WASHINGTON, June 20,
2024 /PRNewswire/ -- MCRA, the leading privately
held independent medical device, diagnostics, and biologics
Clinical Research Organization (CRO) and advisory firm is
pleased to announce its role in the U.S. Food and Drug
Administration's (FDA) De Novo granting for Onkos Surgical's
antibacterial coating for tumor and revision orthopedic
implants.
Onkos Surgical engaged MCRA in December of 2020 to support its
De Novo preparations. MCRA's Regulatory and Biocompatibility teams
worked jointly to provide strategic support on the De Novo
submission planning, technical information and test report review.
Onkos and MCRA worked diligently to draft the initial and
supplementary De Novo submissions, as well as manage FDA
correspondence, interactive review questions, labeling, and
finalization of the De Novo grant. The FDA approved the implants
for commercial use in April 2024.
This first-of-its-kind De Novo authorization will combat
bacterial contamination from the operating room environment on
permanent orthopedic implants, which can have devastating effects,
particularly in orthopedic oncology and revision arthroplasty
applications where the patient population is highly vulnerable. In
testing, the data revealed that the proprietary coating does not
elute and has been proven to be bactericidal, with a 99.999% (5
log) kill rate in in-vitro testing of bacteria that are
commonly found in the operating room environment.
This De Novo approval further adds to MCRA's unparalleled
track record of success, especially in the orthopedic space where
MCRA has supported more than 50% of all orthopedic De Novos granted
to date.
Eric Sussman, PhD, Director,
Biocompatibility at MCRA states, "We at MCRA are very proud to work
on the first De Novo approval for antibacterial coatings on behalf
of Onkos Surgical. Introducing a new medical device coating is a
unique opportunity to work closely with the FDA on a complex
review. We are grateful for the opportunity to work with Onkos
Surgical through the process of demonstrating safety and efficacy
of this antibacterial coating."
Gene Kulesha Executive Director
at Onkos Surgical said, "The DeNovo authorization of the Onkos
antibacterial technology is a significant milestone on a long,
collaborative journey with the FDA. A great deal of in-depth and
first-of-its-kind science and engineering provided the body of
evidence for this authorization, opening the door for further
advancements with this technology. We are very thankful to MCRA for
advising us and providing expert guidance on scientific as well as
regulatory planning."
Anthony Viscogliosi, CEO of MCRA
states, "MCRA's experts in regulatory and biocompatibility
provide top of the line service to all of our clients every day.
Achieving the first De Novo authorization for this new
antibacterial coating allows us to continue our mission of bringing
high-quality medical technology to improve patient care around the
world."
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, London, England, 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 Onkos Surgical: Onkos Surgical is a leader in
innovative solutions for musculoskeletal oncology and complex
orthopaedic conditions. With its Precision Orthopaedics solutions,
surgeons are better informed about patient-specific clinical
challenges and are able to plan and implement more precise
reconstructions. Their personalized approach supports improved
patient outcomes and experiences using the latest innovations in
virtual surgical planning, 3D anatomic modeling and printing,
implant design, and workflow optimization. More than 350 of the
leading academic medical institutions in the US choose Onkos
Surgical Precision Orthopaedics.
www.onkossurgical.com.
For more information, please contact:
Erin Hagan, Associate Director, Business
Development
Phone: 202.552.5908 | Email: ehagan@mcra.com
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SOURCE MCRA, LLC