Orthobond, a company specializing in covalently-bound antibacterial surface technologies, reported the successful in-house production and commercial delivery of its Ostaguard coated first-in-human components.

This comes eight months after the U.S. Food and Drug Administration (FDA) awarded de novo clearance for Ostaguard. The non-eluting coating actively kills bacteria that contaminate the surface of a medical device in the operating room.

Ostaguard was tested on numerous surfaces against a set of microbes that represent almost all cases of device-related infections, Orthobond said. It’s applied to the device surface during manufacturing before packaging and sterilization, providing a transparent use benefit.

The de novo approval, which the company announced in April 2024, covers spinal implants.

“We are immensely proud to have reached this remarkable milestone in such a short timeframe,” said David Nichols, CEO of Orthobond. “We have established ten partnerships across diverse applications in several medical fields, including orthopedics, plastic surgery reconstruction, ophthalmology, ENT, and dental, demonstrating industry interest in a novel antibacterial technology to address significant clinical issues. Our team’s relentless dedication and hard work have been instrumental in achieving this success, and we look forward to leveraging our development and commercialization capabilities with our partners.”

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.

“With the successful implementation and US commercialization of the OSTAGUARD technology, we are now poised to contribute to the revolutionization of the medical device industry by setting new standards for infection control and patient safety,” said George Landau, executive VP of business development and commercialization at Orthobond. “As Orthobond continues to expand its commercial reach and forge additional partnerships, we remain focused on delivering transformative solutions that meet the evolving needs of the medical community.”