BURLINGTON, Mass., April 5 /PRNewswire-FirstCall/ -- Palomar Medical
Technologies Inc (Nasdaq: PMTI) announced today that it has received clearance
from the U.S. Food and Drug Administration (FDA) to market the LuxV(TM)
handpiece for the treatment of acne. Prior to this clearance, Palomar
marketed and sold the LuxV handpiece for the treatment of pigmented lesions.
With this new clearance, Palomar can now market the LuxV handpiece for the
treatment of mild to moderate inflammatory acne vulgaris. The LuxV is a
handpiece attachment for use with Palomar's family of Lux Pulsed Light
systems, including the StarLux(TM), MediLux(TM), and EsteLux(R) system. The
LuxV is Palomar's first handpiece to treat acne.
According to the American Academy of Dermatology, it is estimated that
acne affects more than 80% of the world's population at some point in their
lives. In the past, a combination of over the counter cleansers and prescribed
topical medications including topical antibiotics, peroxide compounds and
topical retinoids have been traditionally recommended to treat acne.
Unfortunately, many topical and oral acne treatments provide inconsistent
results and are known to cause side effects. These factors, combined with an
aversion to long-term dependence on antibiotics, have made light-based acne
treatments increasingly appealing to the general public.
Christine C. Dierickx, M.D., a world renowned dermatologist and Director
of the Boom Laser Clinic in Belgium commented, "The advantage of Palomar's
approach to the treatment of acne is that it doesn't involve medication and
can be performed in the office without relying on the patient's compliance at
home. Use of the LuxV handpiece offers acne sufferers a non-drug, easy and
effective alternative without the side effects commonly found with drugs.
Patients have been extremely happy with the results and enjoy benefits of long
lasting clear skin after just a few treatments."
Joseph P. Caruso, Chief Executive Officer of Palomar added, "We are
extremely pleased to receive the additional FDA clearance for the treatment of
acne with the LuxV handpiece. This clearance, combined with the recent
addition of the StarLux system, could dramatically increase consumer interest
in Palomar's light-based cosmetic technology, and propel us to an even greater
market share in this growing worldwide market."
The LuxV handpiece offers a long-term acne solution by treating the root
cause of acne which is the sebaceous glands. The LuxV emits pulses of intense
light that alter the structure and function of the sebaceous glands to reduce
acne lesions without the many side effects common to drugs while offering
longer remission times and improved efficacy rates when compared to other
treatments. Acne treatment is the most rapidly growing therapeutic category in
the dermatology sector and in the U.S. alone; more than $1.4 billion annually
is spent on anti-acne medication and treatment.
About Palomar Medical Technologies Inc: Palomar is a leading researcher
and developer of light-based systems for hair removal and other cosmetic
treatments. Last year, Palomar and the Gillette Company (NYSE: G) entered into
an agreement to complete development and commercialize a patented home-use,
light-based hair removal device for women. New and exciting indications are
being tested to further advance the hair removal market and other cosmetic
applications. 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.
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 E-mail Alerts page in 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, 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, the impact of competitive products and pricing,
governmental regulations with respect to medical devices, including whether
FDA clearance will be obtained for future products, 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, 2003 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: Investor Relations
Palomar Medical Technologies Inc
781-993-2411
ir@palomarmedical.com
SOURCE Palomar Medical Technologies Inc
 back to top
Related links:
http://www.palomarmedical.com
Company News On-Call:
http://www.prnewswire.com/comp/107555.html
CONTACT:
Investor Relations - Palomar Medical
Technologies Inc, +1-781-993-2411, ir@palomarmedical.com
|
