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Investor releaseQuarter not tagged2026-08-10Envoy Medical Reports Second Quarter 2026 Results and Achieves Key Regulatory and Clinical Milestones
TMX Newsfile
Envoy Medical Reports Second Quarter 2026 Results and Achieves Key Regulatory and Clinical Milestones
Submitted First Module of Modular PMA Application to FDA Subsequent to Quarter End, the Company Reported Positive 12-Month Stage 1 Data Showing Continued Improvement in Speech Perception White Bear Lake, Minnesota--(Newsfile Corp. - August 10, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today reported financial results for the second quarter ended June 30, 2026, and provided a business update, highlighting continued execution on its corporate initiatives. "The second quarter moved us measurably closer to bringing our fully implanted cochlear implant to market," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We submitted the first of four modules of our modular PMA application and our pivotal clinical trial continued to advance. We expect to submit the remaining modules on a rolling basis, with the fourth and final module targeted during the second quarter of 2027. Since quarter end, we reported 12-month data on the first 10 participants in Stage 1 and the full trial surpassed the three-month follow-up mark. We remain focused on the successful and timely execution of our clinical trial but continue to lay the operational groundwork for an exciting future with tremendous value creation potential. Should we receive approval to market our device, we believe that the demand will be substantial and we want to be prepared to support that demand quickly and with tremendous success." Corporate and Financial Highlights for Q2 2026: First Module of Modular PMA Application Submitted to the FDA. The Company submitted the first module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its Breakthrough Device-designated investigational Acclaim® cochlear implant. Unlike a traditional PMA, the modular pathway allows the Company to submit completed sections for review as they become available, enabling earlier FDA engagement, iterative feedback, and a defined cadence of milestones. The Company expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027. Expanded Intellectual Property Portfolio. The Australian and European patent offices granted the Company four patents relating to important innovations in imp…Read full documentShow less
Submitted First Module of Modular PMA Application to FDA Subsequent to Quarter End, the Company Reported Positive 12-Month Stage 1 Data Showing Continued Improvement in Speech Perception White Bear Lake, Minnesota--(Newsfile Corp. - August 10, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today reported financial results for the second quarter ended June 30, 2026, and provided a business update, highlighting continued execution on its corporate initiatives. "The second quarter moved us measurably closer to bringing our fully implanted cochlear implant to market," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We submitted the first of four modules of our modular PMA application and our pivotal clinical trial continued to advance. We expect to submit the remaining modules on a rolling basis, with the fourth and final module targeted during the second quarter of 2027. Since quarter end, we reported 12-month data on the first 10 participants in Stage 1 and the full trial surpassed the three-month follow-up mark. We remain focused on the successful and timely execution of our clinical trial but continue to lay the operational groundwork for an exciting future with tremendous value creation potential. Should we receive approval to market our device, we believe that the demand will be substantial and we want to be prepared to support that demand quickly and with tremendous success." Corporate and Financial Highlights for Q2 2026: First Module of Modular PMA Application Submitted to the FDA. The Company submitted the first module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its Breakthrough Device-designated investigational Acclaim® cochlear implant. Unlike a traditional PMA, the modular pathway allows the Company to submit completed sections for review as they become available, enabling earlier FDA engagement, iterative feedback, and a defined cadence of milestones. The Company expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027. Expanded Intellectual Property Portfolio. The Australian and European patent offices granted the Company four patents relating to important innovations in implantable system design, signal analysis, and battery recharge safety, further strengthening the Company's intellectual property position in the implantable medical device and cochlear implant industries. At-the-Market (ATM) Equity Facility Terminated. The Company terminated its ATM equity offering program, under which it was previously authorized to offer and sell up to $15 million of its common stock. Highlights Subsequent to Q2 2026: Positive 12-Month Data Showed Continued Improvement in Speech Perception. The Company reported positive 12-month data from the first 10 participants in Stage 1 of its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant. These participants achieved a mean Consonant-Nucleus-Consonant ("CNC") word recognition score of 53.2% at their 12-month visits, compared to a pre-implantation baseline of 15.2%, a 38.0 percentage point improvement and continued gains from the 24.0 percentage point improvement reported at six months. The trial's primary efficacy endpoint will be evaluated based on 12-month data. Three-Month Follow-Up Window Completed for Full Cohort. The Company announced that its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant passed the three-month follow-up window, marking another key clinical milestone as the Company advances the study toward its primary efficacy endpoint, which will be evaluated on 12-month data. Financial Results for the Quarter Ended June 30, 2026 (dollars in thousands): Net revenue was $51 for the three months ended June 30, 2026. Cost of goods sold for the three months ended June 30, 2026, was $278, compared to $234 for the three months ended June 30, 2025. R&D expenses for the three months ended June 30, 2026, were $3,132 compared to $2,485 for the three months ended June 30, 2025. This increase of $647 mainly reflects additional clinical trial follow-up activity as a result of the clinical trial being fully enrolled, fees related to the submission of the first module of the Company's PMA application, and personnel costs related to the clinical trial. Sales and marketing expenses for the three months ended June 30, 2026, were $181 compared to $361 for the three months ended June 30, 2025. The decrease of $180 is primarily due to the reallocation of resources to research and development activities in support of the clinical trial. General and administrative expenses were $2,029 for the three months ended June 30, 2026, compared to $2,068 for the three months ended June 30, 2025. The decrease of $39 was primarily due to a severance accrual in the prior-year period, partially offset by higher consulting and professional service fees. Net loss attributable to common stockholders was $7,272, or $0.07 per basic and diluted share for the three months ended June 30, 2026, compared to net loss attributable to common stockholders of $6,942, or $0.32 per basic and diluted share for the three months ended June 30, 2025. As of June 30, 2026, cash was approximately $19,679. For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit EnvoyMedical.com. To be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line. About Envoy Medical, Inc. Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the ability to obtain additional patents and develop future products or product improvements; the Acclaim CI being the first to market fully implanted cochlear implant; the timing, content, and results of the Company's modular PMA submissions to the FDA, including the number and timing of modules and the timing of any approval decision; the timing and results of approvals, site documents, logistics, activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, including data from Stage 2 (which may differ from Stage 1); the results of the safety and efficacy data from Stage 2 participants and the effect on its pooling with Stage 1 data; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; and the participation or any changes in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the sufficiency of the Company's capital resources; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. Investor Contact:Phil CarlsonKCSA Strategic CommunicationsO: 212.896.1233E: [email protected] ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(UNAUDITED)(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(UNAUDITED)(Dollars in thousands) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/308813
Investor releaseQuarter not tagged2026-07-23Envoy Medical, Inc. (COCH) May Report Negative Earnings: Know the Trend Ahead of Q2 Release
Zacks
Envoy Medical, Inc. (COCH) May Report Negative Earnings: Know the Trend Ahead of Q2 Release
Envoy Medical, Inc. (COCH) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +71.9%. Revenues are expected to be $0.06 million, down 25% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 16.67% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.…Read full documentShow less
Envoy Medical, Inc. (COCH) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +71.9%. Revenues are expected to be $0.06 million, down 25% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 16.67% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Envoy Medical, Inc., the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination makes it difficult to conclusively predict that Envoy Medical, Inc. will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Envoy Medical, Inc. would post a loss of$0.14 per share when it actually produced a loss of -$0.11, delivering a surprise of +21.43%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Envoy Medical, Inc. doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Envoy Medical, Inc. (COCH) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-14EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results
Benzinga
EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results
Envoy Medical Inc. (NASDAQ:COCH) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data. The company said participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%. The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%. Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study. Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder. Envoy Medical said it is reviewing the underlying cause of that outcome. Excluding the potential non-responder, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months, representing a 42.2 percentage point improvement from baseline. On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits. The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial. Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, while many have also reached their three- and six-month follow-up milestones. The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission. Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later. COCH Price Action: Envoy Medical shares were down 3.24% at $0.67 during premarket trading on Tuesday, according to Benzinga Pro data. Read Also: Mohamed El-Erian Says Kevin Warsh Is 'Serious' About Reforming the Fed, Restor…Read full documentShow less
Envoy Medical Inc. (NASDAQ:COCH) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data. The company said participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%. The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%. Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study. Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder. Envoy Medical said it is reviewing the underlying cause of that outcome. Excluding the potential non-responder, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months, representing a 42.2 percentage point improvement from baseline. On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits. The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial. Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, while many have also reached their three- and six-month follow-up milestones. The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission. Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later. COCH Price Action: Envoy Medical shares were down 3.24% at $0.67 during premarket trading on Tuesday, according to Benzinga Pro data. Read Also: Mohamed El-Erian Says Kevin Warsh Is 'Serious' About Reforming the Fed, Restoring Political Independence Photo by PeopleImages via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: ENVOY MEDICAL (COCH): Free Stock Analysis Report This article EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Investor releaseQuarter not tagged2026-05-06TransMedics (TMDX) Q1 Earnings and Revenues Miss Estimates
Zacks
TransMedics (TMDX) Q1 Earnings and Revenues Miss Estimates
TransMedics (TMDX) came out with quarterly earnings of $0.3 per share, missing the Zacks Consensus Estimate of $0.62 per share. This compares to earnings of $0.7 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -51.46%. A quarter ago, it was expected that this medical technology company would post earnings of $0.41 per share when it actually produced earnings of $0.57, delivering a surprise of +39.02%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. TransMedics, which belongs to the Zacks Medical - Instruments industry, posted revenues of $173.93 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.99%. This compares to year-ago revenues of $143.54 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TransMedics shares have lost about 20.2% since the beginning of the year versus the S&P 500's gain of 5.2%. While TransMedics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TransMedics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Ran…Read full documentShow less
