Nomir announces data from Noveon Laser pivotal trial on onychomycosis

Nomir Medical Technologies, Inc., a leader in novel photobiology and laser therapies, announced today that new data from its landmark pivotal onychomycosis trial first published in the peer-reviewed Journal of the American Podiatric Medical Association (JAPMA) has once again been published in this prestigious journal. The new paper, which reports on a 270 day onychomycosis clinical trial, offers further scientific support for using the Noveon lasers as an effective therapeutic treatment.    

This paper (JAPMA 102(2): 169-171, 2012) is the third in a series of peer reviewed articles published in JAPMA about Nomir's Noveon Laser. No other Podiatric and Dermatologic laser tested in an onychomycosis pivotal trial has been through the rigor of even a single peer-review board resulting in a publication. The first Noveon-related JAPMA paper surveyed the emerging field of laser treatments for podiatric infectious disease. The second paper presented the initial 180 day results of Nomir's pivotal human clinical trial for the Noveon treating onychomycosis.

This latest paper is a companion to the 180 day data presented in the second JAPMA paper and provides additional details after the longer follow-up time frame of 270 days.

The key findings from the 270 day data and the original paper are as follows:

• Infection rates have continued to drop. The study data show that nail fungus infection rates continued to drop at day 270 (i.e. negative mycology) for many study participants even though laser treatments had stopped 150 days earlier.
• Clear nail improvement continues for nine months. At Day 180, 85% of the eligible treated toenails in the pivotal study showed clear linear nail improvement (P = .0015); At Day 270, 35% of these continued to have further improvement even though laser treatments had stopped 150 days earlier.
• Some patients have seen a 'complete cure'. A higher percentage of patients attained a completely normal appearance, or ''clinical cure'' at day 270 than did at day 180.
• No adverse effects. Even over the longer timeframe of 270 days, no patient participating in the study showed any adverse effects.

The paper concludes that the Noveon is indeed a promising treatment option for onychomycosis by stating "…[the data] gives strong indication that the Noveon laser offers a unique, low-risk option to potentially eliminate and then control the infecting fungal agent."

"We have long been committed to scientifically demonstrating that our Noveon Laser is a superior laser device. In every instance, from our multiple pilots to our pivotal human studies, we have submitted our data to the rigors of the peer-review process in the highest quality journals. This third publication in JAPMA adds further evidence to the growing body of positive Noveon clinical and laboratory data." says Dr. Eric Bornstein, Founder and Chief Science Officer of Nomir Medical.