Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 16, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-36445 | |
Entity Registrant Name | NanoVibronix, Inc | |
Entity Central Index Key | 0001326706 | |
Entity Tax Identification Number | 01-0801232 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 525 Executive Blvd | |
Entity Address, City or Town | Elmsford | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10523 | |
City Area Code | (914) | |
Local Phone Number | 233-3004 | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | NAOV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 27,997,793 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 5,990 | $ 7,737 |
Trade receivables | 134 | 200 |
Other accounts receivable and prepaid expenses | 911 | 230 |
Inventory | 355 | 175 |
Total current assets | 7,390 | 8,342 |
Non-current assets: | ||
Fixed assets, net | 5 | 5 |
Other assets | 17 | 19 |
Severance pay fund | 207 | 207 |
Operating lease right-of-use assets, net | 44 | 49 |
Total non-current assets | 273 | 280 |
Total assets | 7,663 | 8,622 |
Current liabilities: | ||
Trade payables | 172 | 87 |
Other accounts payable and accrued expenses | 1,747 | 1,723 |
Deferred revenues | 44 | 44 |
Operating lease liabilities - current | 44 | 49 |
Total current liabilities | 2,007 | 1,903 |
Non-current liabilities: | ||
Accrued severance pay | 253 | 253 |
Deferred licensing income | 142 | 153 |
Total liabilities | 2,402 | 2,309 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Common stock of $0.001 par value - Authorized: 40,000,000 shares at March 31, 2022 and December 31, 2021, respectively; Issued and outstanding: 27,997,793 shares at March 31, 2022 and December 31, 2021, | 28 | 28 |
Additional paid in capital | 63,248 | 63,162 |
Accumulated other comprehensive income | 54 | 60 |
Accumulated deficit | (58,069) | (56,937) |
Total stockholders’ equity | 5,261 | 6,313 |
Total liabilities and stockholders’ equity | 7,663 | 8,622 |
Series C Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Series D Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Series E Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 40,000,000 | 40,000,000 |
Common stock, shares issued | 27,997,793 | 27,997,793 |
Common stock, shares outstanding | 27,997,793 | 27,997,793 |
Series C Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 3,000,000 | 3,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series D Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 506 | 506 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series E Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,999,494 | 1,999,494 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Revenues | $ 272 | $ 103 |
Cost of revenues | 166 | 26 |
Gross profit | 106 | 77 |
Operating expenses: | ||
Research and development | 66 | 64 |
Selling and marketing | 210 | 311 |
General and administrative | 942 | 1,016 |
Total operating expenses | 1,218 | 1,391 |
Loss from operations | (1,112) | (1,314) |
Financial income (expense), net | (13) | (7) |
Change in fair value of derivative liabilities | (1,948) | |
Warrant modification expense | (1,627) | |
Loss before taxes on income | (1,125) | (4,896) |
Income tax expense | (7) | (21) |
Net loss available to common stockholders | $ (1,132) | $ (4,917) |
Basic and diluted net loss available for holders of common stock, Series C Preferred Stock and Series D Preferred Stock | $ (0.04) | $ (0.20) |
Weighted average common shares outstanding: | ||
Basic and diluted | 27,997,793 | 24,170,065 |
Comprehensive loss: | ||
Change in foreign currency translation adjustments | $ (4) | $ 6 |
Comprehensive loss | $ (1,136) | $ (4,911) |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Preferred Stock [Member]Series C Preferred Stock [Member] | Preferred Stock [Member]Series D Preferred Stock [Member] | Preferred Stock [Member]Series E Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 1 | $ 1 | $ 22 | $ 44,959 | $ 66 | $ (42,655) | $ 2,394 | |
Beginning balance, shares at Dec. 31, 2020 | 666,667 | 153 | 875,000 | 21,426,523 | ||||
Stock-based compensation | 44 | 44 | ||||||
Exercise of warrants | $ 2 | 3,492 | 3,494 | |||||
Exercise of warrant, shares | (110,000) | 2,863,112 | ||||||
Reclass liability to equity due to increase in authorized shares | 3,337 | 3,337 | ||||||
Other comprehensive loss | (5) | (5) | ||||||
Net loss | (4,917) | (4,917) | ||||||
Ending balance, value at Mar. 31, 2021 | $ 1 | $ 1 | $ 24 | 51,832 | 61 | (47,572) | 4,347 | |
Ending balance, shares at Mar. 31, 2021 | 666,667 | 153 | 875,000 | 24,109,635 | ||||
Beginning balance, value at Dec. 31, 2021 | $ 28 | 63,162 | 60 | (56,937) | 6,313 | |||
Beginning balance, shares at Dec. 31, 2021 | 27,997,793 | |||||||
Stock-based compensation | 86 | 86 | ||||||
Net loss | (1,132) | (1,132) | ||||||
Currency translation adjustment | (6) | (6) | ||||||
