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Candela Receives FDA Clearance for Its Serenity(TM) Device for Additional Aesthetic Laser Applications

Posted on: Tuesday, 28 August 2007, 09:23 CDT

Candela Corporation (NASDAQ:CLZR) today announced that it received an additional FDA clearance for the Serenity™ device using Pneumatic Skin Flattening (PSF™) technology. This clearance enables the use of the Serenity™ device for the reduction of pain during all laser and intense pulse light (IPL) treatments. According to Millennium Research, the worldwide installed base of laser and IPLs is estimated to be 70,000 worldwide.

Gerard E. Puorro, President and Chief Executive Officer, said, "We are pleased to announce the receipt of this additional FDA approval for our innovative PSF™ technology, which we obtained through our acquisition of Inolase last March. This clearance is a significant milestone in the roll-out of the PSF™ technology and enables us to further implement this technology across a wide range of applications and devices."

"Patients often discontinue their aesthetic laser treatments because of pain. The PSF™ technology relies on the Gate theory for pain reduction which inhibits the transmission of pain signals to the brain, making treatments more tolerable and thus, improving outcomes," said Nicole M. Shugrue, Senior Product Marketing Manager at Candela. "The expanded product claim will allow practitioners to differentiate their aesthetic practice and improve patient retention by offering this device as an adjunct to their entire laser and intense pulse light aesthetic treatment platform."

Eric F. Bernstein, M.D., Laser Surgery and Cosmetic Dermatology Centers, Bryn Mawr, PA, who performed some of the studies leading to FDA clearance stated, "The Serenity™ device with the PSF™ technology has enabled treatment of patients who otherwise were unable to tolerate laser and IPL treatments because of pain. In my practice I have seen a significant increase in patient volume because of this device."

About CANDELA: Candela Corporation 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 70 countries from offices and distributors in the United States, Europe, Japan, China and other Asian locations. Candela established the aesthetic laser market 18 years ago, and currently has an installed base of an estimated 12,000 lasers worldwide. 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. Such statements may relate to, among other things, our future revenue, gross margin, expense levels and earnings, our growth prospects, market acceptance of our products, the strength of our distribution channels, our ability to add new products, our ability to expand regulatory approvals and the liquidity of our common stock. The risks and uncertainties that may affect forward-looking statements include, among others: the difficulty in recruiting new sales personnel; the cancellation or deferral of customer orders, the risk of an adverse judgment in the patent litigation with Palomar Medical Technologies, Inc., (PMTI), successful integration of Inolase, dependence on a small number of strategic distribution relationships, difficulties in the timely development and market acceptance of new products, unanticipated increases in expenses, market developments that vary from the current public expectations concerning the growth of the laser industry, increased competitive pressures, changes in economic conditions, or difficulties in obtaining timely regulatory approvals. 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 July 1, 2006, 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.

Source: Business Wire

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