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What changed in SANUWAVE Health, Inc.'s 10-K2023 vs 2024

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Paragraph-level year-over-year comparison of SANUWAVE Health, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+262 added361 removedSource: 10-K (2025-03-20) vs 10-K (2024-03-21)

Top changes in SANUWAVE Health, Inc.'s 2024 10-K

262 paragraphs added · 361 removed · 83 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

0 edited+135 added185 removed0 unchanged
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AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS December 31, 2023 and 2022 (In thousands, except share data) 2023 2022 ASSETS Current Assets: Cash $ 1,797 $ 1,153 Accounts receivable, net of allowance of $ 1,237 and $ 1,037 , respectively 3,314 4,029 Inventory 2,951 868 Prepaid expenses and other current assets 1,722 570 Total Current Assets 9,784 6,620 Non-Current Assets: Property, equipment and right of use assets, net 938 856 Intangible assets, net 4,434 5,137 Goodwill 7,260 7,260 Total Non-Current Assets 12,632 13,253 Total Assets $ 22,416 $ 19,873 LIABILITIES Current Liabilities: Senior secured debt, in default $ 18,278 $ 14,416 Convertible promissory notes payable 5,404 16,713 Convertible promissory notes payable, related parties 1,705 7,409 Asset-backed secured promissory notes payable 3,117 - Asset-backed secured promissory notes payable, related parties 1,458 - Accounts payable 5,705 4,400 Accrued expenses 5,999 8,512 Factoring liabilities 1,490 2,130 Warrant liability 14,447 1,416 Accrued interest 5,444 4,052 Accrued interest, related parties 669 788 Current portion of contract liabilities 92 60 Other 947 319 Total Current Liabilities 64,755 60,215 Non-Current Liabilities: Lease liabilities 492 438 Contract liabilities 347 230 Total Non-Current Liabilities 839 668 Total Liabilities $ 65,594 $ 60,883 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 2023 and 2022 $ - $ - Common stock, par value $ 0.001 , 2,500,000,000 shares authorized, 1,140,559,527 and 548,737,651 issued and outstanding at 2023 and 2022 , respectively 1,140 549 Additional paid-in capital 175,842 152,750 Accumulated deficit (220,049 ) (194,242 ) Accumulated other comprehensive loss (111 ) (67 ) Total Stockholders’ Deficit (43,178 ) (41,010 ) Total Liabilities and Stockholders’ Deficit $ 22,416 $ 19,873 The accompanying notes to consolidated financial statements are an integral part of these statements.
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Item 1. BUSINESS Overview Sanuwave is a medical device company providing directed energy products into the wound care space. Our mission is to improve patient lives and outcomes by developing and marketing effective, easy to use products to decrease wound burden, lessen healing times, and reduce patient pain.
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AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Years ended December 31, 2023 and 2022 (In thousands, except share and per share data) 2023 2022 Revenue $ 20,398 $ 16,742 Cost of revenues 6,035 4,331 Gross Margin 14,363 12,411 Operating Expenses: General and administrative 8,674 12,556 Selling and marketing 4,898 7,474 Research and development 579 567 Depreciation and amortization 752 766 Total Operating Expenses 14,903 21,363 Operating Loss (540 ) (8,952 ) Other Income (Expense) Interest expense (12,946 ) (12,771 ) Interest expense, related party (2,677 ) (1,361 ) Change in fair value of derivative liabilities (9,621 ) 16,654 Loss on issuance of debt - (3,434 ) Loss on extinguishment of debt - (418 ) Other expense (19 ) (9 ) Total Other Expense (25,263 ) (1,339 ) Net Loss Before Income Taxes (25,803 ) (10,291 ) Income tax expense 4 2 Net Loss $ (25,807 ) $ (10,293 ) Other Comprehensive Loss Foreign currency translation adjustments (44 ) 6 Total Comprehensive Loss $ (25,851 ) $ (10,287 ) Loss per Share: Net loss per share, basic and diluted $ (0.03 ) $ (0.02 ) Weighted average shares outstanding, basic and diluted 793,850,994 549,470,787 The accompanying notes to consolidated financial statements are an integral part of these statements.
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Our focus is regenerative medicine utilizing noninvasive ultrasound or shockwaves to produce a biological response promoting the repair and regeneration of tissue, musculoskeletal, and vascular structures. The Company’s patented and FDA cleared products include the UltraMIST ® system (UM) and the PACE ® family of products, both of which are used to treat a variety of acute and chronic wounds.
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AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT (In thousands, except share data) Common Stock Shares Issued and Outstanding Par Value Additional Paid- in Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total 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 Balances as of December 31, 2022 548,737,651 $ 549 $ 152,750 $ (194,242 ) $ (67 ) $ (41,010 ) Shares issued for services 12,900,000 $ 13 $ 514 $ - $ - $ 527 Shares issued for settlement of August 2022 debt 464,440,813 464 18,113 - - 18,577 Shares issued for settlement of November 2022 debt 114,481,063 114 4,465 - - 4,579 Net loss - - - (25,807 ) - (25,807 ) Foreign currency translation adjustment - - - - (44 ) (44 ) Balance as of December 31, 2023 1,140,559,527 $ 1,140 $ 175,842 $ (220,049 ) $ (111 ) $ (43,178 ) The accompanying notes to the consolidated financial statements are an integral part of these financial statements F-5 Table of Contents SANUWAVE HEALTH, INC.
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These products are backed by an intellectual property (“IP”) portfolio of over 165 patents. In the year ended December 31, 2024 , we had total revenues of $32.6 million , a 60% increase from revenues of $20.4 million in the year ended December 31, 2023 .
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AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS Years ended December 31, 2023 and 2022 (In thousands) 2023 2022 Cash Flows - Operating Activities: Net loss $ (25,807 ) $ (10,293 ) Adjustments to reconcile net loss to net cash used by operating activities Depreciation and amortization 1,028 952 Bad debt expense 781 253 Shares issued for services 224 888 Gain/loss on extinguishment of debt - 418 Income tax expense 4 2 Change in fair value of derivative liabilities 9,621 (16,654 ) Loss on issuance of debt - 3,434 Amortization of debt issuance and debt discounts 6,911 4,950 Changes in operating assets and liabilities Accounts receivable (53 ) (1,748 ) Inventory, prepaid expenses and other assets (3,006 ) (72 ) Accounts payable 1,546 (2,550 ) Accrued interest and accrued interest, related parties 6,306 3,182 Accrued expenses and contract liabilities (2,093 ) 69 Net Cash Used by Operating Activities (4,538 ) (17,169 ) Cash Flows - Investing Activities Proceeds from sale of property and equipment 21 332 Net Cash Flows Provided by Investing Activities 21 332 Cash Flows - Financing Activities Proceeds from convertible promissory notes 3,026 16,227 Proceeds from asset-backed secured promissory notes payable 2,994 - Proceeds from senior secured promissory note - 2,940 (Payments)/Proceeds from factoring (639 ) 695 Proceeds from warrant exercises - 100 Proceeds from short term borrowings - 640 Repayments of debt principal - (2,981 ) Principal payments on finance leases (170 ) (237 ) Net Cash Flows Provided by Financing Activities 5,211 17,384 Effect of Exchange Rates on Cash (50 ) (13 ) Net Change in Cash During Period 644 534 Cash at Beginning of Period 1,153 619 Cash at End of Period $ 1,797 $ 1,153 Supplemental Information: Cash paid for interest $ 1,958 $ 3,712 Non-Cash Investing and Financing Activities: Warrants issued in conjunction with senior secured promissory note payable and convertible promissory notes payable $ 1,682 $ 4,177 Conversion of convertible notes payable and accrued interest to common stock 23,156 - Embedded conversion feature on convertible debt 835 2,760 Common shares issued for advisory shares 302 - Settlement of debt and warrants with stock - 1,361 Common shares issued in conjunction with senior secured debt - 3,720 Warrant issuance in conjunction with convertible notes - 1,708 Reclassification of warrant liabilities to equity due to cashless warrant exercise - 2,166 Working capital balances refinanced into convertible notes payable - 2,363 The accompanying notes to consolidated financial statements are an integral part of these statements.
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UltraMIST systems and consumables represented approximately 98% of 2024 revenues versus 90% of revenues in 2023. Our Products and Services: The Company currently markets directed energy products using both ultrasound and high energy acoustic shockwaves.
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F-6 Table of Contents SANUWAVE HEALTH, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS December 31, 2023 and 2022 1.
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UltraMIST The UltraMIST system delivers low frequency, non-thermal ultrasound to target tissues using a fluid mist to transmit energy in a non-contact and pain free fashion. This energy penetrates deep into wound beds to promote healing while reducing inflammation, killing bacteria and biofilms, and increasing the growth of blood vessels in the wound and peri-wound.
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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.
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This proprietary technology has been shown to speed healing and reduce reported pain, and it has been cleared by the FDA for wound healing and debridement for a variety of acute and chronic wounds including: • diabetic foot ulcers, • venous leg ulcers, • split thickness wounds/skin grafts, • deep tissue pressure injuries, • surgical wounds, and • many more wound types.
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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”) and with the instructions to for 10-K and Regulation S-X. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.
