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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Envoy Medical Inc | NASDAQ:COCH | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 2.28 | 2.28 | 2.37 | 2.36 | 2.28 | 2.31 | 8,891 | 21:00:01 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
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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:
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| 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)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The Stock Market LLC | ||||
exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share |
The |
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
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SECTION 7 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
Envoy Medical, Inc. (the “Company”) is furnishing its updated Investor Presentation (the “Investor Presentation”) that management intends to use, possibly with modifications, in one or more meetings from time to time with current and potential investors.
The foregoing description of the Investor Presentation does not purport to be complete and is qualified in its entirety by reference to the complete text of the Investor Presentation attached as Exhibit 99.1 to this Current Report on Form 8-K. The Investor Presentation contains forward-looking statements. See Page 2 of the Investor Presentation for a discussion of certain forward-looking statements that are included therein and the risks and uncertainties related thereto.
The information set forth in this Item 7.01 of this Report, including without limitation the Investor Presentation, is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such a filing.
SECTION 9 - Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | ||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
1
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. | ||
| July 15, 2024 | By: | /s/ David R. Wells |
| David R. Wells | ||
| Chief Financial Officer | ||
2
Exhibit 99.1
INVESTOR PRESENTATION July 2024 www.envoymedical.com NASDAQ: COCH Hear for Life
Nasdaq: COCH 2 FORWARD LOOKING STATEMENTS This presentation 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 “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions tha t p redict or indicate future events or trends or that are not statements of historical matters, but the absence of these words d oes not statement is not forward - looking. These forward - looking statements include, but are not limited to, statements regarding the exp ectations of Envoy Medical, Inc. ("Envoy Medical,“ "Envoy," or the "Company") concerning the outlook for its business, goals for future operations, regulatory review and approval, and the ability to obtain government or insurance reimbursement for products. These statements are based on various assumptions, whether or not identified in this Presentation, and on of management of Envoy Medical and are not predictions of actual performance. These forward - looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to p red ict and will differ from assumptions. Many actual events and circumstances are beyond the control of Envoy Medical. statements are subject to a number of risks and uncertainties, including, improvements to Envoy Medical 's product candidate, th e outcomes of clinical trials, the ability to obtain regulatory approvals, and other matters, which may be affected by those currently affecting the price of shares of its Common Stock, including; Envoy Medical 's success in retaining or recrui tin g, 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 products; competition in the med ica l 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's suppliers, or disruptions in En voy '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; Envoy Medical 's ability to raise additional capit al; 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 Medica l'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 sectio ns entitled “Risk Factors” and “Cautionary Note Regarding Forward - Looking Statements” in Envoy Medical’s Annual Report on Form 10 - K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) and any subsequ ent updates in Quarterly Reports on Form 10 - Q or other SEC filings made by the Company . If any of these risks materialize or Envoy Medical’s assumptions prove incorrect, actual results could differ materially from the results implied b y t hese forward - looking statements. There may be additional risks that Envoy Medical does not presently know or that it currently believes are immaterial that could also cause actual results to differ from those contained in the forward - looking sta tements. In addition, forward - looking statements reflect Envoy’s expectations, plans or forecasts of future events and views as of the date of this Presentation. While Envoy Medical may elect to update these forward - looking statements at some poin t in the future, Envoy Medical specifically disclaims any obligation to do so except as required by law. These forward - looking statements should not be relied upon as representing Envoy’s assessments as of any date subsequent to the date o f this Presentation. Accordingly, undue reliance should not be placed upon the forward - looking statements. No representations or warranties expressed or implied are given in, or in respect of, this Presentation. Industry and