Laserscope Announces FDA Clearance for Innovative New Acne Laser Treatment
November 25 2003 - 7:00AM
PR Newswire (US)
Laserscope Announces FDA Clearance for Innovative New Acne Laser
Treatment Non-Invasive Treatment Said to Be Ideal for Millions of
Acne Sufferers SAN JOSE, Calif., Nov. 25 /PRNewswire-FirstCall/ --
Laserscope , a pioneer in the development and commercialization of
medical lasers and advanced fiber-optic devices, today reported
that it has received clearance from the U.S. Food and Drug
Administration (FDA) to market its Aura(TM) laser for the treatment
of acne. "We are very excited about receiving this clearance for
our Aura laser," said Eric Reuter, Laserscope's President and CEO.
"According to the American Academy of Dermatology, nearly 80% of
the world's population is affected by acne at some point in their
lifetime and close to 40% of adolescents have acne severe enough to
require some treatment by a physician. Additionally, many of the
existing treatment solutions for acne, such as oral antibiotics,
topical retinoids and topical antibiotics, can be ineffective and,
in some cases, have been associated with significant health risks.
By contrast, the Aura laser treatment is fast, virtually painless
and efficacious." Clinical data was obtained from initial research
conducted at the Wellman Laboratories of Photomedicine at Harvard
Medical School, Massachusetts General Hospital by Dr. Ledya
Elizabeth Bowes, Dr. Dieter Manstein and Dr. R. Rox Anderson of the
Department of Dermatology and by Dr. William Baugh, a dermatologist
from Fullerton, California and a Fellow of both the American
Academy of Dermatology and the American Society of Laser Medicine
and Surgery. "Treatment of facial acne with the 532-nanometer, KTP
Aura laser twice weekly for two weeks resulted in a marked
reduction of the acne lesion counts, which was maintained for at
least 3 months after exposure. A reduction in sebum production was
also noted, as well as an attenuation of the fluorescence
attributable to P. acnes," said Dr. Bowes. "The Aura laser is a
safe and highly effective device for the treatment of acne
vulgaris," said Dr. Baugh. "Our patients have been uniformly
impressed with the ease of treatments and the outstanding results.
This laser not only makes my patients look good but their great
results make me look good too! I highly recommend it to any
physician who treats acne." About Laserscope Laserscope designs,
manufactures, sells and services on a worldwide basis an advanced
line of medical laser systems and related energy delivery devices
for the office, outpatient surgical center, and hospital markets.
More information about Laserscope can be found on the Company's web
site at http://www.laserscope.com/ . Except for historical
information presented, the matters discussed in this announcement
may contain forward-looking statements that are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those projected. These risks are detailed from time
to time in the Company's public disclosure filings with the U.S.
Securities and Exchange Commission (SEC). Copies of Laserscope's
public disclosure filings with the SEC, including the most recent
Annual Report on Form 10-K and the most recent forms 10-Q are
available upon request from its Investor Relations Department. For
further information, please contact: Eric Reuter, President &
CEO, or Dennis LaLumandiere, CFO, both of Laserscope,
+1-408-943-0636; or Analysts, Tricia Ross, or General Inquiries,
Linda Chien, both of Financial Relations Board, +1-310-407-6555,
for Laserscope. DATASOURCE: Laserscope CONTACT: Eric Reuter,
President & CEO, or Dennis LaLumandiere, CFO, both of
Laserscope, +1-408-943-0636; or Analysts, Tricia Ross, or General
Inquiries, Linda Chien, both of Financial Relations Board,
+1-310-407-6555, for Laserscope Web site:
http://www.laserscope.com/
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