Received FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stage
Strengthened balance sheet by extinguishing $32 million in debt
Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant
White Bear Lake, Minnesota--(Newsfile Corp. - March 23, 2026) - Envoy Medical® Inc. (NASDAQ:COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events.
Corporate and Financial Highlights for 2025:
- Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data
- Extinguished over $32 Million in Debt, Strengthening Balance Sheet
- Completed First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant
- Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial
Highlights Subsequent to 2025 Year End:
- Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaim® Cochlear Implant
- Strengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants)
- Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026
Brent Lucas, CEO of Envoy Medical, commented: "We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage.
"We were also, on the financial side, able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global patent portfolio as a leading fully implanted hearing technology company.
"The momentum from 2025 has set the stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational fully implanted Acclaim cochlear implant. We are now in a strengthened position as we continue to gather data and look forward to submitting our PMA application to the FDA.
"The future is bright for Envoy Medical as we aim to revolutionize hearing health by providing fully implanted solutions to address the unmet needs of millions of individuals worldwide. We hope you join us on this meaningful and exciting journey."
Financial Results for the Year Ended December 31, 2025 (dollars in thousands):
Net Revenue was $241 as of December 31, 2025 compared to $225 for year ended December 31, 2024. The increase of $16 was primarily driven by the sales of the Esteem® FI-AMEI implant and related replacement components.
Cost of goods sold increased $132 compared to the year ended December 31, 2024. The increase is primarily due to an increase in scrap and non-recurring expenses of $190, which was partially offset by lower fees for third-parties performing work related to our products of $77.
R&D expenses, which include expenses related to the Acclaim pivotal clinical trial, increased by $2,307 for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase mainly reflects additional clinical trial expense during enrollment.
Sales and marketing expenses of December 31, 2025 were $1,220 compared to $1,734 for the year ended December 31, 2024 a decrease of $514. The decrease is primarily due to a reduction of legal fees associated with reimbursement work for the Esteem FI-AMEI product.
General and administrative expenses increased $1,105 to $7,931 for the year ended December 31, 2025 compared to $6,826 for the year ended December 31, 2024. The increase was primarily due to severance costs associated with the former Chief Financial Officer and increased consulting expenses.
As of December 31, 2025, cash was approximately $3.7 million.
The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.
To be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ:COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.
Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: [email protected]
Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: [email protected]
ENVOY MEDICAL, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| December 31, | December 31, | |||||
| 2025 | 2024 | |||||
| Current assets: | ||||||
| Cash | $ | 3,739 | $ | 5,483 | ||
| Accounts receivable, net | 34 | 38 | ||||
| Other receivable | 19 | 780 | ||||
| Inventories | 1,546 | 1,708 | ||||
| Prepaid expenses and other current assets | 941 | 887 | ||||
| Total current assets | 6,279 | 8,896 | ||||
| Property and equipment, net | 1,035 | 1,275 | ||||
| Operating lease right-of-use asset (related party) | 886 | 879 | ||||
| Prepaid expenses and other assets | 358 | 488 | ||||
| Total assets | $ | 8,558 | $ | 11,538 | ||
| Liabilities, mezzanine equity, and stockholders' deficit | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 2,920 | $ | 1,652 | ||
