Orthobond Receives FDA De Novo Approval for Antibacterial Technology

Orthobond has achieved a significant milestone with FDA de novo approval for its Ostaguard antibacterial technology, marking the first time the FDA has granted such approval for a non-eluting coating designed to actively combat bacteria on medical devices. Developed by Orthobond, Ostaguard utilizes a proprietary quaternary ammonium compound coating to mechanically rupture the cell walls of bacteria, viruses, and fungi, thus reducing the risk of device-related infections during medical procedures.

Founded by Princeton University Chemistry Professor Emeritus Jeffrey Schwartz and the late Dr. Gregory Lutz, Orthobond aims to revolutionize medical device safety with its innovative technology. The approval allows for the expansion of Ostaguard to various medical devices, including spinal fusion implants, with future plans for broader applications in orthopedics, oncology, sports medicine, plastic surgery, and cardiovascular fields. Orthobond's rigorous testing, patent protection until 2037, and potential industrial applications signal a promising future for antibacterial technology in healthcare and beyond.

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