Envoy Medical, Inc.

Envoy Medical Hits Six-Month Milestone, Marks Halfway Point in Final Stage of Data Collection, and Highlights Differentiated Device Design

Envoy Medical surpassed the six-month follow-up milestone in its pivotal trial of the fully implanted Acclaim cochlear implant, the halfway point of the final 12-month data-collection stage. The company says it is the first to reach this milestone in a U.S. pivotal trial of a fully implanted cochlear implant and has submitted two of four planned PMA modules to the FDA, with the final module due by end of Q2 2027. Management still expects 12-month visits complete by early Q2 2027 and a potential FDA decision by end of 2027 or early 2028; no new clinical data was disclosed in this update.

•19d ago

Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant

Envoy Medical submitted the second of four planned modules of its Modular PMA application to the FDA for the Breakthrough Device-designated Acclaim cochlear implant. The second module contained primarily engineering information and follows the first module submitted June 30, 2026; the final module with clinical trial data is targeted for the end of Q2 2027. The submission marks steady regulatory progress on the rolling review, though approval remains more than a year away and hinges on the pivotal trial data still being collected.

•27d ago

New to The Street Airs This Weekend Across Bloomberg Television U.S., Latin America and MENA

Big Sky Industrial Corp. will have its corporate commercials air this weekend on Bloomberg Television across the U.S., Latin America and the MENA region as part of the New to The Street sponsored programming block. The media platform is expanding its international footprint with the new "Nuevo a la Calle" brand in Latin America and plans to enter the Southeast Asia market in Q4 2026, supported by a digital ecosystem of over 6.2 million subscribers. The broadcast features interviews and updates from Envoy Medical, Sagtec Global, RHINO Bitcoin and Virtuix, alongside commercials for several other publicly traded companies.

•2mo ago

Envoy Medical Reports Second Quarter 2026 Results and Achieves Key Regulatory and Clinical Milestones

Envoy Medical reported Q2 2026 net revenue of $51,000 and a net loss of $7.3 million, or $0.07 per share. The company ended the quarter with approximately $19.7 million in cash. The company submitted the first module of its modular PMA application to the FDA for its Acclaim cochlear implant, targeting submission of the final module in Q2 2027. Subsequently, Envoy reported positive 12-month data from the first 10 participants in its pivotal trial, showing a 38 percentage point improvement in CNC word recognition scores compared to baseline. Envoy terminated its At-the-Market (ATM) equity facility, removing an authorization to sell up to $15 million of common stock. Management highlighted continued progress in the clinical trial and regulatory pathway as key drivers for future value creation.

•2mo ago

New to The Street Show 766 Broadcasts Tonight at 6:30 PM ET on Bloomberg Television, Featuring BioVie's Bezisterim Parkinson's Disease Clinical Results

BioVie is scheduled to appear on the 'New to The Street' program on Bloomberg Television to discuss its recently reported Phase 2 SUNRISE-PD clinical results for bezisterim in early Parkinson's disease. The company previously reported that bezisterim showed statistically significant improvements in motor and non-motor symptoms compared to placebo, along with encouraging biomarker findings. The broadcast is sponsored programming airing at 6:30 PM ET, with international distribution across Latin America and MENA regions.

•3mo ago

New to The Street TV Announces Broadcast of Show No. 765 Tonight on Bloomberg Television at 6:30 PM ET Featuring Envoy Medical, Graphene Manufacturing Group, Rhino Bitcoin, and Big Sky Industrial

Big Sky Industrial (BSIN) is scheduled to appear in an interview segment on New to The Street TV Show No. 765, airing tonight at 6:30 PM ET on Bloomberg Television. The broadcast is part of a sponsored programming block that will also air across Latin America and the MENA region to extend visibility to international investors. The episode will feature discussions on corporate strategy, recent milestones, and long-term growth initiatives, alongside debut television commercials from several other participating firms.

•3mo ago

New to The Street to Broadcast Nationwide on Bloomberg Television Tonight at 6:30 PM ET Featuring RHINO Bitcoin, Marina Decisions, Medicus Pharma and Virtuix Holdings

Big Sky Industrial Corp. is sponsoring the latest episode of New to The Street, airing tonight at 6:30 PM ET on Bloomberg Television. The nationally televised program features interviews with executives from RHINO Bitcoin, Marina Decisions, Medicus Pharma, and Virtuix Holdings to discuss business strategies and growth initiatives. The broadcast is supported by integrated national commercial campaigns from BSIN and other public companies to enhance investor awareness through television and digital media.

