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, ...

Investors might want to bet on Envoy Medical, Inc. (COCH) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a chang ...

Core Insights - Envoy Medical has secured a new U.S. patent for an innovative cochlear implant system that features a removable earplug sensor and an implanted battery, reinforcing its leadership in next-generation cochlear implant technology [1][2][3] Company Developments - The newly granted patent, titled "Combination Implant System with Removable Earplug Sensor and Implanted Battery," enhances Envoy Medical's intellectual property portfolio and covers systems that include an implantable subsystem with a stimulator and rechargeable energy storage [2][3] - The patent supports the company's long-term innovation strategy and aims to protect future advancements in implanted technologies, not just current devices [3] - Envoy Medical is making positive progress in its pivotal Acclaim® Cochlear Implant clinical trial, which has received Breakthrough Device Designation from the FDA in 2019 [3][4][8] Product Information - The Acclaim Cochlear Implant is designed for individuals with severe to profound sensorineural hearing loss and utilizes a sensor that leverages the natural anatomy of the ear instead of a microphone [7][8] - The Esteem® fully implanted active middle ear implant is another innovative product from Envoy Medical, which has been commercially available in the U.S. since 2010 and allows for continuous hearing without external components [5][9]

Core Insights - Envoy Medical, Inc. reported a quarterly loss of $0.35 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.27, representing an earnings surprise of -29.63% [1] - The company generated revenues of $0.04 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 23.64% [2] - Envoy Medical's shares have declined approximately 50.9% year-to-date, contrasting with the S&P 500's gain of 14.4% [3] Financial Performance - The company has surpassed consensus EPS estimates only once in the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.30 on revenues of $0.06 million, and for the current fiscal year, it is -$1.17 on revenues of $0.2 million [7] Market Outlook - The earnings outlook and estimate revisions trend for Envoy Medical were favorable prior to the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The Medical - Instruments industry, to which Envoy Medical belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a positive industry outlook [8]

Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $6,482, compared to a net loss of $5,960 for the same period in 2024, and for the nine months ended September 30, 2025, the net loss was $17,170, compared to $16,177 in 2024[144]. - The company has an accumulated deficit of $305,659 as of September 30, 2025, up from $284,734 as of December 31, 2024[144]. - Net revenues for the three months ended September 30, 2025, were $42, a decrease of $14 or 25.0% compared to $56 in the same period of 2024[186]. - Net revenues decreased by $17, or 9.3%, for the nine months ended September 30, 2025, compared to the same period in 2024[198]. - Cash used in operating activities was $12,516 for the nine months ended September 30, 2025, primarily funding a net loss of $17,170[214]. - As of September 30, 2025, the company had $3,556 in cash, down from $5,483 at the end of 2024[209]. Clinical Trials and Regulatory Approvals - The FDA granted the Investigational Device Exemption (IDE) for the Acclaim CI in October 2024, allowing the company to begin a pivotal clinical study[140]. - The first stage of the clinical trial included 10 participants, and the FDA approved the expansion to a total of 56 participants on October 3, 2025[141][147]. - The second stage of the clinical trial for the Acclaim CI is currently underway, with the first three patients enrolled by October 31, 2025[148]. - The company anticipates obtaining FDA's decision on the Premarket Approval application in the second half of 2027, assuming no panel review is requested[142]. - The company is targeting FDA approval for the Acclaim CI in the second half of 2027 or first half of 2028[166]. Expenses and Costs - Cost of goods sold increased by $16 to $203 for the three months ended September 30, 2025, primarily due to increased material waste[188]. - Research and development expenses for the three months ended September 30, 2025, were $2,700, a slight decrease of $57 or 2.1% from $2,757 in 2024[186]. - General and administrative expenses rose by $752 or 44.5% to $2,442 for the three months ended September 30, 2025, compared to $1,690 in 2024[186]. - The operating loss for the three months ended September 30, 2025, was $5,708, an increase of $736 or 14.8% from a loss of $4,972 in 2024[186]. - The company expects R&D expenses to continue increasing as it initiates clinical trials for the Acclaim CI product[175]. - R&D expenses for the nine months ended September 30, 2025, increased by $225, with personnel costs up 5.2% and other R&D costs up 107.2%[200]. - Total costs and operating expenses increased by $1,161, or 7.8%, with general and administrative expenses rising by 17.7%[197]. Financing Activities - The company entered into a Securities Purchase Agreement on September 22, 2025, to issue 1,908,402 shares of Common Stock at a price of $1.31 per share[154]. - The September 2025 Offering generated gross proceeds of $2,500, with potential additional proceeds of $7,500 if warrants are fully exercised[156]. - The October 2025 Offering resulted in gross proceeds of $4,000, with potential additional proceeds of $12,000 from warrant exercises[160]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $10,593, resulting from proceeds from the issuance of Term Loans of $10,000[217]. Market and Economic Conditions - The company received a deficiency notification from Nasdaq regarding non-compliance with the market value listing requirement, with a grace period until February 23, 2026, to regain compliance[149][152]. - Macroeconomic conditions, including global conflicts and inflation, are impacting the company's financial performance and capital raising ability[162]. - The company is exposed to inflation risk, which may adversely affect operating results if selling prices do not increase in line with rising costs[237]. Miscellaneous - The gain from the change in the fair value of the forward purchase agreement warrant liability was $64, compared to a loss of $311 in the prior year[192]. - There were no customers accounting for 10% or more of sales for the three and nine months ended September 30, 2025 and 2024, indicating a diversified customer base[236]. - The company has not had any off-balance sheet arrangements during the periods presented, ensuring transparency in financial reporting[220]. - The estimated cost per unit for the product warranty is $6, with an average battery life of five years, impacting the liability recorded[229]. - The company has not experienced any material differences between accrued costs and actual costs incurred since inception, indicating effective cost estimation practices[227].

