Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications
Summary
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices and beyond medtech.The Monmouth Junction, New Jersey-based device developer says its the first time the FDA has granted a de novo request for a non-eluting coating designed to actively kill bacteria that could contaminate the surface of a medical device.Orthobond was founded by Princeton University Chemistry Professor Emeritus Jeffrey Schwartz and the late Dr. Gregory Lutz, who was physiatrist-in-chief emeritus at the Hospital for Special Surgery. Those could be used in patients early next year, Nichols (a former Zimmer Biomet executive) said in an exclusive interview with MassDevice.Orthobonds proprietary technology is a quaternary ammonium compound coating thats highly effective in neutralizing the different bacteria responsible for most device-related infections and can be applied to almost any device, he said.The Ostaguard method permanently modifies the surface of a device to mechanically rupture the cell walls of bacteria, viruses and fungi. When present in the operating room, those infection-causing microbes sometimes end up on an implant after its been removed from its sterile packaging or when its being placed inside a patient.Unlike antibiotic-eluting devices, Ostaguard doesnt use antibiotics so theres no risk of creating drug-resistant superbugs. And while antimicrobial materials like silver, palladium and copper can kill bacteria, those toxic metals arent biocompatible with human tissue, Nichols said.Those have been the barriers for decades, he said. Those tests submitted to the FDA and considered by the agency in its review showed the technology is safe for mammalian cells but lethal for microbes such as Staphylococcus aureus, Pseudomonas aeruginosa, E. coli, methicillin-resistant Staphylococcus aureus (MRSA), E. cloacae and C. acnes.While Orthobond said it found no evidence of local or systemic toxicity in sheep, guinea pig and canine testing, the coating technology has not been evaluated in human clinical trials.Orthobond says the technologys intellectual property is protected through 2037 through three patent fences covering the covalent surface chemistry, antimicrobial layer and analytical processes, including 27 patents and 12 pending applications.Orthobond intends to seek 510(k) clearances for additional orthopedic spinal implant indications before expanding to other fields such as joint reconstruction, oncology, sports medicine, plastic surgery and cardiovascular.Were working on a neuromodulation device, theres a trauma device were working on, and were going to work on a cochlear implant, Nichols said.