COCH

This article first appeared on GuruFocus. - Net Revenue: $66,000 in Q3 2026, up from $42,000 in Q3 2025 (ESTEEM implants and battery replacements). - Cost of Goods Sold: $244,000, compared with $203,000 in Q3 2025. - Research & Development Expenses: $3.1 million, up from $2.7 million in the prior year period, driven by Stage 2 pivotal trial expansion. - Sales & Marketing Expenses: $157,000, down from $405,000 in Q3 2025. - General & Administrative Expenses: $2.1 million, compared with $2.0 million in Q3 2025. - Net Loss: $5.2 million, or $0.50 per share, versus $7.7 million, or $3.55 per share, in the same period last year. - Cash: Approximately $14.6 million as of September 30, 2026. - Warning! GuruFocus has detected 7 Warning Signs with COCH. - Is COCH fairly valued? Test your thesis with our free DCF calculator. Release Date: November 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. - Envoy Medical Inc (NASDAQ:COCH) has over three decades of experience and $350 million invested in fully implanted hearing technology, with the ESTEEM device being the first and only FDA-approved fully implanted active middle ear implant. - The Acclaim fully implanted cochlear implant (FCI) is designed with key differentiators: no head-worn externals, a middle ear sensor that uses the natural hearing pathway, no magnet (potentially better for MRI compatibility), and a large replaceable battery in the chest for multiple days of use. - The pivotal trial for the Acclaim FCI is fully enrolled with 56 participants, and all have passed the six-month follow-up; 12-month data collection is expected to be complete by April 2027. - Stage 1 12-month results showed a mean CNC word recognition score improvement of 38 percentage points (from 15.2% to 53.2%), which is in line with competitors' performance. - The modular PMA submission strategy allows Envoy Medical Inc (NASDAQ:COCH) to address FDA questions incrementally, with two of four modules already submitted, potentially streamlining the final review. - The cochlear implant market is significantly underpenetrated (only ~5% of eligible adults in the US), and Envoy Medical Inc (NASDAQ:COCH) believes its fully implanted device could expand the market and capture share, needing only a few thousand implants annually to generate significant revenue. - Envoy Medical Inc (NASDAQ:COCH) plans to expand manufacturing capacity to 10,000-15,000 units per year within five years, with a modest capital investment of a couple of million dollars for a clean room. - The company anticipates low sales and marketing expenses due to the established cochlear implant market, identifiable surgeons and audiologists, and the potential for earned media and patient testimonials to drive demand. - Envoy Medical Inc (NASDAQ:COCH) reported a net loss of $5.2 million for Q3 2026, although this was an improvement from the $7.7 million loss in Q3 2025. - Net revenue from ESTEEM implants and battery replacements was only $66,000 in Q3 2026, and the company is not actively pursuing ESTEEM sales, focusing instead on the Acclaim FCI. - Research and development expenses increased to $3.1 million from $2.7 million year-over-year, primarily due to the expansion into Stage 2 of the pivotal trial, contributing to ongoing cash burn. - The company had $14.6 million in cash as of September 30, 2026, which may not be sufficient to fund operations through the anticipated PMA submission and potential commercialization, requiring additional financing. - The Acclaim FCI has not yet received FDA approval, and the PMA submission is not expected to be complete until the first half of 2027, with potential FDA decisions by end of 2027 or first half of 2028, representing significant regulatory and timeline risk. - There is a learning curve for investigators programming the Acclaim device due to its novel middle ear sensor, which may slow patient ramp-up compared to traditional cochlear implants. - The company faces competition from two other companies developing fully implanted cochlear implants, which could intensify and potentially delay market adoption. - Envoy Medical Inc (NASDAQ:COCH) needs to expand its team from ~50 to 70-75 employees and build out manufacturing capacity, which will require additional capital and management attention. - The ESTEEM device is classified as a hearing aid by CMS, limiting Medicare coverage and patient access, and any policy change to reclassify it as a prosthetic is uncertain. - The company is not currently generating meaningful revenue and may need to raise additional capital to fund operations through commercialization, potentially diluting shareholders. Q: What feedback has the FDA provided on Modules 1 and 2 of the modular PMA submission, and how is that strategy progressing? A: CEO Brent T. Lucas said the feedback has validated the modular PMA strategy, which suits a smaller company without a large regulatory team. FDA questions so far have been limitedsuch as rationale for certain benchtop tests or sample sizesand management is not overly concerned. Clearing these questions module by module should allow the company to focus fully on the final clinical module when it is submitted. Q: How do efficacy trends in Stage 2 patients compare with Stage 1, and are CNC word recognition scores improving beyond 12 months? A: CEO Brent T. Lucas said Stage 2 appears to be tracking similarly to Stage 1, with nothing suggesting different efficacy, though he is blinded to the full database. He noted a slight learning curve for investigators due to the novel middle ear sensor and healing time, but Stage 1's 12-month dataa 38 percentage point CNC word score improvementis in line with competitors. Efficacy data is collected through 12 months; the next Stage 1 visit is at 24 months. Q: What are the plans for building a commercial team and preparing for an initial launch if Acclaim is approved? A: CEO Brent T. Lucas said the company currently has about 50 full-time employees and expects to grow to roughly 7075 within 1218 months, mainly in manufacturing and commercial roles. Envoy aims to hire a commercial leader within the next year, ideally with active implantable and high-ASP device experience. He expects limited sales and marketing spend given the established cochlear implant market, identifiable surgeons and audiologists, and strong earned-media potential from patient testimonials. Q: What is required to expand manufacturing capacity to support commercialization? A: CEO Brent T. Lucas said Envoy currently has about 17,000 square feet of office, manufacturing, and R&D space and plans to expand to roughly 30,00035,000 square feet. The main investment is a certified clean room, expected to cost a couple of million dollars. The company plans to acquire space in early 2027 and build out the clean room in the back half of 2027, targeting capacity of 10,00015,000 units per year within about five years of commercialization, versus roughly 2,500 units today on multiple shifts. Q: How does Envoy view the competitive landscape for fully implantable cochlear implants? A: CEO Brent T. Lucas said two competitors are now publicly embracing fully implanted cochlear implants as the future of the industry, building momentum around three clinical programs. He believes patients may wait for a fully implanted option given it is not life-or-death technology. Envoy differentiates through its middle ear sensor (no external or subcutaneous microphone), no magnet (potential MRI advantages), compatibility