SANUWAVE Health, Inc. 10-K

Item 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Page Consolidated Financial Statements Report of Independent Registered Public Accounting Firm (PCAOB ID: 688 ) F-1 Consolidated Balance Sheets as of December 31, 2022 and 2021 F-2 Consolidated Statements of Comprehensive Loss for the years ended December 31, 2022 and 2021 F-3 Consolidated Statements of Stockholders’ Deficit for the years ended December 31, 2022 and 2021 F-4 Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021 F-5 Notes to Consolidated Financial Statements F-6 35 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and Board of Directors of SANUWAVE Health, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of SANUWAVE Health, Inc. (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of comprehensive loss, stockholders’ deficit and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America. Explanatory Paragraph – Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred recurring losses and needs to raise additional funds to meet its obligations and sustain its operations and the occurrence of the events of default on the Company’s debt. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. Valuation of Financial Instruments (2022 Convertible Promissory Notes and Warrant Liability) Critical Audit Matter Description As described in Notes 11 and 13 to the consolidated financial statements, the Company entered into a Securities Purchase Agreements for the sale in a private placement of (i) Future Advance Convertible Promissory Notes in an aggregate principal amount of $16.2 million in August and $4.0 million in November, (ii) Common Stock Purchase Warrants to purchase 504.4 million shares of common stock with an exercise price of $0.067 per share and (iii) Common Stock Purchase Warrants to purchase 504.4 million shares of common stock with an exercise price of $0.04 per share. The Company determined certain embedded conversion features associated with the 2022 Convertible Promissory Notes were required to be bifurcated and recorded at fair value. The warrants issued in connection with the 2022 Convertible Promissory Notes were recorded at fair value. The Company utilized the Black-Scholes model to determine the fair value of the embedded conversion option and warrant liability which consist of all liability warrants utilizing key inputs including discounted stock price and implied volatility. The principal considerations for our determination that the valuation of the 2022 Convertible Promissory Notes and Warrant Liability is a critical audit matter are the significant judgment by management in determining the fair value of the embedded conversion option and warrant liability; this in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to the discounted stock price and implied volatility. Also, the audit effort involved the use of professionals with specialized skill and knowledge. How the Critical Audit Matter was Addressed in the Audit Our audit procedures related to the valuation of the 2022 Convertible Promissory Notes and Warrant Liability included the following, among others: • We obtained an understanding of the design of the Company's controls over the valuation of the 2022 Convertible Promissory Notes and Warrant Liability, including controls over management's review of the valuation model and the significant assumptions used in determining the fair value of the embedded conversion option of the 2022 Convertible Promissory Notes and Warrant Liability. • With assistance of our valuation specialists, we audited the fair value of the embedded conversion option and warrant liability, valuation methodology, and key assumptions used in determining the fair value of the embedded conversion option of the 2022 Convertible Promissory Notes and Warrant Liability by: a. Evaluating the appropriateness of the valuation model and techniques used in determining the fair value; b. Assessing the significant valuation assumption inputs of discounted stock price and implied volatility are consistent with those that would be used by market participants through the testing of source information, checking the mathematical accuracy of the calculation, and developing independent estimates and comparing to those selected by management, where applicable; and c. Recalculating the fair value that management arrived to verify it was reasonable. • We audited the completeness and accuracy of the underlying data supporting the significant valuation assumption inputs. /s/ Marcum LLP Marcum LLP We have served as the Company’s auditor since 2018. New York, NY March 31, 2023 F-1 Table of Contents PART I - FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS December 31, 2022 and 2021 (In thousands, except share data) 2022 2021 ASSETS Current Assets: Cash $ 1,153 $ 619 Accounts receivable, net of allowance of $ 1,037 in 2022 and $ 785 in 2021 4,029 2,415 Inventory 868 1,040 Prepaid expenses and other current assets 570 326 Total Current Assets 6,620 4,400 Non-Current Assets: Property, equipment and right of use assets, net 750 1,012 Intangible assets, net 5,137 5,841 Goodwill 7,260 7,260 Other assets 106 106 Total Non-Current Assets 13,253 14,219 Total Assets $ 19,873 $ 18,619 LIABILITIES Current Liabilities: Senior secured debt, in default $ 14,416 $ 11,586 Convertible promissory notes 16,713 11,601 Convertible promissory note, related parties 7,409 1,596 Factoring liabilities 2,130 2,183 Accounts payable 4,400 7,644 Accrued expenses 8,512 8,641 Warrant liability 1,416 9,614 Current portion of SBA loans - 158 Accrued interest 4,052 2,521 Accrued interest, related parties 788 289 Current portion of contract liabilities 60 48 Other 291 382 Total Current Liabilities 60,187 56,263 Non-Current Liabilities: SBA loans - 875 Contract liabilities 230 293 Lease liabilities 438 118 Deferred tax liability 28 28 Total Non-Current Liabilities 696 1,314 Total Liabilities $ 60,883 $ 57,577 Commitments and Contingencies (Footnote 21) STOCKHOLDERS’ DEFICIT Preferred stock, par value $ 0.001 , 5,000,000 shares authorized, 6,175 Series A, 293 Series B, 90 Series C, and 8 Series D designated shares, respectively; no shares issues and outstanding at 2022 and 2021 $ - $ - Common stock, par value $ 0.001 , 2,500,000,000 shares authorized, 548,737,651 and 481,619,621 issued and outstanding at 2022 and 2021 , respectively 549 482 Additional paid-in capital 152,750 144,582 Accumulated deficit ( 194,242 ) ( 183,949 ) Accumulated other comprehensive loss ( 67 ) ( 73 ) Total Stockholders’ Deficit ( 41,010 ) ( 38,958 ) Total Liabilities and Stockholders’ Deficit $ 19,873 $ 18,619 The accompanying notes to consolidated financial statements are an integral part of these statements. F-2 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Years ended December 31, 2022 and 2021 (In thousands, except share and per share data) 2022 2021 Revenue $ 16,742 $ 13,010 Cost of revenues 4,331 4,986 Gross Margin 12,411 8,024 Operating Expenses: General and administrative 12,556 11,690 Selling and marketing 7,474 8,591 Research and development 567 1,101 Depreciation and amortization 766 784 Total Operating Expenses 21,363 22,166 Operating Loss ( 8,952 ) ( 14,142 ) Other Income (Expense) Interest expense ( 12,771 ) ( 6,883 ) Interest expense, related party ( 1,361 ) ( 212 ) Change in fair value of derivative liabilities 16,654 ( 2,622 ) Loss on issuance of debt ( 3,434 ) ( 3,572 ) Gain/(loss) on extinguishment of debt ( 418 ) 204 Loss on foreign currency exchange ( 9 ) ( 4 ) Total Other Expense ( 1,339 ) ( 13,089 ) Net Loss Before Income Taxes ( 10,291 ) ( 27,231 ) Income tax expense 2 28 Net Loss $ ( 10,293 ) $ ( 27,259 ) Other Comprehensive Loss Foreign currency translation adjustments 6 ( 11 ) Total Comprehensive Loss $ ( 10,287 ) $ ( 27,270 ) Loss per Share: Net loss per share, basic and diluted $ ( 0.02 ) $ ( 0.05 ) Weighted average shares outstanding, basic and diluted 549,470,787 518,355,642 The accompanying notes to consolidated financial statements are an integral part of these statements. F-3 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT (In thousands except share data) Common Stock Accumulated Other Shares Issued and Additional Paid- Accumulated Comprehensive Outstanding Par Value in Capital Deficit Loss Total Balances as of December 31, 2020 470,694,621 $ 471 $ 142,563 $ ( 156,690 ) $ ( 62 ) $ ( 13,718 ) Cashless warrant exercise 10,925,000 11 ( 11 ) - - - Reclassification of warrant liability due to cashless warrant exercise - - 2,030 - - 2,030 Net loss - - - ( 27,259 ) - ( 27,259 ) Foreign currency translation adjustment - - - - ( 11 ) ( 11 ) Balances as of December 31, 2021 481,619,621 $ 482 $ 144,582 $ ( 183,949 ) $ ( 73 ) $ ( 38,958 ) Cashless warrant exercise 14,000,000 $ 14 $ 2,152 $ - $ - $ 2,166 Warrant exercise 909,091 1 99 - - 100 Shares issued in conjunction with senior note 20,666,993 20 3,700 - - 3,720 Shares issued for settlement of debt and warrants 19,444,446 20 1,341 - - 1,361 Shares issued for services 12,097,500 12 876 - - 888 Net loss - - - ( 10,293 ) - ( 10,293 ) Foreign currency translation adjustment - - - - 6 6 Balance as of December 31, 2022 548,737,651 $ 549 $ 152,750 $ ( 194,242 ) $ ( 67 ) $ ( 41,010 ) The accompanying notes to the consolidated financial statemetns are an integral part of these financial statements F-4 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS Years ended December 31, 2022 and 2021 (In thousands) 2022 2021 Cash Flows - Operating Activities: Net loss $ ( 10,293 ) $ ( 27,259 ) Adjustments to reconcile net loss to net cash used by operating activities Depreciation and amortization 952 1,236 Bad debt expense 253 442 Shares issued for services 888 - Gain/loss on extinguishment of debt 418 ( 204 ) Income tax expense 2 28 Change in fair value of derivative liabilites ( 16,654 ) 2,622 Loss on issuance of debt 3,434 3,572 Amortization of debt issuance and debt discounts 4,950 3,226 Changes in operating assets and liablities: Accounts receivable ( 1,748 ) ( 395 ) Inventory, prepaid expenses and other assets ( 72 ) 1,687 Accounts payable ( 