AI Earnings Predictions for Envoy Medical Inc. (COCH)

EX-99.1

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PRESS RELEASE DATED AUGUST 10, 2026

Exhibit 99.1

Envoy Medical Reports Second Quarter 2026 Results and Achieves Key Regulatory and Clinical Milestones

Submitted First Module of Modular PMA Application to FDA

Subsequent to Quarter End, the Company Reported Positive 12-Month Stage 1 Data Showing Continued Improvement in Speech Perception

White Bear Lake, Minnesota--(Newsfile Corp. – August 10, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing health company pioneering fully implanted hearing solutions, today reported financial results for the second quarter ended June 30, 2026, and provided a business update, highlighting continued execution on its corporate initiatives.

“The second quarter moved us measurably closer to bringing our fully implanted cochlear implant to market,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “We submitted the first of four modules of our modular PMA application and our pivotal clinical trial continued to advance. We expect to submit the remaining modules on a rolling basis, with the fourth and final module targeted during the second quarter of 2027. Since quarter end, we reported 12-month data on the first 10 participants in Stage 1 and the full trial surpassed the three-month follow-up mark. We remain focused on the successful and timely execution of our clinical trial but continue to lay the operational groundwork for an exciting future with tremendous value creation potential. Should we receive approval to market our device, we believe that the demand will be substantial and we want to be prepared to support that demand quickly and with tremendous success.”

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 the U.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 earlier FDA 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 June 30, 2026 (dollars in thousands):

Net revenue was $51 for the three months ended June 30, 2026.

Cost of goods sold for the three months ended June 30, 2026, was $278, compared to $234 for the three months ended June 30, 2025.

R&D expenses for the three months ended June 30, 2026, were $3,132 compared to $2,485 for the three months ended June 30, 2025. This increase of $647 mainly reflects additional clinical trial follow-up activity as a result of the clinical trial being fully enrolled, fees related to the submission of the first module of the Company’s PMA application, and personnel costs related to the clinical trial.

Sales and marketing expenses for the three months ended June 30, 2026, were $181 compared to $361 for the three months ended June 30, 2025. The decrease of $180 is primarily due to the reallocation of resources to research and development activities in support o

EX-99.1

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PRESS RELEASE DATED MARCH 11, 2026

Exhibit 99.1

Envoy Medical Reports Landmark Accomplishments, Advancing Toward

FDA Approval of First-Of-Its-Kind Fully Implanted Cochlear Implant

Company Completes Historic Trial Enrollment, Secures Transformational Financing, and

Sees Promising Early Clinical Data Presented at Industry Conferences

White Bear Lake, Minnesota – 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 Strengthened

Envoy 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 month

EX-99.1

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PRESS RELEASE DATED MARCH 23, 2026

Exhibit 99.1

Envoy Medical Reports Full Year 2025 Financial Results

Received FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stage

Strengthened balance sheet by extinguishing $32 million in debt

Subsequent to year-end, closed on transformational

capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant

White Bear Lake, Minnesota – March 23, 2026 – Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events.

Corporate and Financial Highlights for 2025:

●Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data

●Extinguished over $32 Million in Debt, Strengthening Balance Sheet

●Completed First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant

●Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial

Highlights Subsequent to 2025 Year End:

●Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaim® Cochlear Implant

●Strengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants)

●Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026

Brent Lucas, CEO of Envoy Medical, commented: “We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage.

We were also, on the financial side, able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global patent portfolio as a leading fully implanted hearing technology company.

The momentum from 2025 has set the stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational fully implanted Acclaim cochlear implant. We are now in a strengthened position as we continue to gather data and look forward to submitting our PMA application to the FDA.

The future is bright for Envoy Medical as we aim to revolutionize hearing health by providing fully implanted solutions to address the unmet needs of millions of individuals worldwide. We hope you join us on this meaningful and exciting journey.”

Financial Results for the Year Ended December 31, 2025 (dollars in thousands):

Net Revenue was $241 as of December 31, 2025 compared to $225 for year ended December 31, 2024. The increase of $16 was primarily driven by the sales of the Esteem® FI-AMEI implant and related replacement components.

Cost of goods sold increased $132 compared to the year ended December 31, 2024. The increase is primarily due to an increase in scrap and non-recurring expenses of $190, which was partially offset by lower fees for third-parties performing work related to our products of $77.

R&D expenses, which include expenses related to the Acclaim pivotal clinical trial, increased by $2,307 for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase mainly reflects additional clinical trial expense during enrollment.

Sales and marketing expenses of December 31, 2025 were $1,220 compared to $1,734 for the year ended December 31, 2024 a decrease of $514. The decrease is primarily due to a reduction of legal fees associated with reimbursement work for the Esteem FI-AMEI product.

General and administrative expenses increased $1,105 to $7,931 for the year ended December 31, 2025 compared to $6,826 for the year ended December 31, 2024. The increase was primarily due to severance costs associated with the former Chief Financial Officer and increased consulting expenses.

As of December 31, 2025, cash was approximately $3.7 million.

The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.

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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 hea