US Market News
1月前
Envoy Medical Reports Landmark Accomplishments, Advancing Toward FDA Approval of First-of-Its-Kind Fully Implanted Cochlear ImplantMay 11, 2026 8:00 AM
NewsfileCompany Completes Historic Trial Enrollment, Secures Transformational Financing, and Sees Promising Early Clinical Data Presented at Industry ConferencesWhite Bear Lake, Minnesota--(Newsfile Corp. - May 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that advance the Company another step closer toward commercialization of its investigational Acclaim® cochlear implant."The first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical trial and the successful execution of a significant financing," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Achieving full enrollment in our pivotal clinical study represents a critical step. We continue to be encouraged by the trial's progress and remain focused on advancing toward PMA submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors, we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead."Corporate and Financial Highlights for Q1 2026:Pivotal Trial Enrollment Complete — A First for the Industry
In a defining milestone for the hearing health sector, Envoy Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission to the FDA to follow.Transformational Capital Raise
Envoy Medical closed an upsized public offering for up to $78.0 million, including $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants. The financing was led by Nantahala Capital and included healthcare-dedicated funds such as Broadfin Holdings, as well as existing shareholders including members of the Board and management team.Expanded Intellectual Property Portfolio
As of February 20, 2026, Envoy Medical has expanded its global IP portfolio to 47 patents across North America, Europe, Asia, and Australia. In February alone, the Company secured three new patents strengthening its competitive position in the fully implanted hearing space.Highlights Subsequent to Q1 2026:Promising Early Clinical Data Presented
Interim six-month clinical data from the first 10 patients in the pivotal study showed no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily device wear time of 24 hours, and improvements in quality-of-life and tinnitus scores. Initial safety and performance data for these 10 patients were presented at the American Academy of Audiology Annual Conference and the Combined Otolaryngology Spring Meetings.All 56 Pivotal Trial Patients Activated
Following the completion of enrollment, Envoy Medical confirmed that all 56 patients implanted in the pivotal clinical trial have been activated. This milestone validates that the full patient cohort is progressing through the study protocol on schedule, keeping the Company on track to collect the 12-month endpoint data required for its planned PMA submission to the FDA.Board StrengthenedEnvoy Medical appointed medical device veteran Chas McKhann to its Board of Directors in April 2026, further enhancing the Company's expertise as it prepares to conclude its pivotal clinical study and prepare for commercial launch.First Patients Reach 12-Month Endpoint
The first three patients implanted in the pivotal trial successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress. The primary endpoints for the trial are tied to 12-month data, and achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches toward PMA submission and commercialization.Financial Results for the Quarter Ended March 31, 2026 (dollars in thousands):Net Revenue was $39 for the three months ended March 31, 2026.Cost of goods sold for the three months ended March 31, 2026, were $313, compared to $226. The $87 increase is primarily due to higher scrap and materials usage as well as increased fees for third-parties performing work related to our products.R&D expenses for the three months ended March 31, 2026, were $3,642 compared to $2,748 for the three months ended March 31, 2025. This increase of $894 mainly reflects additional clinical trial activity and related personnel costs during enrollment.Sales and marketing expenses for the three months ended March 31, 2026, were $164 compared to $358 for the three months ended March 31, 2025. The decrease of $194 is primarily due to the reallocation of resources to research and development activities in support of the clinical trial.General and administrative expenses are $1,879 for the three months ended March 31, 2026, compared to $1,821 for the three months ended March 31, 2025. The increase of $58 was primarily due to higher investor relations and legal expenses.As of March 31, 2026, cash was approximately $25,251.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 Envoy@kcsa.com 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: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
March 31,
December 31,
2026
2025
Current assets:
Cash
$25,251
$3,739
Accounts receivable, net
31
