(Nasdaq: COCH) Profile

Envoy Medical, Inc. logo

OUR NEW PROFILE IS:   (NASDAQ: COCH)

AS OF SEPTEMBER 30, 2023 THE COMPANY HAD $7.4 MILLION IN AVAILABLE CASH; TOTAL CASH INCLUDING RESTRICTED FUNDS WAS $16.8 MILLION

ENVOY MEDICAL BECAME A NASDAQ LISTED COMPANY THROUGH A MERGER WITH ANZU SPECIAL ACQUISITION CORP I, WHICH CLOSED ON SEPTEMBER 29, 2023

THE JOURNAL OF CLINICAL MEDICINE HIGHLIGHTED EARLY SURGICAL EXPERIENCE WITH THE INVESTIGATIONAL ACCLAIM® FULLY IMPLANTABLE COCHLEAR IMPLANT. ACCORDING TO THE PUBLICATION, “ALL THREE SURGERIES PROCEEDED WITHOUT COMPLICATION, AND AT ACTIVATION, ALL THREE PATIENTS WERE HEARING THROUGH THEIR DEVICES

COCH PLANS ON FILING FOR AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) IN EARLY 2024 TO COMMENCE A PIVOTAL CLINICAL TRIAL LATER THIS YEAR

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Hello Everyone,

2023 was an incredible year for us.  We ended the year with a bang after our last profile exploded from .25 all the way to .35 during the session and was even hitting up at .42 in the aftermarket for a strong double digit move.

We have several companies that we want to profile in the coming weeks.  This next one caught fire at the end of the year closing green 18 out of 21 sessions from November into December.

Pull up COCH immediately.

COCH listed on the Nasdaq back in September by way of a SPAC with Anzu Special Acquisition Corp.

Envoy Medical Corporation was founded in 1995 as a privately-held hearing health company focused on providing innovative technologies across the hearing health spectrum. They have pioneered one-of-a-kind, fully-implanted devices for hearing loss, including—the fully-implanted Esteem® active middle ear implant available in the U.S. since 2010, and the fully-implanted Acclaim® cochlear implant, an investigational device. They are dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance and ultimately quality of life.

Envoy believes that the creation of its fully implanted cochlear implant Acclaim will encourage more people with hearing loss to get a cochlear implant, Envoy Medical CEO Brent Lucas said in a news release. The benefits of this technology include patients not needing to charge or change out a battery daily or have external components on their heads.

The technology is currently in clinical trials at Mayo Clinic and has planned trials at other cochlear implant centers in the US. The company expects to see key milestones reached in these trials within the coming quarter, Lucas noted in the release.

“Millions of people have significant hearing loss that may not be adequately treated by hearing aids, a market that we believe will continue to expand as the population ages. We believe that many prospective patients do not seek cochlear implants because they are not satisfied with the currently available options for treatment,”  said Brent Lucas, Chief Executive Officer of Envoy Medical.

In a statement in a recent news release, Anzu CEO Whitney Haring-Smith called Envoy a leader in the cochlear implant industry.

“We believe that Envoy Medical’s Acclaim device may be the first fully implanted cochlear implant commercialized in the United States and is designed to have longer expected battery life than existing competitors,” Haring-Smith said.

The Acclaim

The Acclaim® novel sensor technology is designed to leverage the natural anatomy of the ear rather than a microphone to capture sound entering the ear. The sound vibrations are intended to be processed into customized electronic signals. Then, the stimulator is intended to send unique electrical signals to stimulate the cochlea and hearing nerve to receive sounds.

Designed to function in environments not ideally suited for external components

Designed to use implanted rechargeable battery intended to last several days between charges

Designed without an external artificial microphone.

The device is intended to allow the ear to pick up the sound naturally.

ENVOY MEDICAL PROVIDES THIRD QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATE

Interim Findings from Early Feasibility Trial Provide Important Learnings and Feedback Ahead of Pivotal Clinical Trial Planned for 2024

Virtual Fireside Chat to be held December 7

WHITE BEAR LAKE, Minn., Nov. 20, 2023 (GLOBE NEWSWIRE) —  Envoy Medical, Inc. (“Envoy Medical”) (NASDAQ: COCH), a hearing health company, today is providing a business update and its financial results for the quarter ended September 30, 2023. The Company will host a virtual fireside chat event on December 7, which will cover a range of topics, including introductions to the technology, financial and clinical aspects of the business, as well as potential participation from cochlear implant key opinion leaders.