TransMedics (TMDX) came out with quarterly earnings of $0.3 per share, missing the Zacks Consensus Estimate of $0.62 per share. This compares to earnings of $0.7 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -51.46%. A quarter ago, it was expected that this medical technology company would post earnings of $0.41 per share when it actually produced earnings of $0.57, delivering a surprise of +39.02%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. TransMedics, which belongs to the Zacks Medical - Instruments industry, posted revenues of $173.93 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.99%. This compares to year-ago revenues of $143.54 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TransMedics shares have lost about 20.2% since the beginning of the year versus the S&P 500's gain of 5.2%. While TransMedics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TransMedics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.74 on $190.57 million in revenues for the coming quarter and $2.48 on $739.75 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Envoy Medical, Inc. (COCH), is yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +51.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Envoy Medical, Inc.'s revenues are expected to be $0.06 million, up 20% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TransMedics Group, Inc. (TMDX) : Free Stock Analysis Report Envoy Medical, Inc. (COCH) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-03-23Envoy Medical Reports Full Year 2025 Financial Results
TMX Newsfile
Envoy Medical Reports Full Year 2025 Financial Results
Received FDA approval to expand fully implanted Acclaimᆴ Cochlear Implant Pivotal Clinical Trial to final stage Strengthened balance sheet by extinguishing $32 million in debt Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant White Bear Lake, Minnesota--(Newsfile Corp. - March 23, 2026) - Envoy Medicalᆴ Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events. Corporate and Financial Highlights for 2025: Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data Extinguished over $32 Million in Debt, Strengthening Balance Sheet Completed First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial Highlights Subsequent to 2025 Year End: Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaimᆴ Cochlear Implant Strengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants) Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026 Brent Lucas, CEO of Envoy Medical, commented: "We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage. "We were also, on the financial side, able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global patent portfolio as a leading fully implanted hearing technology company. "The momentum from 2025 has set the stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational fully implanted Acclaim cochlear implant. W…Read full documentShow less
Received FDA approval to expand fully implanted Acclaimᆴ Cochlear Implant Pivotal Clinical Trial to final stage Strengthened balance sheet by extinguishing $32 million in debt Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant White Bear Lake, Minnesota--(Newsfile Corp. - March 23, 2026) - Envoy Medicalᆴ Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events. Corporate and Financial Highlights for 2025: Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data Extinguished over $32 Million in Debt, Strengthening Balance Sheet Completed First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial Highlights Subsequent to 2025 Year End: Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaimᆴ Cochlear Implant Strengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants) Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026 Brent Lucas, CEO of Envoy Medical, commented: "We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage. "We were also, on the financial side, able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global patent portfolio as a leading fully implanted hearing technology company. "The momentum from 2025 has set the stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational fully implanted Acclaim cochlear implant. We are now in a strengthened position as we continue to gather data and look forward to submitting our PMA application to the FDA. "The future is bright for Envoy Medical as we aim to revolutionize hearing health by providing fully implanted solutions to address the unmet needs of millions of individuals worldwide. We hope you join us on this meaningful and exciting journey." Financial Results for the Year Ended December 31, 2025 (dollars in thousands): Net Revenue was $241 as of December 31, 2025 compared to $225 for year ended December 31, 2024. The increase of $16 was primarily driven by the sales of the Esteemᆴ FI-AMEI implant and related replacement components. Cost of goods sold increased $132 compared to the year ended December 31, 2024. The increase is primarily due to an increase in scrap and non-recurring expenses of $190, which was partially offset by lower fees for third-parties performing work related to our products of $77. R&D expenses, which include expenses related to the Acclaim pivotal clinical trial, increased by $2,307 for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase mainly reflects additional clinical trial expense during enrollment. Sales and marketing expenses of December 31, 2025 were $1,220 compared to $1,734 for the year ended December 31, 2024 a decrease of $514. The decrease is primarily due to a reduction of legal fees associated with reimbursement work for the Esteem FI-AMEI product. General and administrative expenses increased $1,105 to $7,931 for the year ended December 31, 2025 compared to $6,826 for the year ended December 31, 2024. The increase was primarily due to severance costs associated with the former Chief Financial Officer and increased consulting expenses. As of December 31, 2025, cash was approximately $3.7 million. The Acclaimᆴ cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal. To be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line. About Envoy Medical, Inc. Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteemᆴ active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaimᆴ cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life. About the Fully Implanted Acclaimᆴ Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteemᆴ Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. Investor Contact: Phil Carlson KCSA Strategic Communications O: 212.896.1233 E: [email protected] Media Contact: Anne Donohoe KCSA Strategic Communications O: 732-620-0033 E: [email protected] ENVOY MEDICAL, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (Dollars in thousands) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289507
