Submitted First Module of Modular PMA Application to
Subsequent to Quarter End, the Company Reported Positive 12-Month Stage 1 Data Showing Continued Improvement in Speech Perception
"The second quarter moved us measurably closer to bringing our fully implanted cochlear implant to market," said
Corporate and Financial Highlights for Q2 2026:
First Module of Modular PMA Application Submitted to the
FDA . The Company submitted the first module of its Modular Premarket Approval ("PMA") application to theU.S. Food and Drug Administration ("FDA ") for its Breakthrough Device-designated investigational Acclaim® cochlear implant. Unlike a traditional PMA, the modular pathway allows the Company to submit completed sections for review as they become available, enabling earlierFDA engagement, iterative feedback, and a defined cadence of milestones. The Company expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027.Expanded Intellectual Property Portfolio. The Australian and European patent offices granted the Company four patents relating to important innovations in implantable system design, signal analysis, and battery recharge safety, further strengthening the Company's intellectual property position in the implantable medical device and cochlear implant industries.
At-the-Market (ATM) Equity Facility Terminated. The Company terminated its ATM equity offering program, under which it was previously authorized to offer and sell up to
$15 million of its common stock.
Highlights Subsequent to Q2 2026:
Positive 12-Month Data Showed Continued Improvement in Speech Perception. The Company reported positive 12-month data from the first 10 participants in Stage 1 of its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant. These participants achieved a mean Consonant-Nucleus-Consonant ("CNC") word recognition score of 53.2% at their 12-month visits, compared to a pre-implantation baseline of 15.2%, a 38.0 percentage point improvement and continued gains from the 24.0 percentage point improvement reported at six months. The trial's primary efficacy endpoint will be evaluated based on 12-month data.
Three-Month Follow-Up Window Completed for Full Cohort. The Company announced that its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant passed the three-month follow-up window, marking another key clinical milestone as the Company advances the study toward its primary efficacy endpoint, which will be evaluated on 12-month data.
Financial Results for the Quarter Ended
Net revenue was
Cost of goods sold for the three months ended
R&D expenses for the three months ended
Sales and marketing expenses for the three months ended
General and administrative expenses were
Net loss attributable to common stockholders was
As of
For more information about
To be added to the
About
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.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or
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 operational improvements and capital investments; the ability to obtain additional patents and develop future products or product improvements; the Acclaim CI being the first to market fully implanted cochlear implant; the timing, content, and results of the Company's modular PMA submissions to the FDA, including the number and timing of modules and the timing of any approval decision; the timing and results of approvals, site documents, logistics, activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, including data from Stage 2 (which may differ from Stage 1); the results of the safety and efficacy data from Stage 2 participants and the effect on its pooling with Stage 1 data; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; and the participation or any changes in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the sufficiency of the Company's capital resources; 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; 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: envoy@kcsa.com
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
| 2026 | 2025 | ||||||
| (unaudited) | |||||||
| Current assets: | |||||||
| Cash | $ | 19,679 | $ | 3,739 | |||
| Accounts receivable, net | 49 | 34 | |||||
| Other receivable | 17 | 19 | |||||
| Inventories | 1,579 | 1,546 | |||||
| Prepaid expenses and other current assets | 593 | 941 | |||||
| Total current assets | 21,917 | 6,279 | |||||
| Property and equipment, net | 921 | 1,035 | |||||
| Operating lease right-of-use asset (related party) | 818 | 886 | |||||
| Prepaid expenses and other assets | 293 | 358 | |||||
| Total assets | $ | 23,949 | $ | 8,558 | |||
| Liabilities, mezzanine equity, and stockholders' equity (deficit) | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,035 | $ | 2,920 | |||
| Accrued expenses | 10,032 | 7,639 | |||||
| Forward purchase agreement warrant liability | 14 | 24 | |||||
| Product warranty liability, current portion | 255 | 287 | |||||
| Operating lease liability, current portion (related party) | 132 | 174 | |||||
| Other current liabilities | 166 | 518 | |||||
| Total current liabilities | 12,634 | 11,562 | |||||
| Product warranty liability, net of current portion | 1,543 | 1,605 | |||||
| Operating lease liability, net of current portion (related party) | 678 | 745 | |||||
| Private warrant liability | 4,668 | 5,835 | |||||
| Publicly traded warrant liability | 705 | 551 | |||||
| Other liability | 27 | 27 | |||||
| Total liabilities | 20,255 | 20,325 | |||||
| Commitments and contingencies (see Note 14) | |||||||
| Mezzanine equity | |||||||
| Warrants issued to placement agent as part of the 2025 Offerings (see Note 9) | 391 | 391 | |||||
| Stockholders' equity (deficit) | |||||||
| Series A Preferred Stock, | - | - | |||||
