Nomir Medical reports positive preliminary data from onychomycosis trial

According to Nomir Medical, preliminary analysis of the data demonstrates that after Noveon treatment, 76.3% of the toes showed evidence of improvement, and a significant drop in positive culture was seen in 74% of the toes after only two treatments. This data is based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.

Nomir has completed two institutional review board-approved human studies with Noveon against methicillin-resistant Staphylococcus aureus carriage and infection in the nares (nose). Based on positive data from these studies, Nomir is planning a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.

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, the company said.

Richard Burtt, CEO of Nomir Medical, said: “These strong results from our pivotal trial build on prior positive data from pilot studies of Noveon in onychomycosis and provide additional validating efficacy and safety data for the device.

“Nomir is committed to continuing to advance this device forward, with our major goals being to gain a new FDA approval for Noveon for the treatment for onychomycosis, and assuming approval, to pursue the commercial launch of this first product utilizing our therapy-altering technology.”