Orthobond secures US FDA nod for antibacterial surface treatment applied to a spinal device

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Orthobond Corporation has announced that the US Food and Drug Administration (FDA) recently granted its de novo marketing request for the use of Ostaguard—its proprietary antibacterial surface treatment—on a permanent medical device. According to the company, this is the first ever granting by the US FDA of a de novo submission for a non-eluting coating designed to actively kill bacteria that contaminate the surface of a medical device, with an initial application in the field of orthopaedic spinal implants.

The company notes in a press release that “numerous studies” have shown 70–100% of explanted hardware from failed joint implants have some level of contamination from different sources. And, the release adds, despite “strenuous efforts”, most operating rooms and surgical suites are “rife” with bacteria, making implant failures and infections a “tremendous risk” for patients, potentially causing pain, restricted mobility, expensive follow-up surgeries, and even loss of life.

Orthobond says it has pioneered a method to covalently bond its antibacterial molecule to the surface of implants. Tested on numerous surfaces against 12 microbes representing nearly all cases of device-related infections, the treated surface was shown to be highly effective in killing multiple strains of bacteria that could come into contact with an implant in the operating room, while being safe for mammalian cells, the company further claims. The proprietary surface technology is applied during the manufacturing process, prior to packaging and sterilisation.

Currently, Orthobond has a number of devices treated with its Ostaguard technology in various stages of the regulatory process. The technology is specifically designed to be applied to a range of different surfaces, including joint reconstruction, neuromodulation, oncology, sports medicine, plastic surgery, and cardiovascular, and can also be used for non-medical antibacterial purposes like textiles and consumer products, Orthobond says.

“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,” said Orthobond chief executive officer David Nichols. “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. This marks a huge moment in the history of Orthobond and brings to fruition the vision of our co-founders, Gregory Lutz and Jeffrey Schwartz, 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.”

Lutz, who also founded the Physiatry Department at the Hospital for Special Surgery (HSS) in New York, USA, passed away recently, with his death being announced in March 2024. A tribute posted on the HSS website describes Lutz as “one of the world’s leading experts in regenerative sports medicine”.


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