Business and Finance
BURLINGTON, Mass. (Map) -
During the term of the prior Development and License Agreement, a home-
use, light-based hair removal device for women was developed by Palomar
together with Gillette. It is the first light-based aesthetic device to
receive a 510(k) over-the-counter (OTC) clearance from the
In order to achieve FDA clearance, numerous clinical studies with over 600 subjects and thousands of treatments were conducted. These studies demonstrated that, when used as directed, the light-based device created under this agreement delivers comfortable, effective, skin-safe hair removal.
Commenting on this development, Palomar Chief Executive Officer Joseph P. Caruso said, "We strongly believe that we have developed game changing technology, and we look forward to seeing P&G's products on the market. Over the past five years, Palomar and Gillette worked together to advance the technology and we have made tremendous progress in moving closer to penetrating the mass consumer market. Our biggest single achievement together has been penetrating the regulatory barrier to gain FDA approval of the first laser device for the home market."
For more information, please see the non-exclusive License Agreement filed
as Exhibit 10.1 to a Current Report on Form 8-K filed today, the Amended and
Restated Development and License Agreement and Amendment #1 to the Amended and
Restated Development and License Agreement filed as Exhibits 10.1 and 10.2 to
a Current Report on Form 8-K filed
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
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.
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
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