Nomir Medical Announces FDA Clearance for Noveon NaiLaser
WOODMERE, N.Y., March 13, 2014 /PRNewswire-iReach/ -- Nomir Medical Technologies, Inc., the world leader in antimicrobial photobiology, today announced that the US Food and Drug Administration has granted clearance to the company’s Noveon NaiLaser for the treatment of onychomycosis (toenail fungus). (See clearance below)
Jack Kay, Nomir CEO, explained, “We developed the Noveon® NaiLaser™ to meet the needs of physicians for a safer, more effective treatment option for toenail fungus sufferers, with an ergonomic, hands-free design to maximize doctor comfort and minimize labor costs”. Dr. Kay continued, “The FDA clearance provides assurance for physicians and patients that the Noveon provides effective treatment for onychomycosis.”
Dr. Eric Bornstein, the inventor of the Noveon and Nomir’s Chief Science Officer, describes why the Noveon NaiLaser is a more effective solution than other laser options: “Noveon’s onychomycosis data has been published an unprecedented three times in the Journal of the American Podiatric Medical Association. As reflected in our pivotal trial, retrospective trials, and the new FDA indications for use language, our therapy recognizes that a patient’s tinea pedis (foot fungus) must also be treated to see improvement in onychomycosis. This is a net positive, as we are the first laser in the industry to evolve with clearance language that recognizes this major etiology for onychomycosis.”
Support from the Medical Community
“As someone who has evaluated results through several periods of clinical studies and found the Noveon to be very effective, I was glad to learn about the FDA’s approval,” said Dr. Bryan Markinson, Chief of Podiatric Medicine at the Leni and Peter W. May Department of Orthopedic Surgery of the Icahn School of Medicine at Mount Sinai[1]. Dr. Markinson continued, “Unlike other lasers that rely on heat, the Noveon laser uses photobiology with specific light wavelengths at low power intervals to achieve its results and is better tolerated by the patient during treatment. I have been involved with the development of the Noveon from the earliest periods of actual design, and it remains the only laser treatment for onychomycosis with published results in peer reviewed literature.”
Dr. Warren S. Joseph, a specialist in lower extremity infectious diseases noted, “Few of the other lasers have the results of their clinical trials published in the peer reviewed medical literature. However, results with the Noveon show 85% of the eligible treated toenails showing improvement by clear nail in their pivotal trial published in JAPMA.” Dr. Joseph continued, “I am pleased with the new and unique indication for use language, as it distinguishes the Noveon laser as now being in line with the established understanding that describes the necessity of tinea pedis treatment along with onychomycosis therapy as the two conditions are inexorably linked”.
Dr. Paul Lazar, a New York podiatrist agreed, “I have seen a real difference in treatment results compared to conventional drug therapy and to other lasers I have used.” Dr. Lazar continued, “I appreciate how with automatic operation and the ability to treat up to four toes at the time, the Noveon NaiLaser saves valuable time for my patients and me.”
Noveon NaiLaser – FDA Clearance
The Noveon® is indicated for the temporary increase in clear nail in patients with onychomycosis (e.g., dermatophytes - Trichophyton rubrum and T mentagrophytes) only when used together with topical antifungal drug therapies approved to treat the accompanying tinea pedis and/or approved to treat onychomycosis.
About Nomir Medical Technologies, Inc.
Nomir Medical Technologies, Inc. is a medical device company that develops photobiological therapies to treat diseases that afflict millions of people worldwide. The company’s products are designed to meet the needs of patients and physicians based on patented light based technologies that have been rigorously tested in laboratory and clinical trials since 2005. For more information, please visit www.noveoninternational.com.
[1] These views are those of Dr. Markinson only and do not reflect an endorsement on the part of Icahn School of Medicine at Mount Sinai Hospital.
Media Contact: Jack Kay, Nomir Medical Technologies, Inc., 516.546.6647, ext. 100, jack@nomirmedical.com
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SOURCE Nomir Medical Technologies, Inc.
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