Financial Performance - The company reported net losses of approximately $20.8 million and $29.9 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of approximately $284.7 million and $257.3 million as of the same dates[182]. - The company has a history of net losses and negative cash flow from operations, which are expected to continue due to ongoing development costs and operational expenses[213]. - The company may experience fluctuations in operating losses, making period-to-period comparisons of results of operations less indicative of future performance[185]. - The company is exposed to inflation risk, which may adversely affect operating results if costs increase without a corresponding rise in selling prices[386]. Revenue Generation - The company has not generated any revenue from the sale of the Acclaim CI and has historically limited revenue from the legacy Esteem FI-AMEI product[186]. - Future revenue generation will depend heavily on obtaining FDA approval for the Acclaim CI and successfully scaling production and marketing efforts[186]. - The company expects to derive most of its revenues from sales of the Acclaim CI, with a significant dependency on its successful commercialization[226]. - The successful commercialization of the Acclaim CI will depend on obtaining adequate coverage and reimbursement from third-party payors, which is uncertain[217]. Clinical Trials and Regulatory Approval - The company has begun its pivotal trial for the Acclaim CI in Q1 2025 after receiving FDA approval for initial patient implants[188]. - The FDA trial process for the Acclaim CI is uncertain, with potential delays and complications that could affect regulatory approval and commercialization[215]. - The company may face delays in clinical trials due to reliance on third-party CROs, which could affect regulatory approval timelines[237]. Costs and Funding - Significant expenses are anticipated for clinical trials and commercialization efforts for the Acclaim CI, with expectations of continued operating losses for the foreseeable future[183]. - The company expects to incur substantial costs related to establishing sales, marketing, and distribution infrastructure for the Acclaim CI, as well as ongoing research and development expenses[184]. - The company may need to raise substantial additional funding to support commercialization efforts, which may not be available on acceptable terms[190]. - The company anticipates that additional funding will be necessary to support its operations, but there is substantial doubt about its ability to raise funds on favorable terms[209]. Competition and Market Risks - The company faces intense competition from larger medical device companies and may struggle to maintain market share if competitors introduce superior products[224]. - The company is vulnerable to fluctuations in demand for the Acclaim CI, which could adversely affect its financial condition and results of operations[227]. - The addressable market for the Acclaim CI may be smaller than estimated, impacting the company's ability to capture market share[235]. - The company may face pricing pressures and regulatory challenges in international markets, which could limit revenue generation from its product candidates[220]. Intellectual Property and Legal Risks - The company has identified material weaknesses in its internal control over financial reporting, which could lead to inaccurate financial reporting and adversely affect investor confidence[205]. - The company may face challenges in maintaining and enforcing its patent rights, which could adversely affect its ability to operate profitably[247]. - The company may become involved in lawsuits regarding intellectual property, which could drain financial resources and divert management's attention[257]. - The company may be subject to claims of misappropriation of third-party intellectual property, which could lead to litigation and significant costs[267]. Management and Governance - The company is dependent on key members of its executive management team, and losing these individuals could impede its business plan and growth strategies[242]. - The company’s management team has limited experience managing a public company, which may affect its ability to meet regulatory obligations and manage business operations effectively[246]. - As of March 24, 2025, a board member holds approximately 48.2% of the outstanding shares of Class A Common Stock, allowing significant influence over shareholder votes[244]. Market Dynamics and Stock Performance - The Class A Common Stock has experienced extreme volatility, trading as low as $1.21 and as high as $9.60 since the Business Combination[277]. - The trading volume of Class A Common Stock has been inconsistent, with significant fluctuations observed in recent months[277]. - Market dynamics unrelated to the company's fundamentals may be influencing current stock prices, posing risks to investors[278]. - The company faces risks related to the perception of substantial sales of its securities, which could negatively impact market prices[276]. Miscellaneous - The company is involved in various legal proceedings, which may have a material adverse effect on its business and financial condition[290]. - The company intends to retain all available funds and future earnings to fund business development and growth, with no anticipated dividends on Class A Common Stock[286].

Core Points - The Hearing Device Coverage Clarification Act has been reintroduced in both the U.S. House and Senate to clarify that certain hearing implants are considered prosthetics, potentially allowing for Medicare coverage [1][2][4] - The House version of the bill, H.R. 1921, was reintroduced by Representatives Michelle Fischbach and Angie Craig, while the Senate version, S. 983, was reintroduced by Senators Amy Klobuchar and James Lankford, with expectations of bipartisan support [3] - The Act aims to provide Medicare coverage for fully implanted active middle ear hearing devices, distinguishing them from traditional hearing aids, which could benefit companies like Envoy Medical that produce such devices [4][5] Company Insights - Envoy Medical, a company specializing in fully implanted hearing systems, has received FDA PMA approval for its Esteem® device since 2010 and is one of the few companies with a fully implanted active middle ear implant [5][6] - The company believes that the passage of the Hearing Device Coverage Clarification Act would create more well-paying jobs in the U.S. and enhance competitiveness in the hearing implant industry, which is currently dominated by foreign players [5][6] - Envoy Medical's Acclaim Cochlear Implant is designed for severe to profound sensorineural hearing loss and received Breakthrough Device Designation from the FDA in 2019, indicating its innovative nature [6][8]

Core Insights - Envoy Medical has secured $10 million in funding from its largest shareholder, billionaire Glen Taylor, to support its pivotal clinical trial for the Acclaim cochlear implant and other operations [1][2] - The company is optimistic about the enrollment progress in its clinical trial, with significant interest reported from investigational sites [2] Funding Details - The $10 million financing is structured as an unsecured loan with a five-year term, deferring interest for the first two years and bearing an 8% interest rate [2] - Funds will be available as needed to maintain the company's operational momentum during a transformative year [1][2] Product Overview - The Acclaim cochlear implant is a first-of-its-kind fully implanted hearing device designed to address severe to profound sensorineural hearing loss [3][4] - The device leverages the natural anatomy of the ear to capture sound, distinguishing it from traditional hearing aids [3] Regulatory Status - The Acclaim cochlear implant received Breakthrough Device Designation from the U.S. FDA in 2019, indicating its potential to offer significant benefits over existing treatments [4]

