Orthobond receives FDA de novo approval for antibacterial technology
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Key takeaways:
- Orthobond Corporation received FDA de novo approval for its Ostaguard antibacterial coating technology.
- Ostaguard features a non-eluting coating to kill bacteria responsible for device-related infections.
Orthobond Corporation announced FDA de novo approval of Ostaguard, an antibacterial non-eluting coating technology for use on a range of medical devices, according to a press release.
The Ostaguard technology has a non-eluting coating to neutralize bacteria commonly responsible for device-related infections, according to the release.
Ostaguard is designed for procedures in joint reconstruction, neuromodulation, oncology, sports medicine, plastic surgery and cardiology. According to the release, Ostaguard may have non-medical antibacterial purposes such as in textiles and consumer products.
“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,” David Nichols, CEO of Orthobond, said in the release. “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,” Nichols added.
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