| Accrued expenses | 7,639 | 3,713 | ||||
| Accrued interest (related party) | - | 703 | ||||
| Other current liabilities | 518 | 573 | ||||
| Forward purchase agreement warrant liability | 24 | 472 | ||||
| Product warranty liability, current portion | 287 | 282 | ||||
| Operating lease liability, current portion (related party) | 174 | 143 | ||||
| Total current liabilities | 11,562 | 7,538 | ||||
| Term loans payable (related party) | - | 18,716 | ||||
| Product warranty liability, net of current portion | 1,605 | 1,771 | ||||
| Operating lease liability, net of current portion (related party) | 745 | 802 | ||||
| Private warrant liability | 5,835 | - | ||||
| Publicly traded warrant liability | 551 | 662 | ||||
| Other liability | 27 | 891 | ||||
| Total liabilities | 20,325 | 30,380 | ||||
| Commitments and contingencies | ||||||
| Mezzanine equity | ||||||
| Warrants issued to placement agent | 391 | - | ||||
| Stockholders' deficit | ||||||
| Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of December 31, 2025 and December 31, 2024; 4,126,667 shares issued and outstanding as of December 31, 2025 and December 31, 2024 | - | - | ||||
| Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of December 31, 2025 and December 31, 2024; 28,934,960 shares issued and outstanding as of December 31, 2025 and 21,326,609 shares issued and outstanding as of December 31, 2024 | 3 | 2 | ||||
| Additional paid-in capital | 301,355 | 266,013 | ||||
| Accumulated deficit | (313,396 | ) | (284,734 | ) | ||
| Accumulated other comprehensive loss | (120 | ) | (123 | ) | ||
| Total stockholders' deficit | (12,158 | ) | (18,842 | ) | ||
| Total liabilities, mezzanine equity, and stockholders' deficit | $ | 8,558 | $ | 11,538 | ||
ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
| Year Ended | ||||||
| December 31, | ||||||
| 2025 | 2024 | |||||
| Net revenues | $ | 241 | $ | 225 | ||
| Costs and operating expenses: | ||||||
| Cost of goods sold | 874 | 742 | ||||
| Research and development | 12,486 | 10,179 | ||||
| Sales and marketing | 1,220 | 1,734 | ||||
| General and administrative | 7,931 | 6,826 | ||||
| Total costs and operating expenses | 22,511 | 19,481 | ||||
| Operating loss | (22,270 | ) | (19,256 | ) | ||
| Other income (expense): | ||||||
| Change in fair value of forward purchase agreement put option liability | - | 103 | ||||
| Change in fair value of forward purchase agreement warrant liability | 534 | 411 | ||||
| Change in fair value of forward purchase agreement warrant liability due to extension | (24 | ) | (881 | ) | ||
| Loss on offering and change in fair value of private warrant liability | (494 | ) | - | |||
| Change in fair value of publicly traded warrant liability | 111 | (330 | ) | |||
| Interest expense, related party | (1,590 | ) | (816 | ) | ||
| Other expense, net | (23 | ) | (26 | ) | ||
| Total other income (expense), net | (1,486 | ) | (1,539 | ) | ||
| Net loss | (23,756 | ) | (20,795 | ) | ||
| Induced conversion of Series A Preferred Stock into Class A Common Stock | - | (1,162 | ) | |||
| Deemed dividend on waiver of restriction on Class A Common Stock | - | (495 | ) | |||
| Cumulative preferred dividends | (4,906 | ) | (5,521 | ) | ||
| Net loss attributable to common stockholders, basic and diluted | $ | (28,662 | ) | $ | (27,973 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.23 | ) | $ | (1.49 | ) |
| Weighted-average Class A Common Stock outstanding, basic and diluted | 23,259,598 | 18,790,448 | ||||
| Other comprehensive income (loss): | ||||||
| Foreign currency translation adjustment | 3 | (5 | ) | |||
| Other comprehensive income (loss) | 3 | (5 | ) | |||
| Comprehensive loss | $ | (23,753 | ) | $ | (20,800 | ) |
ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in thousands)
| Year Ended | ||||||
| December 31, | ||||||
| 2025 | 2024 | |||||
| Cash flows from operating activities | ||||||
| Net loss | $ | (23,756 | ) | $ | (20,795 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 302 | 173 | ||||
| Interest expense and amortization of debt discount on Term Loans (related party) | 1,590 | 816 | ||||
| Stock-based compensation for services | 88 | - | ||||
| Amortization of prepaid insurance | 964 | 1,047 | ||||