2,550 ) 3,181 Accrued interest and accrued interest, related parties 3,182 1,718 Accrued expenses and contract liabilities 69 3,737 Net Cash Used by Operating Activities ( 17,169 ) ( 6,409 ) Cash Flows - Investing Activites Purchase (proceeds from sale) of property and equipment 332 ( 529 ) Net Cash Flows Used by Investing Activities 332 ( 529 ) Cash Flows - Financing Activities Proceeds from convertible promisorry notes 16,227 1,928 Proceeds from SBA loans - 1,033 Proceeds from senior secured promissory note 2,940 940 Proceeds from factoring 695 1,737 Proceeds from warrant exercises 100 - Proceeds from short term borrowings 640 175 Repayments of debt principal ( 2,981 ) ( 493 ) Principal payments on finance leases ( 237 ) ( 199 ) Net Cash Flows Provided by Financing Activities 17,384 5,121 Effect of Exchange Rates on Cash ( 13 ) ( 1 ) Net Change in Cash During Period 534 ( 1,818 ) Cash at Beginning of Period 619 2,437 Cash at End of Period $ 1,153 $ 619 Supplemental Information: Cash paid for interest $ 3,712 $ 2,580 Non-Cash Investing and Financing Activities: Reclassification of warrant liabilities to equity due to cashless warrant exercise $ 2,166 $ 2,030 Settlement of debt and warrants with stock 1,361 - Working capital balances refinanced into convertible promissory notes 2,363 - Embedded conversion feature on convertible debt 2,760 4,138 Common shares issued in conjunction with senior secured debt 3,720 - Warrant issuance in conjunction with advances on future cash receipts - 1,227 Warrant issuance in conjunction with convertible notes 1,708 1,055 The accompanying notes to consolidated financial statemetns are an integral part of these statements. F-5 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS December 31, 2022 and 2021 1. Nature of the Business and Basis of Presentation SANUWAVE Health, Inc. and Subsidiaries (“SANUWAVE” or the “Company”) is focused on the commercialization of its patented noninvasive and biological response activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures. Basis of Presentation - The accompanying consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. The functional currencies of the Company’s foreign operations are their local currencies. The financial statements of the Company’s foreign subsidiary have been translated into United States dollars. All balance sheet accounts have been translated using the exchange rates in effect at the balance sheet date. Income statement amounts have been translated using the average exchange rate for the year. Translation adjustments are reported in other comprehensive loss in the consolidated statements of comprehensive loss and as cumulative translation adjustments in accumulated other comprehensive loss in the consolidated balance sheets. Segment information - We have determined that we have one operating segment. Our revenues are primarily generated from sales in the United States. All significant expenses are generated, and all significant assets are located in the United States. Reclassification - Certain accounts in the prior period consolidated financial statements have been reclassified to conform to the presentation of the current year consolidated financial statements. These reclassifications had no effect on the previously reported operating results. 2. Going Concern Our recurring losses from operations and dependency upon future issuances of equity or other financing to fund ongoing operations have raised substantial doubt as to our ability to continue as a going concern. We will be required to raise additional funds to finance our operations and remain a going concern; we may not be able to do so, and/or the terms of any financings may not be advantageous to us. The continuation of our business is dependent upon raising additional capital. We expect to devote substantial resources for the expansion and continued commercialization of our UltraMIST and PACE systems which will require additional capital resources. The operating losses and the events of default on the Company’s notes payable indicate substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the filing of this Annual Report on Form 10-K. Management’s plans are to obtain additional capital in 2023 through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt. These possibilities, to the extent available, may be on terms that result in significant dilution to our existing stockholders. Although no assurances can be given, management believes that potential additional issuances of equity or other potential financing transactions if obtained as discussed above should provide the necessary funding for us. If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms. The accompanying consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent realizable or settlement values. The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty. Our consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary should we be unable to continue as a going concern. F-6 Table of Contents 3. Restatement of Previously Issued Financial Statements During the preparation of this Annual Report on Form 10-K, the Company determined that it had not appropriately accounted for certain transactions under US GAAP. These transactions included shares issued for services, which caused general and administrative expense to be understated, and the sale of assets under a financing agreement, which a gain on sale was recognized and overstated. Also, during the preparation of this Annual Report on Form 10-K it was discovered that certain vendor invoices were not properly recorded, causing general and administrative expense to be understated in prior periods, interest calculation on senior debt, which caused interest expense to be understated, and an inventory adjustment was posted improperly, which caused cost of revenues to be understated. In accordance with Staff Accounting Bulletin (“SAB”) 99, Materiality, and SAB 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, the Company evaluated the materiality of the errors from qualitative and quantitative perspectives, individually and in aggregate, and concluded that the errors were material to the Consolidated Financial Statements for the quarters ending March 31, 2022, June 30, 2022, and September 30, 2022. Management restated the impacted financial statements for the quarters ended March 31, 2022, the quarter and six-months ending June 30, 2022, and the quarter and nine-months ending September 30, 2022. Refer to Note 22 for restated quarterly financial statements. 4. Summary of Significant Accounting Policies The significant accounting policies followed by the Company are summarized below: Estimates – These consolidated financial statements have been prepared in accordance with U.S. GAAP. Because a precise determination of assets and liabilities, and correspondingly revenues and expenses, depend on future events, the preparation of consolidated financial statements for any period necessarily involves the use of estimates and assumptions. Actual amounts may differ from these estimates. These consolidated financial statements have, in management’s opinion, been properly prepared within reasonable limits of materiality and within the framework of the accounting policies summarized herein. Significant estimates include the recording of allowances for doubtful accounts, the net realizable value of inventory, fair value of goodwill and intangible assets, the determination of the valuation allowances for deferred taxes, estimated fair value of stock-based compensation, and the estimated fair value of embedded derivatives, including warrants and embedded conversion options. Accounts receivable — Accounts receivable are stated at the amount management expects to collect from outstanding balances. Management provides for probable uncollectible amounts through a charge to earnings based on its assessment of the current status of individual accounts. Receivables are generally considered past due if greater than 60 days old. Balances that are still outstanding after management has used reasonable collection efforts are written off through a charge to the allowance for doubtful accounts. Management routinely assesses the financial strength of its customers and, consequently, believes accounts receivable are stated at the net realizable value and credit risk exposure is limited. Inventory - Inventory consists of purchased medical equipment and parts and is stated at the lower of average cost, which is valued using the first in, first out (“FIFO”) method, or net realizable value less allowance for selling and distribution expenses. The Company analyzes its inventory levels and writes down inventory that has, or is expected to, become obsolete. Goodwill — Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed. The Company accounts for goodwill under Accounting Standards Codification (ASC) Topic 350, Intangibles-Goodwill and Other . The Company tests goodwill for impairment annually, or more frequently whenever events or circumstances indicate impairment may exist. Goodwill is stated at cost less accumulated impairment losses. The Company completes its goodwill impairment test annually in the fourth quarter. The Company performed a qualitative evaluation at the reporting unit level and determined there was no goodwill impairment as of December 31, 2022, and 2021. Intangible Assets — Intangible assets arising from the Company’s acquisition are amortized on a straight‑line basis over the estimated useful life of each asset. Customer relationships have a useful life of seven years . Patents and tradenames have a useful life of nineteen years . Impairment of long-lived assets – The Company reviews long-lived assets for impairment whenever facts and circumstances indicate that the carrying amounts of the assets may not be recoverable. An impairment loss is recognized only if the carrying amount of the asset is not recoverable and exceeds its fair value. Recoverability of assets to be held and used is measured by comparing the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the asset’s