Envoy Medical to Host Fireside Chat with CEO Brent Lucas and the First Acclaim(R) Cochlear Implant PatientEvent to Take Place December 11th at 4:30 P.M. ETDecember 04, 2025 8:00 AM EST | Source: Envoy Medical, Inc.White Bear Lake, Minnesota--(Newsfile Corp. - December 4, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it will host a fireside chat on Thursday, December 11, ...

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]

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].

Group 1: Galecto, Inc. - Galecto, Inc. experienced a stock price surge of 511.59%, reaching $22.69, with trading volumes exceeding 70 million shares, driven by promising developments in its lead product candidates [1][6] - The company focuses on developing treatments for fibrosis, cancer, inflammation, and other diseases, with specific candidates like GB2064 for myelofibrosis and GB0139 for severe fibrotic lung diseases [1] Group 2: Trilogy Metals Inc. - Trilogy Metals Inc. saw its stock price increase by 237.8% to $7.06, with nearly 180 million shares traded, reflecting investor optimism in the base metals sector [2][6] - The surge was influenced by the Trump administration's decision to invest in the Canadian mining company, part of a broader strategy for national security [2] Group 3: Envoy Medical, Inc. - Envoy Medical, Inc. had significant stock gains, with COCH increasing by 88.53% to $1.52 and COCHW rising by 212.25% to $0.10, on trading volumes of over 137 million and approximately 843,111 shares, respectively [3][6] - The company received FDA approval to advance its pivotal clinical trial for the Acclaim® cochlear implant, allowing for an accelerated timeline and reduced capital needs by $10 to $15 million [3] Group 4: Zeta Network Group - Zeta Network Group's stock price climbed 88.55% to $3.13, with over 140 million shares traded, driven by its innovative approach to online entertainment and music education services [4] Group 5: Market Dynamics - The significant price changes and trading volumes across these companies reflect a dynamic market environment, with active investor responses to company developments and technological advancements [5]

Core Insights - Envoy Medical has made significant progress in the third quarter of 2025, focusing on redefining hearing health with fully implanted devices as the standard of care [2][3] Financial Developments - The company eliminated over $32 million in debt, simplifying its capital structure and enhancing shareholder equity [4][3] - This debt elimination allows for a greater focus on strategic growth initiatives to drive shareholder value [5] Patent and Intellectual Property Expansion - Envoy Medical has expanded its global patent portfolio, now holding approximately 38 granted US patents and 40 foreign patents, with seven new patents secured recently [6][3] - The company has solidified its ownership of the "Invisible Hearing" trademark in Australia, complementing existing registrations in the US, UK, and Europe [8][6] Clinical Trial Progress - The pivotal clinical trial for the Acclaim® cochlear implant is progressing as planned, with all 10 patients in the first stage reaching their three-month follow-up visits without serious adverse events [13][3] - The company aims to submit its Premarket Approval (PMA) application to the FDA in 2027 [13] Reimbursement Strategy - New Category III CPT codes for totally-implantable active middle ear implants, including the Esteem® device, took effect on July 1, 2025, enhancing reimbursement potential [16][3] - Positive changes in reimbursement for the Esteem® device could drive broader adoption and create substantial business opportunities for Envoy Medical [17][16] Public Health Impact - Untreated hearing loss is linked to increased dementia risk, emphasizing the importance of timely intervention and the role of Envoy Medical's solutions in supporting long-term brain health [18][19] - The company's fully implanted solutions aim to provide reliable hearing without external devices, addressing both hearing restoration and public health concerns [19] Future Outlook - Envoy Medical is entering the final quarter of 2025 with a strengthened balance sheet, an expanded intellectual property portfolio, and clinical trial momentum, indicating a bright future [20][3] - The company remains committed to redefining hearing health and delivering long-term value to shareholders [21]

