03/19/2014    Eric Bornstein, DMD

Has Laser Nail Fungus Removal Been Proven Effective? (Leonard Levy, DPM)

Nomir Medical Technologies' newly FDA approved for
the treatment of Onychomycosis has indeed
conducted controlled studies with its Noveon
photo-biological laser system on onychomycosis.

First JAPMA article: (J Am Podiatr Med Assoc
99(4): 348-352, 2009)

· Temperatures observed during a human pilot study
of onychomycosis with the Noveon laser never
reached higher than 100.4°F.

Second JAPMA article: (J Am Podiatr Med Assoc
100(3): 166-177, 2010)

· An independent expert panel, blinded regarding
treatment versus control, found that at 180 days,
85% of the eligible treated toenails were improved
by clear nail linear extent (P= .0015);

Third JAPMA article: (J Am Podiatr Med Assoc
102(2): 169-171, 2012)

· Review of 270-day mycological data, con?rmed
that 38% of the treated population, 150 days after
final laser therapy, had negative culture and
microscopy, qualifying as "mycological cures."

As reflected in Nomir’s pivotal trial,
retrospective trial, and the new FDA indication
for use language, the onychomycosis treatment
therapy recognizes that a patient’s tinea pedis
(foot fungus) must also be treated to see
improvement in onychomycosis. This is a net
positive, as we are the first laser in the
industry to evolve with clearance language that
recognizes this major etiology for onychomycosis.

The new FDA approval language is different from
any other in the industry, and is the following:

The Noveon® is indicated for the temporary
increase in clear nail in patients with
onychomycosis (e.g., dermatophytes - Trichophyton
rubrum and T mentagrophytes) only when used
together with topical antifungal drug therapies
approved to treat the accompanying tinea pedis
and/or approved to treat onychomycosis.

Eric Bornstein, DMD, Chief Science Officer at
Nomir Medical Technologies, Inc,
ebornstein@nomirmedical.com

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