with ear-worn devices like earbuds, and a chest-placed, replaceable large-capacity battery allowing multiple days per charge. Q: What were Envoy's third quarter 2026 financial results? A: Chief Accounting Officer and VP of Finance Robby Potashnick reported net revenue of $66,000 from ESTEEM implants and battery replacements, up from $42,000 a year earlier, with ESTEEM sales not actively pursued. Cost of goods sold was $244,000; R&D rose to $3.1 million from $2.7 million on Stage 2 trial expansion; sales and marketing fell to $157,000 from $405,000; G&A was $2.1 million. Net loss attributable to common stockholders was $5.2 million, or $0.50 per share, versus $7.7 million, or $3.55 per share, a year ago. Q: What is Envoy's cash position and capital allocation approach? A: Chief Accounting Officer and VP of Finance Robby Potashnick said Envoy had approximately $14.6 million in cash as of September 30, 2026. Management remains focused on disciplined capital allocation as it advances the pivotal study and PMA submission. Q: What is the status of the Acclaim pivotal trial and the expected timeline for PMA submission and potential FDA decision? A: CEO Brent T. Lucas said all 56 participants are fully enrolled and have passed the six-month follow-up, with 12-month visits expected complete by April 2027 and data collection finished in the second quarter of 2027. Two of four PMA modules have been submitted (June 30 and October 12, 2026), with the remaining two, including the final clinical module, targeted for the first half of 2027. Depending on FDA review, potential decisions could come by the end of 2027 or the first half of 2028. Q: What is the size of the cochlear implant market opportunity Envoy is targeting? A: CEO Brent T. Lucas framed the opportunity in three buckets: the current U.S. market of roughly $1 billion in annual revenue with an estimated 20,00025,000 adult implants per year; an expanded market, given only about 5% penetration of an estimated 2.8 million adult candidates (about 150,000 implanted); and existing recipients who may want the other ear implanted or to replace a legacy device. He believes selling only a few thousand implants a year could generate significant revenue. Q: What is the status of the ESTEEM device and its potential if CMS reimbursement policy changes? A: CEO Brent T. Lucas said ESTEEM is the first and currently only FDA-approved fully implanted active middle ear implant, with roughly 1,000 devices implanted, some over two decades ago. CMS classified it as a hearing aid, making it ineligible for Medicare coverage and limiting patient access. Envoy continues to believe such implants are hearing prosthetics that should be covered; if policy changes, ESTEEM would be well positioned, and ESTEEM revenue could change materially. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Company Reaches Six-Month Milestone in Pivotal Trial of Fully Implanted Cochlear Implant Second Module of Modular PMA Application Submitted to FDA Following Quarter End White Bear Lake, Minnesota--(Newsfile Corp. - November 5, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today reported financial results for the third quarter ended September 30, 2026, and provided a business update, highlighting continued execution on its corporate initiatives. "We continued to make significant progress with our investigational fully implanted cochlear implant during the third quarter, as we approach an extremely exciting 2027," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Not only did we report encouraging 12-month data from the first 10 participants in our trial, but we also surpassed the three-month follow-up mark for the full cohort. Since quarter end, we have now surpassed the six-month follow-up milestone. We remain on track for all participants to complete their 12-month visits by early in the second quarter of 2027. Each milestone brings us closer to offering cochlear implant candidates a fully implanted option they have wanted for decades." Corporate and Financial Highlights for Q3 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. - Expanded Global Intellectual Property Portfolio. The Company was granted Canadian and Hong Kong patents relating to implantable cochlear system design and middle ear sensor signal processing, expanding its global portfolio to 97 granted patents, consisting of 40 U.S. and 57 foreign patents, with an additional 35 applications pending. Highlights Subsequent to Q3 2026: - Second Module of Modular PMA Application Submitted to the FDA. The Company submitted the second 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. The Company expects to submit a total of four modules, with the final module containing final clinical trial data. The Company expects all Stage 2 participants to complete 12-month data collection by early in the second quarter of 2027, with submission of the final module planned to follow a few months thereafter. - Six-Month Follow-Up Visit Milestone Surpassed. The Company announced that its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant surpassed the six-month follow-up visit milestone for all 56 patients. To the Company's knowledge, Envoy Medical is the first company to reach this milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant. The trial's primary efficacy endpoint will be evaluated based on 12-month data. - Atlas Litigation Dismissed. On October 6, 2026, the Company entered into a dismissal agreement with Atlas Merchant Capital SPAC Fund I LP, under which all claims asserted by Atlas in the litigation filed in the Delaware Court of Chancery were dismissed with prejudice, and the litigation was terminated without any payment by the Company or the other defendants. Financial Results for the Quarter Ended September 30, 2026 (dollars in thousands): Net revenue was $66 for the three months ended September 30, 2026, compared to $42 for the three months ended September 30, 2025. Cost of goods sold for the three months ended September 30, 2026, was $244, compared to $203 for the three months ended September 30, 2025. R&D expenses for the three months ended September 30, 2026, were $3,077 compared to $2,700 for the three months ended September 30, 2025. This increase of $377 mainly reflects additional clinical trial follow-up activity following completion of enrollment in the first quarter of 2026 and higher costs related to supporting the clinical trial and ongoing regulatory submissions, partially offset by lower product costs. Sales and marketing expenses for the three months ended September 30, 2026, were $157 compared to $405 for the three months ended September 30, 2025. The decrease of $248 is primarily due to the reallocation of field clinical specialists to research and development activities in support of the clinical trial. General and administrative expenses were $2,125 for the three months ended September 30, 2026, compared to $1,999 for the three months ended September 30, 2025. The increase of $126 was primarily due to modest increases in compensation, stock-based compensation, and professional services expenses. Net loss attributable to common stockholders was $5,240, or $0.50 per basic and diluted share for the three months ended September 30, 2026, compared to net loss attributable to common stockholders of $7,747, or $3.55 per basic and diluted share for the three months ended September 30, 2025. As of September 30, 2026, cash was approximately $14,570. Conference Call Information: Envoy Medical management will host a conference call today at 8:00 A.M. ET to discuss these results and provide a business update. Third Quarter 2026 Financial Results Conference Call: Date: Thursday, November 5, 2026 Time: 8:00 A.M. ET Live Call: 1-800-267-6316 (U.S. Toll Free) or 1-203-518-9783 (International) Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1778210&tp_key=20071611a1 For interested individuals unable to join the conference call, a replay will be available through November 19, 2026, by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 11162715. 