Envoy Medical Provides Business Update Following Transformative Financing and Positive Progress in Clinical Trial

Rhea-AI Summary

Envoy Medical (NASDAQ: COCH) announced an upsized financing and clinical progress for its fully implanted Acclaim cochlear implant. The company closed $30.0M in gross proceeds with up to $48.0M additional upon exercise of milestone warrants, and says this capital could fund commercialization into 2028–2029. The pivotal trial has 47 of 56 implants completed, with the nine remaining participants scheduled for surgery and enrollment expected to finish by end of March 2026. A fireside chat with Dr. Theodore McRackan is set for Feb 25, 2026 at 10:00 AM ET.

Positive

• Closed $30.0M in gross proceeds at offering close
• Up to $48.0M available via milestone-linked warrants
• Funding could support commercialization through 2028–2029
• Pivotal trial implanted 47 of 56 participants to date
• Expected enrollment completion by end of March 2026

Negative

• Additional $48.0M depends on uncertain milestone-warrant exercises
• Remaining 9 surgeries pose operational or scheduling delay risk
• Equity offering and warrants may cause shareholder dilution

News Market Reaction – COCH

-6.29%

10 alerts

-6.29% News Effect

+6.8% Peak Tracked

-6.4% Trough Tracked

-$4M Valuation Impact

$59M Market Cap

0.2x Rel. Volume

On the day this news was published, COCH declined 6.29%, reflecting a notable negative market reaction. Argus tracked a peak move of +6.8% during that session. Argus tracked a trough of -6.4% from its starting point during tracking. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $4M from the company's valuation, bringing the market cap to $59M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Gross proceeds at closing: $30 million Milestone warrant potential: $48 million Upsized offering size: $78.0 million +5 more

8 metrics

Gross proceeds at closing $30 million Upsized offering gross proceeds received at closing

Milestone warrant potential $48 million Additional potential gross proceeds upon full exercise of milestone warrants

Upsized offering size $78.0 million Maximum size of recently closed public offering

Planned trial enrollment 56 participants Total implanted participants specified in pivotal trial protocol

Participants implanted 47 people Number of trial participants implanted as of the update

Remaining participants 9 participants Remaining pivotal trial participants identified and awaiting surgery

Implants by Dr. McRackan 14 of 47 subjects Number of currently enrolled subjects implanted by Dr. McRackan

Fireside chat time Feb 25, 2026, 10:00 AM ET Scheduled time of Envoy Medical fireside chat event

Market Reality Check

Price: $0.7102 Vol: Volume 1,158,834 is at 0....

low vol

$0.7102 Last Close

Volume Volume 1,158,834 is at 0.69x the 20-day average of 1,687,559, indicating no unusual trading pressure. low

Technical Shares at $0.757 are trading below the 200-day MA of $1.09 despite a 9.89% gain.

Peers on Argus

COCH gained 9.89% while momentum peers were mixed: one stock up and two down, wi...

1 Up 2 Down

COCH gained 9.89% while momentum peers were mixed: one stock up and two down, with sector scanner noting a median move of -3.9%. This points to a company-specific reaction to the financing and clinical update rather than a broad medical device move.

Previous Clinical trial Reports

5 past events · Latest: Feb 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	Enrollment update	Positive	+14.8%	Reported 45 of 56 patients implanted and enrollment nearing completion.
Dec 18	Mid-enrollment milestone	Positive	-0.4%	Announced pivotal study reached midway enrollment and remained on schedule.
Dec 10	Activation progress	Positive	+3.1%	Completed first activations in final study stage with no serious adverse events.
Nov 18	Six‑month follow-up	Positive	+17.5%	First 10 trial patients completed six‑month visits with no serious adverse events.
Nov 04	Final-stage enrollment start	Positive	-5.0%	Reported first three patients enrolled and implanted in final trial stage.

Pattern Detected

Clinical trial updates have generally produced positive but uneven reactions, with several strong gains and a couple of negative days, indicating mixed but often favorable responses to trial progress.

Recent Company History

Over recent months, Envoy Medical has repeatedly highlighted milestones in its pivotal trial for the fully implanted Acclaim cochlear implant. Updates from November–December 2025 covered first enrollments in the final stage, six‑month follow‑ups with no serious adverse events, and reaching midway enrollment. A February 17, 2026 update reported 45 of 56 patients implanted and expectations for full enrollment by end of March 2026. Today’s news combines similar clinical progress with additional detail on financing and commercialization runway.

Historical Comparison

+6.0% avg move · Past clinical‑trial updates moved COCH about 6% on average. Today’s 9.89% gain sits somewhat above t...

clinical trial

+6.0%

Average Historical Move clinical trial

Past clinical‑trial updates moved COCH about 6% on average. Today’s 9.89% gain sits somewhat above that norm, suggesting investors responded strongly to the combined financing and enrollment progress detail.