Investor releaseQuarter not tagged2025-11-10Envoy Medical Reports Third Quarter 2025 Financial and Operational Results
Newsfile
Envoy Medical Reports Third Quarter 2025 Financial and Operational Results
Transformational quarter puts Envoy Medical in significantly better position as it eliminated $32 million of debt, strengthened its balance sheet, and further expanded its patent portfolio; In addition, subsequent to quarter end, the Company received FDA approval to expand its pivotal clinical trial to the final stage, restarted enrollment, and successfully raised additional capital White Bear Lake, Minnesota--(Newsfile Corp. - November 10, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the third quarter ended September 30, 2025, as well as other subsequent events. Corporate Highlights for Third Quarter 2025: Extinguished over $32 Million in Debt, Strengthening Balance Sheet Advanced Commercialization Planning as FDA Clinical Trial Remains On Track Expanded Patent Portfolio by Securing Additional European Patent Secured Four New Global Patents Successfully Reached Three-Month Follow-Up Milestone in Clinical Trial Secured an Additional Three New Patents Further Expanded Patent Portfolio with New Issuances in the United States Subsequent to Third Quarter 2025 End Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data Announced Closing of Up to $16 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules Marked three-year anniversary of first successful implantation of fully implanted cochlear implant Announced first three patients were enrolled in the final stage of pivotal clinical trial of the fully implanted investigational Acclaim® cochlear implant "The third quarter was transformational for Envoy Medical as we continue to position ourselves to capitalize on the opportunity ahead of us," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We extinguished $32 million in debt without the issuance of new equity, substantially improving our balance sheet and eliminating the need to satisfy or service that debt in the future. As a result, our Stockholder's Equity materially improved. We continued to make steady progress in our pivotal clinical trial and believe we are on the right track. Throughout the quarter, we received a number of additional global patents in the U.S., Europe, and Australia. We will contin…Read full documentShow less
Transformational quarter puts Envoy Medical in significantly better position as it eliminated $32 million of debt, strengthened its balance sheet, and further expanded its patent portfolio; In addition, subsequent to quarter end, the Company received FDA approval to expand its pivotal clinical trial to the final stage, restarted enrollment, and successfully raised additional capital White Bear Lake, Minnesota--(Newsfile Corp. - November 10, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the third quarter ended September 30, 2025, as well as other subsequent events. Corporate Highlights for Third Quarter 2025: Extinguished over $32 Million in Debt, Strengthening Balance Sheet Advanced Commercialization Planning as FDA Clinical Trial Remains On Track Expanded Patent Portfolio by Securing Additional European Patent Secured Four New Global Patents Successfully Reached Three-Month Follow-Up Milestone in Clinical Trial Secured an Additional Three New Patents Further Expanded Patent Portfolio with New Issuances in the United States Subsequent to Third Quarter 2025 End Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data Announced Closing of Up to $16 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules Marked three-year anniversary of first successful implantation of fully implanted cochlear implant Announced first three patients were enrolled in the final stage of pivotal clinical trial of the fully implanted investigational Acclaim® cochlear implant "The third quarter was transformational for Envoy Medical as we continue to position ourselves to capitalize on the opportunity ahead of us," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We extinguished $32 million in debt without the issuance of new equity, substantially improving our balance sheet and eliminating the need to satisfy or service that debt in the future. As a result, our Stockholder's Equity materially improved. We continued to make steady progress in our pivotal clinical trial and believe we are on the right track. Throughout the quarter, we received a number of additional global patents in the U.S., Europe, and Australia. We will continue to expand our position as a first mover and market leader in fully implanted hearing solutions." Lucas concluded, "Subsequent to quarter end, we achieved a major milestone as we received the critically important approval from the FDA to expand our pivotal clinical trial to its final stage. We continue to see strong interest in our fully implanted cochlear implant trial as new patients are now rapidly enrolling in this trial. I am very proud of the progress the Envoy Medical team is making, and we intend to increase our momentum as we finish 2025." Financial Results for the Quarter Ended September 30, 2025 (dollars in thousands) Third quarter net revenue was $42 for the three months ended September 30, 2025. R&D expenses decreased $57 to $2,700 for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. R&D product costs decreased $282 from the prior period as we moved from the development phase into the clinical trial phase. Personnel costs increased $282 and other R&D costs decreased $57 from the prior period to support the clinical trials with additional headcount. Increases in other R&D costs were more than offset by lower professional services fees. General and administrative expenses increased $752 for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The increase is primarily due to increased public company costs of $268 and expenses directly related to the September 2025 offering of $444. As of September 30, 2025, cash was approximately $3,556. Additional capital was raised post quarter end. For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com. To be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line. About Envoy Medical, Inc. Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain and maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) Investor Contact: Phil Carlson KCSA Strategic Communications O: 212.896.1233 E: [email protected] Media Contact: Anne Donohoe KCSA Strategic Communications O: 732.620.0033 E: [email protected] To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273757
Investor releaseQuarter not tagged2025-11-06Envoy Medical, Inc. (COCH) Expected to Beat Earnings Estimates: Should You Buy?
