September 10, 2008
Nomir Medical Presents Positive Onychomycosis Data for Its Noveon(R) Dual Wavelength Device
Nomir Medical Technologies, announced today the presentation of positive in vitro and in vivo human data for its Noveon(R) direct optical energy device for treating onychomycosis (toe nail fungus). The studies demonstrated that treatment with the Noveon resulted in complete photo-inactivation of the fungi that cause onychomycosis at safe energy densities and temperatures. Nomir will present the data at the New Cardiovascular Horizons "Wound Management of the Diabetic Foot and Wound Healing" conference in New Orleans. The abstract is available online at http://www.newcvhorizons.com/uploads/Abstract_701).pdf. A pivotal product registration trial for Noveon for the onychomycosis indication is currently underway.
"These encouraging results support Nomir's advancement of Noveon into FDA pivotal trials in onychomycosis," said Richard Burtt, Chief Executive Officer of Nomir. "The impressive fungal inactivation seen in these studies, together with the positive safety profile of the device, validates our patent-pending optical energy technology as a potentially paradigm-shifting treatment for fungal infections. Many patients with onychomycosis, as well as the clinicians who treat them, are left with few or no treatment options due to the safety issues associated with current systemic antifungal therapy. Therefore, we believe that Noveon may be able to address this treatment gap."
In the in vitro study, C. albicans and T. rubrum were exposed to Noveon's near-infrared wavelengths for 12 minutes. Results demonstrated that all Noveon-treated fungal isolates were 100% eradicated, and that experimental temperatures did not exceed 40.5 degrees Celsius (104.9 F), which is within normal thermal tolerances for these species.
In the in vivo study, the great toe nails of seven patients with positive fungal cultures were topically exposed to Noveon four times, on days 1, 7, 14 and 60. All patients treated with Noveon achieved a negative fungal culture at 60 days. Importantly, experimental temperatures did not exceed 38 degrees Celsius (100.4 F), providing evidence that Noveon's effect was not due to thermal inactivation. No negative side effects were observed.
In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during contact and non-contact surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir initiated the FDA pivotal study of its Noveon device for the onychomycosis indication in May 2008, an integral step for FDA clearance of the application.
Nomir Medical Technologies, Inc. is a medical device company with a product pipeline of optical energy therapeutics being developed for multiple clinical applications. Nomir's light based systems target the elimination of bacterial and fungal infections, while also promoting healthy tissue recovery. This potential therapy-altering technology may enhance the effectiveness of, or even reduce the need for antibiotics and antifungal agents, and may be associated with fewer treatment side-effects. Nomir has a broad patent portfolio with pending systems, methods and unique photobiological mechanism claims for near infrared photodamage to bacterial and fungal pathogens.
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