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Press release from Lumenis Ltd.(8/19/2002)
Yokneam, ISRAEL , 8/19/2002 --- Lumenis Ltd. (Nasdaq: LUME), announced today that
the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to the
first acne treatment device for moderate inflammatory acne vulgaris. The ClearLight
system uses high-intensity, narrow-band phototherapeutic light to destroy the bacteria
that cause acne.
Acne, a disease involving the sebaceous glands of the skin, is estimated to affect
more than 80% of the world's population at some time during their life. Not surprisingly,
30% of all dermatologist visits each year are for acne related causes and, in the
U.S., more than $1.4 billion is spent on anti-acne medications and treatments. "Studies
indicate about 40% of acne bacteria are resistant to antibiotics," according to
Alon Maor, executive vice president of Lumenis' Aesthetic Division. "And some treatments
are now associated with very severe side effects. The ClearLight solution is designed
as an attractive alternative to acne sufferers."
"Acne often causes social withdrawal, depression and embarrassment, which can have
a devastating effect on self-esteem and self-confidence," says dermatologist A.R.
Shalita, M.D. of SUNY Downstate Medical Center in Brooklyn, NY, one of the world's
leading acne experts, who led the multi-center ClearLight clinical trials. "ClearLight
is an important new treatment for acne. It's effective, painless and, most importantly,
has no known side effects."
About the ClearLight Acne PhotoClearing System
Representing a new paradigm in acne therapy, the ClearLight treatment penetrates
just deeply enough into the skin's tissue to safely and effectively destroy Propionibacterium
acnes bacteria, or P. acnes, the primary cause of acne. The clinical data submitted
to the FDA examined the effects of high-intensity, narrow-band light on P. acnes
bacteria and the studies concluded that ClearLight was "a promising non-invasive,
non-systemic alternative to current anti-acne remedies for moderate inflammatory
The ClearLight technology, developed by CureLight Ltd., treats acne at its source
in a very natural way. P. acnes bacteria produce porphyrins as part of its normal
metabolism. The device's high-intensity light excites the porphyrins, resulting
in photodestruction of the acne bacteria without damaging the surrounding tissue
or skin. "Just exposing the patient's skin to this high-intensity light for 15 minutes
will result in the elimination of bacteria that cause acne," said Macrene Alexiades-Armenakas
M.D., a New York City-based dermatologist who has been using the ClearLight device.
ClearLight treatments are quick, easy and painless, and patients have no disruption
of their normal activities - an important factor for today's busy teens and young
adults. Patients lie comfortably on a bed in their dermatologist's office for 15
minutes during each treatment session. The typical ClearLight treatment regimen
consists of eight visits over a period of four weeks. While any area of the body
that has moderate inflammatory acne can be treated, the most common areas are the
face, neck, chest and back. The ClearLight system works equally well on patients
of all skin colors.
In the clinical validation study, researchers found the ClearLight Acne PhotoClearing
System to be an effective method of reducing moderate inflammatory acne lesions.
All patients were treated twice a week for four weeks, then followed monthly for
an additional three months. Clearing of inflammatory acne was observed to continue
throughout the follow-up period. After eight semi-weekly treatments, patients with
moderate acne showed significant improvement and no side effects were noted. "Study
participants were very satisfied with the clarity of their skin after undergoing
ClearLight therapy," said Dr. Shalita.
"ClearLight is a non-drug alternative that's easy and effective, and, with no known
side effects, this treatment device will surely allow more acne sufferers to enjoy
the benefits of clear skin," said Alon Maor. "ClearLight was launched in Canada,
Europe and Japan last year, and has caused a great deal of excitement among both
dermatologists and acne sufferers."
CureLight was founded in 1999 by Dr. Yoram Harth, a renowned dermatologist and Avner
Korman, an electro-optical engineer and is managed by Dr. Joshua Degani. ClearLightÔ
is the company flag product and CureLight is currently developing additional systems
for treatment of other skin ailments. For additional information: www.curelight.com.
ClearLight is a trademark of CureLight Ltd.
Lumenis, formed by the union between ESC Medical Systems and Coherent Medical Group,
develops, manufactures, and markets state-of-the-art proprietary laser and intense
pulsed light devices. Its systems are used in a variety of aesthetic, ophthalmic,
surgical and dental applications, including, hair removal, non-invasive treatment
of vascular lesions and pigmented lesions, acne, psoriasis, open angle glaucoma,
secondary cataracts, age-related macular degeneration, ENT, gynecology, urinary
lithotripsy, benign prostatic hyperplasia, neurosurgery and dentistry. For more
information about the Company and its products log on to http://www.lumenis.com.
The statements in this press release that are not historical facts are forward-looking
statements which are subject to risks and uncertainties. The Company's actual results
could differ materially from those anticipated in the forward looking statements
based on a variety of factors, including, among others: uncertainties with respect
to market acceptance of the Company's products, obtaining regulatory approvals for
new products or for the sale of existing products in new markets and enforcement
of intellectual property rights; risks associated with competition and competitive
pricing pressures, economic conditions generally, the Company's international operations
and the Company's ability to integrate its operations with those of acquired businesses;
and other risks detailed from time to time in the reports filed by Lumenis with
the SEC, including its annual report on Form 10-K and quarterly reports on Form
Chief Financial Officer