Zacks
Envoy Medical, Inc. (COCH) Expected to Beat Earnings Estimates: Should You Buy?
The market expects Envoy Medical, Inc. (COCH) to deliver a year-over-year increase in earnings on flat revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.27 per share in its upcoming report, which represents a year-over-year change of +27%. Revenues are expected to be $0.06 million, unchanged compared to the year-ago quarter.. The consensus EPS estimate for the quarter has been revised 9.09% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positiv…Read full documentShow less
The market expects Envoy Medical, Inc. (COCH) to deliver a year-over-year increase in earnings on flat revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.27 per share in its upcoming report, which represents a year-over-year change of +27%. Revenues are expected to be $0.06 million, unchanged compared to the year-ago quarter.. The consensus EPS estimate for the quarter has been revised 9.09% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Envoy Medical, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +11.11%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination indicates that Envoy Medical, Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Envoy Medical, Inc. would post a loss of$0.29 per share when it actually produced a loss of -$0.32, delivering a surprise of -10.34%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Envoy Medical, Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Instruments industry, 908 Devices Inc. (MASS), is soon expected to post loss of $0.13 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of +43.5%. This quarter's revenue is expected to be $13.58 million, down 19% from the year-ago quarter. The consensus EPS estimate for 908 Devices has been revised 6.3% lower over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -18.42%. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that 908 Devices will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Envoy Medical, Inc. (COCH) : Free Stock Analysis Report 908 Devices Inc. (MASS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2025-07-31Envoy Medical Reports on Second Quarter 2025 Results
Newsfile
Envoy Medical Reports on Second Quarter 2025 Results
White Bear Lake, Minnesota--(Newsfile Corp. - July 31, 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 second quarter ended June 30, 2025, as well as other subsequent events. Financial and Corporate Highlights for Second Quarter and to date: 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 serious adverse events or unanticipated device events have been reported for any of the 10 participants. The Company anticipates these study participants will complete their three-month follow-up visits in the coming weeks. Five Category III CPT codes for totally implantable active middle ear implants, such as the Company's Esteem® device, were approved by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel and became effective on July 1, 2025.** The previous lack of CPT codes effectively limited market adoption of and access to these groundbreaking, fully implanted hearing devices. Further changes to reimbursement around the Esteem® device would provide additional business opportunities for the Company. Subsequent to the quarter end, two new patents in the US and three new patents in Australia were issued to Envoy Medical, further strengthening its intellectual property portfolio. The Company continues to pursue additional patent protection across the Globe and believes there is strong value in its intellectual portfolio roadmap. Brent Lucas, CEO of Envoy Medical commented: "This quarter was another win for Envoy Medical as we continue to successfully execute our strategy. We continued to make significant strides with our clinical study as all 10 study participants in the Acclaim® trial were successfully activated and completed their one-month follow-up visits with zero reported serious adverse events or unanticipated device events.…Read full documentShow less
White Bear Lake, Minnesota--(Newsfile Corp. - July 31, 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 second quarter ended June 30, 2025, as well as other subsequent events. Financial and Corporate Highlights for Second Quarter and to date: 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 serious adverse events or unanticipated device events have been reported for any of the 10 participants. The Company anticipates these study participants will complete their three-month follow-up visits in the coming weeks. Five Category III CPT codes for totally implantable active middle ear implants, such as the Company's Esteem® device, were approved by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel and became effective on July 1, 2025.** The previous lack of CPT codes effectively limited market adoption of and access to these groundbreaking, fully implanted hearing devices. Further changes to reimbursement around the Esteem® device would provide additional business opportunities for the Company. Subsequent to the quarter end, two new patents in the US and three new patents in Australia were issued to Envoy Medical, further strengthening its intellectual property portfolio. The Company continues to pursue additional patent protection across the Globe and believes there is strong value in its intellectual portfolio roadmap. Brent Lucas, CEO of Envoy Medical commented: "This quarter was another win for Envoy Medical as we continue to successfully execute our strategy. We continued to make significant strides with our clinical study as all 10 study participants in the Acclaim® trial were successfully activated and completed their one-month follow-up visits