Core Insights - Envoy Medical has secured three new patents in the U.S., Australia, and Hong Kong, enhancing its leadership in fully implantable hearing technology [2][3][6] - The patents are aimed at advancing next-generation cochlear implant solutions, providing patients with a discreet and continuous hearing experience [2][3] Patent Details - U.S. Patent No. 12,390,634 relates to a fully implantable modular cochlear implant system that includes a signal processor and an implantable battery or communication module [3] - Australian Patent No. 2022254630 focuses on electrode impedance diagnostics in cochlear implant systems, determining stimulation parameters based on impedance [3] - Hong Kong Patent No. 40101898 pertains to cochlear implant stimulation calibration, adjusting current flow based on testing circuit outputs [3] Company Vision and Strategy - The CEO of Envoy Medical, Brent Lucas, emphasized that the new patents are critical for redefining hearing restoration solutions and expanding the company's global patent portfolio [3][6] - The company aims to eliminate daily limitations faced by millions with hearing loss through innovative, fully implantable solutions [3][6] Product Overview - Envoy Medical's Acclaim Cochlear Implant is designed for severe to profound sensorineural hearing loss and is the first fully implanted cochlear implant [8] - The Esteem fully implanted active middle ear implant is the only FDA-approved device of its kind, providing 24/7 hearing capability without external components [9]

Core Insights - Envoy Medical reported positive progress in its clinical trials for the Acclaim® cochlear implant, with all 10 participants successfully activated and no serious adverse events reported [3][7] - The company anticipates significant market interest for the Acclaim® implant, which is positioned to disrupt the current hearing device market [3] - Changes in reimbursement policies for the Esteem® device could enhance market opportunities, as it is already FDA approved and unique in the marketplace [4] Financial Performance - Net revenues for the second quarter of 2025 increased by $10 thousand compared to the same period in 2024, reaching $78 thousand [5][20] - Research and development expenses decreased by $0.1 million to $2.485 million, reflecting a shift from development to clinical trials [6] - General and administrative expenses rose by $0.5 million, primarily due to a severance accrual [8] Clinical and Regulatory Developments - The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [12] - Five new Category III CPT codes for fully implantable active middle ear implants were approved, effective July 1, 2025, which may facilitate market adoption [7][16] - Envoy Medical was granted two new patents in the US and three in Australia, strengthening its intellectual property portfolio [7] Cash Flow and Financial Position - As of June 30, 2025, the company had approximately $5.3 million in cash [8] - The total liabilities increased to $39.759 million from $30.380 million at the end of 2024, indicating a rise in financial obligations [19] - The net loss for the second quarter was $5.690 million, compared to a loss of $3.947 million in the same quarter of the previous year [21]

Company Overview - Envoy Medical, Inc. is a hearing health company focused on fully implanted hearing devices that utilize the ear's natural anatomy [6] - The company has developed unique devices such as the Esteem® active middle ear implant and the investigational Acclaim® cochlear implant [6][8] Recent Developments - Brent Lucas, CEO of Envoy Medical, will present at the Life Sciences Virtual Investor Forum on June 12, 2025, allowing real-time interaction with investors [1][2] - The Acclaim CI has received Breakthrough Device Designation from the FDA in 2019 and is designed for severe to profound sensorineural hearing loss [8] Clinical Trials - Envoy Medical's pivotal clinical trial for the Acclaim CI is on track after the first month follow-up, with optimism about progressing to the final stage of the trial [9] Product Features - The Acclaim CI is a first-of-its-kind device that captures sound using the ear's natural anatomy and is powered by a rechargeable battery [7] - The Esteem FI-AMEI is the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, offering continuous hearing without external components [11]

Core Insights - Envoy Medical has successfully activated all 10 study participants' fully implanted Acclaim cochlear implants in the first stage of its pivotal clinical trial, marking a significant milestone [1] - The company is optimistic about expanding the study into the second and final stage during the fourth quarter of 2025, driven by reported interest from individuals with significant hearing loss [2] - 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 [4] Company Overview - Envoy Medical focuses on fully implanted hearing devices that utilize the ear's natural anatomy, distinguishing its technology from traditional hearing aids [3] - The Acclaim cochlear implant is a first-of-its-kind device that aims to provide a solution for individuals whose hearing loss is not adequately addressed by conventional hearing aids [4] Market Potential - There is significant pent-up demand for fully implanted cochlear implants, indicating a strong market opportunity for Envoy Medical as it progresses through clinical trials [2] - The Esteem fully implanted active middle ear implant is currently the only FDA-approved device for adults with moderate to severe sensorineural hearing loss, highlighting the competitive landscape in the hearing device market [5]