Nomir Medical Technologies of Waltham, Mass. has received FDA clearance for the company’s Noveon® Dual-Wavelength Device to be used in “procedures of the skin, subcutaneous tissues and nasal passages, for applications in podiatry, dermatology, plastic surgery, and otolaryngology.” Using two near-infrared low energy light beams, the device can kill MRSA, toe nail fungus, and other common pathogens.
From the press release:
President and CEO Richard Burtt commented, “The granting of this 510(k) approval is another significant milestone in Nomir’s regulatory process, which we have been pursuing rigorously, and paves the way for future 510(k) multi-site, disease-specific applications. The Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery. This new FDA clearance highlights the continued success of the Nomir team and its implementation of our regulatory plans for commercialization of our unique photo-biological, anti-infective Noveon system.”
Nomir’s Chief Scientific Officer, Dr. Eric Bornstein, added, “Noveon has also demonstrated its success in the clinic, eliminating MRSA infection in the nose, reversing microbial resistance to common antibiotics, and effecting complete photo-inactivation of toe nail fungus, all at safe energy densities and temperatures. We believe these positive results, combined with our successful regulatory strategy, will make Noveon a potentially attractive option in the future to clinicians treating an array of infections.”
Nomir has completed two IRB human studies with Noveon against methicillin-resistant Staphylococcus aureus (MRSA) carriage and infection in the nares (nose). Based on positive data from these studies, Nomir is initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.
After multiple IRB human pilot studies with Noveon against onychomycosis (toe nail fungus), Nomir initiated an FDA pivotal study of its Noveon device for this indication in May 2008, an integral step for FDA clearance of the application.
Press release: Nomir Medical Announces Second FDA 510(k) Clearance of its Noveon® Dual-Wavelength Device…
Nomir technology page…
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