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The UltraMIST System is cleared for marketing in the U.S. by the FDA (K140782) and has CMS schedule one reimbursement under code 97610.
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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.
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The UltraMIST system treatment must be administered by a healthcare professional. 4 Table of Contents The UltraMIST system is highly portable and is used in hospitals, physician’s offices, wound centers, nursing homes, and skilled nursing facilities, and by mobile wound care providers serving patient homes. Treatment may be provided by a doctor, nurse, nurse practitioner, or physical therapist.
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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.
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Treating chronic wounds is a difficult and time-consuming process. Current modalities for wound management typically involve the use of ointments and liquid solutions, specialized bandages, topical skin substitutes, negative pressure, or hyperbaric oxygen. Despite this, many patients are left with chronic wounds resistant to healing.
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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.
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Sanuwave’s Energy First™ protocol is at the forefront of improving the standard of care for advanced and chronic wounds.
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These reclassifications had no effect on the previously reported operating results. 2.
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Our solutions help expedite the healing process at a cellular level, a better and simpler alternative that can lead to improved patient outcomes and enhanced quality of life. 5 Table of Contents As the UltraMIST device never touches the wound, the treatment is painless and patients report a significant reduction in pain post treatment.
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Going Concern Our recurring losses from operations, the events of default on the Company’s notes payable, 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 for a period of 12 months from the filing of the Form 10-K.
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Significant clinical research demonstrates reductions in healing time, patient pain, and other indicators of patient healing (for more clinical information, please visit our website: https://sanuwave.com/clinical). The UltraMIST system is in use with many top hospitals and wound care providers across the United States. Typical treatment time is 6 minutes (and ranges from 3 to 20 minutes).
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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.
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UltraMIST is sold using a simple “razor/razor blade” model. Customers purchase an UltraMIST system and then each treatment utilizes a sterile, single use applicator sold in cases of 12. UM consumables revenues constitute the majority of Sanuwave revenue amounting to approximately 61% of total revenues in 2024 and are expected to remain the largest revenue stream for the Company.
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We expect to devote substantial resources for the expansion and continued commercialization of our UltraMIST and PACE systems which will require additional capital resources.
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Over 1,000 UM systems were in the field as of December 31, 2024.
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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.
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PACE The PACE systems use acoustic pressure shockwaves generated by the Company’s Pulsed Acoustic Cellular Expression (PACE) technology to converge at precise selected targets to produce an extremely short duration compression burst and 6 Table of Contents are used in both wound and orthopedic applications under the brand names dermaPACE, Profile, and orthoPACE.
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Management’s plans are to obtain additional capital in 2024 primarily through the closure of the Merger Agreement, as described in Note 4. The Company could also obtain funding through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt.
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The PACE systems are marketed in the U.S., and the European Union (CE Mark). Market The wound care market exceeds $45 billion per year in the United States and is spread among a number of key categories: 1) Rice et al. Diabetes Care 2014;37:651-658. 2) Rice et al. J Med Econ. 2014;17-(5): 347-356. 3) National Pressure Ulcer Advisory Panel (NPUAP).
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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.
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The Centers for Medicare and Medicaid Services (the "CMS") have increasingly classified regenerative technology as medically necessary. With an aging population and high incidence of obesity, diabetes, cancers, and autoimmune disorders, the Company believes this market is likely to continue to expand.
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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.
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Strategy The Company plans to focus on building a direct sales force and distribution network to market the UltraMIST product in the United States and to assess potential expansion abroad.
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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.
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The Company sees two broad trends favoring UM adoption: 7 Table of Contents transition to evidence-based medicine in wound care and “care to the edge”, as care is being directed away from hospital settings in an effort to treat patients where they are to increase ease of care and to reduce risks of nosocomial infection.
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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-7 Table of Contents 3.
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Reimbursement is being restructured around efficacy and cost effectiveness as payors, physicians, and patients seek better outcomes for less money. The Company believes that both trends are favorable to Sanuwave.
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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.
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We aim to change the wound care space by bringing cost effective, easy to use technology to market, and putting it into the hands of providers who can easily adopt it as well as integrate it into their workflow and patient treatment plans.
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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.
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To generate broad adoption, a technology needs to be more than just effective, it needs to be both user and patient friendly. Traditionally, many patients have been resistant to seek wound care because treatments are long in duration, difficult, involve cumbersome medical devices that must be worn long term, and are frequently painful.
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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.
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The Company seeks to overcome such patient and provider objections in order to expand access to high quality, modern wound care and to get more patients seen and seen earlier. By lowering the bar of “willing to seek treatment”, Sanuwave seeks to engage with patients and wounds before they become severe.
Removed
Significant estimates include the recording of allowances for credit losses, the net realizable value of inventory, fair value of goodwill and intangible assets, the determination of the valuation allowances for deferred taxes, litigation contingencies, estimated fair value of stock-based compensation, and the estimated fair value of embedded financial instruments, including warrants and embedded conversion options.
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By providing an effective, pain free system with short treatment times that practitioners can learn to use via video conference and for which nationwide CMS reimbursement is already available, the Company seeks to appeal to the “three P’s.” • Patients want to get better sooner and to experience less pain. • Physicians want patients to get better but also need to be able to integrate care into their practice flow and economic models. • Payors want to see patients get better faster and to receive early treatment often outside of hospital settings as such treatments save money.
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Accounts receivable — Accounts receivable are stated at the amount management expects to collect from outstanding balances. The Company maintains an allowance for credit losses to provide for the estimated amount of receivables that will not be fully collected. The allowance is based on the assessment of the following factors: customer creditworthiness; historical payment experience; age of outstanding receivables.
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When the needs of Patients, Physicians, and Payors are aligned, markets are ready adopters of products and markets are ready for change. The Company seeks to move wound care from a more “transactional” mindset to a consultative one, helping practitioners work effective wound treatment into the practice flows and patients' lives. No one wants to live with chronic wounds.
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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.
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We do not believe they should have to. Sales, Marketing and Distribution The Company sells systems through a combination of direct sales representatives and independent distributors. The systems are used in hospitals, clinics, and alternate care facilities.
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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.
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Our primary sales are in the Unites States. 8 Table of Contents Manufacturing The Company has developed a network of suppliers, manufacturers, and contract service providers to provide sufficient quantities of our products.
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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.
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The Company is party to a manufacturing supply agreement with Nortech in Wayzata, MN and Biomerics in Salt Lake City UT, covering the generator and treatment wand components of our products. Our generators and treatment wands are manufactured in accordance with applicable quality standards and applicable industry and regulatory standards.
Removed
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, 2023, and 2022.
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In addition, the Company performs the final product testing for generators and treatment wands internally. The Company is party to a manufacturing supply agreement with Dynamic Group in Ramsey, MN, covering the applicator component of our products. Our applicators are manufactured in accordance with applicable quality standards and applicable industry and regulatory standards.
Removed
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.
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Dynamic Group produces the applicators and applicator kits for our products. Our facility in Eden Prairie, MN consists of 8,199 square feet and provides office, product development, quality control, and warehouse space. It is an FDA-registered facility and is International Organization for Standardization (ISO) 13485:2016 certified.
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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.
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Intellectual Property Our success depends in part on our ability to obtain and maintain proprietary protection for our products, technology, and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing upon our proprietary rights.
Removed
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.
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The Company seeks to protect our proprietary position by, among other methods, filing United States and selected foreign patent applications and United States and selected foreign trademark applications related to our proprietary technology, inventions, products, and improvements that are important to the development of our business.
Removed
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.
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Effective trademark, service mark, copyright, patent, and trade secret protection may not be available in every country in which our products are made available. The protection of our intellectual property may require the expenditure of significant financial and managerial resources. Patents The Company considers the protection afforded by patents important to our business.
Removed
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.
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The Company intends to seek and maintain patent protection in the United States and select foreign countries, where deemed appropriate for products that the Company develops. As of December 31, 2024, Sanuwave held more than 140 issued or pending patents worldwide that cover various aspects of the Company’s technology.
Removed
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.
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In general, our patents are effective, ranging from 6 months to 16 years.
Removed
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.
Added
There are no assurances that any patents will result from our patent applications, or that any patents that may be issued will protect our intellectual property, or that any issued patents or pending applications will not be successfully challenged, including as to ownership and/or validity, by third parties.
Removed
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.
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In addition, if the Company does not avoid infringement of the intellectual property rights of others, the Company may have to seek a license to sell our products, defend an infringement action or challenge the validity of intellectual property in court.
Removed
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.
Added
Any current or future challenges to our patent rights, or challenges by us to the patent rights of others, could be expensive and time consuming.
Removed
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.
Added
The Company believes that our owned and licensed patent rights provide a competitive advantage with respect to others that might seek to utilize certain of our apparatuses and methods incorporating low frequency and non-contact ultrasound and extracorporeal acoustic pressure shockwave technologies that the Company has patented.
Removed
F-8 Table of Contents 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.
Added
However, the Company does not hold patent rights that cover all of our products, product components, or methods that utilize our products. The Company also has not conducted a competitive analysis or valuation with respect to our issued and pending patent portfolio in relation to our current products and/or competitor products.