34
Other receivable
17
19
Inventories
1,490
1,546
Prepaid expenses and other current assets
893
941
Total current assets
27,682
6,279
Property and equipment, net
962
1,035
Operating lease right-of-use asset (related party)
853
886
Prepaid expenses and other assets
325
358
Total assets
$29,822
$8,558
Liabilities, mezzanine equity, and stockholders' equity (deficit)
Current liabilities:
Accounts payable
$1,700
$2,920
Accrued expenses
9,653
7,639
Forward purchase agreement warrant liability
37
24
Product warranty liability, current portion
264
287
Operating lease liability, current portion (related party)
178
174
Other current liabilities
379
518
Total current liabilities
12,211
11,562
Product warranty liability, net of current portion
1,550
1,605
Operating lease liability, net of current portion (related party)
711
745
Private warrant liability
3,830
5,835
Publicly traded warrant liability
941
551
Other liability
27
27
Total liabilities
19,270
20,325
Commitments and contingencies (see Note 13)
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, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of March 31, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of March 31, 2026 and December 31, 2025
-
-
Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 76,881,110 shares issued and outstanding as of March 31, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025
8
3
Additional paid-in capital
329,371
301,355
Accumulated deficit
(319,097)
(313,396)Accumulated other comprehensive loss
(121)
(120)Total stockholders' equity (deficit)
10,161
(12,158)Total liabilities, mezzanine equity, and stockholders' equity (deficit)
$29,822
$8,558
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)
Three Months Ended
March 31,
2026
2025
Net revenues
$39
$46
Costs and operating expenses:
Cost of goods sold
313
226
Research and development
3,642
2,748
Sales and marketing
164
358
General and administrative
1,879
1,821
Total costs and operating expenses
5,998
5,153
Operating loss
(5,959)
(5,107)Other income (expense):
Change in fair value of forward purchase agreement warrant liability
(13)
421
Loss on offering and change in fair value of private warrant liability
2,005
-
Change in fair value of publicly traded warrant liability
(390)
194
Interest expense (related party)
-
(495)Other income (expense), net
6
(11)Total other income (expense), net
1,608
109
Net loss
(4,351)
(4,998)
Cumulative preferred dividends
(1,350)
(1,238)
Net loss attributable to common stockholders, basic and diluted
$(5,701)$(6,236)Net loss per share attributable to common stockholders, basic and diluted
$(0.08)$(0.29)Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted
68,934,960
21,326,609
Other comprehensive (loss) income:
Foreign currency translation adjustment
(1)
6
Other comprehensive (loss) income
(1)
6
Comprehensive loss
$(4,352)$(4,992) ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Dollars in thousands)
Three Months Ended
March 31,
2026
2025
Cash flows from operating activities
Net loss
$(4,351)$(4,998)Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
73
61
Interest expense and amortization of debt discount on Term Loans (related party)
-
495
Stock-based compensation for services
44
-
Amortization of prepaid insurance
227
247
Stock-based compensation
239
160
Loss on offering and change in fair value of private warrant liability
(2,005)
-
Change in fair value of publicly traded warrant liability
390
(194)Change in fair value of forward purchase agreement warrant liability
13
(421)Net change in operating lease (related party)
55
26
Change in inventory reserve
12
(23)Changes in operating assets and liabilities:
Accounts receivable, net
3
(4)Other receivable
2
757
Inventories
44
74
Prepaid expenses and other current assets
(121)
(75)Accounts payable
(1,220)
10
Operating lease liability (related party)
(52)
(22)Accrued expenses
664
199
Product warranty liability
(78)
(17)Net cash used in operating activities
(6,061)
(3,725)
Cash flows from investing activities
Purchases of property and equipment
-
(6)Net cash used in investing activities
-
(6)
Cash flows from financing activities
Payments on insurance financing loans
(208)
(233)Proceeds from the issuance of Term Loans (related party)
-
5,000
Dividends paid to stockholders of Series A Preferred Stock
-
(1,213)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
27,574
3,554
Effect of exchange rate changes on cash
(1)
6
Net (decrease) increase in cash
21,512
(171)Cash, beginning of period
3,739
5,483
Cash, end of period
$25,251
$5,312
Supplemental disclosures of cash flow information:
Cash paid for interest
$11
$13
Non-cash investing and financing activities:
Accrued and unpaid dividends on Series A Preferred Stock
$1,350
$25
Financing of prepaid insurance
$69
$75
Issuance of Term Loan Warrants (related party)
$-
$688
Issuance of Placement Agent Warrants
$678
$-