carrying value is not recoverable, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds its fair value. The Company determines fair value by using a combination of comparable market values and discounted cash flows, as appropriate. Leases – The Company determines whether an arrangement is a lease at inception. When lease arrangements include lease and non-lease components, the Company accounts for lease and non-lease components (e.g. common area maintenance) separately based on their relative standalone prices. F-7 Table of Contents For leases where the Company is the lessee, Right of Use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As the Company’s leases did not provide an implicit interest rate, the Company used the equivalent borrowing rate for a secured financing with the term of equal to the remaining life of the lease at inception. Any lease arrangements with an initial term of 12 months or less are not recorded on our consolidated balance sheets, and the Company recognizes lease costs for these lease arrangements on a straight-line basis over the lease term. In the event a lease arrangement would provide us with options to exercise one or more renewal terms or to terminate the lease arrangement, we would include these options when we are reasonably certain to exercise them in the lease term used to establish ROU assets and lease liabilities. None of our lease agreements include an option to purchase the leased asset, residual value guarantees, or material restrictive covenants. The Company has other lease arrangements that are adjusted periodically based on an inflation index or rate. The future variability of these payments and adjustments are unknown, and therefore they are not included as minimum lease payments used to determine ROU assets and lease liabilities. Variable rental payments are recognized in the period in which the obligation is incurred. Fair value of financial instruments - The carrying values of accounts payable, and other short-term obligations approximate their fair values, because of the short-term maturities of these instruments. The Company utilizes the guidance of ASC Topic 820-10, Fair Value Measurements (“ASC 820-10”), which defines fair value, establishes a framework for measuring fair value and requires disclosures about fair value measurements. The framework that is set forth in this standard is applicable to the fair value measurements where it is permitted or required under other accounting pronouncements. The ASC 820-10 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: Level 1 – Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities: Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly: and Level 3 – Unobservable inputs that are not corroborated by market data, therefore requiring the Company to develop its own assumptions. Sequencing policy – The Company follows a sequencing policy for which in the event partial reclassifications of contracts subject to ASC Topic 815-40-25, Derivatives and Hedging , is necessary, due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be allocated based on earliest issuance date of potentially dilutive instruments with the earliest grants receiving first allocation of shares. Convertible promissory notes – The Company evaluates its convertible instruments to determine if those contracts, or embedded components of those contracts, qualify as derivative financial instruments to be separately accounted for in accordance with ASC Topic 815 “Derivatives and Hedging” (“ASC 815”). The accounting treatment of derivative financial instruments requires that the Company record embedded conversion options and any related freestanding instruments at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date. Conversion options are recorded as a discount to the host instrument and are amortized as amortization of debt discount on the consolidated statements of comprehensive loss over the life of the underlying instrument. The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes because of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. Debt discount – The Company records a debt discount related to warrants issued with debt at fair value and recognizes the cost using the straight-line method, which approximates the effective interest method, over the term of the related debt as interest expense, which is reported in the Other Income (Expense) section in our consolidated statements of comprehensive loss. This debt discount is reported as a reduction of the related debt liability. Contract Liabilities – Device product sales are bundled with an initial one-year warranty and the Company offers a separately priced multi-year warranty. Because the warranty represents an obligation, revenue is deferred as a contract liability and recognized over the time that the Company satisfies its performance obligations, which is generally the warranty term. Revenue Recognition - The core principle of ASC Topic 606 “Revenue from Contracts with Customers” (“ASC 606”) requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The Company allocates the transaction price to all contractual performance obligations included in the contract. If a contract has more than one performance obligation, we allocate the transaction price to each performance obligation based on standalone selling price, which depicts the amount of consideration we expect to be entitled in exchange for satisfying each performance obligation. The Company recognizes revenue primarily from the following types of contracts: F-8 Table of Contents System Sales, Accessory and Part Sales - System sales, accessory and part sales include devices and applicators (new and refurbished). Performance obligations are satisfied at the point in time when the customer obtains control of the goods, which is generally at the point in time that the product is shipped. Licensing Fees - Licensing transactions include distribution licenses and intellectual property licenses. Licensing revenue is recognized as the Company satisfies its performance obligations, which may vary with the terms of the licensing agreement. Other Revenue - Other revenue primarily includes warranties, repairs, and billed freight. The Company allocates the device sales price to the product and the embedded warranty by reference to the stand-alone extended warranty price. Warranty revenue is recognized over the time that the Company satisfies its performance obligations, which is generally the warranty term. Repairs (parts and labor) and billed freight revenue are recognized at the point in time that the service is performed, or the product is shipped, respectively. Shipping and handling costs - Shipping charges billed to customers are included in revenues. Shipping and handling costs incurred have been recorded in cost of goods sold totaled $ 324 thousand and $ 377 thousand for the years ended December 31, 2022, and 2021, respectively. Research and development - Research and development costs are expensed as incurred. Research and development costs include costs of research, engineering, and technical activities to develop a new product, researching an expanded product use or making significant improvements to existing products, including the costs of clinical development. Stock-based compensation - The Company uses the fair value method of accounting for its employee stock option program. Stock-based compensation expense for all stock-based payment awards is based on the estimated fair value of the award measured on the grant date. The Company recognizes the estimated fair value of the award as compensation cost on a straight-line basis over the requisite service period of the award, which is generally the option vesting term. The Company generally issues new shares of common stock to satisfy option and warrant exercises. The expected life of options granted represent the period of time that options granted are expected to be outstanding and are derived from the contractual terms of the options granted calculated under the simplified method. The risk-free rate for periods within the contractual life of the option is based on the United States Treasury yield curve in effect at the time of the grant. The expected volatility is based on the average volatility of the Company’s common stock. The expected dividend yield is based on our historical dividend experience, however, since our inception, we have not declared dividends. Forfeitures are recognized as they occur. Comprehensive income (loss) – Comprehensive income (loss) results from the translation of the Company’s foreign entity’s financial statements from their functional currency to U.S. dollars for consolidation in the accompanying consolidated financial statements. Recent Accounting Pronouncements – In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which was subsequently revised by ASU 2018-19. The ASU introduces a new model for assessing impairment of most financial assets. Entities will be required to use a forward-looking expected loss model, which will replace the current incurred loss model, resulting in earlier recognition of allowance for losses. The ASU is effective for annual reporting periods beginning after January 2023 with early adoption permitted. The Company is currently evaluating the impact of ASU 2016-13 on its consolidated financial statements. F-9 Table of Contents 5. Loss per share The net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares outstanding for the years ended December 31, 2022, and 2021. In accordance with ASC Topic 260-10-45-13, Earnings Per Share , the weighted average of number of shares outstanding includes outstanding common stock and shares issuable for nominal consideration. Accordingly, warrants issued with a $ 0.01 per share exercise price, are included in weighted average shares outstanding as follows: (in thousands) December 31, 2022 December 31, 2021 Common shares 526,530 481,620 Common shares issuable assuming exercise of nominally priced warrants 22,941 36,736 Weighted Average Shares Outstanding 549,471 518,356 Diluted net loss per share would be computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding. To the extent that securities are “anti-dilutive,” they are excluded from the calculation of diluted net loss per share. As a result of the net loss for the years ended December 31, 2022, and 2021, all potentially dilutive shares were anti-dilutive and therefore excluded from the computation of diluted net loss per share. Anti-dilutive equity securities consist of the following: (in thousands) December 31, 2022 December 31, 2021 Common stock options 21,246 31,760 Common stock purchase warrants 1,186,522 168,192 Convertible notes payable, including interest 603,425 90,380 1,811,193 290,332 6. Inventory Inventory consisted of the following: (in thousands) December 31, 2022 December 31, 2021 Finished goods $ 570 $ 343 Parts and accessories 641 931 Reserve for slow moving inventory ( 343 ) ( 234 ) Total Inventory $ 868 $ 1,040 7. Intangible Assets Carrying value of intangible assets consist of the following: December 31, 2022 December 31, 2021 Weighted- Average Useful Life (in years) (in thousands) Gross Accumulated Amortization Gross Accumulated Amortization Definite-lived Intangibles Customer relationships $ 3,820 $ ( 1,308 ) $ 3,820 $ ( 763 ) 2.9 Patent 2,312 ( 292 ) 2,312 ( 171 ) 6.4 Tradenames 693 ( 88 ) 693 ( 50 ) 1.9 Intangible Assets $ 6,825 $ ( 1,688 ) $ 6,825 $ ( 984 ) 3.8 Amortization expense for each of the years ended December 31, 2022, and 2021 totaled $ 704 thousand. Future amortization expense is expected to be the following (dollars in thousands): Year ended December 31, Amortization 2023 704 2024 704 2025 704 2026 704 2027 487 8 . Accrued Expenses Accrued expenses consisted of the following: (in thousands) December 31, 2022 December 31, 2021 Registration penalties $ 1,583 $ 1,950 License fees 892 893 Board of directors fees 415 507 Employee compensation 4,585 4,247 Other 1,037 1,044 Total Accrued Expenses $ 8,512 $ 8,641 F-10 Table of Contents 9. Factoring Liabilities In June 2021, the Company entered into a factoring agreement with an unrelated third party, pursuant to which the Company may sell certain of its accounts receivables for 86.25 % of the value of the receivable. Advances available under the facility are capped at the lesser of $ 3.0 million or a formula amount, as defined in the agreement. Interest on advances is assessed at a fixed amount upon funding, which is equivalent to an annualized rate of 15.0 % for the first 30 days, and daily thereafter at an annualized rate of 14.4 %. The agreement’s term is one month and automatically renews for additional one-month periods, unless either party provides 30 days’ notice of termination. The accounts receivable is sold with recourse back to the Company, therefore, the Company accounts for the arrangement as traditional financing. (In thousands) December 31, 2022 December 31, 2021 Receivables transferred $ 2,564 $ 2,026 Reserve amount held ( 434 ) ( 289 ) Traditional factoring liability 2,130 1,737 Advances on future cash receipts - 446 Factoring liability $ 2,130 $ 2,183 10. Senior Secured Debt, in Default The following table summarizes outstanding senior secured debt: December 31, 2022 December 31, 2021 (In thousands) Principal Debt Discount Carrying Value Principal Debt Discount Carrying Value Senior secured debt $ 19,211 $ ( 4,795 ) $ 14,416 $ 15,000 $ ( 3,414 ) $ 11,586 Senior secured promissory note payable, in default (“Senior Secured Note”) – In August 2020, the Company entered into a Note and Warrant Purchase and Security Agreement (the “NWPSA”). In accordance with the NWPSA, the Company issued a $ 15 million Senior Secured Promissory Note Payable (the “Senior Secured Note”) and a warrant exercisable into shares of the Company’s common stock in exchange for cash to support operations, repay outstanding debt and close on the acquisition of the UltraMIST assets from Celularity Inc. (Celularity) among other transactions. In February 2022, the Company entered into a Second Amendment to Note and Warrant Purchase and Security Agreement (the “Second NWPSA”) for $ 3.0 million, for a total of $ 18.0 million outstanding. Along with the issuance of the note, the Company also issued warrants to purchase 16.2 million shares of common stock with an exercise price of $ 0.18 and 20.6 million shares of common stock. Since the combined fair value of the warrants and common stock issued as part of the Second NWPSA exceeded the face value of the note, the additional amount beyond the face value was recorded as a loss on issuance totaling $ 3.4 million. Interest is charged at the greater of prime rate or 3 % plus 9 %, paid quarterly . Principal increases at a rate of 3 % of the outstanding principal balance (PIK interest) on each quarterly interest payment date. Original maturity date of the Senior Secured Note is September 20, 2025, and it can be prepaid. In June 2022, the Company entered into the Third Amendment to the Note and Warrant Purchase and Security Agreement (the “Third NWPSA”). The Third NWPSA provides for (i) the extension of the agent’s and holder’s forbearance of exercising its remedies arising from Existing Defaults (as defined in the NWPSA) to the earlier of (x) the occurrence of an Event of Default (as defined in the NWPSA) or (y) August 30, 2022, and (ii) the extension to file a registration statement with the Securities and Exchange Commission to register the resale of the Advisor Shares (as defined in the NWPSA) no later than August 30, 2022. F-11 Table of Contents As of December 31, 2022, the Company is in default of the minimum liquidity provisions in the Senior Secured Note and, as a result, it is classified in current liabilities in the accompanying consolidated balance sheets. The Company is accruing interest at the default interest rate of an incremental 5 %. The debt issuance costs, and debt discount related to the Senior Secured Note were capitalized as a reduction in the principal amount and are being amortized to interest expense over the life of the Senior Secured Note. The amortization of the debt issuance costs and debt discount, included in interest expense, for the years ended December 31, 2022, and 2021, totaled $ 1.6 million and $ 910 thousand, respectively. Accrued interest related to the Senior Secured Note was $ 1.9 million and $ 1.6 million on December 31, 2022, and December 31, 2021, respectively. Interest expense on the Senior Secured Note totaled $ 5.9 million and $ 3.1 million for the years ended December 31, 2022, and 2021, respectively. 11. Convertible Promissory Notes and Convertible Promissory Notes, Related Parties December 31, 2022 (In thousands, except conversion price) Conversion Price Principal Debt Discount Conversion Option Carrying Value Acquisition convertible promissory note, in default $ 0.10 $ 4,000 $ - $ - $ 4,000 Convertible promissory note, related party, in default $ 0.10 1,373 - - 1,373 2022 Convertible notes payable $ 0.04 13,660 ( 2,532 ) 1,585 12,713 2022 Convertible notes payable, related parties $ 0.04 6,515 ( 1,234 ) 755 6,036 Total Convertible promissory notes $ 25,548 $ ( 3,766 ) $ 2,340 $ 24,122 December 31, 2021 (In thousands, except conversion price) Conversion Price Principal Debt Discount Conversion Option Carrying Value 2021 Convertible promissory notes payable $ 0.10 $ 2,446 $ ( 1,100 ) $ 6,255 $ 7,601 Acquisition convertible promissory note, in default $ 0.10 4,000 - - 4,000 Convertible promissory note payable, related parties, in default $ 0.10 1,596 - - 1,596 Total Convertible Promissory Notes $ 8,042 $ ( 1,100 ) $ 6,255 $ 13,197 2022 Convertible Notes Payable and 2022 Convertible Notes Payable, Related Parties - In August 2022 and November 2022, the Company entered into a Securities Purchase Agreements (the “Purchase Agreements”), for the sale in a private placement of (i) Future Advance Convertible Promissory Notes (the “Notes”) in an aggregate principal amount of $ 16.2 million in August and $ 4.0 million in November, (ii) Common Stock Purchase Warrants to purchase an additional 504.4 million shares of common stock with an exercise price of $ 0.067 per share and (iii) Common Stock Purchase Warrants to purchase an additional 504.4 million shares of common stock with an exercise price of $ 0.04 per share. The Company paid issuance costs totaling approximately $ 1.4 million. Interest expense for the year ended December 31, 2022, totaled $ 4.4 million, $ 1.2 million in contractual interest expense and $ 3.2 million in amortization of debt discount and issuance costs. Pursuant to the Notes, the Company promised to pay in cash and/or in shares of common stock, at a conversion price of $ 0.04 (the “Conversion Price”), the principal amount and interest at a rate of 15 % per annum on any outstanding principal. The Conversion Price of the Notes is subject to adjustment, including if the Company issues or sells shares of common stock for a price per share less than the Conversion Price of the Notes or if the Company lists its shares of common stock on The Nasdaq Capital Market and the average volume weighted average price of such common stock for the five trading days preceding such listing is less than $ 0.04 per share; provided, however, that the Conversion Price shall never by less than $ 0.01 . The Notes contain customary events of default and covenants, including limitations on incurrences of indebtedness and liens. In addition, pursuant to the Notes, the Company agreed to reduce its outstanding shares via a reverse stock split to provide the number of authorized and unissued shares of common stock sufficient to permit the conversion of these Notes on or before December 31, 2022. However, the Company obtained a waiver of this requirement through December 31, 2023 from all holders of the Notes and amended its Articles of Incorporation to increase its number of authorized shares of common stock from 800,000,000 to 2,500,000,000 . Acquisition Convertible promissory notes payable - In August 2020, the Company entered into an asset purchase agreement with Celularity to acquire Celularity’s UltraMIST assets. A portion of the aggregate consideration of $ 24 million paid for the assets included the issuance of a promissory note to Celularity in the principal amount of $ 4 million (the “Seller Note”). The Seller Note matured on August 6, 2021 , and was not repaid. The Company’s failure to pay the outstanding principal balance when due constituted an event of default under the terms of the Seller Note and, accordingly, it began accruing additional interest of 5.0 % in addition to the 12.0 % initial rate, as of the date of the default. As of December 31, 2022, and 2021, the Seller Notes had outstanding accrued interest of $ 1.5 million and $ 761 thousand, respectively. F-12 Table of Contents The Company evaluated embedded conversion features within the convertible promissory note and determined that the conversion feature does not require to be bifurcated. Upon adoption of ASC 2020-6 effective January 1, 2021, the convertible promissory note is accounted for as a single liability due to the elimination of the beneficial conversion feature accounting model. Convertible promissory notes payable, related party - In August 2020, the Company issued a convertible promissory note payable in the amount of $ 1.4 million. The note matured on August 6, 2021 , and was not repaid and is currently in default. As of December 31, 2022, and 2021, the note had outstanding accrued interest of $ 444 thousand and $ 241 thousand, respectively. 