Latest news with #EnvoyMedical
Yahoo
an hour ago
- Business
- Yahoo
Envoy Medical's Pivotal Clinical Trial for Fully Implanted Acclaim(R) Cochlear Implant Remains On Track After First Month Follow-Up
Positive momentum from the trial's first stage encouraging Company to accelerate plans for expansion and commercialization White Bear Lake, Minnesota--(Newsfile Corp. - June 10, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announced that all 10 of the study participants in the first stage of the Company's pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant have successfully completed their one-month follow-up visits. The investigational sites have reported that the visits are proceeding as expected. Due to the device's breakthrough design, participants are hearing without the need for externally worn devices and have the ability to hear 24 hours a day. No serious adverse events or unanticipated device events have been reported through the first month for all 10 participants. Brent Lucas, CEO of Envoy Medical, commented, "The feedback from investigational sites after the one month follow up visits continues to be positive and indicates we are on track with our pivotal clinical trial. We continue to build positive momentum with each milestone and have begun to accelerate our thinking about expansion and preparing for commercialization. We strongly believe that, if approved, our fully implanted Acclaim® cochlear implant will enjoy substantial patient interest; allowing us a rare opportunity to 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." Envoy Medical remains committed to effective and timely communication with investors. We will continue to update the shareholder community throughout the trial. For more information on the trial, please go to or To be added to the Envoy Medical email distribution list, please email Envoy@ 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 device is powered by a rechargeable battery and has an external charger to charge the internal device when necessary. In addition, patients are given an external remote or programmer to adjust settings or turn the device on or off. 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. For more information on the trial, investors can visit or 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. Patients are given an external remote or "personal programmer" to adjust volume, switch between hearing profiles, or turn the device on or off. Important safety information for the Esteem FI-AMEI can be found at: 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 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 subjects, institutions 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 Contact:Phil CarlsonKCSA Strategic CommunicationsO: 212.896.1233E: pcarlson@ To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
13-05-2025
- Business
- Associated Press
Envoy Medical Achieves Clinical Trial Milestone and is Optimistic About Expansion into Final Stage of Trial
White Bear Lake, Minnesota--(Newsfile Corp. - May 13, 2025) - Envoy Medical ®, Inc. (NASDAQ: COCH) ('Envoy Medical'), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announces achieving the important milestone of successful activation of all 10 study participants' fully implanted Acclaim ® cochlear implants in the first stage of the Company's pivotal clinical trial. Brent Lucas, CEO of Envoy Medical commented: 'We are excited to report the positive and meaningful progress of our pivotal clinical trial, which is currently on track and moving along as anticipated. We are optimistic we will be able to expand the study into the second and final stage during the fourth quarter of this year. We are also encouraged by the reported interest from people suffering from significant hearing loss who want to wait until a fully implanted cochlear implant is an option. We believe there is significant pent-up demand for fully implanted cochlear implants, and we are thrilled to be closer to meeting this unmet need.' 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: 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 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 subjects, institutions 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 Relations [email protected] Media Contact: [email protected] To view the source version of this press release, please visit
Yahoo
13-05-2025
- Business
- Yahoo
Envoy Medical Achieves Clinical Trial Milestone and is Optimistic About Expansion into Final Stage of Trial
White Bear Lake, Minnesota--(Newsfile Corp. - May 13, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announces achieving the important milestone of successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical trial. Brent Lucas, CEO of Envoy Medical commented: "We are excited to report the positive and meaningful progress of our pivotal clinical trial, which is currently on track and moving along as anticipated. We are optimistic we will be able to expand the study into the second and final stage during the fourth quarter of this year. We are also encouraged by the reported interest from people suffering from significant hearing loss who want to wait until a fully implanted cochlear implant is an option. We believe there is significant pent-up demand for fully implanted cochlear implants, and we are thrilled to be closer to meeting this unmet need." 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: 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 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 subjects, institutions 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 RelationsInvestorRelations@ Media Contact:Media@ To view the source version of this press release, please visit
Associated Press
31-03-2025
- Business
- Associated Press
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 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 119 th 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: 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 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 Media Contact: [email protected] ENVOY MEDICAL, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) [This table cannot be displayed. Please visit the source.] ENVOY MEDICAL, INC. (In thousands, except share and per share amounts) [This table cannot be displayed. Please visit the source.] ENVOY MEDICAL, INC. (In thousands)