240 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

44 edited+27 added65 removed140 unchanged
Biggest changeIf we are unable to secure, on a timely basis, sufficient quantities of the materials we depend on to manufacture our products, if we encounter delays or contractual or other difficulties in our relationships with these suppliers, or if we cannot find replacement suppliers at an acceptable cost, the manufacturing of our products may be disrupted, which could increase our costs and have a material adverse effect on our business and results of operations. 21 Table of Contents We have entered into an agreement with companies owned by a current board member and stockholder that could delay or prevent an acquisition of our Company and could result in the dilution of our stockholders in the event of our change of control.
Biggest changeCertain of our suppliers must be approved by regulatory authorities, which could delay our efforts to establish additional or replacement suppliers for these materials. 18 Table of Contents If we are unable to secure, on a timely basis, sufficient quantities of the materials we depend on to manufacture our products, if we encounter delays or contractual or other difficulties in our relationships with these suppliers, or if we cannot find replacement suppliers at an acceptable cost, the manufacturing of our products may be disrupted, which could increase our costs and have a material adverse effect on our business and results of operations.
We anticipate that, as we expand our PACE business, we will in the future be a covered entity under HIPAA. There can be no assurance that our policies and procedures will be adequate or will prevent all incidents of non-compliance with such regulations.
We anticipate that, as we expand our business, we will in the future be a covered entity under HIPAA. There can be no assurance that our policies and procedures will be adequate or will prevent all incidents of non-compliance with such regulations.
Future legislation, regulation or reimbursement policies of third-party payers may adversely affect the demand for our products currently under development and limit our ability to sell our products on a profitable basis. In addition, third-party payers continually attempt to contain or reduce the costs of healthcare by challenging the prices charged for healthcare products and services.
Future legislation, regulation or reimbursement policies of third-party payors may adversely affect the demand for our products currently under development and limit our ability to sell our products on a profitable basis. In addition, third-party payors continually attempt to contain or reduce the costs of healthcare by challenging the prices charged for healthcare products and services.
The market price of our common stock is volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including the following: our ability to obtain additional financing and, if available, the terms and conditions of the financing; changes in our industry; additions or departures of key personnel; sales of our common stock; our ability to execute our business plan; operating results that fall below expectations; period-to-period fluctuations in our operating results; 29 Table of Contents new regulatory requirements and changes in the existing regulatory environment; and general economic conditions and other external factors.
The market price of our common stock is volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including the following: our ability to obtain additional financing and, if available, the terms and conditions of the financing; changes in our industry; additions or departures of key personnel; sales of our common stock; our ability to execute our business plan; operating results that fall below expectations; period-to-period fluctuations in our operating results; new regulatory requirements and changes in the existing regulatory environment; and general economic conditions and other external factors.
If we fail to obtain an adequate level of reimbursement for our approved products by third party payers, there may be no commercially viable markets for our approved products, or the markets may be much smaller than expected. The availability and levels of reimbursement by governmental and other third-party payers affect the market for our approved products.
If we fail to obtain an adequate level of reimbursement for our approved products by third party payors, there may be no commercially viable markets for our approved products, or the markets may be much smaller than expected. The availability and levels of reimbursement by governmental and other third-party payors affect the market for our approved products.
The loss of our key management would likely hinder our ability to execute our business plan. As a small company with less than 40 employees, our success depends on the continuing contributions of our management team and qualified personnel.
The loss of our key management would likely hinder our ability to execute our business plan. As a small company with less than 50 employees, our success depends on the continuing contributions of our management team and qualified personnel.
If reimbursement for our approved products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, market acceptance of our approved products would be impaired and our future revenues, if any, would be adversely affected. 24 Table of Contents Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad.
If reimbursement for our approved products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, market acceptance of our approved products would be impaired and our future revenues, if any, would be adversely affected. Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad.
In addition, due to the material weaknesses in internal control over financial reporting, we have also determined that our disclosure controls and procedures were ineffective as of December 31, 2023.
In addition, due to the material weaknesses in internal control over financial reporting, we have also determined that our disclosure controls and procedures were ineffective as of December 31, 2024.
After regulatory approval has been obtained for medical device products, the product and the manufacturer are subject to continual review, including the review of adverse experiences and clinical results that are reported after our products are made available to patients, and there can be no assurance that such approval will not be withdrawn or restricted.
After regulatory approval has been obtained for medical device products, the product and the manufacturer are subject to continual review, including the review of adverse experiences and clinical results that are reported after our products are 21 Table of Contents made available to patients, and there can be no assurance that such approval will not be withdrawn or restricted.
If we cannot maintain the confidentiality of our technologies and other confidential information in connection with our collaborations, our ability to protect our proprietary information or obtain patent protection in the future may be impaired, which could have a material adverse effect on our business.
If we cannot maintain the confidentiality of our technologies and other confidential information in 25 Table of Contents connection with our collaborations, our ability to protect our proprietary information or obtain patent protection in the future may be impaired, which could have a material adverse effect on our business.
Ultimately, we may be unable to commercialize our products or may have to cease some of our business operations because of patent infringement claims, which could materially harm our business. We cannot guarantee that our products or technologies will not conflict with the intellectual property rights of others.
Ultimately, we may be unable to commercialize our products or may have to cease some of our business operations because of patent infringement claims, which could 27 Table of Contents materially harm our business. We cannot guarantee that our products or technologies will not conflict with the intellectual property rights of others.
These material weaknesses are as follows: Expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with select vendors. A lack of internal resources to analyze and properly apply U.S.
These material weaknesses are as follows: The Company lacked expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with select vendors. A lack of internal resources to analyze and properly apply U.S.
Our inability to enforce our patents against infringers and competitors may impair our ability to be competitive and could have a material adverse effect on our business. Issued patents and patent licenses may not provide us with any competitive advantage or provide meaningful protection against competitors.
Our inability to enforce our patents against infringers and competitors may impair our ability to be competitive and could have a material adverse effect on our business. 26 Table of Contents Issued patents and patent licenses may not provide us with any competitive advantage or provide meaningful protection against competitors.
We also are subject to audits under various government programs in which third-party firms engaged by the Centers for Medicare & Medicaid Services conduct extensive reviews of claims data and medical and other records to identify potential improper payments under the Medicare program. Private pay sources also reserve the right to conduct audits.
We also are subject to audits under various government programs in which third-party firms engaged by the CMS conduct extensive reviews of claims data and medical and other records to identify potential improper payments under the Medicare program. Private pay sources also reserve the right to conduct audits.
Many states have similar breach notification laws. In the event of a breach, to the extent such regulations are applicable to our business, we could incur operational and financial costs related to remediation as well as preparation and delivery of the notices, which costs could be substantial.
In the event of a breach, to the extent such regulations are applicable to our business, we could incur operational and financial costs related to remediation as well as preparation and delivery of the notices, which costs could be substantial.
We expect to devote substantial resources for the commercialization of UltraMIST and PACE which will require additional capital resources. We incurred a net loss of $25.8 million and $10.3 million for the years ended December 31, 2023, and 2022, respectively.
We expect to devote substantial resources for the commercialization of UltraMIST which will require additional capital resources. We incurred a net loss of $31.4 million and $ 25.8 million for the years ended December 31, 2024 , and 2023 , respectively.
Any such required financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing could have a material adverse effect on our business, financial condition, and results of operations, or threaten our ability to continue as a going concern. 20 Table of Contents A variety of factors could impact our need to raise additional capital, the timing of any required financing and the amount of such financings.
Any such required financing may not be available in amounts or on terms acceptable to us, and the failure 17 Table of Contents to procure such required financing could have a material adverse effect on our business, financial condition, and results of operations, or threaten our ability to continue as a going concern.
Other parties may seek and/or be able to duplicate, design around or independently develop products having effects similar or identical to our patented products that are not within the scope of our patents.
In addition, issued patents may not provide commercially meaningful protection against competitors. Other parties may seek and/or be able to duplicate, design around or independently develop products having effects similar or identical to our patented products that are not within the scope of our patents.
We could experience an adverse impact on our operating results due to such changes, including increased pricing pressure in these markets. Governments, hospitals, and other third-party payors also could reduce the amount of approved reimbursement for our products or deny coverage altogether. Reductions in reimbursement levels or coverage or other cost-containment measures could adversely affect our future operating results.
We could experience an adverse impact on our operating results due to such changes, including increased pricing 22 Table of Contents pressure in these markets. Governments, hospitals, and other third-party payers also could reduce the amount of approved reimbursement for our products or deny coverage altogether.
Such an action could hurt our financial condition. We have not paid dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock. We have never paid cash dividends on our common stock and do not anticipate doing so in the foreseeable future.
Any return on investment may be limited to the value of our common stock. We have never paid cash dividends on our common stock and do not anticipate doing so in the foreseeable future.
If another party controls patents or patent applications covering our product candidates, we may not be able to obtain the rights we need to those patents or patent applications in order to commercialize our product candidates or we may be required to pay royalties, which could be substantial, to obtain licenses to use those patents or patent applications. 28 Table of Contents In addition, issued patents may not provide commercially meaningful protection against competitors.
