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Envoy Medical Secures Three New Patents, Strengthening Leadership in Fully Implantable Hearing Technology
Newsfile· 2025-08-20 12:00
Envoy Medical Secures Three New Patents, Strengthening Leadership in Fully Implantable Hearing Technology August 20, 2025 8:00 AM EDT | Source: Envoy Medical, Inc. Patents issued in the U.S., Australia, and Hong Kong advance Envoy Medical's innovation pipeline and protect next-generation cochlear implant solutions for individuals living with hearing loss. White Bear Lake, Minnesota--(Newsfile Corp. - August 20, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on ...
Envoy Medical, Inc. (COCH) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2025-07-31 15:31
Envoy Medical, Inc. (COCH) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to a loss of $0.27 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -10.34%. A quarter ago, it was expected that this company would post a loss of $0.35 per share when it actually produced a loss of $0.29, delivering a surprise of +17.14%.Over the last four quarters, the company has ...
Envoy Medical(COCH) - 2025 Q2 - Quarterly Report
2025-07-31 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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. (Exact name of registrant as specified in its charter) (State or other jurisdiction of in ...
Envoy Medical(COCH) - 2025 Q2 - Quarterly Results
2025-07-31 12:25
● Strong momentum continues in the pivotal clinical trial of its investigational novel hearing device, the fully implanted Acclaim® cochlear implant. ● Successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical trial. ● All 10 of the study participants in the first stage of the Company's pivotal clinical trial have successfully completed their one- month follow-up visits. The visits are proceeding as expected and no ser ...
Envoy Medical to Present at the Life Sciences Virtual Investor Forum June 12th
GlobeNewswire News Room· 2025-06-11 12:30
WHITE BEAR LAKE, Minn., June 11, 2025 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announced that Brent Lucas, CEO of Envoy Medical, will present live at the Life Sciences Virtual Investor Frum hosted by VirtualInvestorConferences.com, on June 12th, 2025. DATE: June 12th TIME: 3pm Eastern LINK: REGISTER HERE Available for 1x1 meetings: June 12th throu ...
Envoy Medical's Pivotal Clinical Trial for Fully Implanted Acclaim(R) Cochlear Implant Remains On Track After First Month Follow-Up
Newsfile· 2025-06-10 12:30
Core Insights - Envoy Medical's pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant is progressing positively, with all 10 participants completing their one-month follow-up visits successfully [1][2][3] - The device allows participants to hear without externally worn devices, providing continuous hearing capability, and no serious adverse events have been reported [2][3] - The CEO of Envoy Medical expressed optimism about the trial's momentum and the potential for rapid market entry if the device receives approval [3] Company Overview - Envoy Medical, Inc. (NASDAQ: COCH) specializes in innovative hearing health technologies, focusing on fully implanted devices for hearing loss [5] - The company has previously launched the Esteem® active middle ear implant, which has been available in the U.S. since 2010, and is now advancing the Acclaim® cochlear implant [5] - The Acclaim CI is designed for individuals with severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA [8] Product Details - The Acclaim CI utilizes a sensor that leverages the ear's natural anatomy instead of a microphone, powered by a rechargeable battery [6][7] - The device is intended for adults deemed suitable candidates by qualified physicians and aims to address hearing loss inadequately managed by traditional hearing aids [8] - The Esteem FI-AMEI is highlighted as the only FDA-approved fully implanted hearing device for moderate to severe sensorineural hearing loss, offering 24/7 hearing without external components [9]
Envoy Medical Achieves Clinical Trial Milestone and is Optimistic About Expansion into Final Stage of Trial
Newsfile· 2025-05-13 13:15
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]
Envoy Medical(COCH) - 2025 Q1 - Quarterly Results
2025-05-01 20:44
Exhibit 99.1 Envoy Medical Reports on First Quarter 2025 Results Company Provides Update on its Pivotal Clinical Study for Fully Implanted Cochlear Implant WHITE BEAR LAKE, Minnesota--(Newsfile Corp. – May 1, 2025) – Envoy Medical, Inc. (Nasdaq: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial results for the first quarter ended March 31, 2025, as well as other subsequent events. Financial and Corporate Hi ...
Envoy Medical Reports on First Quarter 2025 Results
Newsfile· 2025-05-01 20:30
Core Insights - Envoy Medical reported its financial results for the first quarter of 2025, highlighting a decrease in net revenues and an increase in operating expenses, while also providing updates on its pivotal clinical study for the fully implanted Acclaim cochlear implant [1][4][5]. Financial Performance - Net revenues for the first quarter of 2025 were $46 thousand, a decrease of $13 thousand compared to $59 thousand in the same period of 2024 [4][19]. - Cost of goods sold increased by $73 thousand to $226 thousand, primarily due to increased headcount and supplier expenses [4][19]. - Research and development expenses rose by $400 thousand to $2.748 million, attributed to increased staffing in engineering and clinical departments [6][19]. - Sales and marketing expenses increased by $33 thousand to $358 thousand, driven by higher headcount and travel costs [7][19]. - General and administrative expenses decreased by $284 thousand to $1.821 million, mainly due to reduced legal fees [8][19]. - The company reported a net loss of $4.998 million for the quarter, an improvement from a net loss of $6.270 million in the prior year [19][20]. Clinical Study Update - The company secured an additional $10 million in funding to advance its pivotal clinical trial for the Acclaim cochlear implant [5]. - Enrollment of the first 10 participants in the trial was completed, with six participants activated and the remaining four expected to be activated in May [5]. - No serious adverse events or unexpected device effects have been reported, and follow-up visits have met expectations [5]. Cash Position - As of March 31, 2025, cash and cash equivalents were approximately $5.3 million, a decrease from $5.5 million at the end of 2024 [8][21]. Product Overview - The Acclaim cochlear implant is designed to address severe to profound sensorineural hearing loss and utilizes the ear's natural anatomy to capture sound, distinguishing it from traditional cochlear implants [9][10]. - The device received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the hearing health market [10].
Envoy Medical(COCH) - 2025 Q1 - Quarterly Report
2025-05-01 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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. (Exact name of registrant as specified in its charter) Delaware 86-1369123 (State or oth ...