Yahoo
24-03-2025
- Health
- Yahoo
MUSC to study first-ever fully internal cochlear implants as part of national trial
A model of Envoy Medical's fully implantable cochlear implant, which MUSC is studying as part of a national medical trial. (Provided by Envoy Medical) People with hearing loss could have the option of an implant with no external pieces for the first time as part of a medical trial at the Medical University of South Carolina. The Charleston-based teaching and research hospital will place a fully implantable cochlear implant in about 15 adults with significant hearing loss in both ears. Depending on the results of the study, which will last three years, the device could become widely available. Traditional cochlear implants, typically used by people with hearing loss too advanced for hearing aids, include pieces both inside and outside a person's ear. The external piece a person wears picks up sounds and sends it to the implant placed in the inner ear, allowing a person to hear. How to sign up For more information on signing up for MUSC's clinical trial, contact the clinical research program at (843) 792-4611 or CIProgram@ Source: National Institute of Health Companies have been trying to develop a device that places all the external pieces beneath a person's skin for about 20 years, said Kara Leyzac, director of MUSC's cochlear implant program. 'The biggest challenge has always been, where do you put the microphone?' Leyzac said. Envoy Medical, a Minnesota-based company focused on devices that mitigate hearing loss, found a way in 2015 to place the microphone in a person's middle ear, which is past the ear drum but not as deep as the implant itself. Those bones vibrate with sound, which the microphone picks up and sends to the implant itself. For most people with significant hearing loss, those middle ear bones still vibrate, allowing the device to work, Leyzac said. The more often a person wears a cochlear implant, the better they can hear, so having something easy to wear 24/7 helps people with hearing loss better understand language and interpret sounds. This one, people can wear as they shower, swim and sleep, which they can't do with traditional implants, said Envoy CEO Brent Lucas. 'You don't have this thing on the side of your head,' Lucas said. 'It can't fall off in the middle of the day. It's part of you.' Three patients had the device implanted as part of a smaller feasibility study in 2022. After that went well, the study expanded to seven more hospitals across the country, including MUSC. MUSC has implanted its first patient but is searching for more who are interested in participating, Leyzac said. MUSC, which was chosen because of the strength of its cochlear implant program, will submit its data to the FDA to consider as the agency determines whether Envoy can sell the device. If the device makes it to the market, it will likely cost between $25,000 and $35,000, which is similar to a traditional cochlear implant, Lucas said. He expects the devices to be covered by most insurance companies. The company covers the cost of surgery and the device during the trial. Previous attempts at creating a fully implantable device would put the microphone beneath a person's skin, muffling sound or causing a person to hear their own body, MUSC's Leyzac said. Envoy's device avoided this problem by keeping the microphone within the ear. The other major challenge in making a fully implantable device was the question of where to put the battery, Leyzac said. Traditional cochlear implants include an external battery that people can take off and charge at night. The fully implantable device includes a battery pack that a surgeon places in a person's chest, near their shoulder. Patients then place an external charging coil over the internal battery, which charges the device for several days, Leyzac said. 'You can sit there and watch TV, or do whatever, and it's just charging for you, which is pretty cool,' Leyzac said. The fully implanted device also has an on and off switch included with the charger coil, allowing people to decide when they want to hear and not hear. Many patients who have been unable to hear for a long time get used to the quiet and overwhelmed with constant sounds, Leyzac said. 'It's really cool to hear 24/7, but there are some distinct advantages to being able to turn off the world sometimes, right?' Leyzac said. Along with being more practical in some cases, fully implantable cochlear implants allow people with hearing loss to avoid some of the stigma that comes with it, Leyzac said. Stigma could be one reason few people who are eligible for cochlear implants get them. Of the people believed to be eligible, an estimated 12%, at maximum, actually undergo the procedure, 'which is an astoundingly low number,' Leyzac said. That has been the case for decades, and doctors have been trying to figure out why and whether they can do anything to make the surgery more appealing and accessible to more people. Leyzac hopes MUSC's trial will introduce more people to the idea of an implant, whether it's fully implanted or a traditional version, she said. 'If this makes it possible for more people to receive this technology, then that's a really amazing thing,' Leyzac said. 'If it improves their outcomes and makes them hear better with their implant, that's a really amazing thing.' Lucas compared the device to people with failing eyesight getting corrective surgery instead of wearing glasses all the time. Some people will still prefer the traditional implants, but they should still have the choice, he said. 'To us, it's really just a chance where individuals get to pick,' Lucas said. 'They deserve to have options, and some people really want a fully implanted solution, and we're here to provide them with that.'