Ending balance, value at Mar. 31, 2022 | $ 28 | $ 63,248 | $ 54 | $ (58,069) | $ 5,261 | |||
Ending balance, shares at Mar. 31, 2022 | 27,997,793 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (1,132) | $ (4,917) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1 | |
Stock-based compensation | 86 | 109 |
Warrant modification expense | 1,627 | |
Change in fair value of equity investment | 2 | 2 |
Change in fair value of derivative liabilities | 1,948 | |
Changes in operating assets and liabilities: | ||
Trade receivable | 66 | (1) |
Other accounts receivable and prepaid expenses | (679) | 87 |
Inventory | (180) | (28) |
Trade payables | 85 | (43) |
Other accounts payable and accrued expenses | 24 | (231) |
Other liabilities | 390 | |
Deferred revenue | (11) | 105 |
Accrued severance pay, net | (3) | |
Net cash used in operating activities | (1,741) | (954) |
Cash flows from investing activities: | ||
Purchases of property plant and equipment | (2) | |
Net cash used in investing activities | (2) | |
Cash flows from financing activities: | ||
Proceeds from exercise of warrants | 1,406 | |
Net cash provided by financing activities | 1,406 | |
Effects of currency translation on cash and cash equivalents | (6) | (5) |
Net (decrease) increase in cash, cash equivalents | (1,747) | 445 |
Cash, cash equivalents at beginning of period | 7,737 | 7,533 |
Cash, cash equivalents at end of period | 5,990 | 7,978 |
Supplemental non-cash financing and investing activities: | ||
Shares issued from exercise of warrants previously classified as derivatives | 2,088 | |
Reclass liability to equity due to increase in authorized shares | $ 3,337 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 – DESCRIPTION OF BUSINESS NanoVibronix, Inc. (the “Company”), a Delaware corporation, commenced operations on October 20, 2003 and is a medical device company focusing on noninvasive biological response-activating devices that target wound healing and pain therapy and can be administered at home, without the assistance of medical professionals. The Company’s principal research and development activities are conducted in Israel through its wholly owned subsidiary, NanoVibronix (Israel 2003) Ltd., a company registered in Israel, which commenced operations in October 2003. |
LIQUIDITY AND PLAN OF OPERATION
LIQUIDITY AND PLAN OF OPERATIONS | 3 Months Ended |
Mar. 31, 2022 | |
Liquidity And Plan Of Operations | |
LIQUIDITY AND PLAN OF OPERATIONS | NOTE 2 – LIQUIDITY AND PLAN OF OPERATIONS The Company’s ability to continue to operate is dependent mainly on its ability to successfully market and sell its products and the receipt of additional financing until profitability is achieved. During the first quarter of 2022, the Company has incurred losses as well as negative cash outflows from operating activities and expects to occur losses and negative cash outflows from operating activities through fiscal year 2022. The Company’s management believes that the Company has sufficient capital to execute its business plan over the next twelve months. If the Company is unable to successfully commercialize its products over the next twelve months, it may need to raise additional capital at a later time. There are no assurances that the Company would be able to raise additional capital, if required, on terms favorable to it. If the Company is unsuccessful in commercializing its products and raising capital, it will need to reduce activities, curtail, or cease operations. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of presentation and principles of consolidation The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. The unaudited consolidated financial statements include the accounts of all subsidiaries in which the Company holds a controlling financial interest as of the financial statement date. The unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Unaudited interim financial information In the opinion of management, the accompanying unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to state fairly the financial position and results of operations of the Company. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2021, as found in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2022, as amended on May 2, 2022 The balance sheet for December 31, 2021 was derived from the Company’s audited financial statements for the year ended December 31, 2021. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire fiscal year due to seasonality and other factors. Certain information and footnote disclosures normally included in the consolidated financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim reporting. Use of estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions. The Company believe that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Foreign currency translation Non-U.S. dollar denominated transactions and balances have been re-measured to U.S. dollars. All gains and losses from re-measurement of monetary balance sheet items denominated in non-U.S. dollar currencies are reflected in the statements of operations as other comprehensive income, as appropriate. The cumulative translation gains as of the years ended March 31, 2022 and 2021 were $ 6 5 Revenue recognition It is the Company’s policy that revenues from product sales is recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before revenue can be recognized; (1) Identifying the contract(s) with a customer that creates enforceable rights and obligations; (2) Identifying the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) Determining the transaction price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer; (4) Allocating the transaction price to the performance obligations in the contract, which requires the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of each distinct good or services promised in the contract; and (5) Recognizing revenue when (or as) the entity satisfies a performance obligation by transferring a promised good or service to a customer. The amount of revenue recognized is the amount allocated to the satisfied performance obligation. Adoption of ASC 606 has not changed the timing and nature of the Company’s revenue recognition and there has been no material effect on the Company’s financial statements. Revenue from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from coupons, discounts, chargebacks and distributor fees, processing fees, as well as allowances for returns and government rebates. The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. Collectability of revenue is reasonably assured based on historical evidence of collectability between the Company and its customers. Revenues from sales to distributors are recognized at the time the products are delivered to the distributors (“sell-in”). The Company does not grant rights of return, credits, rebates, price protection, or other privileges on its products to distributors. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 4 – STOCKHOLDERS’ EQUITY Common stock The common stock confers upon the holders the right to receive notice to participate and vote in general meetings of the Company, and the right to receive dividends, if declared, and to participate in the distribution of the surplus assets and funds of the Company in the event of liquidation, dissolution or winding up of the Company. On March 3, 2021, the Company filed a proxy statement in connection with a special meeting of stockholders to was to be held on March 31, 2021, but postponed until May 6, 2021 to (i) ratify the increase in the number of authorized shares of common stock from 20,000,000 24,109,635 4,109,635 20,000,000 24,109,635 4,109,635 On August 17, 2021, the Company’s stockholders voted to approve an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of the Company’s Common Stock authorized for issuance from 24,109,635 40,000,000 Stock-based compensation and Options During the three-month period ended March 31, 2022 and 2021, 120,000 180,000 three years 86 109 The fair value for options granted in the first quarter of 2022 and 2021 is estimated at the date of grant using a Black-Scholes-Merton options pricing model with the following underlying assumptions: SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR OPTIONS GRANTED 2022 2021 Price at valuation $ 0.78 $ 1.04 Exercise price $ 0.78 $ 1.04 Risk free interest 2.32 % 0.49 % Expected term (in years) 5 5 Volatility 127.9 % 81.5 % The total stock-based expense recognized in the financial statements for services received from employees and non-employees is shown in the following table. SCHEDULE OF STOCK BASED EXPENSES RECOGNIZED FOR SERVICES FROM EMPLOYEES AND NON-EMPLOYEES Three Months Ended March 31, 2022 2021 Research and development 2 5 Selling and marketing 6 21 General and administrative 78 83 Total $ 86 $ 109 As of March 31, 2022, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $ 554 2.05 Warrant exercises and modification On December 2, 2020, we entered into a Securities Purchase Agreement with certain institutional and accredited investors pursuant to which the Company issued and sold to such investors in a private placement an aggregate of (i) 5,914,285 0.70 2,657,144 0.699 6.0 5.4 1,657,144 0.001 On January 21, 2021, Company entered into letter agreements (the “Letter Agreements”) with certain existing accredited investors to exercise certain outstanding warrants (the “Existing Warrants”) to purchase up to an aggregate of 1,205,968 1.165 1,205,967 1.04 1.4 The New Warrants were accounted for in warrant modification expense, which was measured at the amount equal to the incremental value reflecting the change in the fair value of the warrants before and after the Warrant Amendment. Accordingly, warrant modification expense in the amount of $ 0 1,627 In estimating the warrants’ fair value, the Company used the following assumptions: SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR WARRANTS Risk free interest 1.44 % Dividend yield 0 % Volatility 138.4 % Contractual term (in years) 0.79 2.67 |