2021 Convertible Promissory Notes Payable – Previously, the Company entered into a Securities Purchase Agreement (the “2021 Purchase Agreement”) for the sale by the Company in a private placement (the “2021 Private Placement”) of (i) the Company’s future advance convertible promissory note in an aggregate principal amount of up to $ 3.4 million, later amended to $ 4.2 million and (ii) a warrant to purchase up to an additional 16,666,667 shares of common stock of the Company. The warrants had an exercise price of $ 0.18 per share and a four-year term. Advances totaled $ 1.9 million and warrants to purchase 9.3 million shares were outstanding prior to the settlement discussed below. In addition, the Company issued notes to five institutional investors totaling approximately $ 0.5 million, which were subject to substantially the same terms and conditions as the Purchase Agreement. Warrants to purchase 2.8 million shares of common stock with an exercise price of $ 0.18 per share were issued and outstanding prior to the settlement discussed below. Upon the closing of the Private Placement in August 2022, the 2021 Convertible Promissory Notes Payable were paid and settled in full using proceeds from the Private Placement. The settlement payment included cash totaling $ 3.9 million, which included accrued interest and penalties, and the issuance of Company shares of common stock totaling 19.4 million shares. The lenders surrendered the outstanding warrants to the Company. The Company recognized a $ 0.9 million loss on extinguishment of debt during the year ended December 31, 2022. 12. SBA Loans In February 2021, the Company received proceeds from a U.S. Small Business Administration (SBA) loan in the amount of $ 1.0 million pursuant to the Paycheck Protection Program under the CARES Act. The SBA Loan was evidenced by a promissory note that matured on February 20, 2026 , and bears interest of 1 % per annum. The SBA loan contained customary events of default relating to, among other things, payment defaults and breaches of representations, warranties and covenants. All or a portion of SBA loan may be fully or partially forgiven by the SBA upon application by the Company not later than June 2022 in accordance with SBA regulations. The Company received approval of the loan forgiveness application and recognized a gain on the extinguishment totaling $ 1.0 million during the year ended December 31, 2022. 13. Fair Value Measurements The Company uses various inputs to measure the outstanding warrants and certain embedded conversion features associated with convertible debt on a recurring basis to determine the fair value of the liabilities. The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy: Fair value measurement at December 31, 2022 (in thousands) Fair value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Warrant liability $ 1,416 - - $ 1,416 Conversion option 2,340 - - 2,340 Total Fair Value $ 3,756 $ - $ - $ 3,756 F-13 Table of Contents Fair value measurement at December 31, 2021 (in thousands) Fair value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Warrant liability $ 9,614 - - $ 9,614 Conversion option 6,255 - - 6,255 Total Fair Value $ 15,869 $ - $ - $ 15,869 There were no transfers between Level 1, 2, or 3, during the years ended December 31, 2022, and 2021. Both observable and unobservable in puts were used to determine fair value of the positions that the Company classified within the Level 3 category. Unrealized gains and losses associated with the liabilities within the Level 3 category include changes in fair value that were attributable to both observable and unobservable inputs. Warrant Liability Significant Black Scholes valuation model inputs related to the Company’s warrants are listed below: December 31, 2022 December 31, 2021 Weighted average expected life in years 4.68 4.67 Weighted average volatility 92 % 116 % Value of underlying shares $ 0.005 $ 0.17 Weighted average risk free interest rate 4.00 % 1.20 % Expected dividend yield - - A summary of the Level 3 warrant activity is as follows: (in thousands, except per share data) Warrants Outstanding Fair Value per Share Warrant Liability Fair Value Balance December 31, 2020 48,091 $ 0.18 $ 8,856 Cashless exercise ( 11,400 ) 0.18 ( 2,030 ) Issuance of warrants classified as liabilities 25,926 0.10 2,282 Change in fair value - 506 Balance December 31, 2021 62,617 $ 0.15 $ 9,614 Warrants exercised ( 27,037 ) 0.09 ( 3,130 ) Issuance of warrants classified as liabilities 1,031,277 0.06 4,873 Change in fair value - ( 9,941 ) Balance December 31, 2022 1,066,857 $ 0.06 $ 1,416 Embedded Conversion Option Certain convertible notes include a Conversion Option that meets the definition of a derivative liability and, accordingly, is required to be bifurcated. The fair value of the conversion option was valued using the Black-Scholes model as of December 31, 2022, and the binomial pricing model as of December 31, 2021. Significant inputs related to the Level 3 fair value determination are as follows: F-14 Table of Contents Initial Valuation Assumptions Year End Valuation Assumptions August 2022 Convertible Notes November 2022 Convertible Notes December 31, 2022 December 31, 2021 Conversion price (1) $ 0.04 $ 0.04 $ 0.04 $ 0.11 Value of underlying shares $ 0.006 $ 0.005 $ 0.005 $ 0.17 Interest Rate (annual) (2) 3.24 % 4.48 % 4.64 % 0.18 % Volatility (annual) (3) 349 % 438 % 503 % 290 % Time to maturity 1.00 0.73 0.60 0.50 (1) Based on the terms provided in the convertible promissory note agreements to convert to common stock of the Company (2) Interest rate for U.S. Treasury Bonds, as of each presented period ending date, as published by the U.S. Federal Reserve. (3) Based on the historical daily volatility of the Company as of each presented period ending date. As of December 31, 2022 the Company applied a discount rate to the historical volatility. A summary of the conversion option liability activity is as follows: (in thousands) Conversion Liability Balance December 31, 2020 $ - Convertible feature 4,139 Change in fair value 2,116 Balance December 31, 2021 $ 6,255 Issuance of Convertible Notes 2,760 Settlement of convertible notes ( 218 ) Change in fair value ( 6,457 ) Balance December 31, 2022 $ 2,340 14. Contract Liabilities The Company has contract liabilities from contracts with customers as follows: During the years ended December 31, 2022, and 2021, the Company recognized revenue related to these contract liabilities of $ 253 thousand and $ 32 thousand, respectively, that were included in the beginning contract liability balances for each of those periods. The following table summarizes the changes in contract liabilities: Year Ended December 31, (in thousands) 2022 2021 Beginning balance $ 341 $ 69 New service agreements 202 100 Deposit on future equipment purchases - 204 Revenue recognized ( 253 ) ( 32 ) Total Contract Liabilities $ 290 $ 341 15. Common Stock Purchase Warrants A summary of the warrant activity is as follows: F-15 Table of Contents (in thousands, except per share data) Warrants Weighted Average Exercise Price Weighted Average Remaining Life (years) Warrants at December 31, 2020 190,357 $ 0.19 3.43 Issuances 25,926 0.18 Exercised ( 11,400 ) 0.01 Forfeited or expired - - Outstanding at December 31, 2021 204,883 $ 0.20 2.54 Issuances 1,031,276 0.06 Exercised ( 27,943 ) 0.09 Forfeited or expired - - Outstanding at December 31, 2022 1,208,216 $ 0.07 3.55 On February 3, 2021, the Company issued 10,925,000 shares of its commons stock to a third party upon the cashless exercise of 11,400,000 of common stock warrants under the terms of the warrant agreement. 16. Common Stock In December 2022, the Company’s stockholders approved, an amendment to the Company’s Articles of Incorporation to increase the number of authorized shares of common stock from 800,000,000 to 2,500,000,000 . In January 2023, the Company filed the amendment to the Articles of Incorporation with the state of Nevada to affect the increase in authorized shares. Also in December 2022, the Company’s stockholders approved the Company to amend the Company’s Articles of Incorporation to affect a reverse stock split of the Company’s outstanding common stock at a reverse stock split ratio ranging from any whole number between 1-for- 50 and 1-for- 100 , with the exact ratio to be determined by the board of directors of the Company in its sole discretion. The Company has not yet affected a reverse stock split of its common stock. 