Financial Performance - Third quarter net revenue was $42,000 for the three months ended September 30, 2025 [10]. - Net revenues for the three months ended September 30, 2025, were $42,000, a decrease of 25% compared to $56,000 for the same period in 2024 [20]. - The operating loss for the three months ended September 30, 2025, was $(5,708,000), compared to $(4,972,000) for the same period in 2024, reflecting a 14.7% increase in losses [20]. - Net loss attributable to common stockholders for the nine months ended September 30, 2025, was $(20,925,000), compared to $(20,287,000) in 2024, indicating a 3.2% increase in losses [20]. - Cash flows from operating activities resulted in a net cash used of $(12,516,000) for the nine months ended September 30, 2025, slightly improved from $(12,858,000) in 2024 [21]. - The company reported cash and cash equivalents of $3,556,000 at the end of the period, down from $4,424,000 at the end of September 2024 [21]. - The net loss per share attributable to common stockholders for the nine months ended September 30, 2025, was $(0.97), an improvement from $(1.09) in 2024 [20]. Expenses - R&D expenses decreased by $57,000 to $2.7 million compared to the same period in 2024, as the company transitioned from development to clinical trial phase [10]. - General and administrative expenses increased by $752,000 primarily due to public company costs and expenses related to a September 2025 offering [10]. - Total costs and operating expenses for the nine months ended September 30, 2025, increased to $16,051,000, up 7.8% from $14,890,000 in 2024 [20]. - Research and development expenses for the nine months ended September 30, 2025, were $7,933,000, an increase of 2.9% from $7,708,000 in 2024 [20]. - The company issued $10,000,000 in Term Loans (related party) during the nine months ended September 30, 2025, compared to $15,000,000 in 2024 [21]. Debt and Liabilities - Envoy Medical extinguished over $32 million in debt, significantly improving its balance sheet and stockholder's equity [4]. - Total liabilities decreased from $30.38 million in December 2024 to $15.71 million as of September 30, 2025 [19]. Clinical and Regulatory Developments - The company received FDA approval to expand its pivotal clinical trial to the final stage based on promising three-month data [5]. - The first three patients were enrolled in the final stage of the pivotal clinical trial for the fully implanted Acclaim cochlear implant [5]. - The company marked the three-year anniversary of the first successful implantation of its fully implanted cochlear implant [5]. - Envoy Medical secured four new global patents and expanded its patent portfolio with additional patents in the U.S., Europe, and Australia [5].

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 Viewpoint - The market anticipates Envoy Medical, Inc. (COCH) to report a year-over-year increase in earnings despite flat revenues for the quarter ending September 2025, with actual results being crucial for stock price movement [1][2]. Earnings Expectations - The consensus EPS estimate for Envoy Medical is a loss of $0.27 per share, reflecting a year-over-year change of +27% [3]. - Revenues are projected to remain unchanged at $0.06 million compared to the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 9.09% higher in the last 30 days, indicating a positive reassessment by analysts [4]. - The Most Accurate Estimate is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +11.11%, suggesting a bullish outlook on earnings [12]. Earnings Surprise Prediction - A positive Earnings ESP is a strong indicator of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [10]. - Envoy Medical holds a Zacks Rank of 2, enhancing the likelihood of beating the consensus EPS estimate [12]. Historical Performance - In the last reported quarter, Envoy Medical was expected to post a loss of $0.29 per share but actually reported a loss of -$0.32, resulting in a surprise of -10.34% [13]. - Over the past four quarters, the company has only beaten consensus EPS estimates once [14]. Industry Context - In the Zacks Medical - Instruments industry, 908 Devices Inc. is expected to report a loss of $0.13 per share for the same quarter, indicating a year-over-year change of +43.5% [18]. - 908 Devices' revenue is projected to decline by 19% to $13.58 million, with a consensus EPS estimate revised 6.3% lower, resulting in an Earnings ESP of -18.42% [19][20].

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 Viewpoint - Envoy Medical, Inc. (COCH) has shown a downtrend recently, losing 5.2% over the past week, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with the formation suggesting that selling pressure may be exhausting [2][5]. - A hammer pattern typically forms when a stock opens lower, makes a new low, but then finds support and closes near its opening price, signaling a potential reversal in control from bears to bulls [4][5]. Fundamental Analysis - There is rising optimism among Wall Street analysts regarding COCH's future earnings, with a 6.6% increase in the consensus EPS estimate over the last 30 days, indicating a stronger earnings outlook than previously predicted [8][9]. - COCH holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperform the market [9][10]. - The upward trend in earnings estimate revisions is a bullish indicator, as empirical research shows a strong correlation between these revisions and near-term stock price movements [7][8].