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/296857 Original: Envoy Medical Reports Landmark Accomplishments, Advancing Toward FDA Approval of First-of-Its-Kind Fully Implanted Cochlear Implant
US Market News
2月前
Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear ImplantApril 28, 2026 8:30 AM
NewsfilePositive Initial 6-Month Data from First 10 Patients and Improvements in Speech Understanding and Quality of Life Scores Presented; Additional Presentations Scheduled in Early MayDetails to be Discussed During Fireside Chat on April 29, 2026 at 4:30 pm ETWhite Bear Lake, Minnesota--(Newsfile Corp. - April 28, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the first podium presentations of clinical data from the first stage of its pivotal clinical study of the investigational Acclaim® cochlear implant, a first-of-its-kind, fully implanted cochlear implant system. The Company will host a Fireside Chat with Dr. Theodore McRackan, MD, MSCR and Dr. Elizabeth Camposeo, AuD from the Medical University of South Carolina (MUSC) on Wednesday April 29, 2026 at 4:30 pm ET to review the data and its clinical implications.A planned interim analysis of the clinical data for the first 10 patients was conducted following completion of their six-month follow-up visits. Initial safety and performance data were presented this past weekend by Dr. Camposeo at the American Academy of Audiology (AAA) Annual Conference and Dr. McRackan at the Combined Otolaryngology Spring Meetings (COSM). Additional podium presentations are scheduled for May including the American Cochlear Implant Alliance (ACIA) Conference on Friday, May 8, 2026, and the International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) on Monday, May 11, 2026."We are encouraged by the initial data from the first stage of the investigational Acclaim® clinical study being presented across several industry conferences," said Brent Lucas, Chief Executive Officer of Envoy Medical. "In addition to promising early safety and performance signals, we are seeing evidence of a strong interest in a fully implanted solution. Many participants had previously declined traditional cochlear implants due to the required use of an external processor, underscoring the potential for the Acclaim cochlear implant to expand the addressable market. While the study remains ongoing and these interim results are preliminary, the data reinforces our belief in the clinical and commercial promise of a fully implanted approach." Envoy Fireside Chat Details
Event: Envoy Medical Fireside Chat
Date: Wednesday, April 29, 2026
Time: 4:30 P.M. ET
Webcast Link: https://ir.envoymedical.com/news-events/ir-calendarKey Takeaways from Investigator PresentationsPreliminary Safety Profile DataNo serious adverse events (SAEs) as defined by the study protocol were reported.Adverse events were mild or moderate and resolved with routine care or programming adjustments.Preliminary Hearing Performance DataSpeech recognition improved by 6 months: Consonant-Nucleus-Consonant (CNC) word recognition, mean scores increased from 15.2% pre-CI to 39.2% (24 percentage point improvement).Device UseParticipants reported a median daily hearing-device wear time of 24 hours a day. This was a noticeable increase from their pre-operative median of 15.5 hours a day with hearing aids.Drivers of Choice to ParticipateParticipants were surveyed to understand why they previously declined traditional cochlear implants. Top responses included:Not wanting to wear an external processor (80%).Concern that an external processor would draw unwanted attention (70%). Discomfort with external processor size (60%).Participants were surveyed to understand their motivations for choosing a fully implanted cochlear implant system. Top responses included:Wanted the ability to hear during water activities, exercise, or while wearing headgear (100%).Wanted to be able to hear 24-hours a day with device (100%).Wanted an invisible, fully implanted device (90%). Quality of LifePatients demonstrated improvements in quality-of-life scores as measured by the CI-QOL35, a validated cochlear implant-specific quality of life instrument.Tinnitus Handicap Inventory (THI)Four patients who reported having tinnitus prior to surgery experienced a reduction in tinnitus as assessed by the Tinnitus Handicap Instrument (THI). For these patients, mean THI scores decreased from 24.5 pre-implant to 6.25 in 6 months.Upcoming Conference PresentationsAmerican Cochlear Implant Alliance (ACIA) Conference - Friday, May 8, 2026International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) - Monday, May 11, 2026The 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 Envoy@kcsa.com 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; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; 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: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/294479
Original: Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant
