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FDA grants De Novo approval for Onkos Surgical’s antibacterial-coated implants

Onkos Surgical announced that the U.S. Food & Drug Administration (FDA) has granted the company a De Novo approval for its novel antibacterial coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.

“Implant contamination is a growing concern to the orthopaedic surgical community,” said Steven Gitelis, MD, Onkos Surgical Chief Medical Officer, Rush Medical College, Endowed Professor of Orthopaedic Oncology and Director, Musculoskeletal Oncology at Rush Cancer Center. “When bacteria contaminate the artificial joint, it can lead to a cascade of issues that can significantly impact the patient’s health. The current tools in our armamentarium are simply not enough to help solve this multifactorial problem. The increasing prevalence of joint procedures underscores the importance of implementing effective strategies to address the presence of bacteria. The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant.”

A robust body of preclinical safety and efficacy data was generated to support the De Novo application. The data showed 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.

“Receiving De Novo approval to market this technology represents a significant milestone for our surgeon customers and the patients they care for,” said Patrick Treacy, Onkos CEO and Co-founder. “When it comes to implant bacterial contamination and failure, patient complications may include decreased limb function, amputation, and increased rates of mortality. We are proud to bring this meaningful solution to the market and we look forward to working with the regulatory agencies to expand the application of the technology across our portfolio of market-leading personalized and limb reconstructive implants. This exciting technology has the potential to be one of the most important advances in orthopedic medical devices in decades.”

The technology’s effectiveness has not been shown in human clinical trials to prevent or reduce infection rates.
MB Bureau

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