If another party controls patents or patent applications covering our product candidates, we may not be able to obtain the rights we need to those patents or patent applications in order to commercialize our product candidates or we may be required to pay royalties, which could be substantial, to obtain licenses to use those patents or patent applications.
The Health Information Technology for Economic and Clinical Health (“HITECH") Act and its implementing regulations also require healthcare providers to notify affected individuals, the Secretary of the U.S. Department of Health and Human Services, and in some cases, the media, when PHI has been breached as defined under and following the requirements of HIPAA.
The HITECH Act and its implementing regulations also require healthcare providers to notify affected individuals, the Secretary of the U.S. Department of Health and Human Services, and in some cases, the media, when PHI has been breached as defined under and following the requirements of HIPAA. Many states have similar breach notification laws.
These financings could result in substantial dilution to the holders of our common stock or require contractual or other restrictions on our operations or on alternative business opportunities that may be available to us.
These financings could result in substantial dilution to the holders of our common stock or require contractual or other restrictions on our operations or on alternative business opportunities that may be available to us. If we can raise additional funds by issuing debt securities, these debt securities could impose significant additional restrictions on our operations.
Failure to comply with applicable requirements could result in, among other things, any of the following actions: warning letters fines and other monetary penalties unanticipated expenditures product recall or seizure interruption of manufacturing operating restrictions injunctions, and criminal prosecutions. 23 Table of Contents In addition to the approval and clearance requirements, numerous other regulatory requirements apply to us and our products, our suppliers and contract manufacturers.
Failure to comply with applicable requirements could result in, among other things, any of the following actions: warning letters, fines and other monetary penalties, unanticipated expenditures, product recall or seizure, interruption of manufacturing, operating restrictions, injunctions, and criminal prosecutions.
The cost of compliance with these laws and regulations could be significant. 26 Table of Contents Risks Related to Intellectual Property The protection of our intellectual property is critical to our success, and any failure on our part to adequately protect those rights could materially adversely affect our business.
Risks Related to Intellectual Property The protection of our intellectual property is critical to our success, and any failure on our part to adequately protect those rights could materially adversely affect our business.
The availability of infringing products in markets where we have patent protection, or the availability of competing products in markets where we do not have adequate patent protection, could erode the market for our products, negatively impact the prices we can charge for our products, and harm our reputation if infringing or competing products are manufactured to inferior standards. 27 Table of Contents Patent applications owned by us or licensed to us may not result in issued patents, and our competitors may commercialize the discoveries we attempt to patent.
The availability of infringing products in markets where we have patent protection, or the availability of competing products in markets where we do not have adequate patent protection, could erode the market for our products, negatively impact the prices we can charge for our products, and harm our reputation if infringing or competing products are manufactured to inferior standards.
On an annual basis, less than five percent of our revenue comes from international sources. While we have no current plan to materially expand our international operations, there can be no assurance we will not pursue such an expansion in the future.
While we have no current plan to materially expand our international operations, there can be no assurance we will not pursue such an expansion in the future.
We are taking certain measures to remediate these material weaknesses described above as described in Part II, Item 9A of this Annual Report on Form 10-K; however, such material weaknesses had not been remediated as of December 31, 2023.
As such, we believe that accounting and IT processes and procedures need to be tested for operating effectiveness. We are taking certain measures to remediate these material weaknesses described above as discussed further in Part II, Item 9A of this Annual Report on Form 10-K; however, such material weaknesses had not been remediated as of December 31, 2024.
In addition, if our arrangements were found to violate the Federal Anti-Kickback Statute, False Claims Act or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition. 25 Table of Contents Failure to comply with the HIPAA Privacy, Security and Breach Notification Regulations, as such rules become applicable to our business, may increase our operational costs.
In addition, if our arrangements were found to violate the Federal Anti-Kickback Statute, False Claims Act or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition.
Some of the following provisions in our Articles of Incorporation or Bylaws that may decrease our attractiveness to be acquired are: advance notice of business to be brought is required for a meeting of our stockholders; no cumulative voting rights for the holders of common stock in the election of directors; and vacancies in the board of directors may be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum.
Some of the following provisions in our Articles of Incorporation or Bylaws that may decrease our attractiveness to be acquired are: advance notice of business to be brought is required for a meeting of our stockholders; the affirmative vote of the holders of at least sixty-six and two-thirds percent of the Company’s outstanding voting power is required for stockholders to amend our Bylaws; stockholders are prohibited from requesting or calling a special meeting of stockholders; no cumulative voting rights for the holders of common stock in the election of directors; and 20 Table of Contents vacancies in the board of directors may be filled by a majority vote of the directors then in office or by a sole remaining director, in either case though less than a quorum.
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 Form 10-K.
The operating losses and the current portion of our Senior Secured Debt 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 2025.
If we fail to comply with applicable regulations or if post market safety issues arise, we could be subject to enforcement sanctions, our promotional practices may be restricted, and our marketed products could be subject to recall or otherwise impacted. Each of these potential actions could result in a material adverse effect on our business, operating results and financial condition.
If we fail to comply with applicable regulations or if post market safety issues arise, we could be subject to enforcement sanctions, our promotional practices may be restricted, and our marketed products could be subject to recall or otherwise impacted.
Our suppliers may encounter problems during manufacturing due to a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction and environmental factors. In addition, some of our suppliers have been and will continue to be affected by supply chain problems resulting from the pandemic.
Our suppliers may encounter problems during manufacturing due to a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction and environmental factors.
We may conduct experiments in which we may use small quantities of chemicals, including those that are corrosive, toxic, and flammable. The risk of accidental injury or contamination from these materials cannot be eliminated. We do not maintain a separate insurance policy for these types of risks.
Our research and development process may, at times, involve the controlled use of hazardous materials and chemicals. We may conduct experiments in which we may use small quantities of chemicals, including those that are corrosive, toxic, and flammable. The risk of accidental injury or contamination from these materials cannot be eliminated.
Any such interruption or breach of our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business, and reputational harm to us. 22 Table of Contents We generate a portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results.
Any such interruption or breach of our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business, and reputational harm to us.
In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of companies. These market fluctuations may also materially and adversely affect the market price of our common stock. There is currently a limited trading market for our common stock, and we cannot predict how liquid the market might become.
In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of companies. These market fluctuations may also materially and adversely affect the market price of our common stock. We have not paid dividends in the past and do not expect to pay dividends in the future.
Additionally, amendments to HIPAA provide that the state attorneys general may bring an action against a covered entity for a violation of HIPAA. As we expand our business such that Federal laws regarding PHI and privacy apply to our operations, any noncompliance with such regulations could have a material adverse effect on our business, results of operations and financial condition.
As we expand our business such that Federal laws regarding PHI and privacy apply to our operations, any 23 Table of Contents noncompliance with such regulations could have a material adverse effect on our business, results of operations and financial condition.
The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty. The Company’s 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 the Company be unable to continue as a going concern.
The Company’s 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 the Company be unable to continue as a going concern. 16 Table of Contents We have identified material weaknesses in our internal control over financial reporting.
We have not submitted to our stockholders a say-on-pay vote to approve an advisory resolution regarding our compensation program for our named executive officers, or a say-on-frequency vote.
We have not submitted to our stockholders a say-on-pay vote to approve an advisory resolution regarding our compensation program for our named executive officers, or a say-on-frequency vote. Consequently, the board of directors has not considered the 28 Table of Contents outcome of our say-on-pay vote results when determining future compensation policies and pay levels for our named executive officers.
These possibilities, to the extent available, may be on terms that result in significant dilution to the Company’s existing stockholders. In addition, there can be no assurances that the Company’s plans to obtain additional capital will be successful on the terms or timeline it expects, or at all.
In addition, there can be no assurances that the Company’s plans to obtain additional capital will be successful on the terms or timeline it expects, or at all. If these efforts are unsuccessful, the Company may be required to significantly curtail or discontinue operations or, if available, obtain funds through financing transactions with unfavorable terms.
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 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.
In the event of an accident or environmental discharge or contamination, we may be held liable for any resulting damages, and any liability could exceed our resources. We are subject to Federal, state, and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.
We are subject to Federal, state, and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations could be significant.
The use of hazardous materials in our operations may subject us to environmental claims or liability. We conduct research and development and manufacturing operations in our facility. Our research and development process may, at times, involve the controlled use of hazardous materials and chemicals.
Each of these potential actions could result in a material adverse effect on our business, operating results and financial condition. 24 Table of Contents The use of hazardous materials in our operations may subject us to environmental claims or liability. We conduct research and development and manufacturing operations in our facility.
Management’s plans are to obtain additional capital in early 2024, primarily through closing the Merger Agreement. The Company could also obtain additional capital through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt.
The Company could obtain additional capital through the 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 the Company’s existing stockholders.
Removed
Risks Related to the Business Combination The Business Combination is subject to conditions, including certain conditions that may not be satisfied on a timely basis, if at all. Unless waived by the parties to the Merger Agreement, and subject to applicable law, the consummation of the Business Combination is subject to several conditions set forth in the Merger Agreement.
Added
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.