US Market News
2月前
Envoy Medical Appoints Chas McKhann to Board of DirectorsApril 16, 2026 8:00 AM
NewsfileProven Med Tech Leader with an Established Track Record of Commercial Success and Optimizing Shareholder Value Leading to over $3.4 Billion in Successful ExitsWhite Bear Lake, Minnesota--(Newsfile Corp. - April 16, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, today announced the appointment of Chas McKhann, a seasoned medical technology executive with documented success, to its Board of Directors.Mr. McKhann is a well-known and respected med tech leader with extensive experience creating and executing commercialization plans that have scaled into high-growth companies creating significant shareholder value. Most recently, he served as Chief Executive Officer of Silk Road Medical, which sold to Boston Scientific for $1.16 Billion, and Apollo Endosurgery, which also sold to Boston Scientific for approximately $615 million. Prior to those roles, Mr. McKhann served as the Chief Commercial Officer of Torax Medical and Intersect ENT prior to their acquisitors by Johnson and Johnson and Medtronic, respectively. "We are extremely excited to welcome Chas to our Board," said Brent Lucas, CEO of Envoy Medical. "Chas brings a proven track record of commercial success and delivering strong outcomes for investors. We look forward to benefitting from his deep industry knowledge and experience to advance our mission of bringing our first-of-its-kind fully implanted cochlear implant to the millions of patients who are not treating their hearing loss. Adding his experience and perspective will further strengthen our strategic positioning and visibility."Mr. McKhann currently serves as Executive Chair of Distalmotion SA, an independent director at Exagen Inc., and is a Senior Advisor to McKinsey & Company. Mr. McKhann holds an MBA from the Stanford University Graduate School of Business and a BA in Political Science from Stanford University."I am thrilled to be joining the Envoy Medical team," said Mr. McKhann. "As a first-of-its-kind fully implanted Cochlear implant, I believe the Acclaim® device has the ability to be a true game-changing advancement that has the potential to transform the lives of patients with hearing loss. With the pivotal trial enrollment now complete, I am excited to work with Brent and his team to develop a commercialization strategy and launch plan that maximizes the patient impact of this amazing technology."In addition to his role as an Independent Director, Mr. McKhann will also serve as a member of the Company's Compensation Committee. 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 Envoy@kcsa.com 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: Envoy@kcsa.comMedia Contact
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/292772
Original: Envoy Medical Appoints Chas McKhann to Board of Directors
US Market News
3月前
Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear ImplantApril 1, 2026 8:00 AM
NewsfileCompany Remains on Schedule for PMA Submission to FDAWhite Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress.The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point. The primary endpoints for the trial are tied to 12-month data. Achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches towards commercialization."We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint," said Brent Lucas, CEO of Envoy Medical. "We believe our first-of-its-kind breakthrough technology has the potential to change the perception around how severe to profound hearing loss is treated and potentially increase adoption rates. Now that the trial has been fully enrolled and we are beginning to collect 12-month data, the future of hearing implants may be closer than you realize."After all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).The Acclaim® cochlear implant is an investigational, first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss without externally worn components. With Envoy Medical's proprietary sensor technology, the Acclaim® device design leverages the ear's natural anatomy to capture sound to support a smooth and discreet hearing experience. Envoy Medical believes fully implanted hearing technology offers the potential to significantly expand adoption among patients unwilling or unable to use traditional hearing devices that rely on external hardware. Per the NIH, only six percent of eligible individuals receive cochlear implants, highlighting a substantial unmet need in the market.The Company continues to build on its leadership in fully implanted hearing solutions, including its FDA-approved Esteem® fully implanted active middle ear implant, which has been commercially available in the United States since 2010.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 Envoy@kcsa.com with COCH in the subject line.NIH Citation: Zhang L, Ding AS, Xie DX, Creighton FX. Understanding Public Perceptions Regarding Cochlear Implant Surgery in Adults. Otol Neurotol. 2022 Mar 1;43(3):e331-e336. doi: 10.1097/MAO.0000000000003439. PMID: 35147605; PMCID: PMC10368452.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 ItCopies 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: Envoy@kcsa.comMedia Contact
