Orthobond has gained U.S. Food and Drug Administration De Novo approval for Ostaguard, the company’s antibacterial surface treatment, on a permanent medical device.
 
The company said this is the first FDA de novo nod for a non-eluting coating to actively kill bacteria that contaminate a medical device’s surface. Its initial application is in orthopedic spinal implants.
 
Orthobond pioneered a method to covalently bond its antibacterial molecule to implant surfaces. The method was tested on surfaces against 12 microbes that represent almost all cases of device-related infections. The treated surface was highly effective in killing multiple bacterial strains that could come in contact with an implant in the OR, while remaining safe for mammalian cells.
 
The surface technology is applied during manufacturing before 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.”
 
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 be used for non-medical antibacterial purposes such as in textiles and consumer products.