Non-employee director compensation	110,000
Non-employee director compensation	to be paid quarterly $12,500 in cash and $15,000 in common stock.	to be paid quarterly $12,500 in cash and $6,250 in common stock.
Board of Directors Chairman [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Non-employee director compensation	140,000
Non-employee director compensation	to be paid quarterly $12,500 in cash and $22,500 in common stock.	to be paid quarterly $12,500 in cash and $12,500 in common stock.
Stock Option Plan 2015 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Available for issuance									6,000,000
Tax benefit associated with stock-based compensation									$ 151,736	$ 56,102
stock-based compensation expense									1,465,567	1,934,935
Fair value of shares			$ 2,679,152			1,909,141			2,679,152	1,909,141
Stock Option Plan 2015 [Member] | Time Based Shares Options [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Cash received from option exercises									$ 314,000	$ 1,230,000
Weighted-average grant-date fair value options granted									600,000	4,800,000
Number of options exercised									831,250	1,000,000
Stock Option Plan 2015 [Member] | Executiveskey Employees And Consultants [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding number of options to purchase shares of common stock			2,650,000						2,650,000
Stock Option Plan 2021 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Available for issuance									1,000,000
Fair value of shares			$ 0			$ 0			$ 0	$ 0
Tax benefit associated with stock-based compensation									20,677	0
Stock Option Plan 2021 [Member] | Restricted Stock Awards [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Tax benefit associated with restricted stock award compensation									$ 107,344	$ 30,554
Stock Option Plan 2021 [Member] | Director [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Non-employee director compensation									475,000

DEBT OBLIGATIONS (Details Narra

DEBT OBLIGATIONS (Details Narrative) - USD ($)				9 Months Ended
	Aug. 05, 2022	Aug. 05, 2022	Jun. 29, 2022	Sep. 30, 2022
Short-Term Debt [Line Items]
Description of the frequency of periodic payments		Monthly payments were due on the first of each month beginning August 1, 2022 through June 1, 2023
A O N Premium Finance L L C [Member] | Promissory Note [Member]
Short-Term Debt [Line Items]
Notes Payable	$ 800,000	$ 800,000
A O N Premium Finance L L C [Member] | Promissory Note [Member] | Line of Credit [Member]
Short-Term Debt [Line Items]
Annual interest rate	6.50%
Key Equipment Finance [Member]
Short-Term Debt [Line Items]
Description of debt obligation				(i) extends the maturity date of the Loan from June 1, 2022 to June 1, 2023; (ii) changes the interest rate applicable to the Loan from Prime – 1.50% to Prime + 0%; (iii) releases the Company from its obligations under a certain security agreement dated June 24, 2021 pursuant to which the Company had previously granted the Lender a first priority security interest in all equipment, inventory, accounts, instruments, chattel paper and general intangibles of the Company (the “Security Agreement”); and (iv) replaces the Security Agreement with a new pledge security agreement dated June 29, 2022 by and between the Company
Key Equipment Finance [Member] | Progress Payment Loan And Security Agreement [Member]
Short-Term Debt [Line Items]
Loans, principal amount			$ 3,500,000

Schedule of components of lease

Schedule of components of lease expense (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Leases [Abstract]
Operating lease cost	$ 157,076	$ 37,093	$ 396,658	$ 112,383
Short-term lease cost	18,300	35,960	96,588	104,396
Total lease cost	175,376	73,053	493,246	216,779
Finance lease cost:
Amortization of right-of-use assets	17,754	597	23,672	2,188
Interest on lease liabilities	1,381	10	1,381	57
Total finance lease cost	$ 19,135	$ 607	$ 25,053	$ 2,245

Schedule of cash flow informati

Schedule of cash flow information related to leases (Details) - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$ 301,150	$ 105,618
Financing cash flows from finance leases	$ 26,443	$ 2,232

Schedule of balance sheet infor

Schedule of balance sheet information related to leases (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Operating Leases
Operating lease right-of-use assets	$ 3,865,370	$ 95,553
Operating lease current liabilities	342,399	95,553
Operating lease long term liabilities	3,741,015
Total operating lease liabilities	4,083,414	95,553
Finance Leases
Property and equipment, at cost	355,071	12,725
Accumulated depreciation	23,671	(12,725)
Property and equipment, net	331,400
Finance lease current liabilities	64,467
Finance lease long term liabilities	265,542
Total finance lease liabilities	$ 330,009
Operating leases	10 years 1 month 6 days	7 months 6 days
Finance leases	4 years 10 months 25 days	0 years
Operating leases	4.02%	4.75%
Finance leases	4.25%	4.75%

Schedule of maturities of lease

Schedule of maturities of lease liabilities (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Leases [Abstract]
2022 (excluding the nine months ended September 30, 2022)	$ 124,876
2022 (excluding the nine months ended September 30, 2022)	19,832
2023	499,503
2023	79,329
2024	499,503
2024	79,329
2025	499,503
2025	79,329
2026	499,503
2026	79,329
Thereafter	2,830,519
Thereafter	33,052
Total undiscounted lease payments	4,953,407
Total undiscounted lease payments	370,200
Less: imputed interest	(869,993)
Less: imputed interest	(40,191)
Total lease liabilities	4,083,414	$ 95,553
Total lease liabilities	$ 330,009