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 and neuroprosthetics 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 Carlson KCSA Strategic Communications O: 212.896.1233 E: [email protected] ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) | | September 30, | | December 31, | | | 2026 | | 2025 | | | (unaudited) | | | Current assets: | | | | | Cash | | $ | 14,570 | | $ | 3,739 | Accounts receivable, net | | | 51 | | | 34 | Other receivable | | | 17 | | | 19 | Inventories | | | 1,510 | | | 1,546 | Prepaid expenses and other current assets | | | 1,114 | | | 941 | Total current assets | | | 17,262 | | | 6,279 | Property and equipment, net | | | 854 | | | 1,035 | Operating lease right-of-use asset (related party) | | | 782 | | | 886 | Prepaid expenses and other assets | | | 260 | | | 358 | Total assets | | $ | 19,158 | | $ | 8,558 | | | | | | | | Liabilities, mezzanine equity, and stockholders' deficit | | | | | | | Current liabilities: | | | | | | | Accounts payable | | $ | 1,583 | | $ | 2,920 | Accrued expenses | | | 11,600 | | | 7,639 | Forward purchase agreement warrant liability | | | - | | | 24 | Product warranty liability, current portion | | | 252 | | | 287 | Operating lease liability, current portion (related party) | | | 185 | | | 174 | Other current liabilities | | | 650 | | | 518 | Total current liabilities | | | 14,270 | | | 11,562 | Product warranty liability, net of current portion | | | 1,496 | | | 1,605 | Operating lease liability, net of current portion (related party) | | | 592 | | | 745 | Private warrant liability | | | 3,467 | | | 5,835 | Publicly traded warrant liability | | | 446 | | | 551 | Other liability | | | 27 | | | 27 | Total liabilities | | | 20,298 | | | 20,325 | | | | | | | | Commitments and contingencies (see Note 14) | | | | | | | | | | | | | | Mezzanine equity | | | | | | | Warrants issued to placement agent as part of the 2025 Offerings (see Note 9) | | | 391 | | | 391 | | | | | | | | Stockholders' deficit | | | | | | | Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of September 30, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of September 30, 2026 and December 31, 2025 | | | - | | | - | Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 7,744,488 shares issued and outstanding as of September 30, 2026 and 2,893,495 shares issued and outstanding as of December 31, 2025 | | | 8 | | | 3 | Additional paid-in capital | | | 330,193 | | | 301,355 | Accumulated deficit | | | (331,609 | ) | | (313,396 | ) Accumulated other comprehensive loss | | | (123 | ) | | (120 | ) Total stockholders' deficit | | | (1,531 | ) | | (12,158 | ) Total liabilities, mezzanine equity, and stockholders' deficit | | $ | 19,158 | | $ | 8,558 | ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2026 | | 2025 | | 2026 | | 2025 | Net revenues | | $ | 66 | | $ | 42 | | $ | 156 | | $ | 166 | Costs and operating expenses: | | | | | | | | | | | | | Cost of goods sold | | | 244 | | | 203 | | | 835 | | | 663 | Research and development | | | 3,077 | | | 2,700 | | | 9,851 | | | 7,933 | Sales and marketing | | | 157 | | | 405 | | | 502 | | | 1,124 | General and administrative | | | 2,125 | | | 1,999 | | | 6,033 | | | 5,888 | Total costs and operating expenses | | | 5,603 | | | 5,307 | | | 17,221 | | | 15,608 | Operating loss | | | (5,537 | ) | | (5,265 | ) | | (17,065 | ) | | (15,442 | ) Other income (expense): | | | | | | | | | | | | | Change in fair value of forward purchase agreement warrant liability | | | 14 | | | 64 | | | 24 | | | 522 | Loss on offering and change in fair value of private warrant liability | | | 1,201 | | | (782 | ) | | 2,368 | | | (782 | ) Change in fair value of publicly traded warrant liability | | | 259 | | | (33 | ) | | 105 | | | 129 | Interest expense (related party) | | | - | | | (471 | ) | | - | | | (1,590 | ) Other income (expense), net | | | 131 | | | 5 | | | 303 | | | (7 | ) Total other income (expense), net | | | 1,605 | | | (1,217 | ) | | 2,800 | | | (1,728 | ) Net loss | | | (3,932 | ) | | (6,482 | ) | | (14,265 | ) | | (17,170 | ) | | | | | | | | | | | | | Cumulative preferred dividends | | | (1,308 | ) | | (1,265 | ) | | (3,948 | ) | | (3,755 | ) | | | | | | | | | | | | | Net loss attributable to common stockholders, basic and diluted | | $ | (5,240 | ) | $ | (7,747 | ) | $ | (18,213 | ) | $ | (20,925 | ) Net loss per share attributable to common stockholders, basic and diluted | | $ | (0.50 | ) | $ | (3.55 | ) | $ | (1.97 | ) | $ | (9.72 | ) Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted | | | 10,434,466 | | | 2,185,161 | | | 9,256,928 | | | 2,152,262 | Other comprehensive (loss) income: | | | | | | | | | | | | | Foreign currency translation adjustment | | | (1 | ) | | (1 | ) | | (3 | ) | | 3 | Other comprehensive (loss) income | | | (1 | ) | | (1 | ) | | (3 | ) | | 3 | Comprehensive loss | | $ | (3,933 | ) | $ | (6,483 | ) | $ | (14,268 | ) | $ | (17,167 | ) ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (Dollars in thousands) | | Nine Months Ended September 30, | | | 2026 | | 2025 | Cash flows from operating activities | | | | | Net loss | | $ | (14,265 | ) | $ | (17,170 | ) Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | Depreciation | | | 222 | | | 222 | Interest expense and amortization of debt discount on Term Loans (related party) | | | - | | | 1,586 | Stock-based compensation for services | | | 140 | | | 152 | Amortization of prepaid insurance | | | 691 | | | 738 | Stock-based compensation | | | 760 | | | 478 | Loss on offering and change in fair value of private warrant liability | | | (2,368 | ) | | 339 | Change in fair value of publicly traded warrant liability | | | (105 | ) | | (129 | ) Change in fair value of forward purchase agreement warrant liability | | | (24 | ) | | (522 | ) Net change in operating lease (related party) | | | 167 | | | (39 | ) Change in inventory reserve | | | 10 | | | 68 | Changes in operating assets and liabilities: | | | | | | | Accounts receivable, net | | | (17 | ) | | 3 | Other receivable | | | 2 | | | 761 | Inventories | | | 26 | | | 1 | Prepaid expenses and other assets | | | (105 | ) | | (74 | ) Accounts payable | | | (1,345 | ) | | 973 | Operating lease liability (related party) | | | (205 | ) | | 1 | Accrued expenses | | | 13 | | | 216 | Product warranty liability | | | (144 | ) | | (120 | ) Net cash used in operating activities | | | (16,547 | ) | | (12,516 | ) | | | | | | | Cash flows from investing activities | | | | | | | Purchases of property and equipment | | | (33 | ) | | (7 | ) Net cash used in investing activities | | | (33 | ) | | (7 | ) | | | | | | | Cash flows from financing activities | | | | | | | Payments on insurance financing loans | | | (572 | ) | | (636 | ) Proceeds from the issuance of Term Loans (related party) | | | - | | | 10,000 | Dividends paid to stockholders of Series A Preferred Stock | | | - | | | (1,820 | ) Payment made for extinguishment of Term Loans (related