LOSS PER SHARE APPLICABLE TO CO
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER | NOTE 5 – LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER Basic net loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. All outstanding stock options and warrants for the three months ended March 31, 2022 and 2021 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for all periods presented. The following table summarizes the Company’s securities, in common stock equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive: SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE March 31, 2022 March 31, 2021 Series D Preferred Stock - 153,000 Series E Preferred Stock - 875,000 Stock Options - employee and non-employee 2,659,999 1,928,544 Warrants 2,309,347 5,447,594 Total 4,969,346 8,404,138 The diluted loss per share equals basic loss per share in the three months ended March 31, 2022 and 2021 because the Company had a net loss and the impact of the assumed exercise of stock options and the vesting of restricted stock would have been anti-dilutive. |
GEOGRAPHIC INFORMATION AND MAJO
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA | 3 Months Ended |
Mar. 31, 2022 | |
Segment Reporting [Abstract] | |
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA | NOTE 6 – GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA Summary information about geographic areas: The Company manages its business on the basis of one reportable segment and derives revenues from selling its products directly to patients as well as through distributor agreements. The following is a summary of revenues within geographic areas: SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS Three Months Ended March 31, 2022 2021 United States $ 231 $ 92 Europe 7 1 New Zealand 2 9 Asia 9 1 Other 23 - Total $ 272 $ 103 For the three months ended March 31, 2022, one customer comprised approximately 39% 58% |
OTHER ASSETS
OTHER ASSETS | 3 Months Ended |
Mar. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
OTHER ASSETS | NOTE 7 – OTHER ASSETS On April 9, 2020, pursuant to a licensing agreement entered into in March 2020, the Company received 10 127,000 0.19 SCHEDULE OF WARRANTS ASSUMPTIONS Price at valuation $ 0.17 Exercise price $ 0.19 Risk free interest 1.44 % Expected term (in years) 8 Volatility 138.4 % The Company considers this to be level 3 inputs and is valued at each reporting period. The fair value of these warrants had no movements during the quarter, leaving a balance of $ 19 Financial Instruments Measured at Fair Value on a Recurring Basis The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows: ● Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 inputs: Inputs, other than quoted prices included in Level 1, that are observable either directly or indirectly; and ● Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. There were no transfers between Level 3 during the quarters ended March 31, 2022 and 2021. The following table presents changes in Level 3 asset and liability measured at fair value for the quarters ended March 31, 2022 and 2021: SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE Asset Balance – December 31, 2020 $ 25 Fair value adjustments – Sanuwave warrants (2 ) Balance – March 31, 2021 $ 23 Balance – December 31, 2021 19 Fair value, net derivative asset liability, beginning 19 Fair value adjustments – Sanuwave warrants (2 ) Balance – March 31, 2022 $ 17 Fair value, net derivative asset liability, ending $ 17 The following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy: SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE Fair Value Measurements as of March 31, 2022 Level I Level II Level III Total Asset: Other assets $ - $ - $ 17 $ 17 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 8 – COMMITMENTS AND CONTINGENCIES Other Risks On March 12, 2020, the World Health Organization declared COVID-19 to be a pandemic, and the COVID-19 pandemic has resulted in significant financial market volatility and uncertainty. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on the market price of our common shares. In addition, U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. A continuation or worsening of the levels of market disruption and volatility could have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on the market price of our common shares. Pending litigation On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $ 3 On March 15, 2022, the arbitrator issued a final award, which, although found that Protrade’s claims failed as a matter of law or were unsupported by the evidence, nevertheless awarded Protrade $ 1,500,250 1,432,000 68,250 on April 13, 2022, the Company submitted an application for the correction of the award. If the application is denied, the Company will continue vehemently opposing the award in all appropriate fora. