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Candela receives FDA clearance for treatment of skin conditions caused by sun damage; 'New application dramatically expands system's capabilities,' leading dermatologist says.


WAYLAND, Mass.--(BUSINESS WIRE)--July 8, 1996--Candela Corp. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CLZR) today announced that the Food and Drug Administrations (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has cleared its ALEXlazr for use in treating pigmented lesions or brown spots of the skin, commonly caused by sun exposure and sun damage. The market potential is projected at $2 billion.

The company estimates that the potential patient population in the U.S alone is over 28 million and includes individuals from 30 to 80 years old, especially with lighter-skin types. With typical treatment charges of $100-400 per session for one-to-four sessions, this procedure is an attractive alternative for individuals currently using bleaching or anti-aging creams which are promoted as lightening these brown spots, and making the skin look younger. However, these creams, if effective, must be used daily for several months before results are seen. In contrast, the laser treatment can be effective after as few as two treatments.

"This FDA clearance substantially diversifies the ALEXlazr's treatment capabilities," said Gerard E. Puorro, Candela's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "At the same time, the clearance will further strengthen the ALEXlazr's leadership position and market share in the growing dermatology and plastic surgery markets."

The ALEXlazr device had previously been cleared for treatment of two conditions with an estimated multi-billion dollar worldwide market: tattoos, which affect up to nine percent of the U.S. population; and dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 pigmented lesions, such as Nevus of Ota nevus of Ota A bluish or gray-brown macular lesion of the periorbital skin innervated by the 1st and 2nd branches of trigeminal nerve Treatment Selective photothermolysis with a Q-switched ruby laser, surgical removal, skin grafting, , a condition common in Asians. As a result, the ALEXlazr has already received strong acceptance in Candela's international markets, especially in the Pacific Rim countries. With this new clearance, the company expects a similar response in the U.S.

"The new application dramatically expands the system's capabilities," said Stanley Kovak, M.D., director of the Oak Brook Dermatologic Laser Center of Illinois. "It means that physicians will now be able to treat a number of prevalent cosmetic conditions more safely and effectively than ever before. This is very exciting news for us and our patients."

At the Candela candela (kăndĕ`lə), in weights and measures: see candle.


A unit of measurement of the intensity of light. Part of the SI system of measurement, one candela (cd) is the monochromatic radiation of 540THz with a radiant intensity
 Skin Care Center (Framingham, Mass.), a facility operated by a wholly-owned subsidiary of Candela, the medical director, Dr. Thomas Rohrer, commented, "with this new solid-state laser, we will be able to treat patients with almost no post-operative symptoms. For patients seeking treatment for pigment associated with photoaging pho·to·ag·ing
n.
1. The process by which skin is changed or damaged as a result of exposure to ultraviolet radiation in sunlight and other sources.

2.
, this laser may be a viable, and much less painful, alternative to skin-resurfacing. In addition, most patients who are being treated with the CO2 laser for signs of aging on the face would benefit from the ALEXlazr treatment for the sun spots on the backs of the hands."

Candela Corp. is an increasingly diversified, international company that provides clinical solutions to the dermatology, plastic surgery, urology urology

Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones.
, oncology, gynecology and pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 markets through medical laser products and services, as well as cryogenic surgery products. Founded in 1970, the company recently changed its name from Candela Laser Corporation. For more information, visit Candela's Web site at http://www.clzr.com.

CONTACT: Candela Corp.

Richard J. Olsen, 508/358-7400 x224
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jul 8, 1996
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