Palomar Receives FDA Clearance for Acne Treatment
05 4월 2004 - 10:00PM
PR Newswire (US)
Palomar Receives FDA Clearance for Acne Treatment BURLINGTON,
Mass., April 5 /PRNewswire-FirstCall/ -- Palomar Medical
Technologies Inc 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. Thesefactors, 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 acnesufferers 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 rateswhen
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 maybe 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 DATASOURCE: Palomar Medical Technologies Inc CONTACT:
Investor Relations - Palomar Medical Technologies Inc,
+1-781-993-2411, Web site: http://www.palomarmedical.com/ Company
News On-Call: http://www.prnewswire.com/comp/107555.html
Copyright
Palomar Medical Technologies, Inc. (MM) (NASDAQ:PMTI)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Palomar Medical Technologies, Inc. (MM) (NASDAQ:PMTI)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024