Lumenis Receives FDA Marketing Clearance for ReLume A Breakthrough in the Treatment of Hypopigmented Scars and Stretch
Marks
Yokneam, ISRAEL (October 29, 2002) LumenisTM Inc. (NASDAQ: LUME)
announced today that it has received marketing clearance from the U.S.
Food & Drug Administration (FDA) for the new ReLumeTM Repigmentation
Phototherapy System for the treatment of leukoderma, or the loss of skin
pigmentation including stretch marks, acne scars, post-surgical and traumatic
scars. According to the company lost pigment can now be restored safely
and effectively, often within just weeks.
According to Dr. Daniel Man, board certified plastic surgeon, the device
is the first one of its kind in Palm Beach County and offers the first
real treatment for scars due to trauma, injury, and acne. Of these conditions,
stretch marks and acne scars are two of the most common examples of hypopigmented
skin, which affect men and women of all ages, including adolescents. According
to the American Academy of Dermatology, 90 percent of pregnant women develop
stretch marks, and 80 percent of Americans between 11 and 30 years-of-
age suffer from acne, with millions bearing scars from this skin condition.
The ReLume systems unique light-based therapy masks the appearance of
stretch marks and acne scars by pigmenting skin affected by such conditions.
According to physicians, conventional therapies have been largely ineffective
in treating hypopigmentation. Topical retinoids and laser treatments can
improve the clinical appearance of early stretch marks and scars, but,
until now, for mature stretch marks and hypopigmented scars, physicians
have had to turn patients away or offer them surgical options, said Alon
Maor, Executive Vice President of Lumenis. The ReLume system provides
an innovative and effective solution for these conditions. Patients return
to their normal activities immediately and, within weeks, the appearance
of stretch marks and scars is significantly improved.
Loss of skin pigmentation occurs as a complication of injury to the skin
from trauma, surgery, laser therapy and burns. Diminished pigmentation
is also noted in mature stretch marks that occur as a result of pregnancy
or from rapid weight fluctuation. As stretch marks or striae distensae
enlarge, they become fibrotic and devoid of color. Like scars, such conditions
can have a negative impact on self-esteem and may lead to psychological
impairment.
"Scars received during trauma are a constant and painful reminder
of the injury, said dermatologist Roy Geronemus, M.D. "The appearance
of scars can be unsightly and have psychological effects on a persons
well being. The use of light to pigment scars during cosmetic procedures
can significantly improve the quality of life for many patients."
ReLume is the first FDA cleared device of its kind to offer a practical
treatment solution for patients with white stretch marks and hypopigmented
scars. Utilizing the latest advances in fiber-optic technology, the ReLume
system precisely delivers therapeutic 290 to 320 nanometer light to the
targeted area. The devices unique light stimulates melanocytes and enhances
the production of melanin to restore lost pigment in the affected area.
Macrene Alexiades-Armenakas, M.D., Ph.D., a dermatologist who has been
using the ReLume device in a clinical study, stated, Five to six treatments
often achieved 75 to 100 percent repigmentation of stretch marks. ReLume
treatments are painless, safe for all skin types, and require no downtime.
Study participants were very satisfied with the cosmetic improvement after
undergoing ReLume therapy.
About Lumenis
Lumenis 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 10-Q.
Contacts:
Kevin Morano CFO
212-515-4187
Debbie Emery Creative Media Marketing
310-470-7622 debbie@cmmpr.com
