03/21/2014 Eric Bornstein, DMD
Has Laser Nail Fungus Removal Been Proven Effective? (David Zuckerman, DPM)
Please allow me to clarify the issue of ROS and
Bio-stimulation as it relates to laser
onychomycosis therapy.
Below, is s series of non-published data from
Nomir’s pivotal onychomycosis trial, where the
majority of the data (clinical and mycology) was
published in two separate JAPMA articles in 2010
and 2012. (1,2)
When assessing the antifungal nature of the Noveon
laser wavelengths, (i.e. if the 870nm/930nm light
is treating the fungal infection itself) we
compared the Noveon trial nail growth rate data to
a landmark study by Yu et al (2004) 3 In this
study in Clinical and Experimental Dermatology, Yu
et al measured growth rates of nails that had
different levels of onychomycosis involvement, and
the growth rates of these same nails after
oral/systemic onychomycosis therapy. He compared
them to control (non-infected) great toes in the
same patient.
Yu, et al. determined two different important
additions to the body of onychomycosis and nail
growth knowledge:
1) The degree of difference between fungally
affected and unaffected great toenails was
determined by the amount of fungally affected
area, i.e. the larger the fungally affected area,
the slower the nail growth rate.
2) Yu, et al then showed that there were no
differences in growth rate between the healed
great toenail with a history of onychomycosis, and
the other great toenail without a history of
onychomycosis (same patient), after the fungus was
killed.
When this data is examined in relation to the
Noveon “Growth Speed” data (below and non-
published from the pivotal trial), it shows that
the increased linear growth and area seen with the
Noveon laser therapy (even in the most severe
cases of disease), only increases and returns to
normal with inactivation of the fungus (negative
culture).
Noveon Pivotal Trial Growth Sped Data:
At Day 180 in the pivotal trial, in patients that
had moderate to severe disease, we looked
specifically at patients that attained “Negative
Culture” after the second Noveon treatment (Day
14).
For these patients in the treatment arm, the
average Negative Culture was:
· 50% for mild OM cases
· 43% for moderate OM cases
· 57% for severe OM cases.
For these patients in the control arm, the average
Negative Culture was:
· 25% for mild OM cases
· 17% for moderate cases
· 0% for severe cases.
When these patients were looked at for Clear Area
Growth at day 180 (last treatment occurred at day
120) the breakdown of Clear Area Growth (from
baseline) was the following:
Mild OM Control arm: + 11mm2
Mild OM Treatment arm: + 12mm2
Moderate OM Control arm: - .07mm2
Moderate OM Treatment arm: + 6.7mm2
Severe OM Control arm: - 133mm2
Severe OM Treatment arm: + 16mm2
It was clearly seen that not only did the control
OM cases get worse (positive mycology) and the
treatment OM cases get better (negative mycology),
but ONLY in the “Mild Disease” patients was there
NO increase over control in growth speed of the
clear nail area.
· These data when looked at through the prism of
Yu, et al 3, speak against any Bio-stimulation for
nail growth, and on behalf of negative mycology as
the key to onychomycosis therapy, independent of
the method used to achieve it.
This is most likely true because the enzyme
Keratinase (produced by live fungi) is a
proteolytic enzyme that will attack the disulfide
(-S-S-) bond of the keratin amino acids and digest
the nail and nail bed.4 When the Noveon laser
photo-inactivates the fungus with ROS, the fungi
(in the nail and nail bed) stop producing
keratinase, and the nail begins to grow out clean.
Our in vitro (non-thermal) anti-fungal data was
also published in the peer-reviewed journal of
Photochemistry and Photobiology in 2009 5 and our
antifungal drug potentiation data (with
itraconazole and terbinafine) was published in
2010. 6
I welcome any and all inquiries and further
discussion.
1. Landsman, A. et al. "Treatment of mild,
moderate, and severe onychomycosis using 870-and
930-nm light exposure." Journal of the American
Podiatric Medical Association 100.3 (2010): 166-
177.
2. Landsman, A and Robbins, A. "Treatment of Mild,
Moderate, and Severe Onychomycosis Using 870-and
930-nm Light Exposure Some Follow-up Observations
at 270 Days." Journal of the American Podiatric
Medical Association 102.2 (2012): 169-171.
3. Yu, H. et al, Is slow nail growth a risk factor
for onychomycosis. Clinical and Experimental
Dermatology, 29, 415-418, 2004
4. Takasuka, Tsuyoshi. "Amino acid-or protein-
dependent growth of Trichophyton mentagrophytes
and Trichophyton rubrum." FEMS Immunology &
Medical Microbiology 29.4 (2000): 241-245.
5. Bornstein, Eric, et al. "Near-infrared
Photoinactivation of Bacteria and Fungi at
Physiologic Temperatures." Photochemistry and
photobiology 85.6 (2009): 1364-1374.
6. Bornstein E., and Gridley S. , Antifungal
synergy produced in Candida albicans with
870nm/930nm Near Infrared Photo-damage, 9th
International Mycological, Congress, Future
strategies for the control of fungal diseases,
Edinburgh Uk. Aug 1-6 2010.
Eric Bornstein, DMD, Chief Science Officer
Nomir Medical Technologies,
ebornstein@nomirmedical.com
