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
SOURCE MCRA, LLC
