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Here are 1-2 brief analogies for Envoy Medical (COCH):

• The Invisalign for hearing aids: Envoy Medical is developing fully implantable hearing devices, aiming to eliminate the need for external components, much like Invisalign offered an invisible alternative to traditional braces.
• A Tesla for fully implantable hearing devices: Envoy Medical represents an innovative, next-generation approach to hearing restoration, focusing on advanced, fully internal technology to disrupt the traditional hearing aid market.

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• Fully Implantable Acclarent Aera System: An investigational medical device designed as a fully implanted hearing solution for individuals with moderate to severe sensorineural hearing loss.

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Envoy Medical (symbol: COCH) primarily sells its medical devices and systems to other companies and organizations within the healthcare sector.

Due to the nature of its business and a diverse customer base, Envoy Medical does not publicly disclose specific names of individual hospitals, hospital systems, or other healthcare facilities as major customers that account for a significant portion of its revenue. Instead, it categorizes its customers as various types of healthcare providers. These customer organizations purchase Envoy Medical's products, such as the Acclarent AEX System and investigational neurosurgical devices, for use in patient care.

The primary categories of customer organizations for Envoy Medical include:

• Hospitals: This includes a wide range of medical centers, from local community hospitals to large university-affiliated and multi-hospital systems, where complex surgical procedures are performed. While specific customer names are not disclosed by Envoy Medical, examples of large publicly traded hospital systems in the U.S. (which operate numerous hospital facilities that could be customers) include HCA Healthcare (HCA), Universal Health Services, Inc. (UHS), and Tenet Healthcare Corporation (THC). Envoy Medical would sell to individual facilities within such systems or to independent hospitals.
• Ambulatory Surgical Centers (ASCs): These are specialized outpatient facilities where patients undergo surgical procedures that do not require an overnight hospital stay.
• Physician Offices and Clinics: Particularly those specializing in ear, nose, and throat (ENT) procedures or neurosurgery, where Envoy Medical's devices are utilized by medical professionals.

Envoy Medical also leverages distributors to reach its customer base, though specific major distributor partners are not named as major customers in its public filings.

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Brent Lucas, Chief Executive Officer, Director
Mr. Lucas has served as CEO of Envoy Medical since November 2015, bringing nearly two decades of direct experience with implanted medical devices in the hearing industry. He progressed from an intern to CEO and Board Member, holding various roles within the organization, including General Counsel and Business Development Manager. His family's investment in St. Croix Medical, the company's predecessor, dates back to 1995, indicating a deep personal commitment to the organization. He holds a Bachelor's from the University of St. Thomas and a JD from Mitchell Hamline School of Law.

Robert Potashnick, Interim Chief Financial Officer, Principal Accounting Officer
Mr. Potashnick was appointed interim CFO and Principal Accounting Officer effective June 23, 2025, serving on a fractional consultant basis through Oasis Business Consulting LLC. He has over 35 years of experience in corporate finance, with 18 years as CFO of publicly traded companies. He has previously served as CFO for ENDRA Life Sciences, Sionix, Voyant Technologies, and PowerHouse Technologies Group. Mr. Potashnick has founded and grown two companies in the bookkeeping, financial reporting, and compliance fields and has advised on more than 15 reverse mergers. His background includes finance and capital planning roles at UnitedHealth Group and a Certified Public Accountant at PricewaterhouseCoopers LLP. He holds a Bachelor of Arts in Economics from Northwestern University, a Master’s Degree in Accountancy from the University of Illinois, and an MBA in Finance and Strategy from DePaul University.

Karin Simonson, Vice President, General Counsel & Corporate Secretary
Ms. Simonson has been Envoy Medical's Vice President, General Counsel & Corporate Secretary since December 2023. Prior to this, she was General Counsel for Monarch Healthcare Management from April to December 2023. She has over 20 years of diverse in-house counsel experience, primarily focused on the medical device industry for the last 15+ years, supporting various functions including clinical, regulatory, sales, marketing, and compliance. Ms. Simonson holds a BS, magna cum laude, from the University of Minnesota-Twin Cities and a JD, magna cum laude, from Mitchell Hamline School of Law.