•3mo ago

Envoy Medical Surpasses Three-Month Visit Milestone for All 56 Patients in Pivotal Clinical Trial

Envoy Medical announced that all 56 patients in its pivotal clinical trial have surpassed the three-month visit milestone for the fully implanted Acclaim cochlear implant. The company anticipates reaching the six-month visit milestone by late 2026 and the 12-month visit milestone by April 2027, with full data intended for a PMA submission to the FDA. CEO Brent Lucas noted that these milestones mark steady progress toward the ultimate goal of bringing the first fully implanted cochlear implant to the U.S. market.

•3mo ago

New to The Street(R) to Broadcast Show #762 Tonight on Bloomberg Television at 6:30 PM ET, Featuring Envoy Medical (NASDAQ:COCH), AlphaCompute (NASDAQ:ALP), RHINO Bitcoin (OTC PINK:RHNO), and Big Sky Industrial (NASDAQ:BSIN)

AlphaCompute is scheduled to appear on New to The Street Show #762 airing tonight at 6:30 p.m. ET on Bloomberg Television. The segment will showcase the company's next-generation artificial intelligence infrastructure and high-performance computing solutions. The broadcast will reach audiences in the U.S., MENA, and Latin America, alongside features on Envoy Medical, RHINO Bitcoin, and Big Sky Industrial.

•3mo ago

Envoy Medical Reports Positive 12-Month Data Showing Continued Improvement in Speech Perception in Study of First-of-Its-Kind Fully Implanted Cochlear Implant

Envoy Medical reported positive 12-month data from Stage 1 of its pivotal clinical trial for the fully implanted Acclaim cochlear implant, showing CNC word recognition scores improved to 53.2% from a 15.2% baseline. The data reflects a 38 percentage point improvement with no serious adverse events reported, validating the device's safety profile and continued efficacy gains over the 6-month readout. Stage 2 of the pivotal trial is now fully enrolled, with 12-month data collection expected to complete by early Q2 2027 ahead of a planned PMA submission to the FDA.

•3mo ago

New to The Street Show #761 to Broadcast Across Bloomberg U.S., Latin America and MENA, Featuring Sagtec Global, Virtuix, Lantern Pharma and YY Group

Big Sky Industrial (BSIN) will be featured in television commercials during the broadcast of New to The Street Show #761 on Bloomberg Television. The program is scheduled to air at 6:30 PM ET across the U.S., Latin America, and the MENA region as sponsored programming. In addition to BSIN, the show features interviews with executives from Sagtec Global, Virtuix, Lantern Pharma, and YY Group.

•3mo ago

Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device

Envoy Medical submitted the first module of its Modular Premarket Approval application to the FDA for its Acclaim cochlear implant, a Breakthrough Device-designated product. The company expects to submit a total of four modules, with the final module containing clinical trial data targeted for the second quarter of 2027. Management stated that this modular strategy reduces regulatory risk by enabling earlier FDA engagement and iterative feedback throughout the review process.

•4mo ago

Envoy Medical Terminates At-the-Market (ATM) Equity Facility

Envoy Medical announced that it has formally terminated its at-the-market equity facility, effective June 24, 2026. The facility had previously authorized the company to offer and sell up to $15 million worth of shares of its common stock. Management stated that the termination reflects confidence in the company's current capital position, eliminating the potential for future dilution under this agreement.

•4mo ago

Envoy Medical Announces New Patents Expanding Intellectual Property Portfolio in Fully Implanted Hearing Technology

Envoy Medical announced the issuance of four new patents in Australia and Europe, expanding its intellectual property portfolio for fully implanted hearing technology. The granted patents cover key innovations in implant system design, signal analysis, and battery recharge safety, specifically for the investigational Acclaim cochlear implant. One additional European patent regarding rechargeable battery management is expected to be granted in June 2026, further reinforcing the company's IP position in the cochlear implant market.

•5mo ago

Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant

Envoy Medical presented positive initial 6-month data from the first 10 patients in the pivotal study of its fully implanted Acclaim cochlear implant. Interim results showed a 24 percentage point improvement in speech recognition scores and no serious adverse events, with participants reporting 24-hour daily wear time. The data reinforces the clinical promise of the fully implanted approach, with additional presentations scheduled for May and a Fireside Chat set for April 29.

•6mo ago

Envoy Medical Reaches Critical Milestone in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant

Envoy Medical announced that all 56 subjects in its pivotal trial of the fully implanted Acclaim cochlear implant have completed their activation visits. This milestone provides increased confidence in the study timeline, allowing the scheduling of remaining 12-month follow-up visits ahead of data analysis and PMA submission. The Acclaim device holds FDA Breakthrough Device Designation and aims to be the first fully implanted solution for severe to profound hearing loss.

•6mo ago