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).
MCRA provided strategic due diligence
support for Anzu Special Acquisition Corp I ahead of the deal with
Envoy Medical.
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
Phone: 215.870.3952 | Email: ahoward@mcra.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mcra-provides-anzu-special-acquisition-corp-i-with-strategic-diligence-support-leading-to-envoy-medical-merger-nasdaq-coch-302039694.html
SOURCE MCRA, LLC