Orthobond wins FDA approval for versatile antimicrobial technology

Orthobond has obtained FDA de novo approval for its Ostaguard antimicrobial technology, which holds the potential for application across a broad spectrum of medical devices and extends beyond the realm of medical technology.

Based in Monmouth Junction, New Jersey, Orthobond is a device developer that emphasizes the significance of this approval, marking the first time the FDA has granted de novo status for a non-eluting coating designed to actively eliminate bacteria that may contaminate the surface of medical devices.

Founded by Princeton University Chemistry Professor Emeritus Jeffrey Schwartz and the late Dr. Gregory Lutz, Orthobond continues its mission despite Lutz’s passing, with CEO David Nichols expressing pride in carrying forward Lutz’s legacy into the future.

Nichols, a former executive at Zimmer Biomet, disclosed plans for the initial application of Ostaguard-treated SeaSpine Mariner pedicle screws, slated for potential use in patients as early as next year.

Orthobond’s proprietary technology involves a quaternary ammonium compound coating known for its efficacy in neutralizing various bacteria responsible for device-related infections. Unlike antibiotic-eluting devices, Ostaguard doesn’t employ antibiotics, mitigating the risk of generating drug-resistant bacteria. Moreover, it addresses concerns regarding the biocompatibility of other antimicrobial materials like silver, palladium, and copper.

This groundbreaking technology represents a new category for the FDA, offering a permanent modification to device surfaces that mechanically ruptures bacteria cell walls, viruses, and fungi, thus actively eliminating potential sources of infection.

The FDA has categorized the new technology under the name “spinal fusion device with quaternary ammonium compound coating,” defining it as a rigid metallic implant device designed to promote fusion in mature skeletal patients, featuring a coating intended to reduce microbial contamination on the device’s surface prior to implantation.

Orthobond, in collaboration with the FDA, conducted rigorous testing against various microbes known to cause device-related infections, demonstrating Ostaguard’s safety for mammalian cells while effectively combating bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA), among others.

While Orthobond has conducted testing in animal models without detecting local or systemic toxicity, human clinical trials are pending.

The company has secured intellectual property protection for its technology until 2037 through multiple patents, with plans to pursue additional clearances for orthopedic spinal implant indications before branching into other medical fields.

Orthobond envisions broader applications beyond medical technology, including potential uses in commercial and industrial sectors such as automotive, consumer products, and textiles.