Envoy Medical is a medical technology company specializing in revolutionary “fully” or “totally” implanted hearing devices. Its propriety sensor technology leverages the unique benefits of the human ear to pick up and relay sound rather than relying on external microphones. Envoy Medical currently has its sights on disrupting what it believes to be a complacent cochlear implant industry with new, fully implanted solutions designed to address well-known shortcomings in existing devices.

The Company’s first product, the Esteem®, remains the only FDA approved fully implanted active middle ear implant. In fact, it is the only fully implanted active hearing device to have received FDA approval for any set of clinical indications. The Esteem® is indicated for use in adults diagnosed with moderate to severe sensorineural hearing loss who no longer benefit from their hearing aids.

Envoy Medical is now leveraging its extensive understanding of fully implanted hearing devices for the development of a fully implanted Acclaim® cochlear implant, an investigational device that is currently in an early feasibility trial at Mayo Clinic in Rochester, Minnesota. The Acclaim® is expected to be the first fully implanted cochlear implant to use the natural ear to pick up sound. The Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and is currently considered Investigational (not yet commercially available). A pivotal clinical trial is expected to commence in 2024. Upon FDA approval of the Acclaim® cochlear implant, Envoy Medical intends to target the significantly under-penetrated adult cochlear implant market, which it believes may represent more than an $80 billion opportunity in the US alone.

“The third quarter was transformative for Envoy Medical – we completed a merger to become a publicly traded company on the Nasdaq Stock Exchange, enhanced our balance sheet with new capital, and reported key findings from our Acclaim® Early Feasibility Study conducted at the Mayo Clinic. We believe these accomplishments put Envoy Medical on track to advance our strategic plan over the next several years. Over the next few quarters, we anticipate finalizing our design, filing another Investigational Device Exemption (IDE) with the FDA, launching a pivotal clinical trial and beginning to educate professionals on why we believe fully implanted devices are the future of hearing implants. We are encouraged by the large and underserved adult cochlear implant market with existing strong reimbursement coverage,” said Brent T. Lucas, CEO of Envoy Medical.

“Interim results in the early feasibility study confirmed that we are on the right track with the current design and provided important feedback for final design refinements ahead of our pivotal trial, which are now being implemented. The data provided additional confidence in many aspects of the Acclaim®’s functionality, and also revealed an early indication that the device may improve quality of life for patients. We hope to offer a new and highly differentiated solution that encourages more people who are eligible to receive a cochlear implant to pursue hearing improvement through this important technology.”

Third Quarter and Recent Business Highlights

  • Envoy Medical became a Nasdaq Listed company through a merger with Anzu Special Acquisition Corp I, which closed on September 29, 2023. Envoy Medical subsequently began trading its Class A common stock and warrants on the Nasdaq stock exchange under the new ticker symbols “COCH” and “COCHW”, respectively.
  • The Journal of Clinical Medicine highlighted early surgical experience with the investigational Acclaim® fully implantable cochlear implant. According to the publication, “All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices.”
  • 6-Month findings from the Early Feasibility Trial demonstrated improved Quality of Life metrics for two of the three participants at three and six months. The third participant’s scores remained stable.
  • A signal to noise issue was identified as part of the feasibility trial, which appears to be electrical noise and not body noise or inherent to the Acclaim® architecture. A design update is in progress that is expected to resolve this issue prior to the FDA pivotal trial planned to commence in 2024.
  • The Early Feasibility Study also provided an unanticipated discovery related to using a hearing aid in the Acclaim® cochlear implant ear. Envoy Medical intends to explore this further as this would be unique to Acclaim®, which uses the ear to pick up sound while other devices use external or subdermal microphones.
  • Initiated efforts with the Minnesota Congressional Delegation to address the CMS’s improper classification of the Envoy Esteem® as a heading aid. Successful reclassification of Esteem® as a fully implanted active middle ear implant could have a material change in reimbursement prospects.
  • Announced additional patent award as part of a growing IP portfolio covering current and future implantable hearing device technologies.
  • As part of the Nasdaq listing, Envoy Medical appointed a Board of Directors comprised of seven leaders strategically selected from the bio/pharmaceutical, accounting and financial fields. This along with the highly regarded audiologists and surgeons on the existing advisory panel provide world class guidance and counsel to the management team.

