Onkos Surgical has begun using its NanoCept Antibacterial Technology in surgical procedures, arming patients with protection against implant infections. NanoCept is an antibacterial coating applied to orthopedic implants to help address intraoperative bacterial contamination.

“Limb salvage and revision procedures are challenging, and the rate of complication is much higher than most index orthopedic procedures,” said Onkos Surgical Chief Medical Officer Steven Gitelis, M.D., director of Musculoskeletal Oncology at Rush University Medical Center. “The risk of implant infection is on my mind every time I take a patient to the operating room, and this is especially true for patients with bone cancer, as they are more susceptible. The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants. It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem.”

Orthopedic implant-related infections are clinically challenging and have significant negative effects on patients. Periprosthetic joint infection (PJI) has a lower survival rate than several forms of cancer¹ and is expected to cost the U.S. healthcare system up to $1.8 billion dollars by 2030.² It is estimated that 60% to 70% of all early and delayed-onset PJI (<3 months and 12-24 months post-surgery) are initiated at the time of the procedure through intraoperative contamination.³

Onkos received De Novo market authorization from the Food and Drug Administration (FDA) in April 2024 for its NanoCept Antibacterial Technology. Data submitted to support the De Novo application showed that NanoCept has up to a 99.999% (five-log reduction) kill rate in standardized in-vitro testing of bacteria commonly found in the operating room. The initial FDA authorization for NanoCept was for the company’s ELEOS Limb Salvage System, which is a modular total joint system used for patients with bone loss.  

“The successful completion of these initial surgeries is a key achievement and significant milestone in our strategy to deploy the NanoCept Technology across our portfolio,” Onkos Surgical Co-Founder/CEO Patrick Treacy stated. “We believe NanoCept is a platform technology that will substantially extend our reach and capability in broad orthopedic markets, and we are actively working to expand regulatory clearances beyond ELEOS to include implants used in orthopedic reconstruction due to tumor, trauma and other orthopedic revision procedures.”

Onkos Surgical develops solutions for complex orthopedic conditions. Its product portfolio helps to better inform surgeons about patient-specific clinical challenges and assists them in planning and implementing more precise reconstructions. Onkos Surgical’s personalized approach supports improved patient outcomes and experiences using the latest innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 U.S. academic medical institutions choose Onkos for their complex revision and tumor orthopedic cases.

References
^{1, 2} Premkumar et.al. Projected economic burden of periprosthetic joint infection of the hip and knee in the United States. The Journal of Arthroplasty.  Volume 36, Issue 5 P1484-1489.E3May 2021
³ Tande AJ, Patel R. Prosthetic joint infection. Clin Microbiol Rev. 2014 Apr;27(2):302-45. doi: 10.1128/CMR.00111-13. PMID: 24696437; PMCID: PMC3993098.