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].