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重大事件 即時報告 8-K 2026-06-30

Envoy Medical 終止1,500萬美元ATM股票發行機制

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Envoy Medical 終止 ATM 股票發行機制 💡 申報類型:8-K(重大事項報告) 日期:2026年6月24日 Envoy Medical(納斯達克代碼:COCH)宣佈,已正式終止其「市價發行」(At-the-Market, ATM)股權融資機制。該機制原授權公司不時發行及出售最多 1,500 萬美元 的普通股,終止即日生效。 管理層表示,終止 ATM 機制反映公司對現有資本狀況充滿信心,無需繼續依賴該渠道集資。 公司背景:Envoy Medical 是一家專注全植入式聽力解決方案的企業,旗下已獲美國 FDA 批准上市的全植入式 Esteem® 主動式中耳植入體(適用中度至重度感音神經性聽力損失),以及仍在臨床研究階段的 Acclaim® 全植入式人工耳蝸(獲 FDA 突破性設備認定),後者採用人體自然耳部結構代替麥克風,設計用於助聽器無法充分改善的重度至極重度聽力損失。 注意:Acclaim 人工耳蝸仍屬研究性設備,僅限美聯邦法律規定的研究用途。 對投資者的潛在影響:終止 ATM 機制通常被市場視為公司認為自身股價被低估或流動性足夠的正面信號,短期內可減少股權攤薄壓力。然而,公司仍處於 Acclaim 關鍵臨床試驗及未來 PMA 申請階段,資金需求仍然存在,未來或需透過其他融資途徑補充資本。投資者應留意後續研發進度及財務報告。
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EX-99.1
2
ea029652401ex99-1.htm
PRESS RELEASED ISSUED BY THE COMPANY ON JUNE 24, 2026

 

Exhibit 99.1

 

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

 

Termination Reflects Company’s Confidence
in Current Capital Position

 

White Bear Lake, Minnesota, June 24, 2026 — Envoy Medical®,
Inc. (NASDAQ: COCH) (“Envoy Medical”), a hearing health company pioneering fully implanted hearing solutions, today announced
that it has formally terminated its at-the-market equity facility (the “ATM Facility”).

 

The ATM Facility, under which the Company was previously authorized
to offer and sell up to $15 million worth of shares of its common stock from time to time, has been terminated effective June 24, 2026.

 

To be added to the Envoy Medical email distribution list, please email [email protected] 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 23, 2026, 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: [email protected]