party) | | | - | | | (100 | ) Proceeds from the issuance of Class A Common Stock from ATM offering | | | - | | | 414 | Proceeds from the issuance of Class A Common Stock from exercise of warrants | | | 100 | | | - | Proceeds from issuance of Class A Common Stock under employee stock purchase plan | | | 104 | | | 77 | Proceeds from exercise of forward purchase agreement warrants | | | - | | | 158 | Proceeds from the issuance of Class A Common Stock and Investor Warrants from registered direct offering | | | - | | | 2,500 | Proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants | | | 29,997 | | | - | Offering costs from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants | | | (2,215 | ) | | - | Net cash provided by financing activities | | | 27,414 | | | 10,593 | | | | | | | | Effect of exchange rate changes on cash | | | (3 | ) | | 3 | Net increase (decrease) in cash | | | 10,831 | | | (1,927 | ) Cash, beginning of period | | | 3,739 | | | 5,483 | Cash, end of period | | $ | 14,570 | | $ | 3,556 | | | | | | | | Supplemental disclosures of cash flow information: | | | | | | | Cash paid for interest | | $ | 19 | | $ | 22 | Non-cash investing and financing activities: | | | | | | | Accrued and unpaid dividends on Series A Preferred Stock | | $ | 3,948 | | $ | 1,935 | Financing of prepaid insurance | | $ | 704 | | $ | 75 | Issuance of Term Loan Warrants (related party) | | $ | - | | $ | 1,570 | Accrued interest capitalized into term loans payable (related party) | | $ | - | | $ | 800 | Modification of forward purchase agreement warrant | | $ | - | | $ | 62 | Lease liabilities arising from obtaining right-of-use assets | | $ | - | | $ | 121 | Property and equipment purchased on account | | $ | 8 | | $ | 56 | Modification of Term Loan Warrants (related party) | | $ | - | | $ | 1,455 | Deemed capital contribution associated with the extinguishment of Term Loans (related party) | | $ | - | | $ | 27,883 | Issuance of Placement Agent Warrants | | $ | 678 | | $ | - | To view the source version of this press release, please visit https://www.newsfilecorp.com/release/322572

Image source: The Motley Fool. Thursday, Nov. 5, 2026 - Chief Executive Officer - Brent Lucas - Chief Accounting Officer and Vice President of Finance - Robert Potashnick - Managing Director, KCSA Strategic Communications - Phil Carlson Operator: Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press 0 and a member of our team will be to help you. Hello, and welcome everyone joining today's Envoy Medical Q3 26 Earnings Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. To register to ask a question at any time, please press Please note this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the conference over to Phil Carlson, KCSA Managing Director. Please go ahead. Phil Carlson: Thank you, operator. Good morning, and welcome, everyone, to the Envoy Medical Third Quarter 26 Earnings Conference Call. This is a special moment as this is Envoy Medical's first ever quarterly earnings call. I am joined today by members of Envoy Medical's leadership team, including Brent Lucas, chief executive officer and Robert Potashnick, chief accounting officer and VP of finance. Before we begin, I would like to remind everyone that statements made during today's call contain or may contain forward looking statements covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 2000 and applicable federal securities laws. Comments made on this call that look forward in time involve risks and uncertainties our forward looking statements within the meaning of the Private Securities Litigation Reform Act of 2000. These statements including statements regarding Envoy Medical's clinical, regulatory and commercial plans, strategies and estimates, the timing, results, data, and outcomes of the clinical trial, timing of FDA submissions and potential approval, the expectations of financial or operational performance are based on management's current plans, and assumptions, and actual results may differ materially. Please refer to the company's filings with the SEC including our Form 10 Q for the quarter ended 09/30/2026, and our Form 10 ks for the fiscal year ended 12/31/2025, a detailed discussion on the risks and uncertainties facing Envoy Medical. With that, I would now like to turn the call over to Envoy Medical's Chief Executive Officer, Brent Lucas. Brent? Please go ahead. Brent Lucas: Thank you, Phil, and good morning, everyone. Before we get into the quarter, I would like to take a few minutes to discuss who we are as a company. Many of you have supported us for years, but a growing number of investors around the world are new to Envoy Medical's story. Whether you are a long term investor or just getting to know us, we hope you will leave today's call with an understanding of why we are so energized about Envoy Medical's future. We believe Envoy Medical is on the cusp of something transformative. With our investigational Acclaim fully implanted cochlear implant, we believe we are uniquely positioned to reshape the multibillion dollar cochlear implant market. If our assumptions prove correct, some may 1 day call Envoy Medical an overnight success. The reality is that our journey to this point spans more than 3 decades and over $350 million of invested capital. Rome, as they say, was not built in a day. Envoy Medical was founded in 2000 with a clear goal to create a fully implanted device that works with the natural ear. The founding principles were simple. Avoid microphones and externally worn components at all costs. And use the body's natural hearing pathway to capture sound. The benefits of a fully implanted hearing device were compelling. Nothing to wear on or behind your ear. The ability to hear all day and all night. No expensive external hardware to lose or break, No discomfort or annoyance from wearing something on the side of your head all day. The potential for better sound localization, fewer limits on everyday and, of course,, nothing for others to see. That was the dream, and Envoy Medical set out to make it a reality. Our solution was a middle ear sensor that leverages the natural hearing pathway No microphone on or behind the ear. No microphone buried under the skin. Instead, the sensor picks up vibrations of the middle ear and uses them as the signal. Much as the natural ear does. We first validated our sensor technology in the Esteem fully implanted active middle ear implant. The Esteem fully implanted hearing device is the first and currently the only of its kind to receive FDA approval. Roughly 1 thousand Esteem devices have been implanted. Some more than 2 decades ago in early clinical trials. We believe no company has more experience with fully implanted hearing devices than Envoy Medical. Unfortunately, for patients with hearing loss and the professionals who serve them, CMS classified the Esteem as a hearing aid. That classification made it ineligible for Medicare coverage, and in practice, limited patients' access to the technology. We continue to believe that fully implanted active middle ear implants are hearing prosthetics, not hearing aids, and should be covered by public and private payers. If that policy changes, we believe the Esteem would be well positioned to benefit. In 2015, we shifted our focus on an opportunity that had been calling for our attention for 2 decades, fully implanted, invisible cochlear implants. Cochlear implants have been commercially available in the United States since the 