market dat a used in this Presentation have been obtained from third - party industry publication and sources as well as from research reports prepared for other purposes. Envoy Medical has not independently verified the data contained from these sour ces and cannot assure you of the data’s accuracy or completeness. This data is subject to change. Recipients of this Presentation are not to constitute its contents, or any prior or subsequent communications from or with Envoy or its represen tat ives as investment, legal or tax advice. In addition, this Presentation does not purport to be all - inclusive or to contain all of the information that may be required to make a full analysis of Envoy Medical. Recipients of this Presentation should eac h make their own evaluation of Envoy Medical and of the relevance and adequacy of the information and should make such other investigations as they deem necessary. Market, ranking and industry data used throughout this Presentation, including statements regarding market size, are based on in dustry sources and the good faith estimates of Envoy’s management. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While Envoy Medical is not aware of any mi sst atements regarding the industry data presented herein, its estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Envoy Medical Corporation” in its Form 10 - K filed on April 1, 2024 with the SEC. Investments in any securities described herein have not been approved or disapproved by the SEC or any other regulatory autho rit y nor has any authority passed upon or endorsed the merits of the offering or the accuracy or adequacy of the information contained herein. Any representation to the contrary is a criminal offense. No Offer or Solicitation: This Presentation is neither an offer to purchase, nor a solicitation of an offer to sell, subscribe for or buy any securities or the solicitation of any vote in any jurisdiction, nor shall there be any sale, issuance or trans fe r or securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a pro spectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom, and otherwise in accordance with applicable law. Additional Information and Where to Find It: On April 1, 2024 Envoy Medical filed its Form 10 - K containing significant informat ion about the business, financial condition of Envoy. This Presentation is not a substitute for the information contained in the Report. Investors and security holders are urged to read the Report to gain additional information regarding Envoy. Copie s o f the Report and other documents filed by Envoy, including under its prior name of Anzu Special Acquisition Corp I, with the SEC may be obtained, once available, free of charge at the SEC’s website at www.sec.gov. Risk factors: For a description of the risks relating to the business of Envoy Medical, please see the section “Risk Factors” in the Form 10 - K.
Nasdaq: COCH 3 INVESTMENT OVERVIEW & KEY METRICS Envoy Medical (NASDAQ: COCH): • Innovative hearing health company based in the United States (MN) focused on hearing implants. • Leading the way in “fully” or “totally” implanted hearing devices. • Only company with an FDA - approved, fully implanted hearing device (the Esteem ® ). • Fully implantable devices disrupt a stagnant hearing industry. • Dedicated to improving patient access, usability, compliance, and ultimately quality of life. ENVOY MEDICAL NASDAQ: COCH $2.30 Stock Price (as of 7/1/24) $4.9M Cash Balance (March 31, 2024) 19.6 Common Shares Outstanding 43.5M Fully Diluted Shares Outstanding $46M Market Capitalization 35,000 Average Daily Volume, 50 day (per Nasdaq)
Nasdaq: COCH 4 PRODUCT OVERVIEW Esteem ® FI - AMEI • The only company in the world that has successfully obtained a fully implanted hearing device approved by the FDA. • Recently introduced bipartisan bill seeks to clarify fully implanted active middle ear devices as prosthetics, opening pathway to be a coverable benefit, directly benefitting the Esteem FI - AMEI. Acclaim ® CI • Acclaim® CI expects to be first of - its - kind Fully Implanted Cochlear Implant (FICI) device and could disrupt a multi - billion dollar cochlear market. • Addressable market (US only) estimated at $84 billion; this assumes ~2.8 million U.S. adult candidates (one ear only) and a price of $30K. • Pivotal study submission planned for the fall of 2024 for enrollment of 50 evaluable subjects for the Acclaim CI product. Esteem ® FI - AMEI The only FDA - approved, fully - implanted active middle ear implant. FDA approval received in 2010. Implanted in approx. 1,000 patients. Acclaim ® CI We are different because our devices: • Leverage the natural ear to pick up sound. • Do not rely on artificial microphones. • Allow the outer ear to be used by the patient. A fully implanted cochlear implant (“FICI” or “TICI”) that represents a paradigm shift in cochlear implants. It is currently in clinical trials and investigational. CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use
Nasdaq: COCH 5 HOW SOUND TRAVELS THROUGH THE EAR Sound waves travel down the ear canal and hit the eardrum The waves are transmitted mechanically through the ossicular chain to the cochlea The cochlea converts sound waves to electrical signals which travel to the brain via the auditory nerve Outer ear collects sound waves and funnels them to the ear canal 1 2 3 4 For illustrative purposes only. Experience and results may vary.
