Onkos Surgical, an orthopedic company dedicated to tackling the intricate clinical challenges associated with bone loss due to tumors, trauma, and revision surgery, has announced the acquisition of a De Novo approval from the US Food and Drug Administration (FDA) for its antibacterial coated implants. 

The approval marks a significant stride in addressing the escalating concern of bacterial contamination in permanent orthopedic implants, particularly prevalent in orthopedic oncology and revision arthroplasty applications where patients face heightened vulnerability.

"Implant contamination is a growing concern to the orthopedic surgical community," stated Steven Gitelis, MD, Onkos Surgical Chief Medical Officer, Rush Medical College, Endowed Professor of Orthopedic Oncology, and Director of Musculoskeletal Oncology at Rush Cancer Center. 

"When bacteria contaminate the artificial joint, it can lead to a cascade of issues that 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," Gitelis added.

A comprehensive body of preclinical safety and efficacy data substantiated the De Novo application. The data revealed that the proprietary coating, proven to be bactericidal, does not elute and exhibits a remarkable 99.999 percent (5 log) kill rate in in-vitro testing of bacteria 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," expressed 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 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," Treacy added. 

Despite the approval, it's imperative to note that the technology's effectiveness has not yet been demonstrated in human clinical trials to prevent or reduce infection rates.