The primary objective of the trial is to test the efficacy and safety of Noveon in treating patients with onychomycosis (toenail fungus). The target population for this study is patients with toenail onychomycosis, as confirmed by culture, with the goal of gaining a new FDA approval to use the device for the treatment of onychomycosis.
Richard Burtt, CEO of Nomir Medical Technologies, said: “This pivotal trial initiation is a major step for Nomir, moving us closer to commercial launch of our first product utilizing our proprietary dual-wavelength optical energy technology. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation.”