1.98 thousands and are well established as a solution for severe to profound hearing loss. Yet only a small fraction of adult candidates, roughly 5%, have pursued 1. We believe the significant reason for this low penetration is that most people do not want to live with or be limited by an external component worn on the side of their head. We quickly got to work with no preconceived notions holding us back, our team was able to examine different design choices from the ground up. After carefully weighing the options and trade offs, we selected a design built to support long-term interest of the patient. A modular implanted system with 4 main components. These are our sensor, a processor connected, to the electrode array, a large capacity battery placed in the chest, and a power lead connecting the battery to the processor. We built the system ourselves using our own designs and intellectual property, which we believe makes it a more valuable independent technology. That work became our investigational Acclaim fully implanted cochlear implant or FCI. We are extremely proud of the Acclaim and believe its design offers several key advantages. No required head-worn externals, The Acclaim FCI is designed so that no sound processor or charger needs to be worn on the head. Middle ear sensor. The Acclaim FCI uses our middle ear sensor to pick up sound through the natural hearing pathway. There is no external microphone, and no microphone under the skin. Flexibility. Because the Acclaim FCI uses the ear itself to pick up sound, it is designed to allow patients to keep using ear-worn devices such as popular earbuds or even hearing aids. As artificial intelligence drives rapid innovation in ear-worn consumer electronics, we believe an Acclaim patients will be positioned to take advantage of those new devices. No magnet. There is no magnet anywhere in the Acclaim system. Because nothing needs to be held in place on the head, a magnet is not required. We believe this may offer advantages for patients who eventually need MRI or other imaging of the head. Currently, the investigational Acclaim FCI has not received MR conditional labeling, but we are hopeful that this will change once testing is submitted and approved. Large capacity rechargeable battery. Perhaps our most intentional design choice was placing a large capacity rechargeable battery in the chest rather than in the head. In general, a larger battery generally means more time between charges. The Acclaim FCI is designed to run for several days, uninterrupted, on a single charge. Replaceable battery. All rechargeable batteries eventually lose capacity. The Acclaim FCI was designed so that when that happens, the battery can be replaced through a straightforward procedure without explanting the entire device. The Acclaim FCI received breakthrough device designation from the FDA in 2019. The first patients were implanted in an early feasibility study at Mayo Clinic in Rochester, Minnesota in October 2022. In 2024, we advanced into our pivotal study. Which the FDA requested we conduct in 2 stages. Stage 1 with 10 participants followed by stage 2 with an additional 46 participants for a total cohort of 56. Stage 1 was fully enrolled in April 2025. After 3 months of follow-up, we submitted the data to the FDA and requested expansion into stage 2. In October 2025, the FDA authorized us to expand the study into stage 2. Enrollment in stage 2 moved quickly. The trial was fully enrolled in March 2026. All 56 participants have now passed their 6-month follow-up milestone. We anticipate that all 56 will complete their 12-month follow-up visit by April 2027, at which point data collection for the trial will be complete. In July, we reported encouraging 12-month results from 10 participants in stage 1. The mean of 53.2%, compared with a pre implantation baseline of 15.2%. Representing a 38 percentage point improvement. While data in the full cohort needs to be collected and analyzed prior to drawing any conclusions, we are encouraged by these results and look forward to seeing the final data. We are pursuing a modular premarket approval or PMA, submission strategy. Rather than submitting 1 large PMA application, we plan to submit 4 modules over time. On 06/30/2026, we submitted our first module. And on 10/12/2026, after quarter end, we submitted our second. With 2 of 4 modules now with the FDA, the agency can review these sections while clinical data collection continues. We continue to target submission of the remaining 2 modules, including the final clinical module in the first half of 27. The market opportunity reinforces why we believe this work matters. And why we are so energized about Envoy Medical's future. We currently think about the cochlear implant market in 3 buckets. The first bucket is the current market. In The United States, cochlear implants represent roughly $1 billion in annual revenue. Exact numbers are difficult to pinpoint, but we estimate that roughly 20 thousand to 25 thousand cochlear implants are implanted in US adults each year. The second bucket is the expanded market. Today's market is substantially underpenetrated. We estimate that approximately 2.8 million in the United States could be candidates for a cochlear implant. Yet only about 150 thousand adults within that candidate pool have received 1. That represents only about 5% penetration of the estimated addressable population. If a new technology that patients want were able to increase that penetration, we believe the market could grow significantly. The third bucket is existing cochlear implant recipients. Some may want the other ear implanted, and others may want to replace their legacy device with a fully implanted cochlear implant. If the acclaim is approved, we believe Envoy Medical would need to sell only a few thousand implants a year to generate significant revenue. And we see ample opportunity to do so. More importantly, we believe we have designed a device that could capture the market's attention gain market share, and help expand the market. With that, I will turn the call over to Robert Potashnick, our Chief Accounting Officer and Vice President of Finance, to review our third quarter financial results. Robert Potashnick: Thank you, Brent, and good morning, everyone. Let me walk you through our financial results for the third quarter ended 09/30/2026. Net revenue for the third quarter from Esteem implants and battery replacements was $66 thousand compared to $42 thousand in the third quarter of 25. We are not actively pursuing Esteem sales as our focus is the Acclaim FCI. But we continue to support existing Esteem recipients. We believe Esteem revenue could change materially if CMS changes how it classifies fully implanted active middle ear implants. Cost of goods sold was $244 thousand compared to $203 thousand in the third quarter of 25. Research and development expenses were $3.1 million compared with $2.7 million in the prior year period. The increase was primarily driven by the expansion into stage 2 of the pivotal trial. Following FDA authorization in the fourth quarter of 25. Sales and marketing expenses for the third quarter were $157 thousand compared with $405 thousand in the third quarter of 25. The decrease was primarily due to employees who previously supported sales and marketing and are currently supporting the clinical trial and related research and development activities. General and administrative expenses were $2.1 million compared with $2 million in the third quarter of 25. Net loss attributable to common stockholders for the quarter was $5.2 million or $0.50 per share. Compared with $7.7 million or $3.55 per share in the same period last year. As of 09/30/2026, we had cash of approximately $14.6 million We remain focused on disciplined capital allocation as we advance the pivotal study and PMA submission. With that, I will turn the call back to Brent for closing remarks. Brent Lucas: Thank you, Robbie. To summarize, Envoy Medical has spent more than 3 decades pioneering fully implanted hearing solutions. With our investigational Acclaim FCI, we believe we have developed a fully implanted cochlear implant that is fundamentally differentiated from other products. We believe patients want fully implanted options, and ultimately, it is patients who will decide this market. Our pivotal trial is fully enrolled, and we expect data collection to be complete in the second quarter of 27. We remain on track to submit the remaining 2 modules of our PMA application. Including the final clinical module, by the end of the second quarter of 27. Depending on the FDA's review, we could see potential FDA decision by the end of 27 or the first half of 28. We believe the Envoy medical opportunity is substantial. We are focused on disciplined execution through the remaining clinical follow-up and regulatory steps while preparing for potential commercialization if approved. 2026 has been a year of meaningful progress, and we continue to be confident in the path forward. With that, operator, we are ready to open the line for questions. Operator: We will take our first question from Frank Takich with Lake Street Capital Markets. Please go ahead. Frank Takinen: Brent. Thanks, guys. Appreciate you taking the questions, and congrats on all the progress. I was hoping to start with 1, Brent, just on the initial commercial launch. Maybe speak to how large of a team you want to have in place at that point in time and when you might think it makes sense to start, recruiting that team and then maybe any other commercial preparedness actions you think are relevant to the conversation? Thanks. Brent Lucas: Thanks, Frank. Yeah. So we are currently kind of planning out how we intend to go about this. 1 of the things that Envoy Medical has successfully done over the last, 11 years since I have been CEO is run a very lean team. So what we have been able to accomplish with who we have, I think, has been pretty darn impressive, especially when you compare us to the size and budget of our competitors. But 1 of the things we are mindful of is it is time to start to ramp up for commercialization, being that we are very encouraged by how the trial is proceeding. So we are currently around 50 full time employees. And I think in the next 12 to 18 months, we need to see that number closer to 70 or 75. A lot of that will be geared towards manufacturing personnel as well as commercial. Definitely want to locate a commercial leader in the next year. Ideally, somebody who has experience with active implantables as well as high ASP devices. So we are going to be identifying that person. Also, we are based in White Bear Lake, Minnesota. We are in a building that is quite large that has another company here that might be willing to give up some space. So we plan to expand in our existing location and build capacity for manufacturing that should get to a point where we could do 10 thousand to 15 thousand units a year. Which is what I think is attainable within about 5 years of commercialization if things go according to plan. So right now, we are at about 2.5 thousand units, and that is if we are doing multiple shifts, and it is going to be crowded in there. So we definitely need to build out our clean room and get ready to expand. I think, 1 of the things I would also highlight is I do not anticipate having to spend a lot of sales and marketing dollars compared to some other companies that are coming to market. The cochlear implant market is established. it is well known. The surgeons are easy to identify, and the audiologists who work with patients are easy to identify. As well as the fact that I think earned media such as patient testimonials and things like that, are really going to drive the demand here. So I think the demand will be there right out of the gate. This is something people have wanted for a very long time. I do not anticipate having to spend a dramatic amount of sales and marketing dollars as some other companies have had to do when they come to the market. So I think we will be in a very, very good position to be efficient yet strong as we enter the market. Frank Takinen: Got it. Very helpful. And then my second was actually a topic you started to speak a little bit about. Maybe you could go a little deeper into what is required to expand manufacturing? Obviously, I heard expanding the footprint a little bit, but maybe talk through what other items need to occur to get the manufacturing to that level. Brent Lucas: Sure. We need to expand our footprint a little bit, and we have currently about I think we are right around 17 thousand square feet for offices and manufacturing. and R&D, and get that up to about 30 thousand around that number, 35 thousand for offices and manufacturing space. The big list is gonna be clean room. So, obviously, we are very highly regulated, so we will need to build a clean room out. That will include various equipment and proper staging. For the devices. Not a huge expense, I mean, we are talking a couple million dollars here. We are not talking anything that is crazy. To be able to source that and build it out and properly certify it. But we wanna make sure we start that process probably towards the back half of next year or first part of this year by kind of acquiring the-- sorry, first part of next year to acquire the space. Start to plan it out, and then maybe start building it towards the back half of 2027 so that when we get to 2029, when we really expect quite a large jump in annual sales, we will be. We will have that capacity. The clean room will be up and running. We will have them certified and all of that. Frank Takinen: Got it. Very helpful. Appreciate you taking the questions. Thanks. Thanks, Frank. Brent Lucas: Thank you. Operator: We will take our next from Alex Nowak with Craig-Hallum Capital Group. Please go ahead. Your line is open. Alex Nowak: Okay, great. Good morning, everyone. I was hoping you could share any feedback you have had from the FDA on modules 1 and 2 of the PMA submission. Brent Lucas: Sure. So I think the thing I just sort of generally speak about it is it is just validated our strategy. So the PMA, the modular PMA submission strategy is absolutely perfect for companies and our situation. So these are smaller companies. Do not have a team of, you know, 25 people. In the regulatory department that can answer questions on the final Q and submission. So being able to clear the decks of questions as we go through each module is just wildly beneficial to us. So far, the feedback has been, you know, to answer a question around why did you do this test or benchtop testing, you know, maybe sample size on a test or 2. We have had good conversations there. Not overly concerned about anything that we have received. it is just gonna give us the opportunity to clear the deck. So that when we get ready for that final clinical submission, we can focus all of our attention on that module. Hopefully, by that point, everything else will have been answered, and we can move on. Alex Nowak: Alright. No. that is great. 