| Class A Common Stock, | 8 | 3 | |||||
| Additional paid-in capital | 329,786 | 301,355 | |||||
| Accumulated deficit | (326,369 | ) | (313,396 | ) | |||
| Accumulated other comprehensive loss | (122 | ) | (120 | ) | |||
| Total stockholders' equity (deficit) | 3,303 | (12,158 | ) | ||||
| Total liabilities, mezzanine equity, and stockholders' equity (deficit) | $ | 23,949 | $ | 8,558 | |||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)
| Three Months Ended | Six Months Ended | ||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||
| Net revenues | $ | 51 | $ | 78 | $ | 90 | $ | 124 | |||||
| Costs and operating expenses: | |||||||||||||
| Cost of goods sold | 278 | 234 | 591 | 460 | |||||||||
| Research and development | 3,132 | 2,485 | 6,774 | 5,233 | |||||||||
| Sales and marketing | 181 | 361 | 345 | 719 | |||||||||
| General and administrative | 2,029 | 2,068 | 3,908 | 3,889 | |||||||||
| Total costs and operating expenses | 5,620 | 5,148 | 11,618 | 10,301 | |||||||||
| Operating loss | (5,569 | ) | (5,070 | ) | (11,528 | ) | (10,177 | ) | |||||
| Other income (expense): | |||||||||||||
| Change in fair value of forward purchase agreement warrant liability | 23 | 37 | 10 | 458 | |||||||||
| Loss on offering and change in fair value of private warrant liability | (838 | ) | - | 1,167 | - | ||||||||
| Change in fair value of publicly traded warrant liability | 236 | (32 | ) | (154 | ) | 162 | |||||||
| Interest expense (related party) | - | (624 | ) | - | (1,119 | ) | |||||||
| Other income (expense), net | 166 | (1 | ) | 172 | (12 | ) | |||||||
| Total other income (expense), net | (413 | ) | (620 | ) | 1,195 | (511 | ) | ||||||
| Net loss | (5,982 | ) | (5,690 | ) | (10,333 | ) | (10,688 | ) | |||||
| Cumulative preferred dividends | (1,290 | ) | (1,252 | ) | (2,640 | ) | (2,490 | ) | |||||
| Net loss attributable to common stockholders, basic and diluted | $ | (7,272 | ) | $ | (6,942 | ) | $ | (12,973 | ) | $ | (13,178 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.07 | ) | $ | (0.32 | ) | $ | (0.15 | ) | $ | (0.62 | ) | |
| Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted | 104,039,109 | 21,383,852 | 86,584,007 | 21,355,388 | |||||||||
| Other comprehensive (loss) income: | |||||||||||||
| Foreign currency translation adjustment | (1 | ) | (2 | ) | (2 | ) | 4 | ||||||
| Other comprehensive (loss) income | (1 | ) | (2 | ) | (2 | ) | 4 | ||||||
| Comprehensive loss | $ | (5,983 | ) | $ | (5,692 | ) | $ | (10,335 | ) | $ | (10,684 | ) | |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Dollars in thousands)
| Six Months Ended | |||||||
| 2026 | 2025 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (10,333 | ) | $ | (10,688 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation | 147 | 146 | |||||
| Interest expense and amortization of debt discount on Term Loans (related party) | - | 1,118 | |||||
| Stock-based compensation for services | 76 | - | |||||
| Amortization of prepaid insurance | 463 | 493 | |||||
| Stock-based compensation | 453 | 306 | |||||
| Loss on offering and change in fair value of private warrant liability | (1,167 | ) | - | ||||
| Change in fair value of publicly traded warrant liability | 154 | (162 | ) | ||||
| Change in fair value of forward purchase agreement warrant liability | (10 | ) | (458 | ) | |||
| Net change in operating lease (related party) | 111 | 51 | |||||
| Change in inventory reserve | 26 | 10 | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable, net | (15 | ) | (5 | ) | |||
| Other receivable | 2 | 760 | |||||
| Inventories | (59 | ) | 111 | ||||
| Prepaid expenses and other assets | 40 | (42 | ) | ||||
| Accounts payable | (912 | ) | (33 | ) | |||
| Operating lease liability (related party) | (152 | ) | (44 | ) | |||
| Accrued expenses | (247 | ) | 312 | ||||
| Product warranty liability | (94 | ) | (60 | ) | |||
| Net cash used in operating activities | (11,517 | ) | (8,185 | ) | |||
| Cash flows from investing activities | |||||||
| Purchases of property and equipment | (6 | ) | (7 | ) | |||
| Net cash used in investing activities | (6 | ) | (7 | ) | |||
| Cash flows from financing activities | |||||||
| Payments on insurance financing loans | (421 | ) | (469 | ) | |||
| Proceeds from the issuance of Term Loans (related party) | - | 10,000 | |||||
| Dividends paid to stockholders of Series A Preferred Stock | - | (1,820 | ) | ||||
| Proceeds from the issuance of Class A Common Stock from ATM offering | - | 204 | |||||
| Proceeds from issuance of Class A Common Stock under employee stock purchase plan | 104 | 77 | |||||
| Proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants | 29,997 | - | |||||
| Offering costs from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants | (2,215 | ) | - | ||||
| Net cash provided by financing activities | 27,465 | 7,992 | |||||
| Effect of exchange rate changes on cash | (2 | ) | 4 | ||||
| Net increase (decrease) in cash | 15,940 | (196 | ) | ||||
| Cash, beginning of period | 3,739 | 5,483 | |||||
| Cash, end of period | $ | 19,679 | $ | 5,287 | |||
| Supplemental disclosures of cash flow information: | |||||||
| Cash paid for interest | $ | 17 | $ | 20 | |||
| Non-cash investing and financing activities: | |||||||
| Accrued and unpaid dividends on Series A Preferred Stock | $ | 2,640 | $ | 670 | |||
| Financing of prepaid insurance | $ | 69 | $ | 75 | |||
| Issuance of Term Loan Warrants (related party) | $ | - | $ | 1,570 | |||
| Accrued interest capitalized into term loans payable (related party) | $ | - | $ | 600 | |||
| Property and equipment purchased on account | $ | 27 | $ | - | |||
| Issuance of Placement Agent Warrants | $ | 678 | $ | - | |||
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SOURCE