Nomir Medical Announces Second FDA 510(k) Clearance of its Noveon® Dual-Wavelength Device
WALTHAM, Mass.--(BUSINESS WIRE)--Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced today that the Food and Drug Administration (FDA) has granted a second 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. Advancements in the ease and simple operation of the Noveon system may enhance professional office workflow while eliminating the requirement for a physician to operate the device in most states.
President and CEO Richard Burtt commented, “The granting of this 510(k) approval is another significant milestone in Nomir’s regulatory process, which we have been pursuing rigorously, and paves the way for future 510(k) multi-site, disease-specific applications. 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. This new FDA clearance highlights the continued success of the Nomir team and its implementation of our regulatory plans for commercialization of our unique photo-biological, anti-infective Noveon system.”
Nomir’s Chief Scientific Officer, Dr. Eric Bornstein, added, “Noveon has also demonstrated its success in the clinic, eliminating MRSA infection in the nose, reversing microbial resistance to common antibiotics, and effecting complete photo-inactivation of toe nail fungus, all at safe energy densities and temperatures. We believe these positive results, combined with our successful regulatory strategy, will make Noveon a potentially attractive option in the future to clinicians treating an array of infections.”
Nomir has completed two IRB 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 initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.
After multiple IRB human pilot studies with Noveon against onychomycosis (toe nail fungus), Nomir initiated an FDA pivotal study of its Noveon device for this indication in May 2008, an integral step for FDA clearance of the application.
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.
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.