Nasdaq: COCH 6 SOURCE OF MOST HEARING LOSS – THE COCHLEA • The cochlea, or inner ear, is filled with fluid and contains thousands of tiny hair cells that move as sound vibrations are transferred from the middle ear to the cochlea. • Hair cell movement causes signals to be sent via the hearing nerve to the brain where they are interpreted as sound. • Hearing hair cell damage, which can originate from many different sources (e.g. age, noise, genetics, ototoxic drugs), results in the most common form of hearing loss – sensorineural. • The level or severity of hearing loss will depend on the extent of damage to the hearing hair cells. • The greater amount of damage to the hair cells the less information they can provide as a whole to the brain, hence a greater level of hearing loss. For illustrative purposes only. Experience and results may vary.
Nasdaq: COCH Acclaim CI Hearing Aids Esteem FI - AMEI 7
Nasdaq: COCH 8 NATURE’S MICROPHONE – THE EAR Both of Envoy Medical’s devices leverage the ear’s anatomy. There is nothing in the ear. Sound enters the outer ear and funnels down the ear canal causing the eardrum to vibrate. All as nature designed and intended. 0 10 20 250 500 750 1000 1500 2000 3000 4000 6000 Frequency (Hz) Total of Pinna and Resonance Pinna Effect Ear Canal Resonance Blatrix , Minary , Leisses , 2004
Nasdaq: COCH 9 HEARING LOSS: GLOBAL MARKET Key Facts from the World Health Organization 1 : • More than 1.5 billion people may have some form of hearing loss during their lifetime. • Approximately 430 million of those individuals have “disabling hearing loss” that requires intervention. 2 • By 2050, these numbers are expected to jump significantly. ⎼ 2.5 billion people are projected to have some degree of hearing loss. ⎼ 700 million may have “disabling hearing loss” that requires hearing rehabilitation. • It is estimated that nearly $1 trillion (USD) may be lost every year globally due to a failure to address hearing loss properly. • Hearing loss is significantly more common with increased age. Approximately 1 in 4 (25%) of people over the age of 60 are impacted by “disabling hearing loss.” NOTES: (1) (1) World report on hearing. Geneva: World Health Organization; 2021. License: CC BY - NC - SA 3.0 IGO. (2) (2) “Disabling hearing” refers to a level of hearing loss that is 35 decibels (dB) or more in the better hearing ear.
