Palomar Receives FDA Over-the-Counter Clearance for the First Home Use Light- Based Hair Removal Device
Clearance Opens Door To Home Use Hair Removal Market
BURLINGTON, Mass., Dec. 11 /PRNewswire-FirstCall/ -- Palomar Medical
Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of
light- based systems for cosmetic treatments, today announced that it has
become the first company to receive a 510(k) over-the-counter (OTC)
clearance from the United States Food and Drug Administration (FDA) for a
new, patented, home use, light-based hair removal device. OTC clearance
allows the product to be marketed and sold directly to consumers without a
prescription.
This consumer device was initially developed by Palomar and completed
together with The Gillette Company, part of The Procter & Gamble Company
(NYSE: PG), under a previously announced agreement to develop a light-based
hair removal device for women. Designed specifically for use in the home
and based on over a decade of research, this consumer device represents a
major breakthrough in the aesthetic device industry.
Commenting on the achievement, Palomar Chief Executive Officer Joseph
P. Caruso said, “We are extremely pleased to receive FDA clearance for this
patented OTC device. This is a significant milestone for Palomar. The
market opportunity for an OTC product is bigger than any market we have
addressed to date. We have demonstrated again that we are the clear leader
in this technology, just as we did in 1997 when we received the first FDA
clearance for a high powered light-based hair removal device for the
professional market. Professional light-based hair removal treatments are
among the most popular cosmetic treatments offered today with millions of
treatments performed each year. This latest clearance further validates
Palomar’s investment in research and development in the field of
light-based hair removal and adds to the list of distinctions for Palomar
as a technology leader in this industry.”
Mr. Caruso continued, "Years ago, we believed that light-based hair
removal could be brought to the home. We invested significant resources in
research, development and patent protection to make this a reality and
ensure that Palomar would be the leader with this innovative technology.
This clearance makes Palomar the only company in the world with both
professional and direct-to-consumer light-based cosmetic devices cleared
for U.S. marketing. We envision a strong potential market for an OTC
product and an increase in consumer awareness to help drive growth in our
professional business. We are fortunate to have developed this technology
in close cooperation with Gillette.
“This is an exciting milestone, with significant future potential,”
said Chip Bergh, President, Global Grooming, Gillette. “Our association
with Palomar is yet another example of Gillette taking the lead in new and
innovative technologies in hair removal.”
For more information, please see Exhibit 99.2 to a Current Report on
Form 8-K filed today.
About Palomar Medical Technologies Inc: Palomar is a leading researcher
and developer of light-based systems for cosmetic 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.
There are now millions of light-based cosmetic procedures performed around
the world every year in physician offices, clinics, spas and salons.
Palomar is testing many new and exciting applications to further advance
the hair removal market and other cosmetic applications. Palomar is
uniquely focused on developing proprietary light-based technology for
introduction to the mass markets. Palomar has an agreement with The
Gillette Company to develop and potentially commercialize a patented
home-use, light-based hair removal device for women. Palomar also has an
agreement with Johnson & Johnson Consumer Companies to develop and
potentially commercialize home-use, light-based devices for reducing or
reshaping body fat including cellulite, reducing the appearance of skin
aging, and reducing or preventing acne, and was awarded a contract by the
Department of the Army to develop a light-based, self- treatment device for
Pseudofolliculitis Barbae (“PFB”).
For more information on Palomar and its products, visit Palomar’s
website at http://www.palomarmedical.com. To continue receiving the most
up-to-date information and latest news on Palomar as it happens, sign up to
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of the website.
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,
development and introduction of new products, and financial projections
that 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, 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, 2005 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.
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