2-part question related to the efficacy of the study, both Stage 1 and Stage 2. For the stage 2 patients, how is the patient signal ramp up occurring? Is that occurring at kind of around that 6-month mark? And all in line with what you are seeing? And just, I guess, how does that compare to stage 1 patients and also the non fully implantable cochlear implants? And then the second part of the question is, for those stage 1 patients, are you seeing the CNC word recognition scores improve beyond the 12-months? Brent Lucas: So it is a great question, and, you know, some of this I only understand a high level of information that is coming back from feedback from the sites as I am not privy to the full database, blinded to the full database. So I am as excited as everybody else to see the final results. When we do the proper analyzation and send that to the FDA. But what I can tell you from what I have heard is that the Stage 1 and Stage 2 is on a similar track. Stage 2 is on a similar track to stage 1. So in terms of. The numbers are progressing as we expect to see based on Stage 1. there is nothing from stage 2 that I am aware of to this point that suggests the efficacy is going to be any different. Hopefully a little bit better as we go and people are better in terms of turning programming the device and getting things ramped up. In terms of our ramp up, there is a slight difference from what we have seen in the beginning of the study. Which was traditional cochlear implants. You know, these traditional cochlear implants have been around for 40 years. I mean, some of these products got their first FDA approval in the '90s-- in the '80s. And then the multichannel in the 1.99 thousands for some of them. So the pro. The people programming these, the audiologists and the surgeons, are very comfortable with kind of the process of these devices. And the fact of the matter is the Acclaim is an investigational device that is different. And the. Well, 1 of the very obvious differences is the sensor in the middle ear. This has been an adjustment for the folks working with the device for the investigators, and there has been sort a little bit of a learning curve with that. So we have seen a slight difference in terms of the ramp up timing. We are seeing that our patients are eventually appear, at least from what we have seen to date, to be getting to where they need to get with that stage 1 data, the 12-month data, you know, 38 percentage points of improvement for CNC Word Scores is right in the ballpark of what the other companies are doing across the board. So very comfortable with what we have seen so far from that standpoint. I do also believe that as time goes, and our device is. People are more comfortable with our device and more comfortable programming it in the clinic, and kind of more comfortable pushing the envelope earlier in the programming. I think you are going to see the ramp up time sort of start to trend with what other companies see with their device. There will be also the fact that we have a middle ear device, middle ear sensor. And so, you know, there needs to be healing of that before you can really optimize the programming And for some patients, because there is a lot of patient to patient variability, that could take a little bit longer with some folks. All right. that is great. Alex Nowak: And in terms of your last-- yeah. No. Go ahead. Brent Lucas: Sorry, Alex. The last part of your question there I have not seen the, like, the 24-month data or anything else. Our time points for the stage 1 patients were 12-months. And then their next scheduled visit is 24 months for those stage 1 patients. But we are only collecting efficacy data for purposes of reporting it through 12-months. Alex Nowak: Okay. Understood. That makes sense. So we will get to see that later. Okay. And then just lastly, just your current view on the competitive landscape for a fully implantable cochlear implant? Brent Lucas: Yeah. So it is very interesting what is going on in the cochlear implant world. If you have been paying attention to this as long as I have, you are seeing now that 2 of the competitors are starting to vocalize how excited they are about fully implanted cochlear implants. I really absolutely believe this is the future of the cochlear implant industry, and I think more people are starting to admit that publicly. there is a lot of buzz around the technologies that are coming out from our competitors as well as on Envoy Medical. So I am. I just wanna say, generally, think there is more of an acceptance and a broad awareness that fully implanted cochlear implants are being studied by 3 different companies. And people are starting to ask questions about it. Get very excited about it. And I anticipate that patients are gonna start to say, you know what? You know, this is not a life and death technology. Right? So if you if you have significant hearing loss and you are considering a cochlear implant, and you know that 3 devices are in clinical studies, you might wait and decide that, you know, I will wait for the fully implanted. So I think you are gonna see people starting to really pay attention to the timelines for the 3 companies, Envoy, as well as 2 of our competitors. So I just think it is really great to see that the momentum is starting to build. People publicly talking about it. 2 of my competitors who have been saying for a while, oh, maybe fully implanted is not the future. They are not talking about fully implanted cochlear implants being the biggest innovation in the hearing industry. So this is absolutely starting to get attention, and you are gonna see more and more of that as all 3 companies move through. Clinical trials. And then when it comes to the products, Envoy Medical is still successfully differentiated itself from the other 2 players. But, right now, we are the only ones with the middle ear sensor. Middle ear sensor being the way of picking up sound through the hearing pathway. So we actually leverage vibrations coming through the ear. I think that is a transformational design attribute that really will give us an advantage in the market. It also allow for things like patient having the flexibility to use their ear with other devices. So, you know, I am a big AirPod user, for example, and somebody wants to throw in an AirPod on top of an Acclaim, you can do so very easily without having to do anything different or special. I think that is gonna be a big thing. We do not have a magnet in our system. The other 2 do. So not having a magnet is definitely something that I think can offer patients benefits when you think about imaging and not having to wear anything on the side of your head to charge or do something like that. And then the replaceable nature of our batteries. So we are the only company that has made the intentional design choice to put the battery in the chest. And we think that was a very wise choice in part because you have a larger capacity battery, allowing for multiple days between a charge. And then also the replaceable nature of that battery. So as the capacity begins to diminish over time, which happens to all rechargeable batteries, and we all know this because of our cell phones or smartphones, Over time, you wanna replace a battery. Having it in the chest allows for a very simple straightforward procedure. Without having to replace or explant the entire system. So of course, all of this has to be studied in our investigational clinical study. So we are gathering data on this, and hopefully being able to talk more about the specifics of it in the future. But I think those factual design attributes are very exciting, and I am very excited to really study this more as we go. Alex Nowak: that is great. I appreciate the update. Thank you. Thank you. Brent Lucas: Thank you. Operator: At this time, this concludes our question-and-answer session. I will now turn the call back to Brent Lucas for closing remarks. Brent Lucas: Thank you all for joining us today. We are excited about the continued progress and the path ahead for Envoy Medical. We look forward to updating you on our progress in a future call. Thank you very much for joining. Operator: This concludes today's meeting. We appreciate your time and participation. You may now disconnect. Thank you. Before you buy stock in Envoy Medical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Envoy Medical wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $358,037!