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'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]

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]

[First Quarter 2025 Highlights and Business Overview](index=1&type=section&id=First%20Quarter%202025%20Highlights%20and%20Business%20Overview) Envoy Medical reported positive Q1 2025 clinical study progress for its Acclaim CI and detailed its fully implanted hearing device portfolio [Company Overview and CEO Commentary](index=1&type=section&id=Company%20Overview%20and%20CEO%20Commentary) Envoy Medical, a hearing health company focused on fully implanted hearing devices, announced its Q1 2025 corporate and financial results - Envoy Medical (Nasdaq: COCH) is a revolutionary hearing health company focused on fully implanted hearing devices[2](index=2&type=chunk) - CEO Brent Lucas reported positive progress in the pivotal clinical study for the fully implanted Acclaim cochlear implant, noting quick and efficient enrollment of the first 10 patients and excitement from investigational sites[4](index=4&type=chunk) - The company believes a meaningful percentage of cochlear implant candidates will be drawn to a fully implanted solution that uses the ear to pick up sound, does not have an implanted magnet, and offers multiple days of battery life[4](index=4&type=chunk) [Corporate and Clinical Study Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Study%20Highlights) Envoy Medical secured an additional $10 million in funding to advance its pivotal clinical trial for the Acclaim cochlear implant - Secured additional **$10 Million in funding** to advance the Pivotal Clinical Trial[6](index=6&type=chunk) - Completed Enrollment of **10 participants** in the 'first stage' of the Pivotal Clinical Trial of the fully implanted Acclaim cochlear implant[6](index=6&type=chunk) - Activated **six of 10 participants**, with the remaining four due to be activated in May; two participants completed 1-Month Follow-Up visits[6](index=6&type=chunk) - No reports of Serious Adverse Events or Unanticipated Adverse Device Effects[6](index=6&type=chunk) - Modifications and mitigations put in place between the Early Feasibility Study and Pivotal Clinical Trial appear to address previously discussed electrical system noise[6](index=6&type=chunk) [Product Portfolio](index=2&type=section&id=Product%20Portfolio) Envoy Medical's product portfolio includes the fully implanted Acclaim Cochlear Implant (Acclaim CI) and the FDA-approved Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) - The fully implanted Acclaim Cochlear Implant (Acclaim CI) is a first-of-its-kind hearing device designed to leverage the natural anatomy of the ear to capture sound[10](index=10&type=chunk) - The Acclaim CI is designed to address severe to profound sensorineural hearing loss and received Breakthrough Device Designation from the U.S. FDA in 2019; it is currently an investigational device[11](index=11&type=chunk)[12](index=12&type=chunk) - The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing 24/7 invisible hearing without external components[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 saw decreased net revenues, increased operating expenses, a widened stockholders' deficit, and improved operating cash flow [Summary of Financial Performance](index=1&type=section&id=Summary%20of%20Financial%20Performance) Envoy Medical reported a slight decrease in net revenues for Q1 2025, primarily due to supply chain limitations affecting battery replacement sales - Net revenues decreased by **$13 thousand** for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to a decrease in Battery replacement sales from supply chain limitations[5](index=5&type=chunk) - Cost of goods sold increased by **$73 thousand**, mainly due to increased headcount for Esteem FI-AMEI production, new supplier expenses, and an inventory reserve adjustment[5](index=5&type=chunk) - R&D expenses increased by **$400 thousand**, driven by increased headcount and contractors in engineering and clinical departments for the Acclaim CI pivotal clinical study, including site start-up costs[7](index=7&type=chunk) - Sales and marketing expenses increased by **$33 thousand** due to increased headcount, travel, and a patient engagement program, partially offset by reduced legal and professional fees[8](index=8&type=chunk) - General and administrative expenses decreased by **$284 thousand**, primarily due to reduced legal fees and professional service costs[9](index=9&type=chunk) - Cash and cash equivalents were approximately **$5.3 million** as of March 31, 2025[9](index=9&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets ($ in thousands) | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :---------------------------------- | :------------------------- | :------------------ | | Cash | $5,312 | $5,483 | | Total current assets | $8,312 | $9,384 | | Total assets | $10,385 | $11,538 | | Total current liabilities | $7,595 | $7,538 | | Term loans payable (related party) | $23,106 | $18,716 | | Total liabilities | $34,609 | $30,380 | | Total stockholders' deficit | $(24,224) | $(18,842) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss ($ in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net revenues | $46 | $59 | | Cost of goods sold | $226 | $153 | | Research and development | $2,748 | $2,360 | | Sales and marketing | $358 | $325 | | General and administrative | $1,821 | $2,105 | | Total costs and operating expenses | $5,153 | $4,943 | | Operating loss | $(5,107) | $(4,884) | | Change in fair value of publicly traded warrant liability | $194 | $(1,177) | | Net loss | $(4,998) | $(6,270) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.29) | $(0.41) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows ($ in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,725) | $(5,589) | | Net cash used in investing activities | $(6) | $(109) | | Net cash provided by financing activities | $3,554 | $6,426 | | Net (decrease) increase in cash | $(171) | $727 | | Cash, end of period | $5,312 | $4,945 | - Key financing activities included **$5,000 thousand** in proceeds from term loans (related party) in both 2025 and 2024, and **$1,213 thousand** in dividends paid to Series A Preferred Stockholders in 2025[24](index=24&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section includes forward-looking statement disclaimers and contact information for investor and media relations [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, indicating they are subject to numerous known and unknown risks, uncertainties, and assumptions - The press release includes 'forward-looking statements' as defined by the United States Private Securities Litigation Reform Act of 1995[17](index=17&type=chunk) - These statements are subject to numerous known and unknown risks, uncertainties, assumptions, and changes in circumstances that may cause actual results to differ significantly[17](index=17&type=chunk) - Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes, except as required by applicable law[17](index=17&type=chunk) [Investor and Media Contacts](index=3&type=section&id=Investor%20and%20Media%20Contacts) This section provides contact information for investor relations and media inquiries - Investor Relations contact: InvestorRelations@envoymedical.com[18](index=18&type=chunk) - Media Contact: Media@envoymedical.com[18](index=18&type=chunk)

