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 ...

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]

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].