Food & Drug Administration Clears Candela's Low-Cost Hair Removal Laser; Company Can Now Accelerate U.S. Sales Efforts for GentleLASE System in U.S

Business Wire, July 16, 1998

WAYLAND, Mass.--(BW HealthWire)--July 16, 1998--The U.S. Food & Drug Administration has cleared the GentleLASE(TM) advanced, low-cost laser system for hair removal, it was announced today by Candela Corporation (Nasdaq:CLZR).

The GentleLASE system developed by Candela is based on a high-energy, long-pulse alexandrite laser with dynamic cooling. It was initially cleared by the FDA last December for treating facial veins and other vascular lesions, when Candela also applied to the FDA for clearance to market the system for hair removal, as well. The selling price of $59,500 makes GentleLASE the lowest priced hair removal laser in the market, the company said.

Commenting on the regulatory decision and its impact on the company, Gerard R. Puorro, Candela's president and chief executive officer, said: "We have had a strong favorable reaction to the GentleLASE system from the moment late last year we were first able to sell it in the U.S. Now that we can also sell it for hair removal, we expect to see an acceleration of this momentum, and our sales force is geared up to capitalize on what we are confident is the best product in the market in terms of both cost and efficacy." The company has been able to sell the GentleLASE system in most parts of the world for hair removal and vascular lesions, but was not allowed to sell it as a hair removal device in the large U.S. market until now.

Candela said that the GentleLASE system has a longer wavelength (755nm), high energy (50J/cm2) and a large spot size (12mm diameter), characteristics which enable deeper penetration by laser energy of the targeted area and faster treatments than first-generation, long-pulse ruby or alexandrite lasers, or flashlamp devices.

"In addition, GenteLASE is the first and only hair removal/vascular lesion laser available with dynamic cooling," Mr. Puorro continued. "Candela's proprietary Dynamic Cooling Device (DCD) selectively cools the upper layers of skin an instant before applying the laser pulse, minimizing thermal injury and pain without decreasing effectiveness. And because the cooling is happening virtually simultaneously, the practitioner has full visibility of the skin's surface so that the laser treatments can progress unimpeded. As a result, doctors can apply higher levels of therapeutic laser exposure -- more quickly and over fewer sessions -- so that patients can finish their treatments much sooner.

"As for the system's low $59,500 price," Mr. Puorro said, "we can do this because of the advanced technology we have developed that produces high laser energy levels more efficiently than ever before. Thus, the GentleLASE system is a simpler design which we are able to produce at far less cost, and we are passing these savings along to our customers while maintaining excellent profit margins for the company."

Concluding his remarks, Mr. Puorro said: "We believe that GentleLASE breaks new ground in technology, efficacy and cost, making it the very system that dermatologists, plastic surgeons and other practitioners have been telling us they need for their practices and their patients."

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, cryosurgery and other proven technologies. Founded near Boston in 1970, Candela markets and services its products in over 40 countries from offices in the United States, Europe and Asia. Candela established the aesthetic laser market 11 years ago. With an installed base of over 1,500 lasers worldwide, more than 500,000 aesthetic laser procedures are performed annually with Candela laser systems. For more information about Candela, visit the company's web site at http://www.clzr.com.

This press release includes certain forward-looking statements. Any such statements are subject to risks that could cause the actual results to vary materially, including negative developments relating to unforeseen order cancellations or push-outs, Candela's strategic relationships, the impact of intense competition, and changes in the laser industry.

    CONTACT: Candela Corporation
              F. Paul Broyer 508/358-7400 x435
              or
              Phase Two Strategies
              Stuart Pearlman, 212/716-3400