Third Quarter Financial Results

  • As of September 30, 2023 the Company had $7.4 million in available cash; total cash including restricted funds was $16.8 million.
  • Operating costs were $3.5 million for the 3 months ended September 30, 2023, this includes costs associated with the Company’s business combination and Nasdaq listing of approximately $0.4 million.
  • Research and Development expense totaled $1.9 million as the Company conducted early feasibility trials and advanced refinements intended to finalize the Acclaim® design ahead of the Company’s pivotal trial, expected to begin in 2024.

“With our new public listing, Envoy Medical enhanced its balance sheet, providing an improved cash position on which to advance our strategic plans,” said David R. Wells, Chief Financial Officer. “We intend to maintain our low-cost operating model, which maximizes our cash resources ahead of our pivotal trial, while also moving ahead on these important corporate matters.”

Upcoming Milestones

Over the next few months, Envoy Medical will continue to advance its efforts on a number of key milestones relating to its clinical progress, including:

  • Finalizing and integrating select design enhancements based on the initial feedback and learnings of the Early Feasibility Study.
  • Filing for an investigational device exemption (IDE) in early 2024 to commence a pivotal clinical trial later that year.
  • Updates pertaining to the continuing efforts underway to properly reclassify its Esteem® as a fully implanted active middle ear implant, and not as a hearing aid. Hearing aids are statutorily excluded from Medicare and Medicaid coverage, and if the Esteem® is properly reclassified as a fully implanted active middle ear implant it can pursue reimbursement coverage, which the Company believes would encourage additional adoption by potential patients.

NEW CLINICAL PUBLICATION REPORTS FIRST THREE PATIENTS IN EARLY FEASIBILITY TRIAL FOR ENVOY MEDICAL’S FULLY IMPLANTED COCHLEAR DEVICE

Surgical Experience with Three Initial Acclaim® Patients Documents Innovation Efforts in the Growing Cochlear Implant Market

WHITE BEAR LAKE, Minnesota, Oct. 19, 2023 (GLOBE NEWSWIRE) — A recent clinical publication in the Journal of Clinical Medicine (JCM) highlighted early surgical experience with Envoy Medical®, Inc.’s (“Envoy Medical”) (NASDAQ: “COCH”) investigational Acclaim® fully implantable cochlear implant. According to the publication, “All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can be mastered by a dedicated otologic surgeon.”

Minnesota-Based Envoy Medical Goes Public Via SPAC

The Company currently expects to file for an investigational device exemption (IDE) in early 2024 to commence a pivotal clinical trial later that year.

Current cochlear implants rely on bulky external hardware that are held in place on the head by a magnet, which can cause discomfort and may not be suitable for all activities, including sleeping, showering, swimming, strenuous activity and other common daily events.

Envoy Medical’s device, the fully implanted Acclaim® cochlear implant seeks to alleviate these limitations by being the first fully implanted cochlear implant (sometimes referred to as a totally implanted cochlear implant or “TICI”). By using an implanted middle ear sensor and an implanted rechargeable power supply, Acclaim® aims to eliminate the need for any externally worn components.

Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration(FDA) and is currently in an early feasibility study at Mayo Clinic (Rochester, Minnesota).

Envoy Medical’s Acclaim® may become the first fully implanted cochlear implant to begin a pivotal trial in the United States. Unlike other cochlear implants, Acclaim® intends to leverage the patient’s natural ear – rather than an external microphone – to capture acoustic energy. The Acclaim® is designed to not require the use of an external processor during the day or daily recharging.

“We are excited to see the Mayo Clinic’s team publish on their initial experience with the fully implanted Acclaim® cochlear implant, which we believe will be a significant advancement in a growing but underserved hearing health market,” said Brent Lucas, Envoy Medical’s Chief Executive Officer. “By detailing actual surgical experience, the authors provide cochlear implant specialists an early opportunity to learn about this innovation, the potential quality of life benefits of a fully implanted device, and that the additional surgical steps required likely will not be an impediment to adoption with appropriate training.”