Clinical news has tracked a clear progression: initial final‑stage enrollments in late 2025, early activations and six‑month follow‑ups without serious adverse events, reaching midway enrollment, and then nearing full enrollment by early 2026 for the fully implanted Acclaim cochlear implant.

Market Pulse Summary

The stock moved -6.3% in the session following this news. A negative reaction despite constructive f...

Analysis

The stock moved -6.3% in the session following this news. A negative reaction despite constructive financing and clinical news would fit past mixed responses, where some positive trial milestones still saw declines. Updates around enrollment and safety have previously produced both gains and pullbacks, suggesting sentiment can swing as investors weigh dilution, commercialization timing, and execution risk. Clinical progress to 47 of 56 implants might not always offset broader concerns in risk‑off tape conditions.

Key Terms

milestone warrants, pivotal clinical trial, Pre-Market Approval (PMA), cochlear implant, +2 more

6 terms

milestone warrants financial

"with up to an additional $48 Million upon exercise of milestone warrants"

Milestone warrants are rights that let holders buy a company’s stock only if specific goals—such as regulatory approvals, sales targets, or project completions—are met. Think of them as a coupon that only becomes usable when the company hits agreed checkpoints; they matter to investors because they create contingent value and potential share dilution, and they signal which outcomes the company and its backers consider most important.

pivotal clinical trial medical

"expand the Company's pivotal clinical trial for the investigational fully implanted Acclaim"

A pivotal clinical trial is a late-stage medical study designed to provide the main evidence regulators use to decide whether a drug or medical device can be approved and sold; think of it as the product’s final exam. For investors, the trial’s outcome is critical because a clear pass can unlock regulatory approval, market access and future revenue, while failure can halt commercialization and materially affect a company’s valuation.

Pre-Market Approval (PMA) regulatory

"pivotal clinical trial studying a fully implanted cochlear implant in support of a Pre-Market Approval (PMA) application"

Pre-market approval (PMA) is the most rigorous regulatory review process for high-risk medical devices, where a regulatory agency (such as the U.S. FDA) evaluates detailed clinical and manufacturing evidence to determine whether the device is safe and effective for sale. For investors, PMA matters because approval can unlock commercial sales and revenue after a lengthy, costly review—like receiving a final building permit that allows construction and occupancy after extensive inspections.

cochlear implant medical

"fully implanted Acclaim4 cochlear implant to the second and final stage"

A cochlear implant is a surgically implanted medical device that converts sound into electrical signals and stimulates the inner ear to provide a sense of hearing for people with severe hearing loss, working like a tiny radio and wiring that bypasses damaged parts of the ear. Investors track cochlear implants because they involve durable hardware, ongoing service and upgrades, regulatory approvals, reimbursement rules and surgical volumes—factors that drive revenue, margins and long-term market growth.

Principal Investigators medical

"Dr. McRackan is one of the Principal Investigators involved in the Acclaim4 pivotal clinical trial"

Principal investigators are the lead researchers who run and oversee a clinical study or medical trial at a site, like a project manager or head coach who ensures the study follows the plan, treats participants safely, and collects reliable data. Investors pay attention because the investigator’s experience and reputation affect how well a trial is conducted, how credible the results will be, and therefore the timeline and risk for a drug or device reaching the market.

webinar technical

"Webinar Registration Link: https://ir.envoymedical.com/news-events/ir-calendar"

A webinar is a live or recorded presentation delivered over the internet where a company’s executives, analysts, or experts explain results, strategy, products, or plans and often take questions from viewers. For investors it matters because webinars provide direct access to management’s explanations and tone—like a town‑hall you can attend from home—so new information, emphasis, or candid answers can change expectations and influence a security’s price.

AI-generated analysis. Not financial advice.

Financing was led by new investor and top-tier healthcare fund Nantahala Capital and longtime Envoy Medical shareholder, billionaire Glen Taylor

Closing of $30 million in gross proceeds in upsized offering, with up to an additional $48 Million upon exercise of milestone warrants, provides potential funding through commercialization

Company hosting Fireside Chat with Dr. Theodore McRackan, on February 25^th at 10 a.m. ET, to discuss his initial experiences as clinical trial's leading implanter

White Bear Lake, Minnesota--(Newsfile Corp. - February 19, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today provided a business update highlighting its recent transformative financing led by long-term institutional investors and existing shareholders, noting further positive clinical trial progress, and announcing an upcoming fireside chat.

"Envoy Medical has had an extremely strong start to 2026, and, frankly, we are fired up about what is ahead of us as we continue to make meaningful progress across our strategic priorities," said Brent Lucas, Chief Executive Officer of Envoy Medical.

