Onkos Surgical, an orthopedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the FDA 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.
A 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.