17. Concentration of Credit Risk and Limited Suppliers Major customers are defined as customers whose accounts receivable, or sales individually consist of more than ten percent of total trade receivables or total sales, respectively. The percentage of accounts receivable from major customers of the Company were as follows: Accounts Receivable: December 31, 2022 December 31, 2021 Customer A - 24 % Customer B - 16 % The Company currently purchases most of its product component materials from single suppliers and the loss of any of these suppliers could result in a disruption in our production. The percentage of purchases from major vendors of the Company that exceeded ten percent of total purchases were as follows: Year ended December 31, 2022 2021 Purchases: Vendor A 19 % 50 % Vendor B - 21 % 18. Revenue The disaggregation of revenue is based on type and geographical region. The following table presents revenue from contracts with customers: F-16 Table of Contents Year ended December 31, 2022 Year ended December 31, 2021 United States International Total United States International Total Accessory and parts revenue $ 9,790 $ 72 $ 9,862 $ 7,770 $ 302 $ 8,072 System revenue 5,179 149 5,328 2,766 350 3,116 License fees and other 283 38 321 135 60 195 Product Revenue $ 15,252 $ 259 $ 15,511 $ 10,671 $ 712 $ 11,383 Rental Income 1,231 - 1,231 1,627 - 1,627 Total Revenue $ 16,483 $ 259 $ 16,742 $ 12,298 $ 712 $ 13,010 19. Stock-Based Compensation On November 1, 2010, the Company approved the Amended and Restated 2006 Stock Incentive Plan of SANUWAVE Health, Inc. effective as of January 1, 2010 (the “Stock Incentive Plan”). The Stock Incentive Plan permits grants of awards to selected employees, directors, and advisors of the Company in the form of restricted stock or options to purchase shares of common stock. Options granted may include non-statutory options as well as qualified incentive stock options. The Stock Incentive Plan is administered by the board of directors of the Company. The Stock Incentive Plan gives broad powers to the board of directors of the Company to administer and interpret the form and conditions of each option. The stock options granted under the Stock Incentive Plan are generally non-statutory options which generally vest over a period of up to three years and have a ten-year term. The options are granted at an exercise price determined by the board of directors of the Company to be the fair market value of the common stock on the date of the grant. As of December 31, 2022, and 2021, the Stock Incentive Plan reserved a total of 35,000,000 shares of common stock for grant. On December 31, 2022, there were 3,240,615 shares of common stock available for grant under the Stock Incentive Plan. 20. Income Taxes The Company files income tax returns in the United States Federal jurisdiction and various state and foreign jurisdictions. The Company is subject to United States Federal and state income tax examinations by tax authorities for any years that have net operating losses open until the net operating losses are used. The components of the net loss before income taxes are as follows: Year ended December 31, (In thousands) 2022 2021 Domestic $ ( 10,279 ) $ ( 27,208 ) Foreign ( 12 ) ( 23 ) Net loss before income taxes $ ( 10,291 ) $ ( 27,231 ) In accordance with ASC Topic 740, Income Taxes (“ASC 740”), the Company accounts for income taxes utilizing the asset and liability method. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided for the deferred tax assets, including loss carryforwards, when it is more likely than not that some portion or all a deferred tax asset will not be realized. The income tax provision (benefit) from continuing operations consists of the following: F-17 Table of Contents (In thousands) December 31, 2022 December 31, 2021 Current: Federal $ - $ - State 2 28 Foreign - - Current Tax Provision $ 2 $ 28 Deferred: Federal $ ( 5,657 ) $ ( 5,038 ) State 753 ( 869 ) Foreign ( 1 ) 4 Change in valuation allowance 4,905 5,903 Deferred Tax Provision $ - $ - As of December 31, 2022, and 2021, the Company did no t have any undistributed earnings of our foreign subsidiaries. As a result, no additional income or withholding taxes have been provided for. The Company does not anticipate any impacts of the global intangible low taxed income (“GILTI”) and base erosion anti-abuse tax (“BEAT”) and as such, the Company has not recorded any impact associated with either GILTI or BEAT. The income tax provision (benefit) amounts differ from the amounts computed by applying the United States Federal statutory income tax rate of 21 % for the years ended December 31, 2022, and 2021. Adjustments to determine income tax expense are as follow: (In thousands) Years ended December 31, 2022 2021 Tax benefit at statutory rate $ ( 2,161 ) $ ( 5,718 ) Increase (reduction) in income taxes resulting from: State incomes tax benefits, net of federal benefit ( 473 ) ( 837 ) Non-deductible gain on warrant adjustment valuation ( 3,270 ) 417 Change in valuation allowance 4,905 5,903 Registration penalites 67 354 Other 934 ( 91 ) Income Tax Expense $ 2 $ 28 The tax effects of temporary differences that give rise to the deferred tax assets are as follows: F-18 Table of Contents (In thousands) December 31, 2022 December 31, 2021 Deferred Tax Assets Net operating loss carryforwards $ 38,323 $ 33,238 Net operating loss carryforwards - foreign 24 23 Excess of tax basis over book value of property and equipment 9 14 Excess of tax basis over book value of intangible assets 1,325 1,622 Lease liability 150 96 Stock-based compensation 1,487 1,613 Accrued employee compensation 750 698 Capitalized equity costs - 49 Capitalized research and development 116 - Net change in reserve accounts 1,031 898 Gross deferred tax asset 43,215 38,251 Valuation Allowance ( 43,070 ) ( 38,165 ) Net Deferred Tax Asset 145 86 Deferred Tax Liabilities Right-of-use asset ( 145 ) ( 86 ) Gross deferred tax liability ( 145 ) ( 86 ) TOTAL $ - $ - On August 16, 2022, the U.S. government enacted the Inflation Reduction Act of 2022 (the “Inflation Reduction Act”) into law. The Inflation Reduction Act imposes an excise tax of 1% on the fair market value of net stock repurchases made after December 31, 2022. The impact of this provision will be dependent on the extent of share repurchases made in future periods. We continue to analyze the impacts of the Inflation Reduction Act; however, it is not expected to have a material impact on our financial statements. Additionally, the Inflation Reduction Act includes a new corporate alternative minimum tax which is not currently applicable to the Company. The Tax Cuts and Jobs Act (“TCJA”) requires taxpayers to capitalize and amortize research and development (“R&D”) expenditures under section 174 for tax years beginning after December 31, 2021. This rule became effective for the Company during 2022 and resulted in capitalized R&D costs of $ 0.6 million as of December 31, 2022. The Company will amortize these costs for tax purposes over five years for R&D performed in the U.S. and over 15 years for R&D performed outside the U.S. In 2022, all R&D was performed in the U.S. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. In assessing the realization of deferred tax assets, management considers, whether it is “more likely than not”, that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. ASC 740 requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. A review of all available positive and negative evidence needs to be considered, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After consideration of all the information available, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of December 31, 2022, and 2021. The Company’s ability to use its net operating loss carryforwards could be limited and subject to annual limitations. Since a full analysis under Section 382 of the Internal Revenue Code has not been performed, the Company may realize a “more than 50% change in ownership” which could limit its ability to use its net operating loss carryforwards accumulated to date to reduce future taxable income and tax liabilities. Additionally, because United States tax laws limit the time during which net operating loss carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take advantage of all or portions of its net operating loss carryforwards for Federal income tax purposes. The Federal net operating loss carryforwards of approximately $ 159.7 million from years ending December 31, 2005, through December 31, 2017, will begin to expire in 2025 . The Federal net operating loss carryforward for the years ended December 31, 2018, through 2022 of approximately $ 81.8 million will not expire. The state net operating loss carryforwards of approximately $ 70.5 million from years ending December 31, 2005, through December 31, 2022, will expire at various dates through 2042 . The foreign net operating loss carryforward on December 31, 2022, of $ 0.1 million will begin to expire in 2024 . F-19 Table of Contents A provision of ASC 740 specifies that companies are to account for uncertainties in income tax reporting, and prescribes a methodology for recognizing, reversing, and measuring the tax benefits of a tax position taken, or expected to be taken, in a tax return. ASC 740 requires the evaluation of tax positions taken or expected to be taken while preparing the Company’s tax returns to determine whether the tax positions would “more-likely-than-not” be sustained if challenged by the applicable tax authority. Tax positions not deemed to meet the more-likely-than-not threshold would be recorded as a tax benefit or expense in the current year. Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financial statements as of December 31, 2022, and 2021. The Company does not expect any significant changes in the unrecognized tax benefits within twelve months of the reporting date. The Company will recognize in income tax expense, interest and penalties related to income tax matters. For the years ended December 31, 2022, and 2021, the Company did no t have any amounts recorded for interest and penalties. 