Nasdaq: COCH 10 ~2.8M U.S. ADULTS MAY BE CANDIDATES FOR COCHLEAR IMPLANTS 1 • “Hearing loss is the third most common chronic physical condition in the United States and is twice as prevalent as diabetes or cancer.” 5 • Approximately 48 million Americans have some form of hearing loss. Over the next four decades, that number may increase to approximately 80 million. 6 • As Americans live longer, more people will experience hearing loss. 6 ⎼ 68% of people in their 70s experience hearing loss. 7 ⎼ 90% of people 80 or older experience hearing loss. 7 • Age - related hearing loss has been estimated to have an economic cost to society of approximately $297,000 (USD) per affected person over their lifetime. 8 • Hearing loss is correlated with risk of cognitive decline, depression, anxiety, and a higher risk of falls. 6 Only ~5% - 8% of the people that could benefit from an implantable hearing solution have received one. 2 Our View: a primary reason adults do not get cochlear implants is the external hardware. NOTES: 1. Goman , Adele M., and Frank R. Lin. "Prevalence of hearing loss by severity in the United States." American journal of public healt h 106.10 (2016): 1820 - 1822.; Goman , Adele M., Nicholas S. Reed, and Frank R. Lin. "Addressing estimated hearing loss in adults in 2060." JAMA Otolaryngology – Head & Neck Surgery 143.7 (2017): 733 - 734 2. Cochlear Limited Annual Report 2022 3. S2N Market Model prepared for Envoy Medical Corporation 4. Assumes device price of ~$30,000 for 2.8M U.S. population of potential candidates for cochlear implants ~$84B and growing untapped potential cochlear implant U.S. market opportunity 3,4 5. CDC citing Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for US adults: National Health Interview Survey, 2012. Vital Health Stat 10. 2014;260:1 - 161. 6. Everett, Carla. National Council on Aging. (2023) https:// www.ncoa.org /adviser/hearing - aids/hearing - loss - america / 7. Goman , Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. 2016. Found on the internet at https:// www.ncbi.nlm.nih.gov / pmc /articles/PMC5024365/ 8. National Academies of Sciences, Engineering, and Medicine. Hearing health care for adults: Priorities for improving access an d affordability. Washington, DC: The National Academies Press; 2016. (doi:10.17226/23446)
Nasdaq: COCH 11 TRADITIONAL COCHLEAR IMPLANTS Cochlear implants replace the function to the inner ear by providing direct electrical stimulation of the auditory nerve. Sound processor - External • Picks up and processes sound into digital information. Implant - Internal • Receives signal from the sound processor and transmits electrical stimulation to the cochlea through an electrode array. Illustrative Device Overview: 1. Microphones on the sound processor pick up sound, and the processor converts them into digital information. 2. This information is transferred through the coil to the implant; the implant sends electrical signals into the cochlea. 3. The hearing nerve fibers in the cochlea pick up the signals and send them to the brain, giving the sensation of sound. Outer Ear, Ear Canal, Middle Ear Not Used. Sound Picked Up by External Microphones For illustrative purposes only. Experience and results may vary. 1 2 3
Nasdaq: COCH 12 FULLY IMPLANTED COCHLEAR IMPLANT: AN OBVIOUS OPPORTUNITY • Envoy Medical believes that if, given an opportunity to choose between a fully - implanted cochlear implant with no externals, and a partially - implanted cochlear implant with externals, a significant portion of patients would choose a fully implanted cochlear implant. • Externals associated with traditional cochlear implants are obvious and can get in the way of a person’s life. • Envoy Medical has developed an important missing piece in the solution – our sensor technology. • Envoy Medical intends to be a catalyst for change the market wants and, frankly, needs – a fully implanted solution. • Envoy Medical’s sensor is an elegant solution for a fully implanted device: ⎼ Leverages the natural outer and middle ear. ⎼ Low power needs. ⎼ Not an artificial microphone. ⎼ Not a sub - dermal microphone (lowers chances of body noise issues). CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use
Nasdaq: COCH 13 ACCLAIM ® CI EXPECTS TO BE FIRST OF - ITS - KIND FULLY IMPLANTED COCHLEAR IMPLANT (FICI) DEVICE DISCREET • No need for externally worn components. • Designed to use the ear to pick up sound. No external artificial microphone needed. DEPENDABLE • Designed to allow true 24/7 hearing. • For use in many environments and activities. EASY • No expensive external sound processors to replace when lost or damaged. • No frequent battery changes or charging. Rechargeable battery expected to last several days between charges and designed to last 8 - 12 years. • No magnets. Designed to be MRI compatible.* *MRI testing and compatibility not yet determined). CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use
Nasdaq: COCH 14 PRODUCT OVERVIEW – ESTEEM ® FI - AMEI The Esteem ® FI - AMEI is the first and only FDA - approved, fully - implanted active middle ear implant (FI - AMEI) 1. The Envoy Sensor converts the vibrations into electrical signals that are sent to the implanted Esteem Sound Processor. 2. The Esteem Sound Processor receives, adjusts and intensifies the signals to fit individual hearing needs. 3. The Esteem Driver directly transfers these signals to the inner ear where the hair cells are stimulated, causing you to hear. Product Summary For illustrative purposes only. Experience and results may vary.