with zero reported serious adverse events or unanticipated device events. We are confident that, once approved, our fully implanted Acclaim® cochlear implant will enjoy substantial patient interest, allowing us a rare opportunity to disrupt an established market and grow into a significant market participant relatively quickly. We believe our investigational fully implanted Acclaim® cochlear implant is well-positioned to be able to capture market share as the industry moves towards fully implanted cochlear implants and away from bulky externals. As it relates to the Esteem® fully implanted active middle ear implant, which already has FDA approval, we are excited to see the potential for renewed opportunity and possibility. Meaningful changes to reimbursement around this class of hearing devices would provide Envoy Medical with a viable pathway for a product that already has FDA approval, is currently one-of-a-kind in the marketplace, and has demonstrated patient demand. We continue to see wisdom in strategic investments around this product, as a shift in policy or reimbursement could rapidly change Envoy Medical's position in the market. As we continue to execute our strategy and drive shareholder value, we remain steadfast in our belief that Envoy Medical will be a significant player in the hearing device industry in the near future." Financial Results for the Quarter Ended June 30, 2025 Net revenues increased $10 thousand for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. R&D expenses decreased $0.1 million to $2.485 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. R&D product costs decreased $0.5 million from the prior period as we moved from the development phase into the clinical trials phase. Personnel costs and other R&D costs increased $0.3 million and $0.1 million, respectively, from the prior period to support the clinical trials with additional headcount and equipment, respectively. Sales and marketing expenses decreased $0.1 million to for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. General and administrative expenses increased $0.5 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The increase is primarily due to a $0.3 million severance accrual for the three months ended June 30, 2025. As of June 30, 2025, cash was approximately $5.3 million. For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com. To be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line. About Envoy Medical, Inc. Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. ** Category III CPT codes are temporary codes for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the ability to obtain additional patents and develop future products or product improvements, the Acclaim CI being the first to market fully implanted cochlear implant, the timing and results of approvals, site documents, logistics, activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the impact of CPT codes for active middle ear hearing devices, changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ### Investor Contact: Phil Carlson KCSA Strategic Communications O: 212.896.1233 E: [email protected] SOURCE: Envoy Medical, Inc. Media Contact: [email protected] To view the source version of this press release, please visit https://www.newsfilecorp.com/release/260779
Investor releaseQuarter not tagged2025-05-02Envoy Medical Reports on First Quarter 2025 Results
Newsfile
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 Highlights for First Quarter and to date: Secured additional $10 Million in funding to advance Pivotal Clinical Trial. Completed Enrollment of 10 participants in "first stage" of Pivotal Clinical Trial of the fully implanted Acclaim® cochlear implant. Activated (i.e., turned on) six of 10 participants with remaining four participants due to be activated in May. Additionally, two participants completed 1-Month Follow-Up visits. No reports of Serious Adverse Events or Unanticipated Adverse Device Effects. Thus far, activations and follow-up visits have been reported to be within expectations of "typical" or "normal" cochlear implant activations and 1-month follow-up visits over a similar timeframe. Modifications and mitigations put in place between Early Feasibility Study and Pivotal Clinical Trial appear to address previously discussed electrical system noise. Brent Lucas, CEO of Envoy Medical commented: "We could not be more pleased with the positive progress of our pivotal clinical study and the reported excitement from the investigational sites. Enrollment of the first 10 patients happened quickly and efficiently, and we believe it is yet another indication that, if given the choice, a meaningful percentage of patients who are candidates for cochlear implants will be drawn to a fully implanted solution that uses the ear to pick up sound instead of a microphone, does not have an implanted magnet in the head, and has multiple days of battery life with typical use. We designed our fully implanted Acclaim cochlear implant with patient's quality of life and preferences in mind, and we are thrilled to see anecdotal reports coming back that people want what our device is designed to offer. Personally, I'm extremely excited about Envoy Medical's future and our position in the hearing industry." Financial Results for the Quarter Ended March 31, 2025 Net revenues decreased $13 thousand for the three months ended Marc…Read full documentShow less