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,229,708!* Now, it's worth noting Stock Advisor's total average return is 897% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of November 5, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Envoy (COCH) Q3 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. - Management attributes the low 5% penetration of the adult cochlear implant market to patient reluctance to wear external components, positioning the fully implanted Acclaim FCI as the solution to this barrier. - The company's strategic differentiation relies on a middle ear sensor that leverages the natural hearing pathway, avoiding the need for microphones on or under the skin. - A modular design choice was made to place a large-capacity battery in the chest rather than the head, allowing for multi-day use and simplified replacement without explanting the entire device. - The Acclaim system intentionally excludes magnets, which management believes provides a strategic advantage for patients requiring future MRI or head imaging. - Envoy is utilizing a modular PMA submission strategy to clear technical and benchtop testing hurdles with the FDA while clinical data collection for the pivotal trial remains ongoing. - Performance in the pivotal trial's first stage showed a 38 percentage point improvement in word recognition, which management views as encouraging validation of the technology's efficacy. - The legacy Esteem product remains a secondary focus, with revenue potential largely dependent on a potential CMS reclassification from a hearing aid to a prosthetic. - Management expects all 56 pivotal trial participants to complete their 12-month follow-up by April 2027, marking the completion of data collection. - The company targets the submission of the final two PMA modules, including the critical clinical data, in the first half of 2027. - Potential FDA decisions are anticipated between late 2027 and the first half of 2028, depending on the agency's review timeline of the modular submissions. - Commercial scaling plans include increasing headcount from 50 to approximately 75 employees and doubling manufacturing footprint to 35,000 square feet to support future demand. - Long-term manufacturing goals aim for a capacity of 10,000 to 15,000 units annually within five years of commercialization, supported by a new certified clean room. - The Acclaim FCI holds FDA Breakthrough Device designation, which has facilitated the modular PMA process and ongoing agency dialogue. - CMS classification of the legacy Esteem device as a hearing aid continues to limit Medicare coverage and broader patient access. - Management noted that while the Acclaim is designed for MRI compatibility due to its magnet-free design, it has not yet received formal MR conditional labeling. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. - Management plans to hire a commercial leader with experience in high-ASP active implantables within the next year. - The company intends to remain lean, focusing on earned media and patient testimonials rather than heavy sales and marketing spend to drive demand. - Manufacturing expansion will require a clean room build-out costing approximately a couple million dollars, Construction on the manufacturing expansion is targeted to begin in the back half of 2027, with the goal of having the capacity ready by 2029. - Feedback on the first two modules has validated the modular strategy, allowing the company to resolve technical questions regarding benchtop testing and sample sizes early. - Management expressed confidence that clearing these technical modules now will allow them to focus exclusively on the clinical module in 2027. - Stage 2 patients are tracking a similar efficacy path to Stage 1, with no indicators suggesting different outcomes in the larger cohort. - Management noted a slight learning curve for audiologists programming the unique middle ear sensor compared to traditional microphone-based implants. - Healing of the middle ear sensor site can cause patient-to-patient variability in the timing of optimal programming ramp-up. - Management observes that two major competitors are now publicly acknowledging fully implanted devices as the industry's future, validating Envoy's long-term vision. - Envoy believes its middle ear sensor and chest-placed battery remain unique differentiators that competitors using microphones and head-placed batteries cannot match.

IQVIA Holdings (IQV) came out with quarterly earnings of $3.34 per share, beating the Zacks Consensus Estimate of $3.24 per share. This compares to earnings of $3 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +3.09%. A quarter ago, it was expected that this clinical testing company would post earnings of $3.02 per share when it actually produced earnings of $3.15, delivering a surprise of +4.3%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. IQVIA, which belongs to the Zacks Medical - Instruments industry, posted revenues of $4.43 billion for the quarter ended September 2026, surpassing the Zacks Consensus Estimate by 1.44%. This compares to year-ago revenues of $4.1 billion. The company has topped consensus revenue estimates four 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. IQVIA shares have added about 21.4% since the beginning of the year versus the S&P 500's gain of 12.1%. While IQVIA has outperformed 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 IQVIA 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 $3.63 on $4.52 billion in revenues for the coming quarter and $12.92 on $17.4 billion 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 top 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. Another stock from the same industry, Envoy Medical, Inc. (COCH), has yet to report results for the quarter ended September 2026. This company is expected to post quarterly loss of $0.70 per share in its upcoming report, which represents a year-over-year change of -100%. 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 50% 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 IQVIA Holdings Inc. (IQV) : 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

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

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

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.

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