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/290776
Original: Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear Implant
US Market News
3月前
Envoy Medical Reports Full Year 2025 Financial ResultsMarch 23, 2026 8:30 AM
NewsfileReceived FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stageStrengthened balance sheet by extinguishing $32 million in debtSubsequent 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 implantWhite 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 DataExtinguished over $32 Million in Debt, Strengthening Balance SheetCompleted First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear ImplantAchieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical TrialHighlights Subsequent to 2025 Year End:Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaim® Cochlear ImplantStrengthened 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, 2026Brent 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 Envoy@kcsa.com 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: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comENVOY 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
Original: Envoy Medical Reports Full Year 2025 Financial Results
US Market News
3月前
Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear ImplantMarch 11, 2026 8:00 AM
NewsfileFirst Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA ApprovalWhite Bear Lake, Minnesota--(Newsfile Corp. - March 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical is the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval. "Completing enrollment of a pivotal clinical trial that is evaluating a breakthrough-designated medical device that has the potential to bring about generational change to an entire industry is a very big deal," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We strongly believe in our device design and look forward to gathering additional data throughout the trial as we substantially differentiate ourselves from the competition. We believe today brings us significantly closer to redefining the standard of care for adults with severe to profound hearing loss and potentially growing the overall cochlear implant user base to include those patients who could benefit from a cochlear implant but have sat on the sidelines waiting for a fully implanted solution."The final two study participants were both implanted yesterday by Dr. Patrick Antonelli at the University of Florida. With these procedures, Dr. Antonelli became the second leading enroller in the trial, having implanted 11 of the 56 participants."Participating in the Acclaim Cochlear Implant Pivotal Trial has been an eye opener for me," Dr. Antonelli shared, "I've been placing traditional cochlear implants for so long-over 30 years-and these devices evolved so little over that time that I didn't give much thought to how dramatically they could be improved. The Acclaim changed that." Dr. Antonelli continued, "People with profound hearing loss desperately want to be able to hear 24 x 7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with an external processor. I think just about every Acclaim recipient that we've enrolled in this study said, often tearfully, 'you've really made my day,' when I told them they were cleared to get the Acclaim. Tears of joy followed activation as well. It's been a real privilege to be able to offer the Acclaim cochlear implant to our patients in this clinical trial. I am delighted that completion of study enrollment brings us a step closer to FDA approval and hopefully being able to offer the Acclaim to all of our properly qualified patients." With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with the trial protocol. Once 12-month follow up data has been collected for all patients, the data will then be analyzed and submitted to the FDA as part of a PMA application seeking FDA approval. Subject to FDA review and approval, commercialization in the United States would follow.Envoy Medical believes it is the first cochlear implant manufacturer to complete enrollment in a U.S. pivotal trial for a fully implanted cochlear implant, positioning the Company at the forefront of this next generation of hearing technology. 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 Envoy@kcsa.com 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 31, 2025, 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.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/287997
Original: Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear Implant
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