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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 23, 2026
ENVOY MEDICAL, INC.
(Exact name of registrant as specified in its charter)
| Delaware |
|
001-40133 |
|
86-1369123 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
4875 White Bear Parkway
White Bear Lake, MN |
|
55110 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area
code: (877) 900-3277
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Class A Common Stock, par value $0.0001 per share |
|
COCH |
|
The Nasdaq Stock Market LLC |
Redeemable Warrants, each whole Warrant
exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share |
|
COCHW |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued
Listing Rule or Standard; Transfer of Listing.
On February 23, 2026, Envoy Medical, Inc. (the “Company”)
received a letter from the Nasdaq Listing Qualifications Hearings office confirming that the Company has evidenced compliance with Nasdaq
Listing Rule 5550(b)(2) in compliance with the Nasdaq Hearing Panel’s letter dated October 23, 2025.
In addition, pursuant to Nasdaq Listing Rule 5815(d)(4)(B),
the Company will be subject to a discretionary panel monitor for a period of one year from February 12, 2026.
Item 8.01 Other Events
On February 24, 2026, the Company issued a press release regarding
the confirmation of regarding Nasdaq compliance.
A copy of the press release is attached hereto and incorporated by reference
herein as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number |
|
Description |
| |
|
| 99.1 |
|
Envoy Medical, Inc. Press Release, dated February 24, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
ENVOY MEDICAL, INC. |
| |
|
|
| February 26, 2026 |
By: |
/s/ Brent T. Lucas |
| |
|
Brent T. Lucas |
| |
|
Chief Executive Officer |
Exhibit 99.1
Envoy Medical Regains Compliance with Nasdaq
Listing Requirement
White Bear
Lake, Minnesota – February 24, 2026 – Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”),
a hearing health company pioneering fully implanted hearing solutions, today announced that it has received written notification from
The Nasdaq Stock Market LLC (“Nasdaq”) confirming that the Company has evidenced compliance with Nasdaq Listing Rule 5550(b)(2)
through the alternatives permitted under Listing Rule 5550(b).
As previously
disclosed, the Company received a notice from Nasdaq on February 25, 2025, indicating that it was not in compliance with the continued
listing requirement to maintain a minimum Market Value of Listed Securities (MVLS) of $35 million. The Company subsequently implemented
strategic financing initiatives and substantially strengthened its balance sheet, resulting in regaining compliance with the applicable
continuing listing requirement.
The Company believes
it has an achievable plan to maintain compliance and looks forward to remaining listed on the Nasdaq Capital Market under the symbol “COCH.”
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 maintain compliance with Nasdaq rules and requirements; the timing and future
outcome of its FDA pivotal trial; the ability to raise capital 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 the
Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, 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: Envoy@kcsa.com
Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com
