WALTHAM, Mass.--(BUSINESS WIRE)--Nomir Medical Technologies announced today the presentation of positive in vivo human data for its Noveon® direct optical energy device for treating methicillin-resistant Staphylococcus aureus (MRSA) colonization in the human nares (nose). The study demonstrated that this light-based treatment with the Noveon resulted in reversal of microbial resistance to generic topical 2% erythromycin paste. The study confirmed two years of in vitro experimentation that indicate the device’s method-of-action is due to a unique photo-inactivation effect. This patented method resulted in the eradication of erythromycin-resistant MRSA and erythromycin-resistant, methicillin-sensitive Staphylococcus aureus (MSSA) in the human nose, at safe energy densities and temperatures that are harmless to the delicate tissues of the nares. Nomir is presenting the data on Monday, December 8, 2008 at the TERMIS NA Annual Conference and Exhibition in San Diego, during Poster Session I, from 5:00 - 6:30 pm PST.
Dr. Eric Bornstein, Chief Science Officer of Nomir, said, “After two years of intensive in vitro studies with Noveon that demonstrated its resistance reversal effect on MRSA when tested with generic methicillin, penicillin, erythromycin, tetracycline and bacitracin at physiologic temperatures, our team has now duplicated the phenomenon in an IRB-approved human pilot study. These results open the door to a wide range of potentially safer human applications in the area of bioburden reduction in wounds, catheters and diabetic ulcers. The ability to apply simple generic antimicrobials to multi-drug resistant pathogens after Noveon therapy could improve patient outcomes in many infectious disease treatments. The TERMIS conference is an excellent venue to present our data, as tissue engineering products of all types are more successful with reduced bioburden at the graft sites.”
Positive nares cultures were obtained in six patients before Noveon treatment. One patient had erythromycin-resistant MRSA only, 3 had erythromycin-resistant MSSA only, and 2 had both erythromycin-resistant MRSA and MSSA. All patients were treated with the Noveon, employing a proprietary optical diffuser on day 1 and day 3 of the study. Treatment was followed by a 3x/day application of generic 2% erythromycin paste. After the second and final treatment, all patient cultures were completely clear of MRSA and MSSA in the nares. Importantly, maximum average temperatures did not exceed 99 degrees Fahrenheit and no sequelae or adverse events were observed.
Nomir has completed two IRB-approved human studies with Noveon against MRSA carriage and infection in the human nares. Based on positive data from these studies, Nomir plans to initiate a proof-of-concept study with Noveon for the reduction of bioburden in diabetic foot ulcers.
“This remarkable data further supports Nomir’s advancement of Noveon as a potential device for bioburden reduction and eradication in colonized wounds,” said Richard Burtt, Chief Executive Officer of Nomir. “We believe that treatment of resistant organisms with Noveon may be able to add generic antibiotics back into the arsenal of physicians treating this debilitating condition, providing a safer alternative to the safety and toxicity issues of current front-line antibiotics in use for MRSA.”
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 an 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 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.
MacDougall Biomedical Communications
Jennifer Greenleaf-Conrad, 781-235-3060
Nomir Medical Technologies, Inc.
Richard Burtt, 781-893-1000 ext. 403
Chief Executive Officer
Source: Nomir Medical Technologies, Inc.