Candela Announces FDA Clearance of Breakthrough Laser Treatment for Acne;
Industry's First Approved Laser for Facial Acne Gives Millions of Acne
Sufferers Hope
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Press release From Candela Corporation
WAYLAND, Mass.--Nov. 24,
2003--Candela Corporation (NASDAQ: CLZR) announced today that it has
received expanded clearance from the U.S. Food and Drug Administration (FDA)
to market its Smoothbeam(TM) diode laser for the non-invasive treatment of
acne adding to the previously approved treatments of back acne, acne scars
and wrinkles.
Gerard E. Puorro, Candela's President and Chief Executive Officer, said,
"Patients, who have experienced physical and social trauma from acne,
especially facial acne, can now receive safe and effective, non-invasive
treatment from Smoothbeam during a few visits to their physician's office
and without taking prescribed medications."
Acne affects roughly 80 percent of the population worldwide in some form,
is the most commonly diagnosed skin disorder in the U.S. and is the #1
reason why patients visit a dermatologist. Acne can have a crippling effect
on a patient's self esteem and is often a source of anxiety, low
self-confidence and even depression.
Acne is caused by an enlargement of the sebaceous follicles, which
contain oil-producing sebaceous glands, the root cause of acne. A serious
skin disorder, acne often goes untreated resulting in pain, debilitating
scar formations and skin damage. For years, traditional oral and topical
acne treatments haven't treated the direct source of acne - overactive, oil
producing sebaceous glands. Frustrated patients have long been searching for
alternatives to the traditional acne treatment methods, which have been
known to cause side effects. Now, the Smoothbeam laser offers a long-term
solution by directly altering the structure and function of the sebaceous
glands, which drastically reduces acne lesions without significant side
effects.
Tina S. Alster M.D., Director, Washington Institute of Dermatologic Laser
Surgery and a world-renowned lecturer on cosmetic laser surgery, was one of
the first physicians to use this breakthrough treatment. "After a series of
treatments with Smoothbeam, patients experienced dramatic improvement in the
reduction of acne lesions," said Dr. Alster. "I found it to be a safe and
cost-effective treatment that dramatically changed the patients' lives for
the better."
"I couldn't believe the difference after using Smoothbeam - not only me,
but my family and everyone noticed," said Stella Petrakis, a Smoothbeam
patient from New York City. "I don't wear makeup anymore, no more cover up.
I don't have to use it," continued Petrakis. "I'm very, very happy with the
results. Excellent - I recommend it to anyone."
About Smoothbeam:
Smoothbeam creates a mild thermal injury just below the skin's surface,
which alters the structure of the sebaceous glands, the root cause of acne.
This allows for effective, long-lasting acne clearance. Smoothbeam emits a
wavelength of light that is strongly absorbed by water in the skin. As the
laser penetrates into the skin, heat is generated in and around the
sebaceous glands in the upper layers of the skin. The integrated dynamic
cooling device (DCD(TM)) also emits a cooling spray, which allows
preservation of the skin, thus minimizing treatment side effects. For more
information about this treatment and how to locate a physician, call:
1-800-733-8550, ext 444.
About Candela:
Candela Corporation develops, manufactures, and distributes innovative
clinical solutions that enable physicians, surgeons, and personal care
practitioners to treat selected cosmetic and medical conditions using
lasers, aesthetic laser systems, and other advanced technologies. Founded
near Boston in 1970, the company markets and services its products in over
60 countries from offices in the United States, Europe, Japan and other
Asian locations. Candela established the aesthetic laser market 15 years
ago, and currently has an installed base of over 6,500 lasers worldwide.
Candela is an Equal Opportunity and Affirmative Action Employer, M/F/H/V.
Visit Candela on the Web at
http://www.candelalaser.com.
Safe Harbor Statement: Except for the historical information contained
herein, this news release contains forward-looking statements that
constitute Candela's current intentions, hopes, beliefs, expectations or
predictions of the future, which are therefore inherently subject to risks
and uncertainties. Candela's actual results could differ materially from
those anticipated in Candela's forward-looking statements based on various
factors, including without limitation: the cancellation or deferral of
customer orders, dependence on a small number of strategic distribution
relationships, difficulties in the timely development and market acceptance
of new products, market developments that vary from the current public
expectations concerning the growth of the laser industry, increased
competitive pressures, or changes in economic conditions. Further
information on factors that could affect Candela's performance is included
in Candela's periodic reports filed with the SEC, including but not limited
to, Candela's Annual Report on Form 10-K for the year ended June 28, 2003
and subsequent Quarterly Reports on Form 10-Q. Candela cautions readers not
to place undue reliance upon any such forward-looking statements, which
speak only as of the date made. Candela expressly disclaims any obligations
or undertaking to release publicly any updates or revisions to any such
statements to reflect any change in Candela's expectations or any change in
events, conditions or circumstances on which any such statement is based. |
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