Components will be the First-in-Human Use of OSTAGUARD™
PRINCETON, N.J., January 13, 2025–(BUSINESS WIRE)–Orthobond Corporation, a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, today announced the successful in-house production and commercial delivery of its OSTAGUARD™ coated first in human components. This accomplishment comes only eight months after the FDA granted De Novo clearance for OSTAGUARD, a non-eluting coating designed to actively kill bacteria that contaminate the surface of a medical device in the operating room.
“We are immensely proud to have reached this remarkable milestone in such a short timeframe,” said David Nichols, Chief Executive Officer 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.”
OSTAGUARD is uniquely positioned to address the unmet need for bacteria control in medical devices as it is the first of its kind to be granted this De Novo classification. The proprietary surface technology is designed to actively kill bacteria that contaminate the surface of a medical device in the operating room and has been tested on numerous surfaces against a set of microbes which represent nearly all cases of device-related infections. OSTAGUARD is applied to a medical device surface during the manufacturing process prior to packaging and sterilization permitting a transparent usage benefit to clinicians.
“With the successful implementation and US commercialization of the OSTAGUARDtechnology, 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 Vice President 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.”
About Orthobond
Orthobond Corporation is a surface technology company that has developed proprietary antibacterial surfaces with broad applications in multiple industries such as medical device, commercial, industrial, automotive, and beyond. In 2024, Orthobond received FDA De Novo clearance for a non-eluting coating designed to actively kill bacteria that contaminate the surface of a medical device. Its proprietary surface coating, OSTAGUARD™ was approved with an initial application in the field of Orthopedic Spinal Implants.
Contacts
Media
Sean Leous
ICR Healthcare
Sean.Leous@icrhealthcare.com
646-866-4012