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 Highlights for First Quarter and to date: Secured additional $10 Million in funding to advance Pivotal Clinical Trial. Completed Enrollment of 10 participants in "first stage" of Pivotal Clinical Trial of the fully implanted Acclaim® cochlear implant. Activated (i.e., turned on) six of 10 participants with remaining four participants due to be activated in May. Additionally, two participants completed 1-Month Follow-Up visits. No reports of Serious Adverse Events or Unanticipated Adverse Device Effects. Thus far, activations and follow-up visits have been reported to be within expectations of "typical" or "normal" cochlear implant activations and 1-month follow-up visits over a similar timeframe. Modifications and mitigations put in place between Early Feasibility Study and Pivotal Clinical Trial appear to address previously discussed electrical system noise. Brent Lucas, CEO of Envoy Medical commented: "We could not be more pleased with the positive progress of our pivotal clinical study and the reported excitement from the investigational sites. Enrollment of the first 10 patients happened quickly and efficiently, and we believe it is yet another indication that, if given the choice, a meaningful percentage of patients who are candidates for cochlear implants will be drawn to a fully implanted solution that uses the ear to pick up sound instead of a microphone, does not have an implanted magnet in the head, and has multiple days of battery life with typical use. We designed our fully implanted Acclaim cochlear implant with patient's quality of life and preferences in mind, and we are thrilled to see anecdotal reports coming back that people want what our device is designed to offer. Personally, I'm extremely excited about Envoy Medical's future and our position in the hearing industry." Financial Results for the Quarter Ended March 31, 2025 Net revenues decreased $13 thousand for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, primarily due to the decrease in the number of Battery replacement sales due to supply chain limitations. Cost of goods sold increased $73 thousand for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The increase is primarily due to an increase in headcount in preparation of production growth of the Esteem FI-AMEI product, new supplier expenses and an adjustment to the inventory reserve. R&D expenses increased $400 thousand for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The increase is primarily due to an increase in headcount and contractors in our engineering and clinical departments for the three months ended March 31, 2025, as we increased headcount across our clinical and cochlear departments in preparation for our pivotal clinical study for the Acclaim CI. The Company incurred additional expenses related to the pivotal clinical study in the form of initial site start-up costs, parts and supplies, and data capturing platform. Sales and marketing expenses increased $33 thousand for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The increase is primarily due to increased headcount, travel, and the addition of a patient engagement program, partially offset by the reduction of legal and professional fees to secure insurance reimbursement for the Esteem FI-AMEI product. General and administrative expenses decreased $284 thousand for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease is primarily due to reduced legal fees and professional service costs in 2025 compared to 2024, partially offset by an increase in headcount and miscellaneous administrative expenses. As of March 31, 2025 cash and cash equivalents were approximately $5.3 million. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the timing and results of IRB approvals, site documents, logistics or activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any institution or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. ### Investor Relations:Envoy Medical Investor [email protected] Media Contact:[email protected] ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/250488
Investor releaseQuarter not tagged2025-03-31Envoy Medical Reports Fourth Quarter and Full Year 2024 Financial Results
Newsfile
Envoy Medical Reports Fourth Quarter and Full Year 2024 Financial Results
Company Provides Corporate Update that Includes Information on its Progress Enrolling Subjects in its Pivotal Clinical Study for Breakthrough Device, the Fully Implanted Acclaim® Cochlear Implant White Bear Lake, Minnesota--(Newsfile Corp. - March 31, 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 fourth quarter and full year ended December 31, 2024, as well as other subsequent events. Brent Lucas, CEO of Envoy Medical commented: "Envoy Medical had a successful 2024 and we are off to a wonderful start in 2025. Obtaining FDA's approval to begin our pivotal clinical trial for the fully implanted Acclaim cochlear implant was a milestone many years in the making, and we are very excited to report that enrollment is going extremely well. The investigational sites are reporting a tremendous amount of patient interest in our fully implanted cochlear implant. We believe we have a special product and a great opportunity to change the hearing implant industry. We are also pleased with the progress surrounding the Hearing Device Coverage Clarification Act, which, if passed, could provide our Esteem® implant with a pathway to Medicare coverage. In addition, the establishment of new CPT codes for fully implanted active middle ear implants, which become effective in July of this year, furthered our efforts in the quest for the Esteem implant to become a reimbursed product." Financial and Corporate Highlights for 2024 and to date: Continued to make modifications that have shown promising reduction in previously discussed electrical system noise (i.e., not physiological or "body noise") in initial results of the Early Feasibility Trial of the fully implanted Acclaim® cochlear implant. Several modifications in firmware, software, programming, protocol design, and hardware incorporated into Pivotal Clinical Trial. All three previously implanted Early Feasibility Trial patients have successfully completed 24 months of follow-up. No reported Unanticipated Device Events or Serious Adverse Device Effects. Received FDA approval to initiate a staged Pivotal Clinical Trial for its fully implanted Acclaim® cochlear implant. Selected seven top-tier cochlear implant programs as investigational sites for the Pivotal Clini…Read full documentShow less
