Nomir Medical Technologies has obtained the US Food and Drug Administration (FDA) clearance for its Noveon NaiLaser, desgined for the treatment of onychomycosis (toenail fungus).
The Noveon is indicated for the temporary increase in clear nail in patients with onychomycosis only when used together with topical antifungal drug therapies approved to treat the accompanying tinea pedis and/or approved to treat onychomycosis.
Nomir CEO Dr Jack Kay said the company developed the Noveon NaiLaser to meet the needs of physicians for a safer, more effective treatment option for toenail fungus sufferers, with an ergonomic, hands-free design to maximize doctor comfort and minimize labor costs.
"The FDA clearance provides assurance for physicians and patients that the Noveon provides effective treatment for onychomycosis," Dr Kay added.
Nomir chief science officer, the inventor of the Noveon Dr Eric Bornstein said Noveon’s onychomycosis data has been published an unprecedented three times in the Journal of the American Podiatric Medical Association.
"As reflected in our pivotal trial, retrospective trials, and the new FDA indications for use language, our therapy recognizes that a patient’s tinea pedis (foot fungus) must also be treated to see improvement in onychomycosis," Dr Bornstein added.
"This is a net positive, as we are the first laser in the industry to evolve with clearance language that recognizes this major etiology for onychomycosis."