MEDICAL DEVICE INNOVATION - Medical Device Daily

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Nomir’s Noveon photo-biologically
treats the toughest infections
By LYNN YOFFEE
Medical Device Daily Staff Writer
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
MEDICAL DEVICE INNOVATION 2010
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.
(This story originally appeared in the Sept. 17, 2009, edition
of Medical Device Daily)
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