COCH Envoy Medical Inc

 

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): August 27, 2024

 

 

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 1.01: Entry Into a Material Definitive Agreement

 

On August 27, 2024, Envoy Medical, Inc. (the “Company”) issued a promissory note (the “Note”) in the principal amount of up to $10,000,000 to GAT Funding, LLC (“GAT”), an entity controlled by Glen Taylor, who is a member of the Company's board of directors and controlling stockholder of the Company. Upon meeting certain conditions, the Company may draw funds in $2,500,000 tranches under the Note up to a total of $10,000,000. The Note has a five year term and matures on August 27, 2029. The principal amount drawn bears interest at a rate of 8.0% per annum and is paid quarterly in arrears after the second anniversary of the Note. Interest will accrue and not be paid for the first two years of the term, and will compound and be added to the principal balance of the Note on the first and second anniversaries of the Note. The Company may prepay the accrued interest and principal of the Note without penalty, with 10 days’ notice. At the initial closing the Company drew $5,000,000 in principal from the Note.

 

As a commitment fee, the Company will issue GAT warrants to purchase 250,000 shares of its Class A Common Stock for each $2,500,000 of principal funded under the Note. The warrants will have an exercise price equal to the closing price on the date of funding of the applicable tranche and a termination date as of the third anniversary of the initial closing for all warrants. At closing of the initial funding, the Company issued GAT warrants to purchase 500,000 shares of Class A Common Stock at an exercise price of $2.97 per share.

 

Item 8.01 Other Events

 

On August 28, 2024, the Company issued a press release regarding its entrance into the Note.

 

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 August 28, 2024.
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.
August 28, 2024	By:	/s/ David R. Wells
		David R. Wells
		Chief Financial Officer

 

 

2

Exhibit 99.1

 

Envoy Medical Secures Lending Facility of $10M

 

Glen Taylor, Committed Investor and Believer in Envoy Medical’s Mission to Help People with Significant Hearing Loss, Provides Significant Additional Funding as the Company Eyes Important Milestones and Seeks to Grow Hearing Implant Market with Breakthrough Device

 

WHITE BEAR LAKE, Minnesota, August 28, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a revolutionary hearing health company focused on fully implanted hearing devices, today announces entry into an additional lending facility with long-time investor, majority shareholder, and billionaire entrepreneur Glen Taylor. The financing allows the Company to draw up to $10 million, of which the Company drew $5 million on the facility at its origination.

 

“We believe that Envoy Medical is on the cusp of something great that will forever change the hearing implant landscape,” said Envoy Medical CEO Brent Lucas. “This new funding from Glen Taylor allows us to remain focused on building and growing the business without losing momentum. Mr. Taylor’s support gives us the flexibility and security to reach our next milestones securely and intelligently.”

 

The $10 million lending facility has a five-year term, is unsecured, does not have a conversion feature, and defers interest for the first two years. Funds will be available as needed and bear interest at 8% over the term of the loan. Please see the Current Report on Form 8-K filed by Envoy Medical today for additional discussion of terms and conditions of the investment.

 

The Company has previously stated that it intends to seek an Investigational Device Exemption (IDE) to start a Pivotal Study of its fully implanted Acclaim® cochlear implant in the coming months. Should the IDE be granted in a timely manner, first enrollments could be expected by the end of calendar year 2024 or the first part of 2025.

 

“We know people both inside and outside of the hearing implant industry are excited for us to move forward with the fully implanted Acclaim® cochlear implant,” continued Lucas. “As we progress, our hope is that we can make the decades old dream of a fully implanted cochlear implant a reality. If we are successful, we anticipate substantial value from realizing that dream for millions of people with severe-to-profound levels of hearing loss.”

 

In addition to its investigational, fully implanted Acclaim® cochlear implant, which previously received Breakthrough Designation from the FDA, Envoy Medical also has the only FDA-approved fully implanted active middle ear implant, the Esteem® device.

 

Concurrently, the Company has worked closely with members of Congress to introduce bills in both the House of Representatives and the Senate to properly re-classify fully implanted active middle ear implants. Should these bills pass and become law, it would provide greater patient access to important hearing implant technologies and encourage more innovation and competition within the hearing implant category.

 

The investigational fully implanted Acclaim® cochlear implant is expected to have reimbursement once it becomes available, as it is a cochlear implant, and cochlear implants are classified as coverable benefits.

 

About the Fully Implanted Acclaim® Cochlear Implant

 

We believe the fully implanted Acclaim Cochlear Implant (“Acclaim CI”) will be a first-of-its-kind fully implanted cochlear implant. 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. We believe the Acclaim CI was the first hearing-focused device to receive Breakthrough Device Designation.

 

 

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 operational improvements and capital investments, the availability and benefits of future funding, the Acclaim CI being the first to market fully implanted cochlear implant, the performance of the Acclaim CI and availability of insurance reimbursement of the Acclaim CI, the timing of Envoy Medical’s IDE submission, the approval of the IDE submission, and the beginning of its clinical trial, the effect of such clinical trial on the development of Envoy Medical’s business, the impact of proposed legislation on the hearing health market, reimbursement for the Esteem FI-AMEI device, and the Envoy Medical business, and future market conditions or economic performance, as well as 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 transactions and 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; 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 April 1, 2024, 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:

 

CORE IR
516-222-2560
investorrelations@envoymedical.com

 

 

 

v3.24.2.u1

Cover	Aug. 27, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 27, 2024
Entity File Number	001-40133
Entity Registrant Name	ENVOY MEDICAL, INC.
Entity Central Index Key	0001840877
Entity Tax Identification Number	86-1369123
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	4875 White Bear Parkway
Entity Address, City or Town	White Bear Lake
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55110
City Area Code	877
Local Phone Number	900-3277
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Class A Common Stock, par value $0.0001 per share
Title of 12(b) Security	Class A Common Stock, par value $0.0001 per share
Trading Symbol	COCH
Security Exchange Name	NASDAQ
Redeemable Warrants, each whole Warrant exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share
Title of 12(b) Security	Redeemable Warrants, each whole Warrant exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share
Trading Symbol	COCHW
Security Exchange Name	NASDAQ

---