Tom Hoegh, Vice President, Research and Development
Mr. Hoegh brings over 30 years of experience in the medical device industry, specializing in the development and support of active implantable devices, including neuromodulation systems. He has led engineering teams at companies such as Nuvectra, ICU/Smiths Medical, Medtronic, and Apnex Medical. Mr. Hoegh holds dual Bachelor of Science degrees in Mechanical Engineering and Chemistry from Valparaiso University and a Master's in Technology Management from the University of St. Thomas.

Susan Kantor, Independent Director
A seasoned financial executive, Ms. Kantor served as Advisory Partner at PwC from 2011 to 2016 and as Partner, CFO & Treasurer at PRTM Management Consultants from 1997 to 2011. She has also held prior CFO roles at Monitor Group, BCG, and Parexel International. She was a board director and Audit Chair for Lionbridge Technologies, a $550M public company, until its sale to private equity in 2016. She chairs audit committees for several organizations and is a CPA in Massachusetts. Ms. Kantor holds a Bachelor's in Accounting and Business Administration from Grove City College.

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Envoy Medical (COCH) faces several significant risks to its business, primarily centered around product commercialization, regulatory hurdles, and financial stability.

1. Uncertainty of Reimbursement and Market Acceptance for Key Products: Envoy Medical's Esteem Active Middle Ear implant has struggled commercially due to its classification as a hearing aid by Medicaid, which typically precludes insurance coverage. Private insurance companies often align with Medicaid's reimbursement policies, making the device's approximately $25,000 cost prohibitive for many without coverage. The company is seeking legislative reclassification to secure broader reimbursement, but success is not guaranteed. Similarly, while the Acclaim cochlear implant has "Breakthrough Device" status and is undergoing clinical trials, its market acceptance and demand are yet to be proven, with historical demand for similar devices being low.
2. Financial Challenges and Need for Additional Capital: Envoy Medical has consistently reported increasing operating and net losses, leading to a substantial accumulated deficit. Although the company recently eliminated a significant debt, it anticipates continued net losses due to high research and development (R&D) and marketing expenses. The company's current cash reserves are projected to sustain operations for a limited time, highlighting an ongoing need for additional funding to support its product development and commercialization efforts. Furthermore, the company's poor financial performance and negative margins pose a risk of Nasdaq delisting.
3. Regulatory Delays for Acclaim Cochlear Implant: The successful commercialization of Envoy Medical's Acclaim cochlear implant is crucial for its future. The device is currently in clinical trials, with an estimated FDA approval by late 2027. Any delays in the FDA approval process, or a failure to obtain approval, would be costly and severely impact the company's ability to generate future revenue. The unpredictability of the medical device regulatory process is a consistent risk for the company.

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Gene Therapy and Regenerative Medicine for Hearing Restoration: This represents a fundamental emerging threat to device-based solutions for hearing loss. Instead of bypassing damaged auditory structures with an implant, gene therapy and regenerative medicine aim to repair or regrow these structures (e.g., hair cells) to restore natural hearing biologically. Numerous companies and research institutions are actively investing in and developing therapies that could potentially offer a biological "cure" for certain types of hearing loss. If successful and widely adopted, these technologies could render electro-mechanical hearing implants obsolete for future generations of patients, fundamentally shifting the treatment paradigm away from implanted medical devices.

Advanced AI-Enhanced Non-Implantable Hearing Solutions and OTC Market Expansion: The market for non-implantable hearing assistance is undergoing significant evolution. The introduction of over-the-counter (OTC) hearing aids has increased accessibility and competition. Crucially, ongoing innovation in traditional and OTC hearing aids, particularly the integration of Artificial Intelligence (AI) for sophisticated sound processing, personalized profiles, and enhanced noise reduction, is significantly improving their efficacy. While Envoy Medical's Acclaim system targets severe-to-profound hearing loss, the continuous advancement of less-invasive, AI-powered non-surgical options could increasingly address a broader spectrum of hearing loss, potentially delaying or even negating the need for implantable devices for some patients who might otherwise progress to them. This trend could reduce the long-term addressable market for surgical hearing solutions.

