PRINCETON, N.J.--(BUSINESS WIRE)--Orthobond Corporation, a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, announced today that the U.S. Food and Drug Administration (FDA) granted its De Novo marketing request for the use of Ostaguard™, its proprietary antibacterial surface treatment, on a permanent medical device. This is the first ever granting by the FDA of a De Novo submission for a non-eluting coating designed to actively kill bacteria that contaminate the surface of a medical device, with an initial application in the field of Orthopedic Spinal Implants.
Numerous studies have shown between 70-100% of explanted hardware from failed joint implants have some level of contamination from different sources. Despite strenuous efforts, most operating rooms and surgical suites are rife with bacteria, making implant failures and infections a tremendous risk for patients. They can cause pain, restricted mobility, expensive follow-up surgeries, and even loss of life.
Orthobond pioneered a method to covalently-bond its antibacterial molecule to the surface of implants. Tested on numerous surfaces against 12 microbes representing nearly all cases of device-related infections, the treated surface was shown to be highly effective in killing multiple strains of bacteria that could come into contact with an implant in the operating room, while being safe for mammalian cells. The proprietary surface technology is applied during the manufacturing process prior to packaging and sterilization.
“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.
