Non-Eluting Coating Actively Kills Bacteria Contaminating Surface of Medical Devices

Millions of medical devices are used or implanted in patients worldwide annually. Despite rigorous sterilization protocols, device-related infections are increasingly problematic. Research indicates that 70-100% of devices removed from joint implants due to failure show contamination from various sources. Operating rooms, despite strict cleanliness standards, often harbor bacteria, leading to high risks of implant failures and infections. These infections can result in pain, reduced mobility, costly additional surgeries, and even fatalities. Now, a novel antibacterial treatment can be applied to any implantable device for robust protection against microbes responsible for most orthopedic device-related issues.

Orthobond Corporation (Monmouth Junction, NJ, USA) has pioneered a technique to covalently-bond its antibacterial molecule to implant surfaces. Using advanced covalent linker technology, the Ostaguard treatment delivers effective antimicrobial protection directly on the device surface, combating a broad spectrum of pathogens including S. aureus, MRSA, S. epidermidis, P. acnes, P. aeruginosa, E. coli, and C. albicans. Ostaguard has been rigorously tested on multiple surfaces against 12 microbes that account for nearly all device-related infections, demonstrating high effectiveness in eliminating several bacteria strains likely to be encountered in surgical settings while remaining harmless to mammalian cells.

The Ostaguard antibacterial surface treatment is versatile enough for application on various device surfaces including those used in joint reconstruction, neuromodulation, oncology, sports medicine, plastic surgery, and cardiovascular procedures. This proprietary technology is integrated during the manufacturing phase before the device is packaged and sterilized. The U.S. Food and Drug Administration (FDA) has approved the De Novo marketing request for Ostaguard to be used on permanent medical devices, marking this as the first FDA-approved non-eluting coating that actively kills bacteria on a medical device surface. The initial application approved is for orthopedic spinal implants.

“We are proud of our evidence-based submission to the FDA and look forward to making our innovative technology available to a wide variety of customers. We believe our surface coating has the potential to be the standard of care for implantable devices to protect patients from pathogens, and that this will be transformative to the field of surgery and beyond,” said David Nichols, CEO of Orthobond. “This marks a huge moment in the history of Orthobond and brings to fruition the vision of our co-founders, Gregory Lutz, M.D. and Jeffrey Schwartz, Ph.D., who were committed to helping patients and physicians by providing a much needed and easy-to-implement antibacterial option to protect implants. This milestone also provides further testament to Gregory’s legacy and we are proud to be able to carry it on into this next chapter.”

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