ANZUU Anzu Special Acquisition Corporation I

 

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 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

 

Envoy Medical, Inc. (the “Company”) has issued a promissory note, effective as of February 27, 2024 (the “Note”) with a 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 $10,000,000 until the second anniversary of the Note. The Note has a five year term and matures on February 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 anniversary of the Note. The Company may prepay the accrued interest and principal of the Note without penalty, with 10 day’s notice. At closing the Company requested and GAT agreed to fund an initial $5,000,000 in principal under 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 $1.24 per share (the “Warrants”), the closing price on February 27, 2024.

 

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

 

The information set forth in Item 1.01 of this Current Report on Form 8-K regarding the Note is incorporated by reference into this Item 2.03.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

The information set forth in Item 1.01 of this Current Report on Form 8-K regarding the Warrants is incorporated by reference into this Item 3.02. The issuance of shares of the Company’s Class A Common Stock underlying the Warrants will be made in reliance on the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D thereunder.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release dated March 4, 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.
March 4, 2024	By:	/s/ David R. Wells
		David R. Wells
		Chief Financial Officer

 

 

2

 

Exhibit 99.1

 

Envoy Medical Secures Up To $10 Million Term Debt Financing to Advance Upcoming Clinical Trial

 

Billionaire Entrepreneur Glen Taylor Commits to a 5-Year Facility to Support Company’s upcoming FDA Clinical Trial for the Acclaim® Fully Implanted Cochlear Implant

 

WHITE BEAR LAKE, Minnesota, March 04, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a revolutionary hearing health company focused on fully implanted hearing systems, today announced the closing of up to a $10 million, five-year lending facility provided by existing investor and billionaire entrepreneur Glen Taylor. The facility is unsecured and does not provide for conversion into equity. Envoy Medical drew $5 million on the facility at its origination.

 

“This new financing will support the launch of our upcoming US-based pivotal clinical trial for our innovative investigational fully implanted Acclaim® cochlear implant,” said Envoy Medical CEO Brent Lucas. “The terms, which we believe are friendly and favorable to the company, of this financing also demonstrate the continued commitment of our largest investor to step up and make sure we are well positioned to move forward.”

 

Funds will be available as needed and bear interest at 8% over the term of the loan. Please see Form 8-K filed today for additional discussion of terms and conditions of the investment.

 

Lucas continued, “Glen remains a dedicated believer in and partner to our innovative approach toward advancing the hearing health market with innovative products. Our revolutionary design – leveraging the natural ear to pick up sound rather than a microphone – is an opportunity to dramatically change the landscape for hearing health, using new, fully implantable technologies. We believe that fully implanted devices, by virtue of their design, come with advantages that patients may value and prefer over the current standard of care devices. We look forward to investigating as we proceed.”

 

In addition to the continued advancement of its fully implanted Acclaim® cochlear implant, which has received Breakthrough Designation from the FDA, Envoy Medical is also the only current company to have a FDA-approved, fully implanted active middle ear hearing device (different from their investigational fully implanted cochlear implant). Approximately 1,000 Esteem® fully implanted active middle ear implants have been installed.

 

Further, the Company believes that recently introduced Congressional legislation to re-classify fully implanted active middle ear implants properly, is long overdue. Should the bill become law, it would provide greater patient access to important technologies and encourage more innovation and competition within the category. See further discussion on this with Messer’s. Lucas and Taylor on Fox Business Network, https://www.foxbusiness.com/video/6347858272112?playlist_id=933116626001.

 

About Envoy Medical

 

Envoy Medical, Inc. (NASDAQ: COCH), headquartered in White Bear Lake, Minnesota, is a hearing health company focused on providing innovative medical technologies. As a U.S. company, Envoy Medical provides jobs in Minnesota.

 

Envoy Medical is dedicated to pushing hearing technology beyond the status quo to provide patients with improved access, usability, independence and quality of life.

 

About the Fully Implanted Acclaim® Cochlear Implant

 

We believe the fully implanted Acclaim Cochlear Implant 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 system is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids.

 

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. We believe the Acclaim system was the first hearing-focused device to receive Breakthrough Device Designation.

 

CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.

 

Important safety information for the Esteem can be found at: https://www.envoymedical.com/safety-information.

 

 

About the Fully Implanted Esteem® Active Middle Ear Hearing Device

 

The fully implanted Esteem® active middle ear hearing device is the only FDA approved, completely internal hearing device designed to improve the hearing of adults diagnosed with moderate to severe sensorineural hearing loss.

 

Instead of a microphone, the Esteem device uses a novel sensor to leverage the natural anatomy of the ear to capture sound and convert it into electrical signals that are used by the implant to address hearing loss.

 

The Esteem implant has no externally-worn components required for daily use which allows for “invisible hearing,” the potential for 24/7 hearing, and removing many limitations of hearing aids. The Esteem implant is available in the U.S. through FDA PMA approval. It is not currently covered by Medicare or Medicaid, and is not widely covered by private insurers.

 

To learn more about the Esteem implant, visit https://www.envoymedical.com/middle-ear-implants.

 

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 being the first to market fully implanted cochlear implant, the impact of proposed legislation on the hearing health market, reimbursement for the Esteem 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; 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 Registration Statement on Form S-4 (File No. 333-271920) filed by Envoy Medical (then known as Anzu Special Acquisition Corp I), 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:

 

Scott Arnold
CoreIR
(310) 497-8817
scotta@coreir.com

 

 

 

 

v3.24.0.1

Cover	Feb. 27, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 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
Title of 12(b) Security	Redeemable Warrants, each whole Warrant
Trading Symbol	COCHW
Security Exchange Name	NASDAQ

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