Envoy Medical Secures $10 Million Lending Facility to Advance Hearing Implant Technology

envoy medical fully implanted cochlear implant
HHTM
August 29, 2024

WHITE BEAR LAKE, MINNESOTA — Envoy Medical®, Inc. (NASDAQ: COCH), a pioneering hearing health company focused on fully implanted hearing devices, announced the establishment of an additional lending facility with long-time investor, majority shareholder, and billionaire entrepreneur Glen Taylor.

The financing agreement allows the company to draw up to $10 million, with an initial draw of $5 million at the facility’s origination.1

“We believe that Envoy Medical is on the cusp of something great that will forever change the hearing implant landscape. 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.”

–Envoy Medical CEO Brent Lucas

Accelerating Cochlear Implant Program

The company has previously stated its intention to seek an Investigational Device Exemption (IDE) to initiate a Pivotal Study of its fully implanted Acclaim® cochlear implant in the coming months. Should the IDE be granted in a timely manner, the first enrollments could be expected by the end of 2024 or early 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 hearing loss.”

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

Concurrently, the company has been working closely with members of Congress to introduce bills in both the House of Representatives and the Senate to properly reclassify fully implanted active middle ear implants. Should these bills pass and become law, they 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 receive reimbursement once it becomes available, as cochlear implants are classified as coverable benefits.

About the Fully Implanted Acclaim® Cochlear Implant

The fully implanted Acclaim Cochlear Implant (“Acclaim CI”) is anticipated to 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 managed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed suitable 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. It is believed that 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, requires no externally worn components, and nothing is placed in the ear canal for it to function. Unlike hearing aids, it does not need to be put on or taken off, cannot be lost, and does not require cleaning. 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.

About Envoy Medical Corporation

Envoy Medical Corporation is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. The company is dedicated to improving the quality of life for people with hearing loss through the development of implantable hearing devices.

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

 

Source: Envoy Medical

 

 

 

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