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Envoy Medical (COCH) offers two main products: the Esteem active middle ear implant and the Acclaim cochlear implant.

Esteem Active Middle Ear Implant

• The global middle ear implants market size was valued at approximately $1.2 billion in 2024 and is projected to reach $2.7 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 9.6%.
• North America holds a significant share, with the United States leading the market.

Acclaim Cochlear Implant

• The global cochlear implants market size was valued at approximately $2.19 billion in 2023 and is projected to grow to $8.06 billion by 2032, exhibiting a CAGR of 15.6%.
• In the United States, there are an estimated 2.8 million adults who are potential candidates for cochlear implants. Envoy Medical estimates the U.S. market opportunity for cochlear implants to exceed $750 million annually by 2026, with an estimated 25,000 to 30,000 adults receiving implants each year. North America dominated the global cochlear implants market in 2023.

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Expected Drivers of Future Revenue Growth for Envoy Medical (COCH)

Over the next 2-3 years, Envoy Medical (COCH) is expected to drive future revenue growth through several key initiatives focused on product development, market access, and strategic expansion:

1. Commercialization of the Acclaim® Cochlear Implant: Envoy Medical is currently conducting a pivotal clinical trial for its fully implanted Acclaim® cochlear implant, with significant patient interest reported by investigational sites. Obtaining FDA approval and subsequently commercializing this breakthrough device is anticipated to be a major revenue driver, positioning the company to potentially transform the hearing implant industry.
2. Enhanced Reimbursement for the Esteem® Fully Implanted Active Middle Ear Implant: The establishment of new Category III CPT codes for totally implantable active middle ear implants, effective July 2025, is expected to enhance the potential for meaningful reimbursement for patients. This, along with ongoing efforts to secure Medicare coverage through initiatives like the Hearing Device Coverage Clarification Act, is anticipated to expand patient access and create a more favorable commercial environment for the Esteem® device, driving broader adoption and substantial business opportunities.
3. Strategic Growth Initiatives and Market Expansion: Envoy Medical is directing capital towards strategic growth initiatives, and there is market speculation about new strategic partnerships that could strengthen its industry position. Reports also suggest robust demand for Envoy Medical's latest product in emerging healthcare markets and a collaboration with a major pharmaceutical company, which could lead to increased market share and revenue growth.
4. Expansion of Intellectual Property Portfolio: The company has been consistently increasing its portfolio of patents and intellectual property. A stronger and broader intellectual property portfolio can provide a competitive advantage, protect future innovations, and potentially open avenues for licensing agreements, contributing to long-term revenue growth.

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Capital Allocation Decisions for Envoy Medical (COCH)

Share Repurchases

• Envoy Medical reported proceeds from the repurchase of equity totaling $63,000 as of December 30, 2024.

Share Issuance

• In October 2025, Envoy Medical closed a registered direct offering, selling 3,007,524 shares of Class A common stock at $1.33 per share, which generated approximately $4.0 million in gross proceeds.
• Concurrently, in October 2025, the company issued unregistered warrants to purchase up to 9,022,572 shares of Class A common stock at an exercise price of $1.33 per share, with the potential to raise an additional $12 million if fully exercised.
• In September 2025, Envoy Medical completed a registered direct offering of 1,908,402 shares of Class A common stock at $1.31 per share, resulting in approximately $2.5 million in gross proceeds, along with warrants that could provide an additional $7.5 million if fully exercised.

Inbound Investments

• During the first quarter of 2025, Envoy Medical secured an additional $10 million in funding specifically to advance its pivotal clinical trial.
• On June 26, 2025, the company drew the remaining $5,000,000 of available principal under a promissory note with GAT Funding, LLC.
• Recent equity capital raises and debt extinguishment have significantly increased the company's stockholders' equity.

Capital Expenditures

• In the last 12 months, as of November 4, 2025, capital expenditures amounted to -$88,000.
• FDA approval for the expansion of its pivotal Acclaim® cochlear implant trial is expected to reduce anticipated capital needs by $10 million to $15 million.
• Proceeds from recent offerings are intended for working capital and general corporate purposes, including the ongoing cochlear implant trial.