Nasdaq: COCH 15 THREE FULLY IMPLANTED COMPONENTS The Esteem ® FI - AMEI Opportunity Driver Sound Processor Sensor
Nasdaq: COCH 16 HOW THE ESTEEM FI - AMEI HEARING IMPLANT WORKS For illustrative purposes only. Experience and results may vary.
Nasdaq: COCH 17 COMPLACENT EXISTING PARTICIPANTS Market Share: ≈65% (ASX: COH) $1.2B Revenue ~$9.9B Market Cap 1 Market Share: ≈15% Privately Held Market Share: ≈10% (SWX: SOON) $3.9B Revenue ~$15.8B Market Cap NOTE: 1. PitchBook Data, as of August 2023; Market share data shown are estimates based on publicly available information and are subject to cha ng e. *. Third party logos and brands are property of their respective owners. Shown for illustrative purposes only SOURCE: Cochlear Ltd. SOURCE: Med - EL SOURCE: Advanced Bionics Market Cap (USD) 1 Gross Margin (%) 1 Revenue (USD) 1 DESCRIPTION COMPANIES ~$13.8B 75% $1.3B TTM Total As of 30 - June - 2023 Cochlear is the leading cochlear implant device manufacturer with around 60% global market share. Developed markets contribute 80% of group revenue where cochlear implants are the standard of care for children with severe to profound hearing loss. The company also actively targets the growing cohort of seniors in developed markets. Main products include cochlear implants, bone - anchored hearing aids, and associated sound processors. 71% 71% $3.9B TTM Total As of 31 March 2023 Sonova is one of the world's largest manufacturers and distributors of hearing aids. The company is based in Switzerland and distributes its products in more than 100 countries through its internal sales team and independent retailers. It also sells cochlear implants through its advanced bionics subsidiary. Current Market Cap of Envoy Medical (COCH) is less than 1% of the existing players. Our belief is that difference will not continue to be as great over time.
Nasdaq: COCH 18 ENVOY MEDICAL COULD DISRUPT A MULTI - $B COCHLEAR MARKET x • • • Feasibility Study on Record x x x • Breakthrough Device Designation from U.S. FDA for Fully Implanted Cochlear Implant x x x • Investigational Device Exemption (IDE) to implant U.S. patients (Early Feasibility Study) X • x End of 2024 (estimated) Enrollment of larger clinical study to support regulatory application(s) X x x x FDA Approval for Commercial Sales in U.S. part of (USA) (Europe) (Australia) SOURCE: Envoy Medical management *. Third party logos and brands are property of their respective owners. Shown for illustrative purposes only (July, 24 Europe)
Nasdaq: COCH $8.0 $16.4 $28.6 $50.6 $82.1 $115.4 $233.4 $407.9 $624.8 $- $100.0 $200.0 $300.0 $400.0 $500.0 $600.0 $700.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 19 REVENUE GROWTH & SHAREHOLDER RETURN Implantable Device Market Opportunity Inspire disrupted the sleep apnea market with the first implantable device Current incumbent market leader in cochlear implants generated material shareholder return since its IPO in 1995 2015 - 2023 Revenue 1 (in millions) NOTE: 1. Inspire 2023 Annual Report 2. Cochlear Limited Annual Report 2022 * Third party logos and brands are property of their respective owners. Shown for illustrative purposes only Total Shareholder Return Since Listing 2 53% REVENUE GROWTH in 2023 over 2022
