Core Viewpoint - Envoy Medical, a hearing health company, is set to participate in the Small Cap Growth Virtual Investor Conference on February 5, 2026, highlighting its commitment to innovation in hearing solutions [1]. Group 1: Company Overview - Envoy Medical (NASDAQ: COCH) specializes in innovative technologies for hearing loss, offering fully implanted devices such as the Esteem® active middle ear implant, available in the U.S. since 2010, and the investigational Acclaim® cochlear implant [2]. Group 2: Event Details - The Small Cap Growth Virtual Investor Conference will take place on February 5, 2026, at 10:00 A.M. ET, featuring a presentation followed by a real-time Q&A session for investors [1]. - A recording of the event will be accessible on Envoy's Investor Relations website for those unable to attend the live session [1].

As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- (State or other jurisdiction of incorporation or organization) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...

Core Insights - Envoy Medical will host a fireside chat featuring CEO Brent Lucas and Craig Eggert, the first patient to receive the Acclaim cochlear implant, on December 11, 2025, at 4:30 P.M. ET [1][2] Company Overview - Envoy Medical, listed on NASDAQ as COCH, is a hearing health company focused on innovative technologies for hearing loss, including fully implanted devices like the Esteem active middle ear implant and the investigational Acclaim cochlear implant [3][4] - The Acclaim cochlear implant is designed to address severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA in 2019 [5] Product Details - The Acclaim cochlear implant utilizes a sensor that leverages the natural anatomy of the ear to capture sound, distinguishing it as a first-of-its-kind hearing device [4] - The Esteem fully implanted active middle ear implant is the only FDA-approved device for adults with moderate to severe sensorineural hearing loss, providing continuous hearing without the need for external components [7]

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

Core Insights - Envoy Medical experienced a transformational third quarter in 2025, significantly improving its financial position by eliminating $32 million in debt and strengthening its balance sheet [2][5][6] - The company received FDA approval to expand its pivotal clinical trial to the final stage, which is expected to enhance its market position in fully implanted hearing solutions [2][8] - Envoy Medical's net revenue for the third quarter was $42 thousand, a decrease from $56 thousand in the same period of 2024 [5][17] Financial Highlights - Research and Development (R&D) expenses decreased by $57 thousand to $2.7 million compared to the same quarter in 2024, as the company transitioned from development to clinical trial phases [5][17] - General and administrative expenses increased by $752 thousand, primarily due to public company costs and expenses related to a September 2025 offering [5][17] - As of September 30, 2025, the company had approximately $3.556 million in cash, down from $5.483 million at the end of 2024 [6][15] Operational Developments - The company continued to receive additional global patents in the U.S., Europe, and Australia, reinforcing its position as a market leader in fully implanted hearing solutions [2][7] - The Acclaim Cochlear Implant, an investigational device, is designed to address severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA [8][9] Market Position - Envoy Medical aims to capitalize on its first-mover advantage in the fully implanted hearing solutions market, with ongoing interest in its cochlear implant trial [2][8] - The company is dedicated to advancing hearing technology to improve access and quality of life for individuals with hearing loss [7][8]

Core Insights - Envoy Medical has enrolled the first three patients in the final stage of the pivotal clinical trial for the Acclaim® cochlear implant, indicating strong market interest and potential for commercialization [1][3][4] Company Overview - Envoy Medical, Inc. is a hearing health company focused on innovative technologies for hearing loss, including the fully implanted Acclaim® cochlear implant and the Esteem® active middle ear implant [5][6] - The Acclaim cochlear implant is designed to operate without external components, utilizing a novel sensor to capture sound, which differentiates it from traditional cochlear implants [2][6] Clinical Trial Progress - The final stage of the clinical trial will involve a total of 46 patients, with 43 spots remaining after the initial three enrollments [3] - The trial is being conducted at seven investigational sites across the United States, with additional surgeries already scheduled and many potential participants in the screening process [3][4] Market Demand - There is significant demand for the fully implanted cochlear device, as indicated by the rapid patient enrollment and interest from individuals with severe hearing loss [3][4] - The CEO of Envoy Medical emphasized the urgency to meet patient needs and the strong product-market fit, which could lead to faster FDA submission and commercialization [3][4] Regulatory Status - The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a pivotal clinical trial [4][7]

As filed with the U.S. Securities and Exchange Commission on October 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3842 86-1369123 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 4875 White Bear P ...

As filed with the U.S. Securities and Exchange Commission on October 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3842 86-1369123 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 4875 White Bear P ...

Core Insights - The article highlights significant advancements in clinical trials for biotech and medical tech companies, particularly focusing on Aethlon Medical, Envoy Medical, Soligenix, and MBX Biosciences, showcasing their recent progress and milestones in the sector [3][4]. Aethlon Medical, Inc. - Aethlon Medical is conducting an ongoing oncology clinical trial in Australia, evaluating the Hemopurifier in cancer patients unresponsive to anti-PD-1 therapy, with preliminary observations showing encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after treatment [5][7]. - In the initial cohort of three patients, decreases in seven out of ten examined microRNAs were noted, indicating potential effects on cancer growth and metastasis [6][8]. - The study's small sample size limits the ability to draw definitive conclusions about clinical efficacy or dose response, with further data needed from subsequent cohorts [11][12]. Envoy Medical, Inc. - Envoy Medical received FDA approval to expand its pivotal clinical trial for the Acclaim® cochlear implant, based on promising data from the first ten patients, allowing for a shortened timeline to commercialization by three to six months [13][14]. - The initial trial phase showed no serious adverse events, and the data indicated that the Acclaim® cochlear implant can achieve effectiveness for its intended use [16]. Soligenix, Inc. - Soligenix's confirmatory Phase 3 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) has concluded its first Data Monitoring Committee meeting, confirming no safety concerns and an acceptable safety profile consistent with prior studies [17][18]. - The company anticipates providing updates on enrollment progress and response rates before year-end, with topline results expected in the second half of 2026 [19]. MBX Biosciences, Inc. - MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint with statistical significance in its Phase 2 Avail™ trial for chronic hypoparathyroidism, with 63% of treated patients meeting the primary composite endpoint [21][22]. - The company plans to initiate a Phase 3 clinical trial in 2026, building on the positive results from the Phase 2 trial, which demonstrated the potential for canvuparatide to become a best-in-class treatment for hypoparathyroidism [23][24].