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:
Highlights Subsequent to Q2 2026:
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 Envoy@kcsa.com 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.