Nasdaq: COCH 20 ILLUSTRATIVE TRACK TO COMMERCIALIZATION 2019 2022 2023 2024 - 2025 2026 FDA Breakthrough Granted Q3 2022 EFS IDE Accepted Q4 2022 First activation First patient implanted at Mayo Clinic Full EFS Enrollment 3 patients Q2 2023 Colin Driscoll, MD ACIA Presentation Planned Funding ~$40 - 50M to FDA approval (estimated) Q4 2024 Pivotal IDE Submission 2024 – 2025* Pivotal Study ~50 patients Commercialization & Market Acceptance / Reimbursement *Estimates for 2024 and beyond are illustrative and are based on management's current assumptions, which are subject to change. Please see “Risk Factors” in the Form 10 - K filed with the SEC on April 1, 2024. * Third party logos and brands are property of their respective owners. Shown for illustrative purposes only
Contact Details Investor & Media Relations: Scott Arnold CoreIR (310) 497 - 8817 scotta@coreir.com www.envoymedical.com /investors
APPENDIX
Nasdaq: COCH HEARING LOSS: TYPES AND SEVERITY OVERVIEW Hearing loss can be due to damage of the outer/middle (conductive) or inner (sensorineural) ear and can range from mild to profound. Conductive Sensorineural Hearing Loss Conductive Hearing loss due to problems with ear canal, ear drum, or middle ear bones • Common causes include middle ear infection, perforation of the eardrum, wax buildup, and dislocation of the middle ear bones Sensorineural Hearing loss due to problems of the inner ear • Common causes include aging, excessive noise exposure, viral infections, and exposure to ototoxic drugs Severity of Hearing Loss example dB Loss Category n/a 0 - 20dB Normal Difficulty hearing soft spoken people 20 - 40dB Mild Often can hear speech but not understand 40 - 70dB Moderate Cannot hear speech 70 - 90dB Severe Unable to hear loud sounds like fire alarms 90+dB Profound 23
Nasdaq: COCH Sleep Apnea Fully Implanted Cochlear Implants Glucose Monitoring Pacemaker FDA Approves Inspire ® Upper Airway Stimulation (UAS) Therapy for Obstructive Sleep Apnea FDA Breakthrough Designation granted for Envoy’s fully implantable cochlear implants FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes FDA approves the first leadless pacemaker to treat cardiac arrhythmias Source: Mayoclinic.org Source: senseonics.com Source: mddionline.com DISCREET AND IMPLANTABLE MEDICAL TECHNOLOGY CONTINUES TO INNOVATE MARKETS Third party logos and brands are property of their respective owners. Shown for illustrative purposes only. 24
Nasdaq: COCH 25 ENVOY’S RECHARGEABLE BATTERY EXPECTED TO LAST SEVERAL DAYS BETWEEN CHARGES Remain mobile while charging with the charging system Battery charging system only worn while charging, a few hours every 4+ days** Envoy’s battery is similar to other medical devices with implanted, rechargeable batteries Rechargeable Implanted Batteries Enhance Quality Of Life Source: Boston Scientific Deep Brain Stimulation System Sleep Apnea Implant Therapy Source: LivaNova Source: Impulse Dynamics Cochlear Implant Cardiac C ontractility M odulation T herapy Third party logos and brands are property of their respective owners. Shown for illustrative purposes only.
