PARSIPPANY, N.J., Jan. 9, 2025
PARSIPPANY, N.J., Jan. 9, 2025 /PRNewswire/ -- Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, today announced that its revolutionary NanoCept Antibacterial Technology has been used successfully in multiple surgical procedures. NanoCept is a novel antibacterial coating applied to orthopaedic implants to help address intraoperative bacterial contamination.
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"Limb salvage and revision procedures are challenging, and the rate of complication is much higher than most index orthopaedic procedures," said Steven Gitelis, MD, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical. "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."
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Orthopaedic 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 60-70% 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 of 2024 for its NanoCept Antibacterial Technology. Data submitted to support the De Novo application showed that NanoCept has up to a 99.999% (5-log reduction) kill rate in standardized in-vitro testing of bacteria that are commonly found in the operating room environment. 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," said Patrick Treacy, Onkos CEO and Co-founder. "We believe NanoCept is a platform technology that will substantially extend our reach and capability in broad orthopaedic markets, and we are actively working to expand regulatory clearances beyond ELEOS to include implants used in orthopaedic reconstruction due to tumor, trauma and other orthopaedic revision procedures."
About Onkos SurgicalOnkos Surgical is a leader in innovative solutions for complex orthopaedic conditions. With our novel product portfolio, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement more precise reconstructions. Our 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 of the leading academic medical institutions in the US choose Onkos for their complex revision and tumor orthopaedic cases. For more information on Onkos Surgical and its products and services, please visit www.onkossurgical.com/nanocept.
Forward Looking StatementsCertain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, launch delays and the possibility that post-market clinical results may be inconsistent with the in-vitro preclinical test results. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only on the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law.
Media Contacts:Sean P. CurryChief Commercial OfficerOnkos [email protected]
Alyssa PaldoVice-President, Media Relations SpecialistFINN [email protected] 847.791.8085
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.
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SOURCE Onkos Surgical