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 9 – SUBSEQUENT EVENTS The Company has evaluated subsequent events through the date of filing this Quarterly Report on Form 10-Q and determined that no material events occurred . |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. The unaudited consolidated financial statements include the accounts of all subsidiaries in which the Company holds a controlling financial interest as of the financial statement date. The unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Unaudited interim financial information | Unaudited interim financial information In the opinion of management, the accompanying unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to state fairly the financial position and results of operations of the Company. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2021, as found in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2022, as amended on May 2, 2022 The balance sheet for December 31, 2021 was derived from the Company’s audited financial statements for the year ended December 31, 2021. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire fiscal year due to seasonality and other factors. Certain information and footnote disclosures normally included in the consolidated financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim reporting. |
Use of estimates | Use of estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions. The Company believe that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. |
Foreign currency translation | Foreign currency translation Non-U.S. dollar denominated transactions and balances have been re-measured to U.S. dollars. All gains and losses from re-measurement of monetary balance sheet items denominated in non-U.S. dollar currencies are reflected in the statements of operations as other comprehensive income, as appropriate. The cumulative translation gains as of the years ended March 31, 2022 and 2021 were $ 6 5 |
Revenue recognition | Revenue recognition It is the Company’s policy that revenues from product sales is recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before revenue can be recognized; (1) Identifying the contract(s) with a customer that creates enforceable rights and obligations; (2) Identifying the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) Determining the transaction price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer; (4) Allocating the transaction price to the performance obligations in the contract, which requires the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of each distinct good or services promised in the contract; and (5) Recognizing revenue when (or as) the entity satisfies a performance obligation by transferring a promised good or service to a customer. The amount of revenue recognized is the amount allocated to the satisfied performance obligation. Adoption of ASC 606 has not changed the timing and nature of the Company’s revenue recognition and there has been no material effect on the Company’s financial statements. Revenue from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from coupons, discounts, chargebacks and distributor fees, processing fees, as well as allowances for returns and government rebates. The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. Collectability of revenue is reasonably assured based on historical evidence of collectability between the Company and its customers. Revenues from sales to distributors are recognized at the time the products are delivered to the distributors (“sell-in”). The Company does not grant rights of return, credits, rebates, price protection, or other privileges on its products to distributors. |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR OPTIONS GRANTED | The fair value for options granted in the first quarter of 2022 and 2021 is estimated at the date of grant using a Black-Scholes-Merton options pricing model with the following underlying assumptions: SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR OPTIONS GRANTED 2022 2021 Price at valuation $ 0.78 $ 1.04 Exercise price $ 0.78 $ 1.04 Risk free interest 2.32 % 0.49 % Expected term (in years) 5 5 Volatility 127.9 % 81.5 % |
SCHEDULE OF STOCK BASED EXPENSES RECOGNIZED FOR SERVICES FROM EMPLOYEES AND NON-EMPLOYEES | The total stock-based expense recognized in the financial statements for services received from employees and non-employees is shown in the following table. SCHEDULE OF STOCK BASED EXPENSES RECOGNIZED FOR SERVICES FROM EMPLOYEES AND NON-EMPLOYEES Three Months Ended March 31, 2022 2021 Research and development 2 5 Selling and marketing 6 21 General and administrative 78 83 Total $ 86 $ 109 |
SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR WARRANTS | In estimating the warrants’ fair value, the Company used the following assumptions: SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR WARRANTS Risk free interest 1.44 % Dividend yield 0 % Volatility 138.4 % Contractual term (in years) 0.79 2.67 |
LOSS PER SHARE APPLICABLE TO _2
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE | The following table summarizes the Company’s securities, in common stock equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive: SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE March 31, 2022 March 31, 2021 Series D Preferred Stock - 153,000 Series E Preferred Stock - 875,000 Stock Options - employee and non-employee 2,659,999 1,928,544 Warrants 2,309,347 5,447,594 Total 4,969,346 8,404,138 |
GEOGRAPHIC INFORMATION AND MA_2
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Segment Reporting [Abstract] | |
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS | The Company manages its business on the basis of one reportable segment and derives revenues from selling its products directly to patients as well as through distributor agreements. The following is a summary of revenues within geographic areas: SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS Three Months Ended March 31, 2022 2021 United States $ 231 $ 92 Europe 7 1 New Zealand 2 9 Asia 9 1 Other 23 - Total $ 272 $ 103 |
OTHER ASSETS (Tables)
OTHER ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
SCHEDULE OF WARRANTS ASSUMPTIONS | SCHEDULE OF WARRANTS ASSUMPTIONS Price at valuation $ 0.17 Exercise price $ 0.19 Risk free interest 1.44 % Expected term (in years) 8 Volatility 138.4 % |
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE | The following table presents changes in Level 3 asset and liability measured at fair value for the quarters ended March 31, 2022 and 2021: SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE Asset Balance – December 31, 2020 $ 25 Fair value adjustments – Sanuwave warrants (2 ) Balance – March 31, 2021 $ 23 Balance – December 31, 2021 19 Fair value, net derivative asset liability, beginning 19 Fair value adjustments – Sanuwave warrants (2 ) Balance – March 31, 2022 $ 17 Fair value, net derivative asset liability, ending $ 17 |
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE | The following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy: SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE Fair Value Measurements as of March 31, 2022 Level I Level II Level III Total Asset: Other assets $ - $ - $ 17 $ 17 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Accounting Policies [Abstract] | ||
Gains and losses from foreign currency translation | $ 6 | $ 5 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR OPTIONS GRANTED (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Equity [Abstract] | ||
Price at valuation | $ 0.78 | $ 1.04 |
Exercise price | $ 0.78 | $ 1.04 |
Risk free interest | 2.32% | 0.49% |
Expected term (in years) | 5 years | 5 years |
Volatility | 127.90% | 81.50% |
SCHEDULE OF STOCK BASED EXPENSE
SCHEDULE OF STOCK BASED EXPENSES RECOGNIZED FOR SERVICES FROM EMPLOYEES AND NON-EMPLOYEES (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock-based compensation | $ 86 | $ 109 |
Research and Development Expense [Member] | ||
Stock-based compensation | 2 | 5 |
Selling and Marketing Expense [Member] | ||
Stock-based compensation | 6 | 21 |
General and Administrative Expense [Member] | ||
Stock-based compensation | $ 78 | $ 83 |
SCHEDULE OF FAIR VALUE ASSUMP_2
SCHEDULE OF FAIR VALUE ASSUMPTIONS FOR WARRANTS (Details) | Mar. 31, 2022 | Apr. 09, 2020 |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contractual term (in years) | 9 months 14 days | |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contractual term (in years) | 2 years 8 months 1 day | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants, measurement input, percentage | 1.44 | 1.44 |
Measurement Input, Expected Dividend Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants, measurement input, percentage | 0 | |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants, measurement input, percentage | 138.4 | 138.4 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jan. 21, 2021 | Dec. 02, 2020 | Jan. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Aug. 17, 2021 | Aug. 16, 2021 | May 06, 2021 | May 05, 2021 |
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Common Stock, Shares Authorized | 40,000,000 | 40,000,000 | 40,000,000 | 24,109,635 | 24,109,635 | 20,000,000 | ||||
Common stock, capital shares reserved for future issuance | 4,109,635 | |||||||||
Excess stock, shares issued | 4,109,635 | |||||||||
Stock-based compensation expense | $ 86 | $ 109 | ||||||||
Proceeds from Warrant Exercises | 1,406 | |||||||||
New Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.04 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,205,967 | |||||||||
Proceeds from Warrant Exercises | $ 1,400 | |||||||||