Company Overview - Envoy Medical, Inc. is a hearing health company focused on fully implanted hearing devices, participating in the 37th Annual ROTH Conference from March 16-18, 2025 [1][2] Product Information - The Acclaim Cochlear Implant (Acclaim CI) is a first-of-its-kind fully implanted hearing device that utilizes a sensor to capture sound by leveraging the natural anatomy of the ear, rather than using a microphone [3] - The Acclaim CI is designed for adults with severe to profound sensorineural hearing loss, which is not adequately addressed by traditional hearing aids, and received Breakthrough Device Designation from the FDA in 2019 [4] - The Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) is the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing 24/7 hearing capability without external components [5][6] Conference Participation - The CEO and CFO of Envoy Medical will hold one-on-one meetings with investors and analysts at the ROTH Conference to discuss recent events and provide updates [2]

Core Viewpoint - Envoy Medical has secured additional patents for its innovative cochlear implant technologies, enhancing its intellectual property portfolio and positioning in the hearing health market [1][2][4]. Patent Developments - The US Patent & Trademark Office issued US Pat. No. 12,214,195 on February 4, 2025, for an Implantable Cochlear System with Inner Ear Sensor, which includes a cochlear electrode, stimulator, inner ear sensor, and signal processor [2]. - US Pat. No. 12,233,256 will be issued on February 25, 2025, focusing on adjustable stereo cochlear implant systems that allow for independent volume adjustments for each subsystem [3]. - The Japanese Patent Office granted three new patents on December 2 and 3, 2024, related to cochlear implant subsystems and lead characterization, all under the title Implantable Cochlear System with Integrated Components and Lead Characterization [4]. - The Hong Kong Patent Office granted HK Patent No. HK40097814 on January 3, 2025, for Programming of Cochlear Implant Accessories, facilitating easier pairing of accessory devices to cochlear implant systems [5]. Product Overview - The Acclaim Cochlear Implant is highlighted as a first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss, leveraging the natural anatomy of the ear for sound capture [6][7]. - The Acclaim CI received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [8].

Core Viewpoint - Envoy Medical has selected seven investigational sites for its pivotal clinical trial of the Acclaim® cochlear implant, with initial patient enrollment expected in Q1 2025 [2][3]. Company Overview - Envoy Medical, Inc. is a hearing health company focused on developing innovative solutions for hearing loss, specifically through its fully implanted Acclaim® cochlear implant [2][3]. Clinical Trial Details - The Investigational Device Exemption (IDE) for the Acclaim® cochlear implant study was approved by the FDA, which previously granted it Breakthrough Device Designation [3][10]. - The Acclaim CI is designed to be fully implanted without external components, utilizing the ear's natural anatomy for sound capture, allowing for all-day hearing with a multi-day rechargeable battery [3][9][10]. - The trial will involve seven cochlear implant centers, each with trained surgeons and audiologists dedicated to the study [5][6]. Study Sites - The selected investigational sites include: - Mayo Clinic, Rochester, Minnesota - Medical University of South Carolina, Charleston, South Carolina - University of Florida Health, Gainesville, Florida - Shohet Ear Associates, Seal Beach, California - Hearts for Hearing, Oklahoma City, Oklahoma - Center for Neurosciences, Tucson, Arizona - Cleveland Clinic Foundation, Cleveland, Ohio [6][7][8]. Product Differentiation - The Acclaim CI is positioned as a first-of-its-kind device aimed at addressing severe to profound sensorineural hearing loss, which is not sufficiently managed by traditional hearing aids [9][10].

Core Viewpoint - Envoy Medical, Inc. has announced the issuance of four new patents related to innovative hearing solutions, emphasizing its commitment to advancing technology in the hearing health industry [1][2][3][4][5]. Patent Announcements - The US Patent & Trademark Office issued US Patent No. 12,151,102 for a Combination Hearing Aid and Cochlear Implant System, focusing on updating transfer functions in cochlear implants to accommodate external hearing aids [2]. - The European Patent Office will grant European Patent No. 4255554, also for a Combination Hearing Aid and Cochlear Implant System, which includes a status indicator for external auditory devices [3]. - European Patent No. 4255555 will be granted for Cochlear Implant Stimulation Calibration, which involves calibrating current flow in cochlear implant systems [4]. - European Patent No. 4319866 will be granted for Cochlear Implant System with Electrode Impedance Diagnostics, allowing for the determination of impedance and stimulation parameters in cochlear implants [5]. Product Innovations - The Acclaim Cochlear Implant is highlighted as a first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss, leveraging the natural anatomy of the ear [6][7]. - The Acclaim CI received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [7]. - The Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) is noted as the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing continuous hearing without external components [9].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number - 001-40133 ENVOY MEDICAL, INC. | --- | --- | |----------------------------------------------------------------------------|--------------- ...

Exhibit 99.1 Envoy Medical Reports Third Quarter 2024 Results and Other Exciting Events FDA approval to begin pivotal trial of fully implanted cochlear implant and AMA approval of CPT codes for the Company's already FDA-approved fully implanted middle ear implant are two of the exciting developments for the growing company WHITE BEAR LAKE, Minn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing ...

The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) --  Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces that its Investigational Device Exemption (IDE) application for its pivotal study of the Acclaim® Fully Implanted Cochlear Implant has been approved by the U.S ...