Candela Announces Expanded FDA Clearance for Smoothbeam.Business Editors/Health/Medical Writers WAYLAND, Mass.--(BUSINESS WIRE)--Sept. 18, 2003 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 Corporation (NASDQ: CLZR) announced today it has received expanded wrinkle clearance from the U. S. Food and Drug Administration (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. ) to market its Smoothbeam(TM) diode laser See laser diode. for the non-invasive treatment of wrinkles on the face. Gerard E. Puorro, Candela's President and Chief Executive Officer, commented: "We are very pleased to gain this additional clearance from the FDA. The treatment of wrinkles and other cosmetic procedures is growing at a tremendous rate. Our involvement in these markets outlines our path for growth in the coming years. This represents our fourth FDA approval for Smoothbeam. Adding multiple indications to our lasers makes purchasing a laser an attractive financial investment for physicians." Smoothbeam remodels collagen in the upper layers of the skin to reduce the appearance of wrinkles and acne scars using its proprietary LASR LASR Leisure and Sport Review LASR Laboratory for Astrophysics and Space Research LASR Low-Altitude Surveillance Radar LASR Local Access Service Request LASR Long and Short Romance (reviews) LASR Local Alarm and Status Report (TM) process. Smoothbeam creates a mild thermal injury just below the skin's surface. The body's natural healing natural healing Alternative healing Alternative health Any healing technique that may be rooted in supernaturalist methods. See Absent healing, Acupuncture, Acupressure, Alexander technique, Applied kinesiology, Ayurvedic medicine, Bioenergetics, Cayce therapies, response stimulates the deposition of new collagen, smoothing out wrinkles and softening the appearance of acne scars. Smoothbeam is also cleared for the treatment of acne on the back. 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, aesthetic laser systems, and other advanced technologies. Founded near Boston in 1970, the company markets and services its products in over 60 countries from offices in the United States, Europe, Japan and other Asian locations. Candela established the aesthetic laser market 14 years ago, and currently has an installed base of over 6,500 lasers worldwide. Candela is an Equal Opportunity and Affirmative Action affirmative action, in the United States, programs to overcome the effects of past societal discrimination by allocating jobs and resources to members of specific groups, such as minorities and women. Employer, M/F/H/V M/F/H/V Male/Female/Handicapped/Veteran (employment) . Visit Candela on the Web at http://www.candelalaser.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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. Candela's actual results could differ materially from those anticipated in Candela's forward-looking statements based on various factors, including without limitation: the cancellation or deferral of customer orders, dependence on a small number of strategic distribution relationships, difficulties in the timely development and market acceptance of new products, market developments that vary from the current public expectations concerning the growth of the laser industry, increased competitive pressures, or changes in economic conditions. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended June 29, 2002, and subsequent Quarterly Reports on Form 10-Q Form 10-Q See 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. |
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