Removed
For more information about conditions for the consummation of the Business Combination, see Part II Item 5 – Management’s Discussion and Analysis of Financial Condition and Results of Operations. 15 Table of Contents The Merger Agreement includes a Minimum Cash Condition as a condition to the consummation of the Merger, which may make it more difficult for SEP Acquisition Corp.(“SEPA”) and the Company to complete the Business Combination as contemplated.
Added
GAAP to account for financial instruments included in service agreements with select vendors. • Failure to implement controls around the following accounting processes: Equity, Financial Reporting, Accounts Payable, Expenses, Revenue, Accounts Receivable, Tax, Cash, Debt, Fixed Assets, Inventory, Commissions, Entity-Level, Human Resources/Payroll, and IT processes: change management, operations, and access security.
Removed
The Merger Agreement provides that the Company’s obligation to consummate the Business Combination is conditioned on, among other things, that as of the Closing, SEPA has at least $12,000,000 (“Minimum Cash Condition Amount”) resulting from (i) proceeds that have not been redeemed in the Redemption and (ii) proceeds of the private placement in SEPA (the “PIPE Investment").
Added
A variety of factors could impact our need to raise additional capital, the timing of any required financing and the amount of such financings.
Removed
Because SEPA Stockholders elected to redeem 495,067 shares of Class A Common Stock, in connection with the Business Combination, then SEPA will need to obtain PIPE Investment in order to satisfy the Minimum Cash Condition.
Added
If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be able to generate anticipated revenue. Building the requisite sales, marketing and distribution capabilities to successfully market and sell our products continues to be expensive and time-consuming and requires significant attention from our leadership team to manage.
Removed
As of the date of this filing, no commitments have been given for the proposed financing from the PIPE Investment, and there is no assurance that SEPA will enter into subscriptions for the PIPE Investment. The actual amount that SEPA raises in the PIPE Investment, if any, will depend on market conditions and other factors.
Added
Any failure or delay in the expansion of our sales, marketing or distribution capabilities would adversely impact the commercialization of our products. Additionally, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties on the commercialization of our products.
Removed
This condition is for the sole benefit of the Company. If such condition is not met, and such condition is not or cannot be waived under the terms of the Merger Agreement, then the Merger Agreement could terminate, and the proposed Business Combination may not be consummated.
Added
If we are unable to enter into arrangements with such third parties on acceptable terms or at all, we may not be able to successfully commercialize our products. 19 Table of Contents If we fail to properly manage our growth effectively, our business could suffer.
Removed
If such condition is waived and the Business Combination is consummated with less than the Minimum Cash Condition Amount in the Trust Account, the cash held by the Combined Company (including the Company) in the aggregate, after the Closing may not be sufficient to allow the Combined Company to operate and pay Combined Company bills as they become due.
Added
We intend to continue to grow and may experience periods of rapid growth and expansion, which could place a significant additional strain on our limited personnel, information technology systems and other resources including but not limited to procuring sufficient office, warehouse, and production space to successfully operate our business and the inherent difficulties arising from acquiring, managing, or moving between such operating spaces.
Removed
Any such event in the future may negatively impact the analysis regarding the Combined Company’s ability to continue as a going concern at such time.
Added
In particular, the hiring of our direct sales force requires significant management, financial and other supporting resources. Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals. To achieve our revenue goals, we must continue to successfully increase manufacturing output to meet expected customer demand.
Removed
There can be no assurance that the shares of the Combined Company’s Class A Common Stock that will be issued in connection with the Business Combination will be approved for listing on Nasdaq, or another U.S national exchange, following the Closing, or that the Combined Company will be able to comply with the continued listing rules of Nasdaq, or another U.S. national exchange.
Added
We may experience difficulties with manufacturing yields, quality control, component supply and shortages of qualified personnel, such as skilled operators who can assemble our product, among other problems. Any of these problems could result in delays in product availability and increases in expenses. Any such delay or increased expense could adversely affect our ability to generate revenue.
Removed
In connection with the Business Combination and as a condition to the Company’s obligations to complete the Business Combination, the Combined Company will be required to demonstrate compliance with Nasdaq’s initial listing requirements.
Added
Future growth will continue to impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure.
Removed
The Company and SEPA cannot assure you that the Combined Company will be able to meet those initial listing requirements or qualify to list on another national securities exchange. Even if the Combined Company’s Class A Common Stock is approved for listing on Nasdaq, the Combined Company may not meet the Nasdaq continued listing requirements following the Business Combination.
Added
In order to manage our operations and growth, we will need to continue to improve our operational and management controls, reporting and information technology systems and financial internal control procedures.
Removed
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because SEPA’s Units, Class A Common Stock, and warrants are listed on Nasdaq, SEPA’s Units, Class A Common Stock and warrants qualify as covered securities under the statute.
Added
If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and may have an adverse effect on our business, financial condition, and results of operations.
Removed
Although the states are preempted from regulating the sale of SEPA’s securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case.
Added
We generate a portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results. On an annual basis, less than one percent of our revenue comes from international sources.
Removed
Certain state securities regulators view blank check companies unfavorably and might use these powers, or threaten to use these powers, to hinder the sale of securities of blank check companies in their states.
Added
In addition to the approval and clearance requirements, numerous other regulatory requirements apply to us and our products, our suppliers and contract manufacturers.
Removed
Further, if SEPA was no longer listed on Nasdaq, SEPA’s securities would not qualify as covered securities under the statute and SEPA would be subject to regulation in each state in which SEPA offers its securities.
Added
Reductions in reimbursement levels or coverage or other cost-containment measures could adversely affect our future operating results.
Removed
The announcement of the proposed Business Combination could disrupt the Company’s relationships with its customers, suppliers, business partners and others, as well as its operating results and business generally.
Added
Failure to comply with the HIPAA and state-specific privacy laws, as such rules become applicable to our business, may increase our operational costs.
Removed
Whether or not the Business Combination and related transactions are ultimately consummated, as a result of uncertainty related to the proposed transactions, risks relating to the impact of the announcement of the Business Combination on the Company’s business include the following: • its employees may experience uncertainty about their future roles, which might adversely affect the Combined Company’s ability to retain and hire key personnel and other employees; • customers, suppliers, business partners and other parties with which we maintain business relationships may experience uncertainty about its future and seek alternative relationships with third parties, seek to alter their business relationships with us or fail to extend an existing relationship with the Company; and • The Company has expended and will continue to expend significant costs, fees and expenses for professional services and transaction costs in connection with the proposed Business Combination.
Added
Additionally, amendments to HIPAA provide that the state attorneys general may bring an action against a covered entity for a violation of HIPAA.
Removed
If any of the aforementioned risks were to materialize, they could lead to significant costs which may impact the Company and, in the future, the Combined Company’s results of operations and cash available to fund its business. 16 Table of Contents We will be subject to contractual restrictions while the Business Combination is pending.
Added
In addition to our obligations under HIPAA, many states have laws that govern the processing, collection, use, disclosure, transfer, storage, disposal and protection of health-related and other sensitive and personal information.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

4 edited+1 added0 removed4 unchanged
Biggest changeGovernance of Cybersecurity Risks The Audit Committee of the Board has the primary responsibility for oversight and review of guidelines and policies with respect to risk assessment and risk management, including cybersecurity. The Company’s Chief Executive Officer, President, and Chief Financial Officer are responsible for assessing and managing cybersecurity risks.
Biggest changeThe Company’s Chief Executive Officer, President, and Chief Financial Officer are responsible for assessing and managing cybersecurity risks. The Company’s management periodically reports on cybersecurity issues and presents information to our Audit Committee as well as our full Board, as appropriate, on cybersecurity matters.
Security awareness and training We provide ongoing security awareness and training to educate internal users on how to identify and report potential issues. Phishing emails are discussed on a regular basis with employees to ensure proper protocols are followed. We also provide periodic updates to employees on emerging cybersecurity trends and ways to protect themselves and our company.
Security awareness and training We provide ongoing security awareness and training to educate internal users on how to identify and report potential issues. Phishing emails are discussed on a regular basis with employees to ensure proper protocols are followed. We also provide periodic updates to employees on emerging cybersecurity trends and ways to protect themselves and the Company.
For additional discussion of the risks posed by cybersecurity threats, see “Item 1A. Risk Factors— Risks to our Business— We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.” 31 Table of Contents
For additional discussion of the risks posed by cybersecurity threats, see “Item 1A. Risk Factors— Risks to our Business— We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.”
The Company’s management periodically reports on cybersecurity issues and presents information to our Audit Committee as well as our full Board, as appropriate, on cybersecurity matters. Upon verifying that a cybersecurity incident has occurred or is occurring, the Chief Executive Officer, President and Chief Financial Officer will promptly conduct a preliminary assessment of the severity level of the cybersecurity incident.
Upon verifying that a cybersecurity incident has occurred or is occurring, the Chief Executive Officer, President and Chief Financial Officer will promptly conduct a preliminary assessment of the severity level of the cybersecurity incident.
Added
Governance of Cybersecurity Risks The Audit Committee of the Board has the primary responsibility for oversight, review and discussion with management of the Company’s information technology, data security, business continuity, artificial intelligence and cybersecurity-related risk exposures and threats; the potential impact of those risk exposures and threats on the Company’s business, operations and reputation; and the processes management has established to assess, manage, monitor and mitigate such risk exposures and threats.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added0 removed1 unchanged
Biggest changeWe also have a research and development office in a leased facility in Alpharetta, Georgia, consisting of 4,332 square feet of space under a lease that expires in July 2027.