21. Commitments and Contingencies Litigation In the ordinary course of business, the Company from time to time becomes involved in various legal proceedings involving a variety of matters. The Company does not believe there are any pending legal proceedings that will have a material adverse effect on the Company’s business, consolidated financial position, results of operations, or cash flows. However, the outcome of such legal matters is inherently unpredictable and subject to significant uncertainties. The Companies expenses legal fees in the period in which they are occurred. Acquisition Dispute The Company received notification alleging that it is not in compliance with the license agreement with Celularity entered in connection with the acquisition of the UltraMIST assets. The Company has responded and asserted that the Company is not in breach and that the supplier has breached various agreements. It is too early to determine the outcome of this matter. Any potential impact to the Company cannot be fully determined at this time and there is no guarantee that the dispute will be resolved in a manner beneficial to the Company or at all. Lease Commitments As of December 31, 2022, the maturities of the Company’s operating and financing leases, which have initial or remaining lease terms more than one year, consist of the following: (In thousands) Operating Leases Finance Leases Year ended December 31, 2023 $ 143 $ 128 2024 85 128 2025 82 78 2026 82 - 2027 55 - Total Lease Payments 447 334 22. Restatement of Previously Issued Interim Condensed Consolidated Financial Statements The following tables present the impact of the restatement adjustments disclosed in Note 3 – Restatement of Previously Issued Financial Statements, to the previously reported financial information as of and for the periods ended March 31, 2022, June 30, 2022, and September 30, 2022. Restated Statements of Stockholders’ Equity are not presented as all impacted items on those statements, Net Income (Loss), Accumulated deficit, and Total stockholders’ equity, are presented within the following tables. F-20 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) March 31, 2022 (In thousands, except share data) Previously Reported Adjustments Restated ASSETS Current Assets: Cash $ 313 $ - $ 313 Accounts receivable, net of allowance of $ 785 1,730 - 1,730 Inventory 1,001 - 1,001 Prepaid expenses and other current assets 365 - 365 Total Current Assets $ 3,409 $ - $ 3,409 Property, Equipment, net 315 - 315 Right of use assets, net 259 - 259 Other Intangible Assets, net 5,665 - 5,665 Goodwill 7,260 - 7,260 Other assets 106 - 106 Total Assets $ 17,014 $ - $ 17,014 LIABILITIES Current Liabilities: Senior secured promissory note payable, in default $ 11,894 $ - $ 11,894 Convertible promissory notes payable, in default 10,532 - 10,532 Convertible promissory notes, related parties, in default 1,596 - 1,596 Advances on future cash receipts 416 - 416 Accounts payable 6,696 64 6,760 Accrued expenses 4,916 554 5,470 Accrued employee compensation 3,623 - 3,623 Due under factoring agreement 1,231 - 1,231 Warrant liability 8,300 - 8,300 Current portion of SBA loans 226 - 226 Accrued interest 3,072 60 3,132 Accrued interest, related parties 345 - 345 Current portion of lease liabilities 268 - 268 Current portion of contract liabilities 58 - 58 Other 58 - 58 Total Current Liabilities $ 53,231 $ 678 $ 53,909 Non-current Liabilities SBA loans $ 807 $ - $ 807 Lease liabilities 34 - 34 Contract liabilities 303 - 303 Deferred tax liability 28 - 28 Total Non-current Liabilities $ 1,172 $ - $ 1,172 Total Liabilities $ 54,403 $ 678 $ 55,081 STOCKHOLDERS’ DEFICIT Preferred Stock $ - $ - $ - Common Stock 517 - 517 Additional Paid-in Capital 150,533 - 150,533 Accumulated Deficit ( 188,372 ) ( 678 ) ( 189,050 ) Accumulated Other Comprehensive Loss ( 67 ) - ( 67 ) Total Stockholders’ Deficit $ ( 37,389 ) $ ( 678 ) $ ( 38,067 ) Total Liabilities and Stockholders’ Deficit $ 17,014 $ - $ 17,014 F-21 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) (In thousands except share data) Three Months Ended March 31, 2022 Previously Reported Adjustments Restated Revenues: Accessory and parts revenue $ 2,192 $ - $ 2,192 Product 645 - 645 Rental Income 343 - 343 License fees and other 15 - 15 Total Revenue 3,195 - 3,195 Cost of Revenues 889 - 889 Gross Margin $ 2,306 $ - $ 2,306 Operating Expenses: General and administrative 2,141 64 2,205 Selling and marketing 1,715 - 1,715 Research and development 166 - 166 Gain on disposal of assets ( 554 ) 554 - Depreciation and amortization 176 - 176 Total Operating Expenses 3,644 618 4,262 Operating Loss $ ( 1,338 ) $ ( 618 ) $ ( 1,956 ) Other Income (Expense): Interest expense ( 3,076 ) ( 60 ) ( 3,136 ) Interest expense, related party ( 56 ) - ( 56 ) Change in fair value of derivative liabilities 3,482 - 3,482 Loss on issuance of debt ( 3,434 ) - ( 3,434 ) Gain / (loss) on foreign currency exchange ( 1 ) - ( 1 ) Other Expense, net ( 3,085 ) ( 60 ) ( 3,145 ) Net Loss before Income Taxes $ ( 4,423 ) $ ( 678 ) $ ( 5,101 ) Provision for Income Taxes - - - Net Loss $ ( 4,423 ) $ ( 678 ) $ ( 5,101 ) Other Comprehensive Loss Foreign currency translation adjustments - - - Total Comprehensive Loss $ ( 4,423 ) $ ( 678 ) $ ( 5,101 ) Loss per Share: Net loss per share, basic and diluted $ ( 0.01 ) $ - $ ( 0.01 ) Weighted average shares outstanding, basic and diluted 525,414,534 - 525,414,534 F-22 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) Three Months Ended March 31, 2022 Previously Reported Adjustment Restated Cash Flows - Operating Activities: Net loss $ ( 4,423 ) $ ( 678 ) $ ( 5,101 ) Adjustments to reconcile net loss to net cash used by operating activities Amortization of intangibles 176 - 176 Depreciation 15 - 15 Change in fair value of derivative liabilities ( 3,482 ) - ( 3,482 ) Loss on issuance of debt 3,434 - 3,434 Amortization of debt issuance costs and original issue discount 889 - 889 Accrued interest 551 60 611 Interest payable, related parties 56 - 56 Changes in operating assets and liabilities Accounts receivable - trade 804 - 804 Inventory 39 - 39 Prepaid expenses ( 39 ) - ( 39 ) Other assets 43 - 43 Operating leases - - - Accounts payable ( 930 ) 64 ( 866 ) Accrued expenses 439 554 993 Accrued employee compensation ( 549 ) - ( 549 ) Contract liabilities ( 155 ) - ( 155 ) Net Cash Used by Operating Activities ( 3,132 ) - ( 3,132 ) Cash Flows - Investing Activities Disposition of property and equipment 360 - 360 Net Cash Flows Provided by (Used in) Investing Activities 360 - 360 Cash Flows - Financing Activities Proceeds from senior promissory notes 2,940 - 2,940 Payments for factoring ( 505 ) - ( 505 ) Proceeds from warrant exercises 100 - 100 Payments of principal on finance leases ( 65 ) - ( 65 ) Net Cash Flows Provided by Financing Activities 2,470 - 2,470 Effect of Exchange Rates on Cash ( 4 ) - ( 4 ) Net Change in Cash During Period ( 306 ) - ( 306 ) Cash at Beginning of Period 619 - 619 Cash at End of Period $ 313 $ - $ 313 Supplemental Information: Cash paid for interest $ 574 $ - $ 574 Non-cash Investing and Financing Activities: Reclassification of warrant liability due to cashless warrant exercise $ 2,167 $ - $ 2,167 Warrants issued in conjunction with senior secured promissory note payable 2,654 - 2,654 Common shares issued in conjunction with senior secured promissory note payable 3,720 - 3,720 F-23 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) June 30, 2022 (In thousands, except share data) Previously Reported Adjustments Restated ASSETS Current Assets: Cash $ 1,484 $ - $ 1,484 Accounts receivable, net of allowance for doubtful accounts of $ 0.8 million, respectively 1,749 - 1,749 Inventory 925 - 925 Prepaid expenses and other current assets 1,181 ( 781 ) 400 Total Current Assets $ 5,339 $ ( 781 ) $ 4,558 Property, Equipment and Other, net 535 - 535 Other Intangible Assets, net 5,489 - 5,489 Goodwill 7,260 - 7,260 Total Assets $ 18,623 $ ( 781 ) $ 17,842 LIABILITIES Current Liabilities: Senior secured promissory note payable, in default $ 12,334 $ - $ 12,334 Convertible promissory notes payable, in default 6,523 - 6,523 Convertible promissory notes, related parties, in default 1,596 - 1,596 Short-term loans 1,484 - 1,484 Advances on future cash receipts 398 - 398 Accounts payable 7,083 76 7,159 Accrued expenses 5,900 741 6,641 Accrued employee compensation 4,264 - 4,264 Due under factoring agreement 1,792 - 1,792 Warrant liability 5,295 - 5,295 Current portion of SBA loans 272 - 272 Accrued interest 3,600 137 3,737 Accrued interest, related parties 402 - 402 Current portion of lease liabilities 185 - 185 Current portion of contract liabilities 64 - 64 Other 107 - 107 Total Current Liabilities $ 51,299 $ 954 $ 52,253 Non-current Liabilities SBA loans $ 761 $ - $ 761 Lease liabilities 40 - 40 Contract liabilities 295 - 295 Deferred tax liability 28 - 28 Total Non-current Liabilities $ 1,124 $ - $ 1,124 Total Liabilities $ 52,423 $ 954 $ 53,377 STOCKHOLDERS’ DEFICIT Preferred Stock $ - $ - $ - Common Stock 529 - 529 Additional Paid-in Capital 151,409 - 151,409 Accumulated Deficit ( 185,671 ) ( 1,735 ) ( 187,406 ) Accumulated Other Comprehensive Loss ( 67 ) ( 67 ) Total Stockholders’ Deficit $ ( 33,800 ) $ ( 1,735 ) $ ( 35,535 ) Total Liabilities and Stockholders’ Deficit $ 18,623 $ ( 781 ) $ 17,842 F-24 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) (In thousands except share data) Three Months Ended June 30, 2022 Six Months Ended June 30, 2022 Previously Reported Adj. Restated Previously Reported Adj. Restated Revenues: Accessory and parts revenue $ 2,663 $ - $ 2,663 $ 4,854 $ - $ 4,854 Product 862 - 862 1,507 - 1,507 Rental Income 344 - 344 688 - 688 License fees and other 13 - 13 28 - 28 Total Revenue 3,882 - 3,882 7,077 - 7,077 Cost of Revenues 1,096 - 1,096 1,986 - 1,986 Gross Margin $ 2,786 $ - $ 2,786 $ 5,091 $ - $ 5,091 Operating Expenses: General and administrative 2,937 793 3,730 5,078 857 5,935 Selling and marketing 1,672 - 1,672 3,387 - 3,387 Research and development 171 - 171 337 - 337 Gain on disposal of assets ( 136 ) 187 51 ( 690 ) 741 51 Depreciation and amortization 210 - 210 386 - 386 Total Operating Expenses 4,854 980 5,834 8,498 1,598 10,096 Operating