FDA Clears Candela Smoothbeam for Acne Scars.Business Editors & Health/Medical Writers WAYLAND, Mass.--(BUSINESS WIRE)--Jan. 30, 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 clearance from the U. S. Food and Drug Administration to market its Smoothbeam(TM) diode laser See laser diode. for the non-invasive treatment of atrophic acne scars. Gerard E. Puorro, Candela's President and Chief Executive Officer, commented: "Acne scars affect an estimated 10 million people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Existing therapies including dermabrasion dermabrasion /derm·abra·sion/ (der?mah-bra´zhun) planing of the skin done by mechanical means, e.g., sandpaper, wire brushes, etc.; see planing. der·ma·bra·sion n. , excision, ablation and chemical peels have only marginal efficacy. Smoothbeam treatment of acne scars is the first effective treatment available." Puorro continued: "Our market studies tell us that the opportunity for this application is as large, or larger, than acne itself, particularly in the baby boomer population. The Smoothbeam now has several large and promising applications and, coupled with its table-top size, reliability and affordability, make it a formidable device in our markets." Tina Alster, M.D., Director, Washington Institute for Dermatologic Laser Surgery, and author of the study used for Candela's 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. submission said: "I am very impressed at how well the Smoothbeam modulates collagen for atrophic acne scars. Our clinical study has shown that patients treated with Smoothbeam showed significant improvement in the appearance of their acne scars." Based on the results of her clinical study, Dr. Alster further stated: "After a series of three monthly treatments with Smoothbeam, every patient showed significant improvement - many times exceeding our expectations, and easily outperforming other lasers." The results of Dr. Alster's study were first presented at the American Society of Lasers in Surgery and Medicine (ASLMS ASLMS American Society for Laser Medicine and Surgery ASLMS Authorized Stockage List Mobility System (US Army) ASLMS Adaptive Signleast Mean Squares ). The full study has been accepted for publication in an upcoming issue of the Journal of the American Society of Dermatologic Surgery. 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 5,000 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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