Biggest changeWe also have a research and development office in a leased facility in Alpharetta, Georgia, consisting of 4,332 square feet of space under a lease that expires in July 2027. 29 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added2 removed2 unchanged
Biggest changeThere are no material proceedings known to us, pending, or contemplated, in which any of our directors, officers or affiliates or any of our principal security holders, or any associate of any of the foregoing, is a party or has an interest adverse to us.
Biggest changeThere are no material proceedings known to us, pending, or contemplated, in which any of our directors, officers or affiliates or any of our principal security holders, or any associate of any of the foregoing, is a party or has an interest adverse to us. Item 4. MINE SAFETY DISCLOSURE Not applicable. PART II
Removed
Acquisition Dispute - In May 2021, the Company received notification alleging that it is not in compliance with the license agreement with Celularity entered into 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.
Removed
Any potential impact to the Company cannot be fully determined at this time. Item 4. MINE SAFETY DISCLOSURE Not applicable. PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+2 added1 removed0 unchanged
Biggest changeThe Company does not anticipate paying any cash dividends in the foreseeable future. Item 6. [Reserved] Not applicable.
Biggest changeDividends The Company did not pay a cash dividend in 2024 or 2023. The Company intends to retain future earnings, if any, to finance the expansion of its business. The Company does not anticipate paying any cash dividends in the foreseeable future. Item 6. [Reserved] Not applicable.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The Company’s common stock is quoted on the OTCQB under the symbol “SNWV”. The quotations reflect inter-dealer prices, without retail mark-up, mark-down, or commissions, and may not necessarily represent actual transactions.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The Company’s common stock is quoted on the Nasdaq Global Market under the symbol “SNWV”.
Removed
Holders of Common Stock As of December 31, 2023, there were 1,140,559,527 shares of common stock outstanding and approximately 238 holders of record of the Company’s common stock. Dividends The Company did not pay a cash dividend in 2023 or 2022. The Company intends to retain future earnings, if any, to finance the expansion of its business.
Added
Holders of Common Stock As of March 18, 2025, there were 8,548,473 shares of common stock outstanding and approximately 204 holders of record of the Company’s common stock. Unregistered Sales of Equity Securities On October 18, 2024, the Company issued 14,359 restricted stock units (“RSUs”) to FNK IR LLC as compensation for investor relations services.
Added
These RSUs vested in substantially equal installments on each of October 18, 2024, October 31, 2024, November 30, 2024, December 31, 2024, January 31, 2025 and February 28, 2025. The Company relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions not involving a public offering.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

31 edited+14 added25 removed9 unchanged
Biggest change(in thousands) For the year ended 2023 2022 Net loss $ (25,807 ) $ (10,293 ) Non-GAAP Adjustments: Interest expense 15,623 14,132 Depreciation and amortization 1,028 952 EBITDA $ (9,156 ) $ 4,791 Non-GAAP Adjustments for Adjusted EBITDA: Change in fair value of derivative liabilities 9,621 (16,654 ) Other non-cash or non-recurring charges: Release of historical accrued expenses (1,866 ) - Shares issued for services 224 888 Loss on issuance of debt - 3,434 Loss on extinguishment of debt - 418 Adjusted EBITDA $ (1,177 ) $ (7,123 ) Results of Operations The following table sets forth our consolidated statement of operations: For the Years Ended December 31, Change (in thousands) 2023 2022 $ % Revenue 20,398 $ 16,742 $ 3,656 22 % Cost of revenue 6,035 4,331 1,704 39 % Gross margin 14,363 12,411 1,952 16 % Gross margin % 70 % 74 % Operating expenses: General and administrative 8,674 12,556 (3,882 ) -31 % Selling and marketing 4,898 7,474 (2,576 ) -34 % Research and development 579 567 12 2 % Depreciation and amortization 752 766 (14 ) -2 % Operating loss (540 ) (8,952 ) 8,412 -94 % Other expense, net (25,263 ) (1,339 ) (23,924 ) nm Income tax expense 4 2 2 100 % Net loss $ (25,807 ) $ (10,293 ) $ (15,514 ) 151 % Revenue Revenues for the year ended December 31, 2023, were $20.4 million, compared to $16.7 million for the same period in 2022, an increase of $3.7 million or 22%.
Biggest changeFor the year ended (in thousands) 2024 2023 Net (Loss) Income $ (31,372) $ (25,807) Non-GAAP Adjustments: Interest expense 13,637 15,623 Depreciation and amortization 1,145 1,028 EBITDA $ (16,590) $ (9,156) Non-GAAP Adjustments for Adjusted EBITDA: Change in fair value of derivative liabilities 31,413 9,621 Other non-cash or infrequent charges: Gain on extinguishment of debt (6,326) - Severance agreement and legal settlement 741 - Release of historical accrued expenses (1,547) (1,866) Stock-based compensation 1,514 - Shares issued for services - 224 License and option agreement (2,500) - Prepaid legal fees expensed from termination of Merger Agreement 457 - Adjusted EBITDA $ 7,162 $ (1,177) Results of Operations The following table sets forth our consolidated statement of operations: For the Years Ended December 31, Change (in thousands) 2024 2023 $ % Revenue $ 32,634 $ 20,398 $ 12,236 60 % Cost of revenue 8,084 6,035 2,049 34 % Gross margin 24,550 14,363 10,187 71 % Gross margin % 75 % 70 % Operating expenses: General and administrative 11,348 8,674 2,674 31 % Selling and marketing 6,323 4,898 1,425 29 % Research and development 673 579 94 16 % Depreciation and amortization 789 752 37 5 % Operating income (loss) 5,417 (540) 5,957 1103 % Other expense, net (36,762) (25,263) (11,499) 46% Income tax expense 27 4 23 575 % Net loss $ (31,372) $ (25,807) $ (5,565) 22 % Revenue Revenues for the year ended December 31, 2024 were $32.6 million , compared to $20.4 million for 2023 , an increase of $12.2 million or 60% .
GAAP). These financial measures are considered “non-GAAP financial measures” and are intended to supplement, and should not be considered as superior to, or a replacement for, financial measures presented in accordance with U.S. GAAP. The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance.
GAAP”). These financial measures are considered “non-GAAP financial measures” and are intended to supplement, and should not be considered as superior to, or a replacement for, financial measures presented in accordance with U.S. GAAP. The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance.
The discussion focuses on our financial results of operations for the years ended December 31, 2023, and 2022. You should read this discussion and analysis in conjunction with our consolidated financial statements and related notes thereto on December 31, 2023, and 2022, and for years 2023, and 2022, which are presented within Part II Item 8.
The discussion focuses on our financial results of operations for the years ended December 31, 2024 and 2023 . You should read this discussion and analysis in conjunction with our consolidated financial statements and related notes thereto for the years ended December 31, 2024 , and 2023 , which are presented within Part II, Item 8.
The following table presents summarized cash flow information: For the period ended December 31, (in thousands) 2023 2022 Cash flows used by operating activities $ (4,538 ) $ (17,169 ) Cash flows provided by investing activities $ 21 $ 332 Cash flows provided by financing activities $ 5,211 $ 17,384 Cash Flows from Operating Activities We have improved our cash flow from operations in 2023 as compared to 2022, which was driven by increased emphasis on improved cash management and operating expense management.
The following table presents summarized cash flow information: For the period ended December 31, (in thousands) 2024 2023 Cash flows provided by (used in) operating activities $ 2,455 $ (4,538) Cash flows (used in) provided by investing activities $ (490) $ 21 Cash flows provided by financing activities $ 6,354 $ 5,211 Cash Flows from Operating Activities We have improved our cash flow from operations in 2024 as compared to 2023, which was driven by increased emphasis on improved cash management and operating expense management.
Our significant input assumptions are discussed in Note 13 to the consolidated financial statements in Part II Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. Recently Issued Accounting Standards Information regarding new accounting pronouncements is included in Note 3 to the consolidated financial statements in Part II Item 8.
Recently Issued Accounting Standards Information regarding new accounting pronouncements is included in Note 3 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. 35 Table of Contents
Net loss for the year ended December 31, 2023, was $25.8 million, or ($0.03) per basic and diluted share, compared to a net loss of $10.3 million, or ($0.02) per basic and diluted share, for the year ended December 31, 2022, a variance of $15.5 million, which was largely driven by a non-cash change in the fair value of derivatives.
Net loss for the year ended December 31, 2024 , was $31.4 million , or $7.03 per basic and diluted share, compared to a net loss of $25.8 million , or $12.19 per basic and diluted share, for the year ended December 31, 2023 , an increase of $5.6 million , which was largely driven by a non-cash change in the fair value of derivatives.
Non-GAAP Financial Measures Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we present certain financial measures that facilitate management’s review of the operational performance of the Company and as a basis for strategic planning; however, such financial measures are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S.) (U.S.