Loss $ ( 2,068 ) $ ( 980 ) $ ( 3,048 ) $ ( 3,407 ) $ ( 1,598 ) $ ( 5,005 ) Other Income (Expense): Interest expense ( 2,826 ) ( 77 ) ( 2,903 ) ( 5,903 ) ( 137 ) ( 6,040 ) Interest expense, related party ( 56 ) - ( 56 ) ( 112 ) - ( 112 ) Change in fair value of derivative liabilities 7,861 - 7,861 11,343 - 11,343 Loss on issuance of debt - - - ( 3,434 ) - ( 3,434 ) Loss on extinguishment of debt ( 211 ) - ( 211 ) ( 211 ) - ( 211 ) Gain / (loss) on foreign currency exchange 2 - 2 2 - 2 Other Income (Expense), net 4,770 ( 77 ) 4,693 1,685 ( 137 ) 1,548 Net Income (loss) before Income Taxes $ 2,702 $ ( 1,057 ) $ 1,645 $ ( 1,722 ) $ ( 1,735 ) $ ( 3,457 ) Provision for Income Taxes - - - - - - Net Income (loss) $ 2,702 $ ( 1,057 ) $ 1,645 $ ( 1,722 ) $ ( 1,735 ) $ ( 3,457 ) Other Comprehensive Income (Loss) Foreign currency translation adjustments - - - - - - Total Comprehensive Income (Loss) $ 2,702 $ ( 1,057 ) $ 1,645 $ ( 1,722 ) $ ( 1,735 ) $ ( 3,457 ) Gain (loss) per Share: Basic $ 0.01 $ ( 0.01 ) $ - $ - $ ( 0.01 ) $ ( 0.01 ) Diluted $ - $ - $ - ( 0.01 ) $ ( 0.01 ) Weighted average shares outstanding; Basic and Diluted Basic 538,560,051 - 538,560,051 532,589,825 - 532,589,825 Diluted 871,984,091 - 871,984,091 532,589,825 - 532,589,825 F-25 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) Six Months Ended June 30, 2022 Previously Reported Adjustment Restated Cash Flows - Operating Activities: Net loss $ ( 1,722 ) $ ( 1,735 ) $ ( 3,457 ) Adjustments to reconcile net loss to net cash used by operating activities Amortization of intangibles 352 - 352 Depreciation 94 - 94 Bad debt expense 52 - 52 Income tax expense - - - Shares issued for service 888 - 888 Loss in extinguishment of debt 211 - 211 Gain on sale of property and equipment, net ( 541 ) 541 - Change in fair value of derivative liabilities ( 11,343 ) - ( 11,343 ) Loss on issuance of debt 3,434 - 3,434 Amortization of debt issuance costs and original issue discount 1,304 - 1,304 Accrued interest 1,078 137 1,215 Interest payable, related parties 112 - 112 Changes in operating assets and liabilities Accounts receivable - trade 733 - 733 Inventory 115 - 115 Prepaid expenses ( 855 ) 781 ( 74 ) Other assets 47 - 47 Accounts payable ( 562 ) 76 ( 486 ) Accrued expenses 1,407 200 1,607 Accrued employee compensation 103 - 103 Contract liabilities ( 108 ) - ( 108 ) Net Cash Used by Operating Activities ( 5,201 ) - ( 5,201 ) Cash Flows - Investing Activities Proceeds from sale of property and equipment 948 - 948 Net Cash Flows Used in Investing Activities 948 - 948 Cash Flows - Financing Activities Proceeds from senior promissory notes 2,940 - 2,940 Proceeds from short term notes 2,130 - 2,130 Proceeds from factoring 55 - 55 Proceeds from warrant exercises 100 - 100 Payments of principal on finance leases ( 121 ) - ( 121 ) Proceeds from related party advances - - - Net Cash Flows Provided by Financing Activities 5,104 - 5,104 Effect of Exchange Rates on Cash 14 - 14 Net Change in Cash During Period 865 - 865 Cash at Beginning of Period 619 - 619 Cash at End of Period $ 1,484 $ - $ 1,484 Supplemental Information: Cash paid for interest $ 2,045 $ - $ 2,045 Non-cash Investing and Financing Activities: Reclassification of warrant liability due to cashless warrant exercise 2,167 - 2,167 Warrants issued in conjunction with senior secured promissory note payable 2,654 - 2,654 Common shares issued in conjunction with senior secured promissory note payable 3,720 - 3,720 F-26 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) September 30, 2022 (In thousands, except share data) Previously Reported Adjustments Restated ASSETS Cash $ 1,112 $ - $ 1,112 Accounts receivable, net of allowance of $ 0.8 million, respectively 2,403 - 2,403 Inventory 1,413 ( 551 ) 862 Prepaid expenses and other current assets 1,935 ( 781 ) 1,154 Total Current Assets $ 6,863 $ ( 1,332 ) $ 5,531 Property and Equipment and Other, net 673 - 673 Other Intangible Assets, net 5,313 - 5,313 Goodwill 7,260 - 7,260 Total Assets $ 20,109 $ ( 1,332 ) $ 18,777 LIABILITIES Current Liabilities: Senior secured promissory note payable, in default $ 12,773 $ - $ 12,773 Convertible promissory notes payable, in default 13,174 - 13,174 Convertible promissory notes, related parties, in default 5,858 - 5,858 Advances on future cash receipts 194 - 194 Accounts payable 5,055 170 5,225 Accrued expenses 4,100 741 4,841 Accrued employee compensation 3,792 - 3,792 Due under factoring agreement 1,510 - 1,510 Warrant liability 1,196 - 1,196 Accrued interest 3,988 218 4,206 Accrued interest, related parties 546 - 546 Current portion of lease and contract liabilities 249 - 249 Other 30 - 30 Total Current Liabilities $ 52,465 $ 1,129 $ 53,594 Non-current Liabilities SBA loans $ - $ - $ - Lease liabilities 263 - 263 Contract liabilities 205 - 205 Deferred tax liability 28 - 28 Total Non-current Liabilities $ 496 $ - $ 496 Total Liabilities $ 52,961 $ 1,129 $ 54,090 STOCKHOLDERS’ DEFICIT Preferred Stock $ - $ - $ - Common Stock 549 - 549 Additional Paid-in Capital 152,750 - 152,750 Accumulated Deficit ( 186,084 ) ( 2,461 ) ( 188,545 ) Accumulated Other Comprehensive Loss ( 67 ) - ( 67 ) Total Stockholders’ Deficit $ ( 32,852 ) $ ( 2,461 ) $ ( 35,313 ) Total Liabilities and Stockholders’ Deficit $ 20,109 $ ( 1,332 ) $ 18,777 F-27 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) (In thousands except share data) Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 Previously Reported Adj. Restated Previously Reported Adj. Restated Revenues: Accessory and parts revenue $ 3,012 $ - $ 3,012 $ 7,866 $ - $ 7,866 Product 902 - 902 2,408 - 2,408 Rental Income 247 - 247 935 - 935 License fees and other 5 - 5 33 - 33 Total Revenue 4,166 - 4,166 11,242 - 11,242 Cost of Revenues 606 551 1,157 2,590 551 3,141 Gross Margin $ 3,560 $ ( 551 ) $ 3,009 $ 8,652 $ ( 551 ) $ 8,101 Operating Expenses: General and administrative 3,404 94 3,498 8,482 951 9,433 Selling and marketing 1,650 - 1,650 5,037 - 5,037 Research and development 157 - 157 494 - 494 Gain on disposal of assets - - - ( 690 ) 741 51 Depreciation and amortization 189 - 189 575 - 575 Total Operating Expenses 5,400 94 5,494 13,898 1,692 15,590 Operating Loss $ ( 1,840 ) $ ( 645 ) $ ( 2,485 ) $ ( 5,246 ) $ ( 2,243 ) $ ( 7,489 ) Other Income (Expense): Interest expense ( 3,301 ) ( 81 ) ( 3,382 ) ( 9,203 ) ( 218 ) ( 9,421 ) Interest expense, related party ( 439 ) - ( 439 ) ( 551 ) - ( 551 ) Change in fair value of derivative liabilities 5,252 - 5,252 16,597 - 16,597 Loss on issuance of debt - - - ( 3,434 ) - ( 3,434 ) Loss on extinguishment of debt ( 86 ) - ( 86 ) ( 297 ) - ( 297 ) Gain / (loss) on foreign currency exchange 1 - 1 ( 1 ) - ( 1 ) Other Income (Expense), net 1,427 ( 81 ) 1,346 3,111 ( 218 ) 2,893 Net Loss before Income Taxes $ ( 413 ) $ ( 726 ) $ ( 1,139 ) $ ( 2,135 ) $ ( 2,461 ) $ ( 4,596 ) Provision for Income Taxes - - - - - - Net Income (loss) $ ( 413 ) $ ( 726 ) $ ( 1,139 ) $ ( 2,135 ) $ ( 2,461 ) $ ( 4,596 ) Other Comprehensive Income (Loss) Foreign currency translation adjustments - - - - - - Total Comprehensive Income (Loss) $ ( 413 ) $ ( 726 ) $ ( 1,139 ) $ ( 2,135 ) $ ( 2,461 ) $ ( 4,596 ) Loss per Share: Basic and Diluted $ ( 0.00 ) $ - $ ( 0.00 ) $ ( 0.00 ) $ ( 0.01 ) $ ( 0.01 ) Weighted average shares outstanding, basic and diluted 561,069,625 - 561,069,625 542,484,779 - 542,484,779 F-28 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES RESTATED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) Nine Months Ended September 30, 2022 Previously Reported Adjustment Restated Cash Flows - Operating Activities: Net loss $ ( 2,135 ) $ ( 2,461 ) $ ( 4,596 ) Adjustments to reconcile net loss to net cash used by operating activities Depreciation and Amortization 681 - 681 Bad debt expense 62 - 62 Shares issued for service 888 - 888 Loss on extinguishment of debt 297 - 297 Gain on sale of property and equipment, net ( 690 ) 741 51 Change in fair value of derivative liabilities ( 16,597 ) - ( 16,597 ) Loss on issuance of debt 3,434 - 3,434 Amortization of debt issuance costs and original issue discount 2,998 - 2,998 Accrued interest 1,618 218 1,836 Interest payable, related parties 168 - 168 Changes in operating assets and liabilities Accounts receivable - trade 69 - 69 Inventory ( 373 ) 551 178 Prepaid expenses and other assets ( 1,437 ) 781 ( 656 ) Accounts payable ( 1,863 ) 170 ( 1,693 ) Accrued expenses 271 - 271 Accrued employee compensation ( 473 ) - ( 473 ) Contract liabilities ( 94 ) - ( 94 ) Net Cash Used by Operating Activities ( 13,176 ) - ( 13,176 ) Cash Flows - Investing Activities Disposition of property and equipment 1,022 - 1,022 Net Cash Flows Provided by (Used in) Investing Activities 1,022 - 1,022 Cash Flows - Financing Activities Proceeds from senior promissory notes 2,940 - 2,940 Proceeds from convertible promissory notes 12,366 - 12,366 Proceeds from short term notes 640 - 640 Payments for factoring ( 227 ) - ( 227 ) Proceeds from warrant exercises 100 - 100 Payments of principal on finance leases ( 174 ) - ( 174 ) Payments of principal on convertible promissory notes and SBA loans ( 2,981 ) - ( 2,981 ) Net Cash Flows Provided by Financing Activities 12,664 - 12,664 Effect of Exchange Rates on Cash ( 17 ) - ( 17 ) Net Change in Cash During Period 493 - 493 Cash at Beginning of Period 619 - 619 Cash at End of Period $ 1,112 $ - $ 1,112 Supplemental Information: Cash paid for interest $ 3,345 $ - $ 3,345 Non-cash Investing and Financing Activities: Reclassification of warrant liability due to cashless warrant exercise $ 2,166 $ - $ 2,166 Settlement of debt and warrants with stock 1,361 - 1,361 Warrants issued in conjunction with senior secured promissory note payable 2,654 - 2,654 Common shares issued in conjunction with senior secured promissory note payable 3,720 - 3,720 Embedded conversion option with issuances of convertible debt 2,309 - 2,309 Working capital balances refinanced into Convertible notes payable 2,273 - 2,273 Warrant issuance in conjunction with convertible debt 1,463 - 1,463 F-29 Table of Contents Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None