Warrants, modification expense | 0 | $ 1,627 | ||||||||
Employee Stock [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Non-vested stock options granted, unrecognized estimated compensation cost | $ 554 | |||||||||
Non-vested stock options granted, weighted average period | 2 years 18 days | |||||||||
Employees and Consultants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of options, granted | 120,000 | 180,000 | ||||||||
Fair value options vesting term | 3 years | 3 years | ||||||||
Stock-based compensation expense | $ 86 | $ 109 | ||||||||
Securities Purchase Agreement [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Gross proceeds from private placement | $ 6,000 | |||||||||
Net proceeds from private placement | $ 5,400 | |||||||||
Securities Purchase Agreement [Member] | Pre-funded Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Sale of stock, number of shares issued | 2,657,144 | |||||||||
Sale of stock, price per share | $ 0.699 | |||||||||
Securities Purchase Agreement [Member] | Private Placement [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Sale of stock, number of shares issued | 5,914,285 | |||||||||
Sale of stock, price per share | $ 0.70 | |||||||||
Two Investors [Member] | Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of shares warrants exercised | 1,657,144 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.001 | |||||||||
Accredited Investors [Member] | Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.165 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,205,968 |
SUMMARY OF COMMON SHARE EQUIVAL
SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 4,969,346 | 8,404,138 |
Series D Preferred Stock Shares [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 153,000 | |
Series E Preferred Stock Shares [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 875,000 | |
Stock Options - Employee and Non-Employee [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 2,659,999 | 1,928,544 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 2,309,347 | 5,447,594 |
SUMMARY OF REVENUE WITHIN GEOGR
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 272 | $ 103 |
UNITED STATES | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 231 | 92 |
Europe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 7 | 1 |
NEW ZEALAND | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 2 | 9 |
Asia [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 9 | 1 |
Other [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 23 |
GEOGRAPHIC INFORMATION AND MA_3
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA (Details Narrative) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | One Customer [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration risk, percentage | 39.00% | 58.00% |
SCHEDULE OF WARRANTS ASSUMPTION
SCHEDULE OF WARRANTS ASSUMPTIONS (Details) | Mar. 31, 2022 | Apr. 09, 2020$ / shares |
Price at Valuation [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.17 | |
Measurement Input, Exercise Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.19 | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 1.44 | 1.44 |
Measurement Input, Expected Term [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (in years) | 8 years | |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 138.4 | 138.4 |
SCHEDULE OF CHANGES IN LEVEL 3
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE (Details) - Derivative Asset [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Offsetting Assets [Line Items] | ||
Fair value, net derivative asset liability, beginning | $ 19 | $ 25 |
Fair value adjustments – Sanuwave warrants | (2) | (2) |
Fair value, net derivative asset liability, ending | $ 17 | $ 23 |
SCHEDULE OF ASSETS AND LIABILIT
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Defined Benefit Plan Disclosure [Line Items] | ||
Other assets | $ 17 | $ 19 |
Fair Value, Inputs, Level 1 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Other assets | ||
Fair Value, Inputs, Level 2 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Other assets | ||
Fair Value, Inputs, Level 3 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Other assets | $ 17 |
OTHER ASSETS (Details Narrative
OTHER ASSETS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Apr. 09, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Fair value of warrants | $ 19 | $ 19 | |
Licensing Agreement [Member] | Sanuwave Health, Inc. [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Warrants, term | 10 years | ||
Warrants issued to purchase common stock | 127,000 | ||
Exercise price of warrants per share | $ 0.19 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | Mar. 15, 2022 | Feb. 26, 2021 |
Arbitrator [Member] | ||
Damages awarded value | $ 1,500,250 | |
Lost profits | 1,432,000 | |
Reimbursement of arbitration costs | $ 68,250 | |
Protrade Systems, Inc [Member] | ||
Damage value | $ 3,000,000 |