Nomir Medical Initiates Pivotal Trial Of Its Noveon(R) Dual Wave Length Device For The Treatment Of Onychomycosis

Main Category: Eye Health / Blindness
Article Date: 20 May 2008 - 2:00 PDT

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Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced the initiation of the pivotal product registration trial for the Company's advanced Noveon® direct optical energy device. 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.

About the Noveon Pivotal Trial in Onychomycosis

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.

About Nomir

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. 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 technological; 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