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The Only FDA-Cleared, Clinically-Proven At-Home Laser for Treating Eye Wrinkles

Tue, 05/01/2012 - 6:45am
The Associated Press

BURLINGTON, Mass., May 1, 2012 (GLOBE NEWSWIRE) -- The Journal of the

American Academy of Dermatology (JAAD), the official publication of

the American Academy of Dermatology, has published the results of a

multi-center clinical study for the PaloVia Skin Renewing Laser, the

first and only non-ablative fractional laser FDA-cleared for the

treatment of fine lines and wrinkles at-home.

As a preeminent journal and resource for dermatologists, other

physicians and the broader medical community, the JAAD is

internationally known as the leading journal in its field. Original,

peer-reviewed articles cover clinical and investigative studies,

treatments, new diagnostic techniques, and other groundbreaking topics

relating to the prevention, diagnosis, and treatment of disorders of

the skin.

The multicenter trial of the PaloVia laser consisted of two clinical

studies completed among 126 subjects and included an active phase

(daily treatments) and a maintenance phase (twice-weekly treatments).

Evaluations included in-person investigator assessment, independent

blinded review of high-resolution images using the Fitzpatrick Wrinkle

Scale, and subject self-assessment.

Dr. James J. Leyden, the study's Principal Investigator, commented,

"The PaloVia laser was tested in two locations and had the following

results: all study participants were able to follow the instructions

and incorporate the treatment into their daily routines; blinded

evaluations revealed improvement in more than 90% of the subjects; and

user satisfaction was high to very high."

The PaloVia laser is manufactured and marketed by Palomar Medical

Technologies, Inc. (Nasdaq:PMTI) -- a global leader in laser and other

light-based systems for aesthetic treatments. Palomar Chief Executive

Officer Joseph P. Caruso said, "Inclusion in the JAAD underscores the

dermatologist community's support for Palomar technology and the

results it can deliver. We are honored that the JAAD chose to publish

this study."

About Palomar Medical Technologies, Inc.: Palomar is a global leader

in laser and other light-based systems for aesthetic treatments.

Palomar pioneered the optical hair removal field, when, in 1997, it

introduced the first high-powered laser hair removal system. Since

then, many of the major advances in light-based hair removal have been

based on Palomar technology.

As a pioneer of fractional technology, Palomar is an owner of

fundamental intellectual property in this area. In December 2009,

Palomar received the first United States Food and Drug Administration

(FDA) clearance for the treatment of stretch marks using a fractional

non-ablative laser. In September 2010, Palomar received the first FDA

clearance for a fractional ablative and fractional non-ablative

combination treatment.

In December 2006, Palomar became the first company to receive a 510(k)

over-the-counter (OTC) clearance from the FDA for a new, patented,

home-use, light-based hair removal device. In June 2009, Palomar

became the first company to receive a 510(k) OTC clearance from the

FDA for a new, patented, home-use, laser device for the treatment of

periorbital wrinkles. OTC clearance allows these products to be

marketed and sold directly to consumers without a prescription.

Palomar introduced the PaloVia(TM) Skin Renewing Laser(TM) in December

2010.

There are now millions of laser- and light-based aesthetic procedures

performed around the world every year in physician offices, clinics,

spas, salons, and homes. Palomar is testing many new and exciting

applications to further advance the aesthetic market and other

surgical applications.

With the exception of the historical information contained in this

release, the matters described herein contain forward-looking

statements, including, but not limited to, statements relating to new

markets, future royalty amounts due from third parties, development

and introduction of new products, and financial and operating

projections. These forward-looking statements are neither promises nor

guarantees, but involve risk and uncertainties that may individually

or mutually impact the matters herein, and cause actual results,

events and performance to differ materially from such forward-looking

statements. These risk factors include, but are not limited to,

results of future operations, technological difficulties in developing

or introducing new products, the results of future research, lack of

product demand and market acceptance for current and future products,

the effect of economic conditions, challenges in managing joint

ventures and research with third parties and government contracts, the

impact of competitive products and pricing, governmental regulations

with respect to medical devices, including whether FDA clearance will

be obtained for future products and additional applications, the

results of litigation, difficulties in collecting royalties, potential

infringement of third-party intellectual property rights, factors

affecting the Company's future income and resulting ability to utilize

its NOLs, and/or other factors, which are detailed from time to time

in the Company's SEC reports, including the report on Form 10-K for

the year ended December 31, 2011 and the Company's quarterly reports

on Form 10-Q. Readers are cautioned not to place undue reliance on

these forward-looking statements, which speak only as of the date

hereof. The Company undertakes no obligation to release publicly the

result of any revisions to these forward-looking statements that may

be made to reflect events or circumstances after the date hereof or to

reflect the occurrence of unanticipated events.

CONTACT: Kerry McAnistan

Investor Relations Assistant

Palomar Medical Technologies, Inc.

781-993-2411

ir@palomarmedical.com

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