Phototherapy to treat infectious diseases isn't new, but Nomir Medical Technologies (Waltham, Massachusetts) is on the verge of commercializing its Noveon dual-wavelength device, which photo-biologically targets the elimination of bacterial and fungal infections in a unique way, combining the therapy with some old reliable antibiotics to more effectively treat the toughest infections such as methicillin-resistant Staphylococcus aureus (MRSA).
While most of the medical world working on infectious diseases is focused on new, stronger drugs for multi-drug resistant pathogens such as MRSA, Nomir has taken a very different tact by first photo-damaging the pathogens so that standard antibiotics can crush the infections.
A study published in Photochemistry and Photobiology describes data that demonstrate how Noveon targets the elimination of bacterial and fungal infections through a unique, near-infrared (NIR), photo-inactivation effect, while preserving healthy tissue and promoting recovery. Combine that with standard antibiotics and this new-style device has the potential to successfully treat a slew of difficult infections such as those that occur around central venous catheters, dialysis port infections, chemotherapy port infections, diabetic food ulcers and pressure wounds.
"With publication of this paper we have codified three to four years of data that show you can selectively damage pathogens without harming human tissues," Eric Bornstein, DMD, chief scientist of Nomir and lead author on the paper, told Medical Device Daily.
The company has submitted data to the FDA from a human pilot study to gain clearance for a first indication in onychomycosis (toenail fungus). The company will file another application early next year for diabetic foot ulcers.
"We submitted the pivotal study for onychomycosis to the FDA in June," Richard Burtt, president/CEO of Nomir told MDD. "We are in the final stages and expect clearance in 4Q 2009. The Noveon system is in manufacturing now. We're outsourcing manufacturing to two separate companies. Upon clearance they'll be ready to roll out the product."
In the most recent onychomycosis study, all seven patients reached a mycological negative culture at 60 days following treatment. No adverse events were observed.
Noveon has dual-wavelengths of 870 nm and 930 nm to decrease trans-membrane potentials, which are measures of the robustness of cellular bioenergetics and simultaneously increase in reactive oxygen species (ROS) in cells. In effect, the light-based therapy selectively damages pathogens.
"What we do is to perturb the bioenergetics of the cells," Bornstein said. "We inhibit the metabolic action of the cells, raising ROS. With this phenomenon, we've been able to photo-inactivate bacterial and fungal pathogens."
The current research paper reveals further information about the efficacy and side-effect profile of Noveon in multiple classes of infectious disease pathogens.
Bornstein predicts Noveon will replace thermal eradication of fungus and bacteria as a more successful treatment option.
In addition to replacing the standard treatment for onychomycosis, Lamisil, both Bornstein and Burtt said the device will have even greater future applications, particularly MRSA.
He explained that MRSA is found in nasal passages. Surgical patients typically get the infection after touching their nose, or sneezing, and then touching the surgical site.
"The only way to get rid of that today is with Bactroban, which 40% of MRSA is resistant to, or an infusion of vancomycin," Bornstein. "If we can do this with six to seven treatments with Noveon and 2% erythromycin, we're going a long way to cutting down the use of sophisticated antibiotics."
In essence, the treatment would roll back the need for the most powerful antibiotics and make use of old standbys such as erythromycin, tetracycline and penicillin in the fight against MRSA and other infections.
"We believe Noveon will be first medical device cleared by the FDA for treatment of onychomycosis," Burtt said. "But it's intended to be a platform technology to treat bacterial and fungal infections. One system will be able to deliver many therapies for dermatologists and podiatrists."
Assuming FDA approval, commercialization will come without reimbursement for onychomycosis therapy.
"For the time being, we will launch on a self-pay business model," Burtt said. "But other applications, such as diabetic foot ulcers and hospital infections will be reimbursable."
Bornstein said no adverse events or side effects have been reported, mainly due to the selective aspect of NIR photo-inactivation.
Results of in vitro studies have also demonstrated 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 vs. control.
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