Transformative Financing

Envoy Medical recently closed an upsized public offering for up to $78.0 million. The financing included $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants. Importantly, if the milestones are reached and the warrants are fully executed, the resulting capital is expected to provide the Company with enough cash to fund its market launch and initial commercialization growth strategy. In other words, this financing has the potential to fund the Company through 2028 and into 2029.

The funding strategy is designed to position Envoy Medical to execute on its clinical and regulatory milestones to bring its breakthrough cochlear implant technology to market to create significant value and substantial impact.

"Our recently closed financing led by Nantahala Capital, a successful and well-respected institutional investor, and our long-time shareholder Glen Taylor has reshaped and significantly improved our outlook. We are thrilled that additional healthcare-dedicated funds, including Broadfin Holdings, joined as new investors while several existing shareholders, including members of the Board and management, also participated. This financing has the potential to not only fund the Company through our pivotal clinical trial and regulatory submission, but also through initial commercialization. We believe we have positioned Envoy Medical to successfully realize its short- and long-term potential. The future of the cochlear implant industry is fully implanted solutions, and we are thrilled to be on the cutting edge and leading the way."

The Company believes that the breadth of participation from both specialized healthcare investors and insiders reflects confidence in Envoy Medical's strategy and probability of success.

Positive Clinical Trial Progress

After receiving approval from the FDA to expand the Company's pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant to the second and final stage, trial enrollment has proceeded in a steady and efficient manner. The trial's protocol calls for a total of 56 implanted participants and, as of today, 47 people have been implanted.

The nine remaining participants have been identified and are waiting for surgery. Assuming the nine remaining surgeries occur as currently scheduled, the Company expects trial enrollment to be completed by the end of March 2026.

To the best of its knowledge, the Company believes that it will be the first cochlear implant manufacturer to complete enrollment of a pivotal clinical trial studying a fully implanted cochlear implant in support of a Pre-Market Approval (PMA) application.

Fireside Chat with Dr. Theodore McRackan

Brent Lucas, Envoy Medical's CEO, will host a Fireside Chat on Wednesday, February 25, 2026, at 10 a.m. ET, with Dr. Theodore McRackan, an experienced cochlear implant surgeon at the Medical University of South Carolina.

Dr. McRackan is one of the Principal Investigators involved in the Acclaim® pivotal clinical trial and has implanted 14 of the 47 currently enrolled subjects. The Medical University of South Carolina was the first site to reach 14 enrolled subjects in this pivotal clinical trial. During the discussion, Dr. McRackan is expected to share initial impressions, insights into patient selection, device design and surgical technique, and the potential impact of Envoy Medical's technology if regulatory approval is achieved.

Event: Envoy Medical Fireside Chat
Date: Wednesday, February 25, 2026
Time: 10:00 AM ET
Webinar Registration Link: https://ir.envoymedical.com/news-events/ir-calendar

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.

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 operations; the ability to obtain additional patents and develop future products or product improvements; the ability to obtain and maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital (including from its recently-completed financing), and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; 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; the ability to engage 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 Envoy Medical's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and in other reports Envoy Medical has filed or may file with the Securities and Exchange Commission. 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: Envoy@kcsa.com

Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/284437

FAQ

How much financing did Envoy Medical (COCH) close on February 19, 2026?

Envoy Medical closed $30.0 million in gross proceeds at closing. According to the company, there is up to an additional $48.0 million available if milestone-linked warrants are fully exercised.

What does the $48 million in milestone warrants mean for COCH shareholders?

The $48.0 million is contingent capital that may dilute existing shares if exercised. According to the company, warrant exercises are linked to milestones and would increase available cash for commercialization.

What is the enrollment status of Envoy Medical's pivotal Acclaim trial (COCH) as of February 19, 2026?

The trial has implanted 47 of 56 participants so far. According to the company, the nine remaining participants are identified and enrollment is expected to finish by the end of March 2026.

Will the recent financing fund Envoy Medical through commercialization for COCH?

The company says the financing could fund the company through initial commercialization into 2028–2029. According to the company, that outcome depends on milestone achievement and warrant exercises.

Who will speak at the Envoy Medical fireside chat on February 25, 2026?

Envoy CEO Brent Lucas will host Dr. Theodore McRackan at the Feb 25, 2026 event at 10:00 AM ET. According to the company, Dr. McRackan will discuss surgical experience and early impressions from the trial.

Does Envoy Medical claim any industry firsts for the Acclaim pivotal trial (COCH)?

The company believes it may be the first to complete enrollment of a pivotal trial for a fully implanted cochlear implant. According to the company, this is stated as "to the best of its knowledge."