Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced today the publication of a scientific paper in the journal Photochemistry and Photobiology that details in vitro and human data demonstrating the unique and patented mechanism-of-action for its Noveon® dual-wavelength device, as well as positive efficacy and safety data. 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 publication provides important information about the efficacy and side-effect profile of Noveon in multiple classes of infectious disease pathogens, as well as the underlying mechanism-of-action that produces its photo-inactivation effect,” said Eric Bornstein, D.M.D., Chief Scientist of Nomir and lead author on the paper. “It is essential that potential light-based therapies for infectious disease be nontoxic to surrounding healthy human tissue. In the past, UV wavelengths have been used to photo-damage pathogens, but unfortunately, UV light is also photo-carcinogenic to human cells, necessitating the study of other phototherapy-based treatments for infectious disease. We believe the selective aspect of near-infrared photo-inactivation provided by Noveon highlights its potential for the treatment of a broad range of infectious diseases. The Noveon is the first system to produce statistical evidence of safe photo-damage to resistant bacterial pathogens like MRSA and fungal pathogens such as C. albicans and T. rubrum, all at physiologic temperatures.”
The Noveon system employs dual-wavelengths of 870 and 930 nanometer, wavelengths that have previously been shown to exhibit cellular photo-damaging properties only in optical traps. In the in vitro study utilizing Noveon against several bacterial and fungal species, Nomir scientists measured a decrease in trans-membrane potentials (a measure of the robustness of cellular bioenergetics) and an increase in reactive oxygen species (ROS) in the cells. Therefore, Noveon’s mechanism-of-action involves selective damage to the pathogens by the endogenously generated ROS. This phenomenon is referred to as the patent-pending “optically mediated mechano-transduction of cellular redox pathways.”
Results of the in vitro studies demonstrate photo-inactivation of 98% of S. aureus colonies and of 97% of E. coli colonies, versus control, at physiologic temperatures. Additionally, complete photo-inactivation of 100% of T. rubrum and C. albicans colonies was achieved versus control.
Results of the MRSA human pilot study demonstrate that erythromycin-resistant MRSA and erythromycin-resistant MSSA were completely cleared in all carriers after two Noveon treatments with the addition of 2% topical erythromycin to the treatment area. This is the first known near-infrared potentiation of a first-generation macrolide antibiotic against MRSA in humans with safe near-infrared therapy. No negative sequelae or adverse events were observed, and the average maximum temperature associated with treatment was well within levels considered safe for human phototherapy and thermal tissue damage thresholds.
In the detailed onychomycosis (toenail fungus) human pilot study, all seven patients reached a mycological negative culture at 60 days following treatment. No negative sequelae or adverse events were observed, and experimental temperatures were again well within accepted safety levels.
“Because of the significant and encouraging data we have seen in our studies, including the present study, Nomir has been pursuing FDA 510(k) clearance for Noveon for the treatment of onychomycosis,” said Richard Burtt, President and CEO of Nomir. “We look forward to making this therapy-altering device available to clinicians and patients soon, and are also studying several additional therapeutic indications for the device, including the treatment of diabetic foot ulcers and MRSA infection.”