WASHINGTON , Jan. 22, 2024 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm integrating seven core services [U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH)] is pleased to announce its role in providing strategic due diligence support for Anzu Special Acquisition Corp I, ahead of the recent deal with Envoy Medical ("Envoy" or "Envoy Medical") (NASDAQ: COCH).

Anzu Special Acquisition Corp I recently completed a business combination with Envoy Medical, developer of the Acclaim^®, an investigational fully implanted cochlear device that received FDA's Breakthrough Device Designation in 2019, and the Esteem^®, an FDA-approved fully implanted active middle ear implant. MCRA's clinical, regulatory, reimbursement, and quality assurance experts were retained by Anzu Special Acquisition Corp I to provide due diligence support ahead of the transaction with Envoy Medical Corporation. The MCRA team reviewed both of Envoy Medical's fully implanted hearing devices and assessed the overall strategy and risk profile. By compiling findings on critical areas, MCRA provided Anzu Special Acquisition Corp I with pertinent analysis to close the deal with Envoy Medical, allowing them to complete the business combination, resulting in Envoy becoming a publicly listed company (NASDAQ: COCH).

MCRA's due diligence service line equips potential investors with the information they need to make informed decisions, mitigate risks, and maximize the chances of a successful investment in the dynamic and highly regulated medical device and biologics industry.

Todd Courtney, Vice President, Anesthesia, Respiratory, Sleep, & ENT Regulatory Affairs at MCRA states, "My team was excited to work with Anzu Special Acquisition Corp I on such an important deal. By reviewing Envoy Medical's devices and regulatory history with FDA, we were able to aid the company in its investment strategy to bring first-of-a-kind fully implantable hearing devices to the market that have the potential to significantly increase quality-of-life for patients needing these devices."

John McDermott, Vice President, Reimbursement Strategy and Policy at MCRA states, "By reviewing current payer policies on hearing devices, we guided Anzu Partners on the viability of establishing reimbursement at the price point they needed to ensure that Envoy Medical's technology will be available for patients, both now and in the future. We are proud to have assisted on such an important due diligence project."

Whitney Haring-Smith, former CEO of Anzu Special Acquisition Corp I states, "MCRA was a dedicated and diligent partner in our evaluation of Envoy Medical, and we are grateful for their perspective on the pathways to FDA approval and Medicaid/Medicare reimbursement."

"Once the merger process was completed, I was able to see some of the diligence work that MCRA had done for Anzu and was impressed by its ability to distill complicated topics into useable pieces of information," commented Brent Lucas, CEO at Envoy Medical.

 Anthony Viscogliosi, CEO of MCRA states, "as a long-term entrepreneur and investor in the medical device industry, I have seen firsthand the value the MCRA team provides by conducting comprehensive diligence in the areas of clinical, regulatory, reimbursement, quality and compliance for these important transactions. I am pleased to see the successful business combination of Anzu Special Acquisition Corp I and Envoy Medical as a result of the diligence work performed."

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, the United Kingdom, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com

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

For more information, please contact:
Alyssa Howard, Vice President, Business Development
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