Recent Developments On March 7, 2025, our common stock began trading on The Nasdaq Global Market under the ticker symbol “SNWV.” Non-GAAP Financial Measures Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we present certain financial measures that facilitate management’s review of the operational performance of the Company and as a basis for strategic planning; however, such financial measures are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S.”) (“U.S.
Some of these limitations are that EBITDA and Adjusted EBITDA: 33 Table of Contents Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments. Do not reflect all changes in our working capital needs. Do not reflect interest expense, or the amount necessary to service our outstanding debt.
Some of these limitations are that EBITDA and Adjusted EBITDA: Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments. Do not reflect all changes in our working capital needs. Do not reflect interest expense, or the amount necessary to service our outstanding debt. 31 Table of Contents As presented in the GAAP to Non-GAAP Reconciliations section below, our non-GAAP financial measures exclude the impact of certain charges that contribute to our net loss.
GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available.
These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available.
Our significant legal proceedings are discussed in Note 21 to the consolidated financial statements in Part II Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.
The Company's volatility is the most significant assumption and changes over time with the market. Our significant input assumptions are discussed in Note 13 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.
Gross margins also decreased to 70% from 74% in 2022. As the Company continues to focus on profitable growth, we have also reduced our operating loss by 94% to $0.5 million for the year ended December 31, 2023.
As the Company continues to focus on profitable growth, we have also increased our operating income by 1103% to $5.4 million for the year ended December 31, 2024, compared to an operating loss of $0.5 million for the year ended December 31, 2023.
The increase was primarily driven by an increased loss from the change in the fair value of derivative liability of $26.3 million, offset by a decrease in loss on issuance of debt along with the loss on extinguishment of debt.
The increase was primarily driven by an increased loss from the change in the fair value of derivative liability of $21.8 million , partially offset by a gain on the extinguishment of debt of $6.3 million and other income of $2.5 million from a license and option agreement.
These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed. The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Company to make operational and strategic decisions.
The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Company to make operational and strategic decisions. The Company believes that providing this information to investors, in addition to U.S.
Other Income (Expense), net Other expense, net consists of the following: For the years ended December 31, Change 2023 2022 $ % Interest expense $ (15,623 ) $ (14,132 ) $ (1,491 ) 11 % Change in fair value of derivatives (9,621 ) 16,654 (26,275 ) nm Loss on issuance of debt - (3,434 ) 3,434 -100 % Gain/(loss) on extinguishment of debt - (418 ) 418 nm Other expense (19 ) (9 ) (10 ) nm Other expense, net $ (25,263 ) $ (1,339 ) $ (23,924 ) nm nm - not meaningful Other expenses totaled $25.2 million for the year ended December 31, 2023, as compared $1.3 million for the same period in 2022, an increase of $23.9 million.
Other Income (Expense), net Other expense, net consists of the following: For the years ended December 31, Change 2024 2023 $ % Interest expense $ (13,637) $ (15,623) $ 1,986 (13 %) Change in fair value of derivatives (31,413) (9,621) (21,792) nm Gain on extinguishment of debt 6,326 - 6,326 nm Other expense (893) (19) (874) nm Other income 2,855 - 2,855 nm Other expense, net $ (36,762) $ (25,263) $ (11,499) nm nm - not meaningful Other expenses totaled $36.8 million for the year ended December 31, 2024 , as compared $25.3 million for 2023 , an increase of $11.5 million .
We also invested in our inventory in 2023, increasing our inventory levels by $2 million for the year ended December 31, 2023. Additional volatility in adjustments of cash flows from operations is the change in fair value of derivative liabilities connected to our convertible debt and warrants issued with the August and November 2022, and May and December 2023 financings.
Additional volatility in adjustments of cash flows from operations is the change in fair value of derivative liabilities connected to our convertible debt and warrants issued. The Company recognized a loss on these liabilities of $31.4 million for the year ended December 31, 2024, as compared to a loss of $9.6 million for the year ended December 31, 2023.
These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other GAAP measures. EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of our results as reported under GAAP.
EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of our results as reported under U.S. GAAP.
Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or non-recurring one-time charges.
Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or non-recurring infrequent charges. EBITDA and Adjusted EBITDA should not be considered as alternatives to net loss as a measure of financial performance or any other performance measure derived in accordance with U.S.
The increase in net sales was primarily driven by the growth in quantity of disposables sold, which increased by 9% in 2023 as compared to 2022. Pricing of the UltraMIST ® system and disposables also showed growth in 2023 as compared to 2022, disposables average selling price increased over 10% in 2023, and system revenue increased 28% in 2023.
Pricing of the UltraMIST ® system and disposables also showed growth in 2024 as compared to 2023; disposables average selling price increased 21% in 2024 , and systems average selling price increased 10% in 2024 . Revenue from UltraMIST ® totaled over 98% of total revenue in 2024 and 90% in 2023 .
Liquidity and Capital Resources Since inception, we have incurred losses from operations each year. As of December 31, 2023, we had an accumulated deficit of $220.0 million. Historically, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.
As of December 31, 2024, we had an accumulated deficit of $251 million . Historically, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities. See Notes 1, 10, 11, 15, and 16, to the consolidated financial statements in Part II, Item 8.
Revenue from UltraMIST totaled 90% of total revenue in 2023 and 2022. 34 Table of Contents Cost of Revenue Cost of revenues for the year ended December 31, 2023, was $6.0 million, compared to $4.3 million for the same period in 2022.
Cost of Revenue Cost of revenues for the year ended December 31, 2024 was $8.1 million , compared to $6.0 million for 2023 . Gross profit as a percentage of revenues was 75% for the year ended December 31, 2024 , compared to 70% for the same period in 2023 .
Research and Development Research and development expenses for the year ended December 31, 2023, were $0.6 million, compared to $0.6 million for the same period in 2022. The research and development costs in 2023 remained consistent with the costs in 2022.
The year-over-year increase in sales and marketing expenses in 2024 was largely driven by increased commission expenses due to increased sales. Research and Development Research and development expenses for the year ended December 31, 2024 were $0.7 million , compared to $0.6 million for 2023 .
The Company believes that providing this information to investors, in addition to GAAP measures, allows them to see the Company’s results through the eyes of Management, and to better understand its historical and future financial performance.
GAAP measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance. These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other U.S. GAAP measures.
EBITDA and Adjusted EBITDA should not be considered as alternatives to net loss as a measure of financial performance or any other performance measure derived in accordance with GAAP, and they should not be construed as an inference that our future results will be unaffected by unusual or non-recurring items.
GAAP, and they should not be construed as an inference that our future results will be unaffected by unusual or infrequent items. These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed.
See Notes 10, 11 and 12 to the consolidated financial statements in Part II Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information regarding additional debt commitments, the convertible notes and accompanying warrants issued in May and December 2023, $4.5 million in asset-backed secured promissory notes, and the Senior Secured Note.
“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information regarding the Convertible Promissory Notes, Senior Secured Note, Reverse Stock Split, and the October 2024 transaction.
Amounts reported in thousands within this annual report are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in thousands due to rounding. 32 Table of Contents Executive Summary We realized significant revenue growth during the year ended December 31, 2023, with a 22% growth in revenue to $20.4 million for the year ended December 31, 2023, as compared to $16.7 million in 2022.
"Financial Statements and Supplementary Data" in this Annual Report on Form 10-K. Amounts reported in thousands within this annual report 30 Table of Contents are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in thousands due to rounding.
Our significant accounting policies are disclosed in Note 3 to the consolidated financial statements in Part II Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. The preparation of the consolidated financial statements, in conformity with U.S.
Changes in estimates used in these and other items could have a material impact on our consolidated financial statements. We have used various accounting policies to prepare the consolidated financial statements in accordance with U.S. GAAP. Our significant accounting policies are disclosed in Note 3 to the consolidated financial statements in Part II, Item 8.
General and Administrative General and administrative expenses for the year ended December 31, 2023, were $8.7 million as compared to $12.6 million for the same period in 2022, a decrease of $3.9 million, or 31%.
This increase in gross margin was largely driven by increased pricing on our UltraMIST systems and applicators. General and Administrative General and administrative expenses for the year ended December 31, 2024 were $11.3 million as compared to $8.7 million for 2023 , an increase of $2.7 million , or 31% .
Selling and Marketing Selling and marketing expenses for the year ended December 31, 2023, were $4.9 million as compared to $7.4 million for the same period in 2022, a decrease of $2.6 million, or 34%. The year-over-year decrease in sales and marketing expenses in 2023 was a result of cost saving initiatives taken by management.
The increase in 2024 as compared to 2023 was primarily due to increased headcount, severance and legal settlement expenses, and non-cash charges for stock-based compensation expense. Selling and Marketing Selling and marketing expenses for the year ended December 31, 2024 were $6.3 million as compared to $4.9 million for 2023 , an increase of $1.4 million , or 29% .
For the year ended December 31, 2023, we received proceeds of $6.0 million from the issuance of the convertible promissory notes and asset backed secured promissory notes discussed above in this section, Liquidity and Capital Resources, as compared to $16.2 million for the year ended December 31, 2022. 36 Table of Contents Going Concern The continuation of our business is dependent upon raising additional capital to fund operations.
