With this latest FDA decision, the era of, literally, 99.99% zero bacterial contamination on any musculoskeletal implant is beginning.
This new technology, which Princeton, New Jersey’s Orthobond Corporation is bringing to market, is a covalently bound antibacterial surface technology with broad applications and implications for any musculoskeletal (and spine) implant.
To be clear, this technology is a non-eluting coating that actively kills bacteria on any implant surface.
FDA Grants De Novo Marketing Approval
The FDA’s decision to grant a De Novo marketing request from Orthobond for its Ostaguard™ antibacterial surface treatment came in early April 2024.
It was the first time the FDA had granted a De Novo submission for a non-eluting coating designed to actively kill bacteria that contaminate the surface of a medical device. The first application will be for orthopedic spinal implants.
Bacterial contamination has been shown to be a major contributing factor behind failed joint implants. Despite everyone’s best efforts, operating rooms and surgical suites have been unable to ensure 100% bacteria free implants. According to the National Institutes of Health (NIH), numerous studies have shown that between 70-100% of explanted hardware from failed joint implants have some level of contamination from different sources.
Testing
Orthobond technology covalently bonds an antibacterial molecule to the surface of implants. It was tested on numerous surfaces against 12 microbes representing nearly all cases of device-related infections. Those tests conclusively showed that particular surface coating actively killed multiple strains of bacteria that come into contact with an implant at any point from manufacturing to implant.
Orthobond’s proprietary surface technology is designed to integrate into any manufacturing process and is applied prior to packaging and sterilization.
Huge Milestone for Surgeons and Patients
“We are proud of our evidence-based submission to the FDA and look forward to making our innovative technology available to a wide variety of customers. We believe our surface coating has the potential to be the standard of care for implantable devices to protect patients from pathogens, and that this will be transformative to the field of surgery and beyond,” said David Nichols, CEO of Orthobond.
“This marks a huge moment in the history of Orthobond and brings to fruition the vision of our co-founders, Gregory Lutz, M.D. and Jeffrey Schwartz, Ph.D., who were committed to helping patients and physicians by providing a much needed and easy-to-implement antibacterial option to protect implants. This milestone also provides further testament to Gregory’s legacy and we are proud to be able to carry it on into this next chapter.”
Currently, Orthobond has a number of devices treated with the technology in various stages of the regulatory process. Ostaguard is specifically designed to be applied to numerous surfaces, including joint reconstruction, neuromodulation, oncology, sports medicine, plastic surgery, cardiovascular, and can even be used for non-medical antibacterial purposes such as in textiles and consumer products.
About Orthobond
Orthobond Corporation is a surface technology company that has developed proprietary antibacterial surfaces, with broad applications in the medical device industry and more such as commercial, industrial, automotive, and beyond. Orthobond is the first company to utilize surface modifications that can be permanently bound to any surface, killing bacteria by mechanically rupturing pathogens without using eluting antibiotics.
For more information: Here is a video about Orthobond and its remarkable, groundbreaking technology.