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].

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 ...

Core Insights - EdgarAgents (EA) has launched the EA34 Plugin, a new technology-enabled solution aimed at simplifying SEC compliance filings, officially introduced at the Centri Capital Conference in New York City [1][6] Group 1: Product Features - The EA34 Plugin utilizes the latest inline eXtensible Business Reporting Language (iXBRL) and EDGAR technology, serving as a hybrid-service financial content management platform that streamlines compliance and reporting workflows for various SEC filings [2][4] - The plugin allows users to work within familiar software like Microsoft Word and Excel, eliminating the tedious XBRL tagging process and enabling collaboration through Microsoft OneDrive [3][4] - EA34 Plugin offers a structured-content hybrid SaaS/managed-services platform, allowing users to maintain control over filing documents while outsourcing XBRL tagging to EdgarAgents' experts [4][5] Group 2: Market Position and Strategy - The company aims to address the needs of mid-to-microcap companies by providing a flexible solution that allows them to switch between full-support and self-service content management as they grow [3][4] - EdgarAgents has filed nearly 500,000 reports to the SEC and other entities since its inception in 2008, positioning itself as a leading regulatory compliance filing agency and financial printer [8]

Financial Performance - Net revenues for the year ended December 31, 2024, decreased by $91 thousand to $225 thousand compared to $316 thousand in 2023, primarily due to a decrease in battery replacement sales caused by supply chain limitations [4]. - The company reported a net loss of $20.8 million for the year ended December 31, 2024, compared to a net loss of $29.9 million in 2023, resulting in a net loss per share attributable to common stockholders of $1.49 [17]. - Net loss for the year ended December 31, 2024, was $20,795,000, an improvement from a net loss of $29,922,000 in 2023, representing a reduction of approximately 30% [19]. Cash and Liquidity - As of December 31, 2024, cash and cash equivalents were approximately $5.5 million, an increase from $4.2 million in 2023 [7]. - The company reported a net increase in cash of $1,265,000, compared to an increase of $4,035,000 in 2023, ending the year with cash of $5,483,000 [19]. - Cash flows from operating activities resulted in a net cash used of $17,949,000, slightly higher than the $17,091,000 used in the previous year [19]. - Proceeds from the issuance of term loans (related party) amounted to $20,000,000, contributing to a net cash provided by financing activities of $20,198,000 [19]. - Cash paid for interest increased to $41,000 from $26,000 in 2023, reflecting higher financing costs [19]. Research and Development - Research and development expenses increased by $1.2 million to $10.2 million for the year ended December 31, 2024, compared to $9.0 million in 2023, driven by increased headcount in engineering and clinical departments [5]. - The company has enrolled six out of ten planned participants in the first stage of its pivotal clinical trial for the fully implanted Acclaim cochlear implant, with two participants activated [3]. - The Acclaim cochlear implant received FDA approval to initiate a staged pivotal clinical trial, marking a significant milestone for the company [3]. Assets and Expenditures - The company reported a total assets increase to $11.5 million as of December 31, 2024, compared to $8.3 million in 2023 [15]. - The company incurred $980,000 in capital expenditures for property and equipment, up from $153,000 in 2023, indicating increased investment in assets [19]. Administrative and General Expenses - General and administrative expenses decreased by $438 thousand to $6.8 million for the year ended December 31, 2024, compared to $7.3 million in 2023, primarily due to reduced professional service costs [7]. Inventory and Financial Instruments - The company reported a change in inventory reserve of $76,000, compared to a reversal of $99,000 in the previous year, suggesting adjustments in inventory management [19]. - The change in fair value of convertible notes payable (related party) was $13,332,000 in 2023, indicating significant fluctuations in financial instruments [19]. Dividends and Reimbursement Opportunities - The company recognized accrued and unpaid dividends on Series A Preferred Stock totaling $3,074,000, an increase from $1,349,000 in the previous year [20]. - The establishment of new CPT codes for fully implanted active middle ear implants is expected to enhance reimbursement opportunities for the Esteem implant starting July 2025 [3]. - The company continues to advocate for the Hearing Device Coverage Clarification Act, which could provide a pathway for Medicare coverage of the Esteem implant [2].

Core Insights - Envoy Medical reported a successful 2024 and a strong start to 2025, highlighting the FDA's approval for its pivotal clinical trial of the Acclaim cochlear implant as a significant milestone [2][3] - The company is experiencing high patient interest in the Acclaim cochlear implant, which is designed to revolutionize the hearing implant industry [2] - Progress on legislative efforts, such as the Hearing Device Coverage Clarification Act, could enhance reimbursement pathways for its Esteem implant [2] Financial Performance - Net revenues for the year ended December 31, 2024, decreased by $91 thousand to $225 thousand compared to $316 thousand in 2023, primarily due to a decline in battery replacement sales [4][19] - Research and development expenses increased by $1.2 million to $10.2 million in 2024, attributed to increased headcount in engineering and clinical departments [7][19] - General and administrative expenses decreased by $438 thousand to $6.8 million in 2024, mainly due to reduced professional service costs compared to 2023 [9][19] Clinical and Product Development - The company received FDA approval to initiate a staged pivotal clinical trial for the Acclaim cochlear implant, with six out of ten planned participants already enrolled [5][19] - Modifications to the Acclaim cochlear implant have shown promising results in reducing electrical system noise during early feasibility trials [5] - The Esteem implant is the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, offering continuous hearing capability [12] Legislative and Market Opportunities - The Hearing Device Coverage Clarification Act aims to classify implanted active middle ear implants as prosthetics, potentially making them eligible for Medicare coverage [2][5] - New CPT codes for fully implanted active middle ear implants will become effective in July 2025, creating new reimbursement opportunities for Envoy Medical's Esteem device [5][19] Balance Sheet Highlights - As of December 31, 2024, cash and cash equivalents were approximately $5.5 million, an increase from $4.2 million in 2023 [9][17] - Total assets increased to $11.5 million in 2024 from $8.3 million in 2023, while total liabilities rose significantly to $30.4 million from $10 million [17][18] Loss and Earnings - The net loss for the year ended December 31, 2024, was $20.8 million, an improvement from a net loss of $29.9 million in 2023 [19][21] - The net loss attributable to common stockholders was $27.9 million, with a net loss per share of $(1.49) compared to $(2.54) in 2023 [20][21]