Company Provides Corporate Update that Includes Information on its Progress Enrolling Subjects in its Pivotal Clinical Study for Breakthrough Device, the Fully Implanted Acclaim® Cochlear Implant White Bear Lake, Minnesota--(Newsfile Corp. - March 31, 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 fourth quarter and full year ended December 31, 2024, as well as other subsequent events. Brent Lucas, CEO of Envoy Medical commented: "Envoy Medical had a successful 2024 and we are off to a wonderful start in 2025. Obtaining FDA's approval to begin our pivotal clinical trial for the fully implanted Acclaim cochlear implant was a milestone many years in the making, and we are very excited to report that enrollment is going extremely well. The investigational sites are reporting a tremendous amount of patient interest in our fully implanted cochlear implant. We believe we have a special product and a great opportunity to change the hearing implant industry. We are also pleased with the progress surrounding the Hearing Device Coverage Clarification Act, which, if passed, could provide our Esteem® implant with a pathway to Medicare coverage. In addition, the establishment of new CPT codes for fully implanted active middle ear implants, which become effective in July of this year, furthered our efforts in the quest for the Esteem implant to become a reimbursed product." Financial and Corporate Highlights for 2024 and to date: Continued to make modifications that have shown promising reduction in previously discussed electrical system noise (i.e., not physiological or "body noise") in initial results of the Early Feasibility Trial of the fully implanted Acclaim® cochlear implant. Several modifications in firmware, software, programming, protocol design, and hardware incorporated into Pivotal Clinical Trial. All three previously implanted Early Feasibility Trial patients have successfully completed 24 months of follow-up. No reported Unanticipated Device Events or Serious Adverse Device Effects. Received FDA approval to initiate a staged Pivotal Clinical Trial for its fully implanted Acclaim® cochlear implant. Selected seven top-tier cochlear implant programs as investigational sites for the Pivotal Clinical Trial. To date, six of the planned 10 participants in the Pivotal Clinical Trial's first stage have been enrolled and implanted, two of which have been activated. Continued to push for the bipartisan Hearing Device Coverage Classification Act, which seeks to clarify that Implanted Active Middle Ear Implants are prosthetics, not hearing aids, making them eligible for Medicare coverage. The respective bills were reintroduced in both the US House of Representatives and US Senate for the 119th Congress. Reported that the American Medical Association approved groundbreaking new CPT codes for totally implantable active middle ear hearing implants opening new potential opportunities for Envoy Medical's fully implanted active middle ear implant – the Esteem® device. Reported that it continued to increase its portfolio of patents and intellectual property. Financial Results from YE 2024 Net revenues decreased $91 thousand for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the decrease in the number of battery replacement sales due to supply chain limitations. Cost of goods sold decreased $47 thousand for the same period and is aligned with the decrease in revenue resulting from the reduced number of Battery replacement sales. R&D expenses increased $1.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily due to an increase in headcount and contractors in our engineering and clinical departments for December 31, 2024, as we increased headcount in preparation for our pivotal clinical study for the Acclaim CI. These increases in headcount included the addition of five new engineers, a clinical research associate, and a clinical research director. Sales and marketing expenses increased $68 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily due to increased legal and professional fees to secure insurance reimbursement for the Esteem FI-AMEI product, partially offset by a reduction in headcount. General and administrative expenses decreased $438 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease is primarily due to reduced professional service costs in 2024 compared to 2023 related to the Business Combination transaction occurring in September 2023. As of December 31, 2024 cash and cash equivalents were approximately $5.5 million. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use. About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the timing and results of IRB approvals, site documents, logistics or activations, enrollments, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any institution or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 28, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. ### Investor Relations:Envoy Medical Investor Relations [email protected] Media Contact:[email protected] ENVOY MEDICAL, INC.CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share amounts) ENVOY MEDICAL, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/246538