“People often refuse to acknowledge the limitations of the current cochlear implants on the market in public, but in private, they do,” said Lucas, “We believe people want a fully implanted cochlear implant, and we are excited to be pushing the industry in that direction just as companies like Inspire Medical pushed the sleep apnea industry towards a fully implanted solution.”

The Mayo Clinic authors note: “While it is only conjecture at this point, one may presume that increased breadth and comfort of use may improve quality-of-life for many recipients, particularly those who feel their disability prevents them from taking part in certain activities.”

The authors also highlight that this novel device is still developing. Certain patients may not be good candidates and that programming requires careful monitoring.

If approved by the FDA, Envoy Medical intends to target a significantly under-penetrated adult cochlear implant market, which it believes to be more than $80 billion in the US. The paper notes that the success of cochlear implants has resulted in steadily widening the criteria by which patients can qualify for a cochlear device.

The complete study can be found under the citation: Dornhoffer, J.R.; Lawlor, S.K.; Saoji, A.A.; Driscoll, C.L.W. Initial Experiences with the Envoy Acclaim® Fully Implanted Cochlear Implant. J. Clin. Med. 2023, 12, 5875. https://doi.org/10.3390/jcm12185875

NEWS

PUBLISHED

DEC 4, 2023

ENVOY MEDICAL TO HOST FIRESIDE CHAT EVENT DECEMBER 7

PUBLISHED

NOV 20, 2023

ENVOY MEDICAL PROVIDES THIRD QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATE

PUBLISHED

NOV 10, 2023

ENVOY MEDICAL ANNOUNCES PUBLICATION OF ADDITIONAL PATENT FOR IMPLANTABLE COCHLEAR SYSTEMS

PUBLISHED

OCT 24, 2023

ENVOY MEDICAL TO PRESENT AT THE EMERGING GROWTH VIRTUAL CONFERENCE NOVEMBER 1

PUBLISHED

OCT 19, 2023

NEW CLINICAL PUBLICATION REPORTS FIRST THREE PATIENTS IN EARLY FEASIBILITY TRIAL FOR ENVOY MEDICAL’S FULLY IMPLANTED COCHLEAR DEVICE

PUBLISHED

OCT 10, 2023

ENVOY MEDICAL ANNOUNCES SETTLEMENT CONTRACT

PUBLISHED

OCT 3, 2023

ENVOY MEDICAL ANNOUNCES PARTICIPATION IN THE LD MICRO MAIN EVENT XVI

MANAGEMENT TEAM

BRENT LUCAS
CEO

Mr. Lucas has been the Chief Executive Officer of Envoy Medical Corporation for the last seven years and brings over 15 years of experience in the active implantables in the hearing health industry. He has served in various roles and gained a tremendous amount of specialized experience, working his way up from an intern to CEO. Mr. Lucas received his Bachelor’s Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law.

DAVID R. WELLS
CFO

Mr. Wells has 20 years of experience in the small-cap public company arena. Mr. Wells joined Envoy Medical, Inc. as its Chief Financial Officer in August, 2023. From 2014 to 2021 he was the CFO of ENDRA Life Sciences Inc. (NASDAQ: NDRA), a publicly traded clinical diagnostics technology company, where he directed ENDRA’s initial public offering (IPO) and subsequently raised an additional $55 million across multiple transactions. In December 2022, David joined the Board of Directors of HeartSciences (NASDAQ: HSCS), which is developing a cardiac device which seeks to bridge today’s “diagnostic gap” in cardiac care by providing effective front-line solutions that assist in the detection of heart disease in at-risk patients.

TOM HOEGH
VP OF R&D

Mr. Hoegh has over 30 years of experience in the medical device industry, primarily in the development and on-market support of active implantable devices such as neuromodulation systems for spinal, sacral, deep brain, and hypoglossal nerve stimulation. Mr. Hoegh’s previous experiences consist of leading engineering teams at Nuvectra, ICU/Smiths Medical, Medtronic, and Apnex Medical. Mr. Hoegh received a dual Bachelor of Science degree in Mechanical Engineering and Chemistry from Valparaiso University and a Master of Science degree in Technology Management from the University of St. Thoma

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