Financial Performance - The company reported net losses of approximately $20.8 million and $29.9 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of approximately $284.7 million and $257.3 million as of the same dates[182]. - The company has a history of net losses and negative cash flow from operations, which are expected to continue due to ongoing development costs and operational expenses[213]. - The company may experience fluctuations in operating losses, making period-to-period comparisons of results of operations less indicative of future performance[185]. - The company is exposed to inflation risk, which may adversely affect operating results if costs increase without a corresponding rise in selling prices[386]. Revenue Generation - The company has not generated any revenue from the sale of the Acclaim CI and has historically limited revenue from the legacy Esteem FI-AMEI product[186]. - Future revenue generation will depend heavily on obtaining FDA approval for the Acclaim CI and successfully scaling production and marketing efforts[186]. - The company expects to derive most of its revenues from sales of the Acclaim CI, with a significant dependency on its successful commercialization[226]. - The successful commercialization of the Acclaim CI will depend on obtaining adequate coverage and reimbursement from third-party payors, which is uncertain[217]. Clinical Trials and Regulatory Approval - The company has begun its pivotal trial for the Acclaim CI in Q1 2025 after receiving FDA approval for initial patient implants[188]. - The FDA trial process for the Acclaim CI is uncertain, with potential delays and complications that could affect regulatory approval and commercialization[215]. - The company may face delays in clinical trials due to reliance on third-party CROs, which could affect regulatory approval timelines[237]. Costs and Funding - Significant expenses are anticipated for clinical trials and commercialization efforts for the Acclaim CI, with expectations of continued operating losses for the foreseeable future[183]. - The company expects to incur substantial costs related to establishing sales, marketing, and distribution infrastructure for the Acclaim CI, as well as ongoing research and development expenses[184]. - The company may need to raise substantial additional funding to support commercialization efforts, which may not be available on acceptable terms[190]. - The company anticipates that additional funding will be necessary to support its operations, but there is substantial doubt about its ability to raise funds on favorable terms[209]. Competition and Market Risks - The company faces intense competition from larger medical device companies and may struggle to maintain market share if competitors introduce superior products[224]. - The company is vulnerable to fluctuations in demand for the Acclaim CI, which could adversely affect its financial condition and results of operations[227]. - The addressable market for the Acclaim CI may be smaller than estimated, impacting the company's ability to capture market share[235]. - The company may face pricing pressures and regulatory challenges in international markets, which could limit revenue generation from its product candidates[220]. Intellectual Property and Legal Risks - The company has identified material weaknesses in its internal control over financial reporting, which could lead to inaccurate financial reporting and adversely affect investor confidence[205]. - The company may face challenges in maintaining and enforcing its patent rights, which could adversely affect its ability to operate profitably[247]. - The company may become involved in lawsuits regarding intellectual property, which could drain financial resources and divert management's attention[257]. - The company may be subject to claims of misappropriation of third-party intellectual property, which could lead to litigation and significant costs[267]. Management and Governance - The company is dependent on key members of its executive management team, and losing these individuals could impede its business plan and growth strategies[242]. - The company’s management team has limited experience managing a public company, which may affect its ability to meet regulatory obligations and manage business operations effectively[246]. - As of March 24, 2025, a board member holds approximately 48.2% of the outstanding shares of Class A Common Stock, allowing significant influence over shareholder votes[244]. Market Dynamics and Stock Performance - The Class A Common Stock has experienced extreme volatility, trading as low as $1.21 and as high as $9.60 since the Business Combination[277]. - The trading volume of Class A Common Stock has been inconsistent, with significant fluctuations observed in recent months[277]. - Market dynamics unrelated to the company's fundamentals may be influencing current stock prices, posing risks to investors[278]. - The company faces risks related to the perception of substantial sales of its securities, which could negatively impact market prices[276]. Miscellaneous - The company is involved in various legal proceedings, which may have a material adverse effect on its business and financial condition[290]. - The company intends to retain all available funds and future earnings to fund business development and growth, with no anticipated dividends on Class A Common Stock[286].