PinPointe FootLaser Launches Major Multi-Center Clinical Trial to Evaluate Its Laser Treatment for Toenail Fungus

Four Separate Research Facilities Across North America Will Evaluate the
Effectiveness of the Revolutionary PinPointe FootLaser Treatment
CHICO, Calif.--(Business Wire)--
PinPointe FootLaser today announced it has begun a major multi-site clinical
trial entitled "Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment
for Infected Toenails (Onychomycosis)" at four separate research centers across
North America.

PinPointe FootLaser uses a patented laser technology to target the pathogens
that cause toenail fungus (Onychomycosis), an infection that afflicts an
estimated 40 million people in the U.S. alone. PinPointe FootLaser recently
received CE Mark approval, certifying that it has met EU consumer and health
safety standards and can be offered by PinPointe certified healthcare providers
throughout Europe.

The current clinical trial initiative is a controlled multi-center study to
evaluate the effectiveness of the PinPointe FootLaser treatment. It is a
significantly expanded follow-up to an initial PinPointe FootLaser clinical
study conducted among a small group of patients (Harris, McDowell and Strisower,
Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009.) The early study
indicated a potential efficacy rate as high as 87%, a finding which the current
study aims to verify.

In the new study`s randomized blind trial, the right and left great toes of
approximately 125 subjects infected with Onychomycosis will be evaluated. The
toes will be randomized and subjected to analysis based on treatment or
no-treatment with PinPointe FootLaser. Before and after samples from infected
areas of each toe will be evaluated for the presence and species of fungus with
the KOH, PCR and culture tests. In addition, a blind study of nail bed clearing
and nail plate growth will be measured using high-resolution photographs by
evaluators. Research subjects will be evaluated at baseline and at intervals out
to 48 weeks for both safety and effectiveness of the PinPointe FootLaser
treatment.

The four sites at which PinPointe FootLaser clinical trials will be held
include:

* Site #1 - London Ontario, Canada. The dermatology clinic and research facility
of Aditya K. Gupta, M.D., Ph.D., M.A.(Cantab), DABD, FAAD, FRCPC, one of the
world`s most respected researchers in Onychomycosis and Director of Mediprobe
Research, a world class dermatology research and clinical trials center where
the study will be conducted.
* Site #2 - Seattle, WA. The private practice/clinical research facility of
Bernard Goffe, MD, Dermatology Associates, a dermatologist and world authority
on nail diseases.
* Site #3 is - San Antonio TX. The chief investigator will be Richard Pollak
DPM, a leading researcher in the field of Onychomycosis. The facility, Endeavor
Clinical Trials, PA, located in the Medical Center of San Antonio, is a
privately owned, multi-therapeutic, dedicated research center set up to conduct
Phase II-V trials.
* Site #4 - Rochester, NY. The trial will be conducted under the guidance of Dr.
Raymond Lanzafame MD MBA FACS and Rochester University. Dr. Lanzafame has been a
pioneer in the development of lasers in surgery and medicine. He is past
president of the American Society for Laser Medicine and Surgery (ASLMS) is
currently Director of CME for ASLMS, and President of the North American
Association for Laser Therapy (NAALT). He is also the editor of Photomedicine
Magazine.

With PinPointe FootLaser, patients are treated safely and quickly with no drugs,
no anesthesia and no pain. PinPointe`s laser light passes through the toenail
without causing damage to the nail or surrounding skin. Following the procedure,
the new nail will grow in healthy and clear. Unlike medication-driven treatments
for toenail fungus, PinPointe FootLaser presents minimal risk of side effects.
Competing medication procedures can result in a wide variety of side effects,
including liver toxicity.

About PathoLase, Inc.

Founded in 2004, PathoLase, Inc. is a privately-held, emerging medical
technology company with headquarters in Chico, California. PathoLase has
assembled a world-class group of top scientists, academic thought leaders, and
leading practitioners from around the world, to bring to market a new generation
of laser technology solutions to address a series of medical issues from toenail
fungus and periodontal disease to more serious life threatening problems, such
as blood borne and respiratory infections. For more information, please visit
www.pinpointefootlaser.com.

Media:
DBA Public Relations
Matthew Calderone, 212-388-1400
mcalderone@dba-pr.com

Copyright Business Wire 2009