Nasdaq: COCH KEY LEADERS – MANAGEMENT TEAM Brent T. Lucas, CEO Mr. Lucas has been the Chief Executive Officer of Envoy Medical Corporation for the last seven years and brings over 15 years of experience in the active implantables in the hearing health industry . He has served in various roles and gained a tremendous amount of specialized experience, working his way up from an intern to CEO. Mr. Lucas received his Bachelor’s Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law. Tom Hoegh , VP of R&D Mr. Hoegh has over 30 years of experience in the medical device industry, primarily in the development and on - market support of active implantable devices such as neuromodulation systems for spinal, sacral, deep brain, and hypoglossal nerve stimulation. Mr. Hoegh’s previous experiences consist of leading engineering teams at Nuvectra , ICU/Smiths Medical, Medtronic, and Apnex Medical. Mr. Hoegh received a dual Bachelor of Science degree in Mechanical Engineering and Chemistry from Valparaiso University and a Master of Science degree in Technology Management from the University of St. Thomas. David R. Wells , CFO Mr. Wells has 20 years of experience in the small - cap public company arena. Mr. Wells joined Envoy Medical, Inc. as its Chief Financial Officer in August, 2023. From 2014 to 2021 he was the CFO of ENDRA Life Sciences Inc. (NASDAQ: NDRA), a publicly traded clinical diagnostics technology company, where he directed ENDRA’s initial public offering (IPO) and subsequently rais ed an additional $55 million across multiple transactions. In December 2022, David joined the Board of Directors of HeartSciences (NASDAQ: HSCS), which is developing a cardiac device which seeks to bridge today’s “diagnostic gap” in cardiac care by providing effective front - line solutions that assist in the detection of heart disease in at - risk patients. Executive Summary Karin Simonson, Vice President, General Counsel & Secretary Karin Simonson has served as our Vice President, General Counsel & Corporate Secretary since December, 2023. From April, 2023 to December, 2023, Ms. Simonson was General Counsel for Monarch Healthcare Management. She has almost 20 years of diverse in - house counsel experience supporting clinical, regulatory, sales, marketing, compliance, data privacy, research and development, HR, IT, contracts and commercial operations with increasing responsibilities at both small and large companies including, Coloplast, Medtronic, American Medical Systems and Carlson Hotels Worldwide. Ms. Simonson has a BS, magna cum laude, from the University of Minnesota - Twin Cities and a JD, magna cum laude, from Mitchell Hamline School of Law. Third party logos and brands are property of their respective owners. Shown for illustrative purposes only. 26
Nasdaq: COCH Envoy Medical, Inc. Board of Directors Glen Taylor Chairman Emeritus • Founder and chairman of Taylor Corporation, a global printing and communications company and one of the nation’s largest privately held companies. • A member (and former chair) of the Board of Governors of the National Basketball Association. • Served in the Minnesota State Senate from 1980 to 1990 and as Minority Leader from 1985 to 1988. • President of the YMCA, director of the Mankato Chamber of Commerce, director of the Greater Minnesota Corporation and the Minnesota Business Partnership, and served on the Minnesota State University Foundation Board of Directors. • Attended Harvard Graduate School of Business and earned his BS at Minnesota State University in Mankato. Janis Smith - Gomez Independent Director, NomGov Committee Chair • Over 30 years of executive experience at Johnson & Johnson, Mars, Kraft and PepsiCo. • Most recent role with J&J, Janis led the brand identity efforts to evolve the $27B medical devices business into a leading patient - centered, customer - focused, digitally powered MedTech innovator. • Previously accountable P&L owner of businesses as large as $3B, managing budgets from $10M to $215M. • On non - profit boards of New York Academy of Medicine and Black Public Media. • Graduate of University of Chicago with an MBA in Marketing & Business Policy and a Bachelor’s degree in Business. Susan Kantor Independent Director, Audit Committee Chair • An Advisory Partner for PwC from 2011 to 2016, a Partner and CFO & Treasurer of PRTM Management Consultants from 1997 to 2011. • Previously a CFO at corporate strategy