Nomir Medical's Noveon(R) Device Achieves 76 Percent Response Rate In Pivotal Trial For The Treatment Of Onychomycosis

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  MRSA / Drug Resistance
Article Date: 08 Mar 2009 - 0:00 PDT

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Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced positive preliminary data from the pivotal product registration trial evaluating the Company's advanced Noveon® direct optical energy device for the treatment of onychomycosis (toenail fungus). 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.

Preliminary analysis of the data demonstrates that after Noveon treatment, 76.3 percent of the toes showed evidence of improvement, and a significant drop in positive culture was seen in 74 percent 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. These results were presented by Eric Bornstein, D.M.D., Nomir's Founder and Chief Scientific Officer, at the Council for Nail Disorders 13th Annual Scientific Meeting, held at the Palace Hotel in San Francisco. The presented data and further background on the Noveon device will also be available in Nomir's exhibit booth #5523 at the American Academy of Dermatology Annual Meeting, being held at the Moscone Center in San Francisco, March 6-10, 2009.

"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," said Richard Burtt, CEO of Nomir Medical Technologies. "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."

"Noveon represents a novel treatment approach that offers considerable promise for the treatment of onychomycosis," added Dr. Bornstein. "In addition to its demonstrated favorable safety profile and positive clinical results, this system offers the advantage of not requiring systemic surveillance for toxicity or mutagenicity, unlike traditional pharmaceutical drugs or other light-based systems. We believe that these positive attributes make Noveon potentially applicable for treating a range of additional infectious agents, several of which Nomir is pursuing."

Nomir has completed two IRB-approved human studies with Noveon against methicillin-resistant Staphylococcus aureus (MRSA) 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.

Nomir Medical also recently announced a second FDA 510(k) clearance of the Company's advanced Noveon system. With this clearance, the device may now be utilized during procedures of the skin, subcutaneous tissues and nasal passages, for applications in podiatry, dermatology, plastic surgery, and otolaryngology.

About the Noveon Pivotal Trial in Onychomycosis

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. Thirty-two subjects were enrolled in the prospective, randomized, controlled, multi-site U.S. trial. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients received 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.

About Nomir

Nomir Medical Technologies, Inc. is a medical device and photobiology 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 multiple patents and patents pending on systems, methods and unique photobiological mechanism claims for near-infrared photodamage to bacterial and fungal pathogens.

http://www.nomirmedical.com

Forward looking statement

Certain statements contained in this press release containing words like believe, intend, may, expect, project and other similar expressions are forward-looking statements involving a number of risks and uncertainties. Factors that can cause actual results to differ materially from those projected in the Company's forward-looking statements include the following: market acceptance of our technologies, therapies, and products; our ability to obtain financing; our financial and technical resources relative to those of our competitors; our ability to keep up with rapidly changing technologies; government regulations of our technologies; our ability to assert and enforce our intellectual property rights and protect our proprietary technologies; the ability to attract and retain key employees; the ability to obtain and develop partnership opportunities; the timing of commercial product launches; the ability to achieve key milestones in key products and other risks factors from time to time in the Company's announcements.

Nomir Medical Technologies, Inc.

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