| Stock-based compensation | 657 | 562 | ||||
| Loss on offering and change in fair value of private warrant liability | 494 | - | ||||
| Change in fair value of publicly traded warrant liability | (111 | ) | 330 | |||
| Change in fair value of forward purchase agreement warrant liability | (534 | ) | (411 | ) | ||
| Change in fair value of forward purchase agreement put option liability | - | (103 | ) | |||
| Change in fair value of forward purchase agreement warrant liability due to extension | 24 | 881 | ||||
| Net change in operating lease right-of-use assets and liability (related party) | 206 | 113 | ||||
| Change in inventory reserve | 36 | 76 | ||||
| Changes in operating assets and liabilities: | ||||||
| Accounts receivable, net | 4 | 32 | ||||
| Other receivable | 761 | (604 | ) | |||
| Inventories | 126 | (380 | ) | |||
| Prepaid expenses and other current assets | (8 | ) | 9 | |||
| Accounts payable | 1,385 | (19 | ) | |||
| Operating lease liability (related party) | (239 | ) | (145 | ) | ||
| Accrued expenses | 839 | (241 | ) | |||
| Product warranty liability | (161 | ) | (181 | ) | ||
| Other liability | (868 | ) | 891 | |||
| Net cash used in operating activities | (18,201 | ) | (17,949 | ) | ||
| Cash flows from investing activities | ||||||
| Purchases of property and equipment | (179 | ) | (980 | ) | ||
| Net cash used in investing activities | (179 | ) | (980 | ) | ||
| Cash flows from financing activities | ||||||
| Payments on insurance financing loans | (827 | ) | (916 | ) | ||
| Proceeds from the issuance of Term Loans (related party) | 10,000 | 20,000 | ||||
| Dividends paid to stockholders of Series A Preferred Stock | (1,819 | ) | (2,447 | ) | ||
| Payment made for extinguishment of Term Loans (related party) | (100 | ) | - | |||
| Proceeds from the issuance of Class A Common Stock from ATM offering | 414 | - | ||||
| Proceeds from issuance of Class A Common Stock under employee stock purchase plan | 184 | 63 | ||||
| Proceeds from exercise of forward purchase agreement warrants | 3,111 | 1,815 | ||||
| Proceeds from the issuance of Class A Common Stock and Investor Warrants from registered direct offering | 6,500 | - | ||||
| Offering costs from the issuance of Class A Common Stock and Investor Warrants from registered direct offering | (768 | ) | ||||
| Deferred offering costs | (62 | ) | - | |||
| Proceeds from the issuance of Class A Common Stock associated with forward purchase agreement, net of transaction costs | - | 1,683 | ||||
| Net cash provided by financing activities | 16,633 | 20,198 | ||||
| Effect of exchange rate changes on cash | 3 | (5 | ) | |||
| Net (decrease) increase in cash | (1,744 | ) | 1,264 | |||
| Cash, beginning of year | 5,483 | 4,219 | ||||
| Cash, end of year | $ | 3,739 | $ | 5,483 | ||
| Supplemental disclosures of cash flow information: | ||||||
| Cash paid for interest | $ | 36 | $ | 41 | ||
| Non-cash investing and financing activities: | ||||||
| Accrued and unpaid dividends on Series A Preferred Stock | $ | 3,087 | $ | 3,074 | ||
| Financing of prepaid insurance | $ | 772 | $ | 843 | ||
| Issuance of Term Loan Warrants (related party) | $ | 1,570 | $ | 1,397 | ||
| Accrued interest capitalized into term loans payable (related party) | $ | 800 | $ | - | ||
| Modification of forward purchase agreement warrant | $ | 62 | $ | 94 | ||
| Lease liabilities arising from obtaining right-of-use assets | $ | 121 | $ | 528 | ||
| Extinguishment of excess warrant liability upon exercise of forward purchase agreement warrant | $ | - | $ | 96 | ||
| Waiver of accrued dividends associated with Sponsor Support Agreement | $ | - | $ | 3,733 | ||
| Deemed dividend on waiver of restriction on Class A Common Stock | $ | - | $ | 495 | ||
| Induced conversion of Series A Preferred Stock to Class A Common Stock | $ | - | $ | 1,162 | ||
| Property and equipment purchased on account | $ | - | $ | 117 | ||
| Modification of Term Loan Warrants (related party) | $ | 1,455 | $ | - | ||
| Deemed capital contribution associated with the extinguishment of Term Loans (related party) | $ | 27,883 | $ | - | ||
| Issuance of Placement Agent Warrants | $ | 391 | $ | - | ||
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289507