and operations consulting firms Monitor Group and BCG, as well as Parexel International, a CRO. • Board member and Audit Committee chair of Anzu, Teknor Apex Company, a $1.2 billion dollar privately - held material science Company, Guest Services Inc., a privately - held hospitality company, and the International Council on Clean Transportation. • Ex - board director and the Audit Committee Chair for Lionbridge Technologies Inc. when it was a $550 million publicly - held company. Sold to private equity in 2016. • Bachelor’s degree from Grove City College in Accounting and Business Administration and her CPA in MA. Mona Patel Independent Director • Over 30 years of experience in medical devices in marketing, market development, clinical education and mergers and acquisitions. • Former VP of Marketing and Clinical Education at Boston Scientific in their neuromodulation division where she helped build the start - up into a market leader with ~$1B in sales. • Introduced the first rechargeable spinal cord stimulator into a market and helped convert the market from non - rechargeables to rechargeables. • Launched the first rechargeable in Deep Brain Stimulation for Parkinson’s. • BSE in Mechanical Engineering from the University of Michigan and an M.B.A. from the Wharton School of Business. Michael Crowe Independent Director • Michael Crowe is currently SVP Operations at Bioventus. In this role he oversees Operations, Supply Chain, Customer Service, Data Integrity, Facilities, Sustaining Engineering, and the Office of Project Management & Alliances reporting to him. • Began his career at General Electric, and has served in management at medical device powerhouses Johnson & Johnson, Covidien Surgical Devices (now part of Medtronic), and Abbott Vascular. • Holds a BS in electrical engineering from the University of Louisville and an MBA from Duke. • Certified master black belt in Six Sigma and lean manufacturing and is a trained facilitator and continuous improvement champion. Brent Lucas CEO of Envoy Medical • Served as CEO of Envoy for the past seven years and brings over 15 years of experience in the active implantables in the hearing health industry. • Served in various roles with Envoy and gained a tremendous amount of specialized experience, working his way up from an intern to CEO. • Received his bachelor’s degree from the University of St. Thomas and Juris Doctor degree from the Mitchell Hamline School of Law. Chuck Brynelsen Independent Director, Board Chair • Most recently serving as Senior VP and President of Abbott Vascular from 2017 to 2021. • Since 2015 he has also been a Venture Partner of SpringRock Ventures, an investment firm that focuses on digital health, devices, services. • Served on private companies boards of directors, including Alebra Technologies since 2010 and Neuspera Medical from 2022 to 2023. • Served as SVP and President of Medtronic Early Technologies from 2015 to 2016, as the Global President of Covidien Early Technologies from 2013 to 2015, and as the CEO of IntraPace from 2005 to 2012. • MBA from Kellogg School of Management at Northwestern University and his BA from Bradley University. Key Leaders 27 Third party logos and brands are property of their respective owners. Shown for illustrative purposes only.
Nasdaq: COCH Jannine “Jan” Larky , M.A. ǀ Stanford Ear Institute (Palo Alto, CA) Dr. Aniket Saoji , Ph.D. ǀ Mayo Clinical (Rochester, MN) Dr. Sarah Sydlowski , Ph.D. & Au.D . ǀ Cleveland Clinic (Cleveland, OH) Dr. Melissa Hall , Au.D . ǀ University of Florida (Gainesville, FL) Dr. Camille Dunn , Ph.D. ǀ University of Iowa (Iowa City, IA) Cochlear Implant ADVISORY BOARD Dr. Colin L. Driscoll , M.D. ǀ Mayo Clinic (Rochester, MN) Dr. Elizabeth “Liz” Toh , M.D. ǀ Lahey Hospital & Medical Center (Boston, MA) Dr. Theodore “Ted” McRackan , MD ǀ Medical University of South Carolina (Charleston, South CA) Dr. Craig A. Buchman, M.D. ǀ Washington University School of Medicine in St. Louis (St. Louis, MO) Dr. John Kveton , M.D. ǀ Ear Nose and Throat Medical and Surgical Group, LLC (New Haven, CT) Dr. Jack Shohet , M.D. ǀ Shohet Ear Associates Medical Group, Inc. (Seal Beach, CA) Audiologists Surgeons Dave Fabry , Ph.D., CIO ǀ Starkey Hearing Technologies Who Are We? 28 Third party logos and brands are property of their respective owners. Shown for illustrative purposes only.
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