MCRA and Onkos Surgical collaborated at the first U.S. Food and Drug Administration De Novo Approval for antibacterial coating for tumour and revision orthopaedic implants.
MCRA has recently announced that its Regulatory and Biocompatibility teams have cooperated with Onkos Surgical to obtain the U.S. Food and Drug Administration (FDA) De Novo Approval for the antibacterial coating for tumour and revision orthopaedic implants, which will combat bacterial contamination from the operating room environment on permanent orthopaedic implants.
As a matter of fact, bacterial contamination can have devastating effects, especially for orthopaedic oncology and revision arthroplasty applications – where the patient population is highly vulnerable. In testing, the data revealed that the new 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.
“The DeNovo authorisation of the Onkos antibacterial technology is a significant milestone on a long but 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 authorisation, 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,” has stated Gene Kulesha, the executive director of Onkos Surgical.
MCRA is a privately-held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm that has been collaborating with Onkos Surgical since December of 2020 to support its preparations, offering strategic support on the De Novo submission planning, technical information and test report review. Together, both companies worked diligently to draft the initial and supplementary De Novo submissions, as well as manage FDA correspondence, interactive review questions, labelling and finalisation of the De Novo grant.
“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,” has added Eric Sussman, the director of the Biocompatibility team at MCRA.
“Our experts in regulatory and biocompatibility provide top of the line service to all of our clients every day. Achieving the first De Novo authorisation for this new antibacterial coating allows us to continue our mission of bringing high-quality medical technology to improve patient care around the world,” has concluded Anthony Viscogliosi, the CEO of MCRA.