For the year ended December 31, 2024, we received proceeds of $12.1 million from the issuance of the convertible promissory notes, sales of common stock, and proceeds from promissory note payable as compared to $6.0 million for the year ended December 31, 2023.
“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our ability to continue as a going concern. Critical Accounting Policies and Estimates We have used various accounting policies to prepare the consolidated financial statements in accordance with U.S. GAAP.
“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our ability to continue as a going concern. 34 Table of Contents Critical Accounting Estimates We consider an accounting estimate to be critical if: (1) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (2) changes in the estimate are reasonably likely to occur from period to period, or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations.
Although no assurances can be given that our plans to obtain additional capital will be successful or on the terms or timeline we expect, or at all, management believes that potential additional issuances of equity or other potential financing transactions, as discussed above, should provide the necessary funding for us over the next 12 months.
Although no assurances can be given that our plans to obtain refinancing will be successful or on the terms or timeline we expect, or at all, management believes that the actions taken to date, along with the planned initiatives, will enable the Company to meet its obligations as they become due and to continue as a going concern..
Removed
“Financial Statements and Supplementary Data" in this Annual Report on Form 10-K.
Added
Executive Summary We realized significant revenue growth during the year ended December 31, 2024 , with a 60% growth in revenue to $32.6 million for the year ended December 31, 2024 , as compared to $20.4 million in 2023 . Gross margins also increased to 75% from 70% in 2023 .
Removed
Operating loss for the year ended December 31, 2023, was $540 thousand, compared to $9.0 million for the year ended December 31, 2022. We continue to focus on profitable growth and reduction in operating expenses. We believe these improvements sets the stage for additional growth as we head into 2024.
Added
We believe these improvements set the stage for additional growth as we head into 2025.
Removed
Merger Agreement with SEPA On August 23, 2023, we entered into an Agreement and Plan of Merger (the “ Merger Agreement ”) by and among SEP Acquisition Corp., a Delaware corporation (“ SEPA ”), SEP Acquisition Holdings Inc., a Nevada corporation, and a wholly owned subsidiary of SEPA (“ Merger Sub ”).
Added
The increase in net sales was primarily driven by the growth in quantity of UltraMIST ® disposables 32 Table of Contents and systems sold. The quantity of UltraMIST ® disposables sold increased by 37% in 2024 as compared to 2023 . The quantity of UltraMIST ® systems sold increased by 77% in 2024 as compared to 2023.
Removed
Pursuant to the terms of the Merger Agreement, a business combination between the Company and SEPA (the “ Merger ”) will be affected.
Added
The research and development costs in 2024 remained approximately consistent with the costs in 2023 .
Removed
More specifically, and as described in greater detail below, at the effective time of the Merger (the “ Effective Time ”): • Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger. • Each issued and outstanding share of the Company common stock will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share, at the Conversion Ratio (as defined in the Merger Agreement); and • Outstanding Company convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.
Added
The change in fair value of the derivative liability mainly relates to warrants issued during 2024, 2023, and 2022 with the convertible debt. That convertible debt and associated warrants were converted to common stock in October 2024, as further discussed in Note 16 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data”.
Removed
Pursuant to the terms of the Merger Agreement, the holders of (i) Company common stock, (ii) in the money options to purchase Company common stock, (iii) in the money warrants to purchase Company common stock, and (iv) convertible promissory notes, collectively will be entitled to receive 7,793,000 shares of Class A Common Stock of SEPA.
Added
The gain on extinguishment of debt was mainly due to the settlement of outstanding notes to Celularity and HealthTronics, as further discussed in Note 10 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data”. 33 Table of Contents Liquidity and Capital Resources Since inception, we have incurred losses from operations each year.
Removed
Out-of-the-money options and out-of-the-money warrants will be assumed by SEPA and converted into options or warrants, respectively, exercisable for shares of Class A Common Stock based on the Conversion Ratio; however, such out-of-the-money options and out-of-the-money warrants shall not be reserved for issuance from the Merger Consideration.
Added
Cash Flows Provided by Financing Activities Cash flows provided by financing activities increased while also paying off outstanding debt.
Removed
As presented in the GAAP to Non-GAAP Reconciliations section below, our non-GAAP financial measure excludes the impact of certain charges that contribute to our net loss (Non-GAAP Adjustments).
Added
In 2024, we paid off outstanding debt owed to Celularity, HealthTronics, and our factoring line of credit for a total of $5.0 million.
Removed
Gross profit as a percentage of revenues was 70% for the year ended December 31, 2023, compared to 74% for the same period in 2022. This decrease in gross margin was largely driven by increased one time inventory write offs and costs to support our growth and alleviate our inventory constraint in 2023.
Added
Going Concern The Company has incurred recurring operating losses in prior years, has negative working capital, and the Senior Secured Note becomes due in September 2025, which raises substantial doubt about our ability to continue as a going concern for a period of 12 months from the filing of the Form 10-K.
Removed
The decrease in 2023 as compared to 2022 was primarily due to the higher legal costs related to patent work and securities work incurred in 2022.
Added
During the current fiscal year, the Company has achieved operating income, reflecting a significant improvement in its financial performance. The Company is addressing its financial obligations, including the significant portion of debt that is coming due in September 2025.
Removed
The increased interest expense of $1.5 million was the result of higher levels of debt outstanding during 2023, due to new issuances of convertible debt, compared with 2022. The change in fair value of the derivative liability relates to warrants issued during 2023 and 2022 with the convertible debt.
Added
Management is actively engaged in discussions with lenders and financial institutions to refinance this debt, which will extend the maturity of the debt and provide additional liquidity to support ongoing operations and strategic initiatives.
Removed
In August 2022,November 2022, May 2023 and December 2023, we 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 2022,$4.0 million in November 2022, $1.2 million in May 2023, and $1.9 million in December 2023 (ii) Common Stock Purchase Warrants to purchase an additional 581.6 million shares of common stock with an exercise price of $0.067 per share and (iii) Common Stock Purchase Warrants to purchase an additional 581.6million shares of common stock with an exercise price of $0.04 per share. 35 Table of Contents 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.
Added
Management has discussed the development and selection of these critical accounting estimates with the Audit Committee of our Board of Directors. In addition, there are other items within our consolidated financial statements that require estimation, but are not deemed critical as defined above.
Removed
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.
Added
“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. The preparation of the consolidated financial statements, in conformity with U.S. GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses.
Removed
The Notes contain customary events of default and covenants, including limitations on incurrences of indebtedness and liens. In August 2023 and November 2023, the Company utilized its election to convert the August and November issued 2022 Convertible Notes Payable into shares of common stock upon the Notes’ maturity.
Added
The Company has reserved approximately $150 thousand for unasserted claims. Our significant legal proceedings are discussed in Note 21 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. Derivative Liabilities from Warrants The Company determined that certain warrants qualified as derivative financial instruments.
Removed
The August notes totaling $16.2 million in principal and $2.4 million in interest were converted to 464,440,813 shares of common stock. The November notes totaling $4.0 million in principal and $0.6 million in interest were converted to 114,481,063 shares of common stock.
Removed
In July 2023, we issued Asset-Backed Secured Promissory Notes in an aggregate principal amount of $4.6 million to certain accredited investors at an original issue discount of 33.33%. These notes bear an interest rate of 0% per annum and matured on January 21, 2024. We received total proceeds of approximately $3.0 million.
Removed
We also entered into a side letter, pursuant to which, we issued Future Advance Convertible Promissory Notes, on January 21, 2024, with the same principal amount as the principal amount of such Notes, plus any accrued and unpaid interest and two Common Stock Purchase Warrants, substantially in the forms of the Notes and Common Stock Purchase Warrants disclosed in the previous paragraphs.
Removed
In August 2020, the Company issued a Senior Secured Promissory Note Payable (the “Senior Secured Note”) to NH Expansion Credit Fund Holdings L.P. pursuant to which the Company had outstanding debt of $21.5 million as of December 31, 2023. Interest is charged at the greater of the prime rate or 3% plus 9%, paid quarterly.
Removed
As of December 31, 2023, the Company is in default of the minimum liquidity provisions on the Senior Secured Note and, as a result, is accruing interest at the default interest rate of an incremental 5%. Interest expense on the Senior Secured Note totaled $6.9 million and $5.9 million for the years ended December 31, 2023, and 2022, respectively.
Removed
The Company recognized a loss on these liabilities of $9.6 million for the year ended December 31, 2023, as compared to a gain of $16.7 million for the year ended December 31, 2022.
Removed
Cash Flows Provided by Financing Activities Cash flows provided by financing activities decreased primarily due to the improvement of operating cash flows which reduced our required cash to fund our growth and operations.
Removed
This, as well as the events of default on various notes payable, raise substantial doubt about our ability to continue as a going concern for a period of at least twelve months. Management plans to obtain additional capital in 2024 through the completion of the Merger Agreement.
Removed
We could also obtain additional capital 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.
Removed
Derivative Liabilities from Embedded Conversion Options and Warrants The Company classified certain convertible instruments as having embedded conversion options which qualified as derivative financial instruments to be separately accounted for. The Company also determined that certain warrants also qualified as derivative financial instruments.
Removed
“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

Other SNWV 10-K year-over-year comparisons