Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle
Treatment Laser Device Without Johnson & Johnson
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
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
ir@palomarmedical.com
SOURCE Palomar Medical Technologies Inc.
Kerry McAnistan, Investor Relations Assistant of Palomar Medical Technologies
Inc., +1-781-993-2411, ir@palomarmedical.com
