Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
16 10월 2009 - 11:00PM
PR Newswire (US)
BURLINGTON, Mass., Oct. 16 /PRNewswire-FirstCall/ -- Palomar
Medical Technologies Inc. (NASDAQ:PMTI), a leading researcher and
developer of light-based systems for cosmetic treatments, today
announced the termination of its agreement with Johnson &
Johnson Consumer Companies Inc ("JJCC"), a Johnson & Johnson
company, to develop, clinically test and commercialize home-use,
light-based devices for (i) reducing or reshaping body fat
including cellulite; (ii) reducing appearance of skin aging; and
(iii) reducing or preventing acne. Despite Palomar having met all
of its deliverables under the agreement, JJCC terminated the
agreement referencing the current unfavorable economic conditions
as the reason for its decision. With this decision, JJCC avoids
having to make a large commercialization payment to Palomar and
avoids having to commit to the significant level of funding
required to successfully launch a new product into the mass market.
Upon termination of the agreement, JJCC's license to Palomar
technology was terminated and all technology and intellectual
property rights related to light-based devices developed under the
agreement were assigned to Palomar. JJCC is also precluded from
further development or commercialization of the light-based devices
developed under the agreement. Palomar will continue with the
commercialization of the light-based devices developed under the
agreement. In June 2009, Palomar was 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 this wrinkle treatment device to be marketed and sold
directly to consumers without a prescription. This consumer wrinkle
treatment device was developed by Palomar and completed together
with JJCC. 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.
In order to achieve FDA clearance, numerous clinical studies with
hundreds of subjects and thousands of treatments were conducted.
These studies demonstrated that the laser-based device delivers
comfortable, effective, skin and eye safe wrinkle treatment around
the eyes. Commenting on this development, Palomar Chief Executive
Officer Joseph P. Caruso said, "We have developed game changing
technology in the consumer area. Over the past few years we have
developed advanced patented technology that allows us to penetrate
the home market. Wrinkle treatments using OTC products are a
multi-billion dollar market opportunity and we plan on entering
that market with our products during the second half of next year.
The current economic climate does not warrant a large scale
investment in a mass market launch at this time. Therefore, we have
adjusted our launch plans to be more in line with current economic
conditions. In the short-term, our goal is to establish our
consumer products in the market using certain specialty channels
and gather the valuable information needed to fully execute our
long-term strategy of a full mass market launch. Our long-term goal
remains the same; to tap into the mass market using our patented
technology in a number of key areas with multiple product offerings
and multiple channels worldwide". Mr. Caruso continued, "We believe
that light-based anti-aging applications will one day be an
ordinary and necessary part of maintaining a healthy appearance
done in the privacy and convenience of the home. We were fortunate
to have advanced this technology with the help of a partner who
invested significant resources along the way in research,
development, clinical testing, consumer testing, and patent
protection that will make this a reality and ensure that Palomar
maintains a leadership position in this innovative technology. We
envision a strong market for this OTC device and an increase in
consumer awareness that will help drive growth in our professional
business." For more information, please see Exhibit 99.1 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. In June 2009,
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, laser
device for the treatment of periorbital wrinkles. 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. 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: Kerry McAnistan Investor Relations
Assistant Palomar Medical Technologies Inc. 781-993-2411
DATASOURCE: Palomar Medical Technologies Inc. CONTACT: Kerry
McAnistan, Investor Relations Assistant of Palomar Medical
Technologies Inc., +1-781-993-2411,
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