Palomar Receives FDA Over-The-Counter Clearance for a Home Use Wrinkle Removal Laser Device
05 6월 2009 - 10:00PM
PR Newswire (US)
Clearance Opens Door To Multi-Billion Dollar Home Skin Care Market
BURLINGTON, Mass., June 5 /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, laser
device for the treatment of periorbital wrinkles. OTC clearance
allows the device to be marketed and sold directly to consumers
without a prescription. This consumer device was developed by
Palomar and completed together with Johnson and Johnson Consumer
Companies, Inc., under a previously announced agreement to develop
light-based anti-aging devices. Designed specifically for use in
the home and based on years of research and clinical testing, this
consumer device represents a major breakthrough in the aesthetic
device industry. Commenting on the achievement, Palomar Chief
Executive Officer Joseph P. Caruso said, "This FDA clearance for a
laser to treat wrinkles in the home opens up a tremendous
opportunity to tap into the multi-billion dollar consumer skin care
market with our patented technology. The professional treatment of
fine lines and wrinkles using lasers has been well established and
proven to be safe and effective for years in the doctors' office
using large and expensive lasers. With this breakthrough, consumers
will be able to use similar technology in the privacy of their own
home for a fraction of the cost. This latest clearance further
validates Palomar's investment in research and development in the
field of light-based anti-aging treatments and adds to the list of
distinctions for Palomar as a technology leader in our industry."
Mr. Caruso continued, "Years ago, we believed that light-based
anti-aging applications could be brought to the home. We invested
significant resources in research, development, clinical testing,
and patent protection to make this a reality and ensure that
Palomar would be the leader with this innovative technology. We
envision a strong market for this OTC device and an increase in
consumer awareness to help drive growth in our professional
business." 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. In December 2006, Palomar became 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. 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 focused
on developing proprietary light-based technology for introduction
to the mass markets. Palomar has granted The Procter & Gamble
Company a non-exclusive License Agreement to certain patents,
technology and FDA documents related to the home-use, light-based
hair removal field for women. In addition, Palomar has an exclusive
development and license agreement with Johnson & Johnson
Consumer Companies, Inc., 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. 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 receive automatic e-mail alerts by going to the Investor
Relations' section of the website. This press release contains
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are based on the Company's current expectations, plans,
intentions, beliefs or predictions. 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, including patent
infringement lawsuits, 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, 2008 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. Contacts: Kayla Castle Investor Relations
Manager Palomar Medical Technologies Inc. 781-993-2411 DATASOURCE:
Palomar Medical Technologies Inc. CONTACT: Kayla Castle, Investor
Relations Manager of Palomar Medical Technologies Inc.,
+1-781-993-2411, Web Site: http://www.palomarmedical.com/
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