Nomir Medical Technologies of Waltham, Mass. is reporting that it plans to initiate a study of its Noveon® direct optical energy device. The company believes that its light-based system can target for elimination a number of bacterial and fungal infections, while also “promoting healthy tissue recovery.” The first target on the company’s list is everyone’s favorite onychomycosis (toenail fungus). The representative for the company tells Medgadget that the device “utilizes two discrete near-infrared wavelengths at low power– it is photobiologic in nature and doesn’t use heat. Nomir is also developing products based off of its optical energy platform for MRSA, periodontal disease, and diabetic foot ulcers (wound care) in addition to OM (onychomycosis).”
From the press release:
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.
“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,” stated Richard Burtt, CEO of Nomir Medical Technologies. “Noveon represents a novel treatment approach of using optical energy to address disease indications, such as onychomycosis, that are typically sub-optimally treated with traditional pharmaceutical drugs. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation.”
In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir’s regulatory strategy accelerates the review process for the FDA by de-coupling the device clearance from the application clearance.
Forty evaluable subjects will be enrolled in the prospective, randomized, multi-site U.S. trial. It is expected that this will provide at least 30 evaluable subjects, two-thirds of which will be treated with Noveon and the remaining serving as controls. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients will receive four treatments over a four-month period and will be followed up to one year following the initial treatment to assess clinical improvement and mycological response.