WESTFORD, Mass., May 17, 2011 /PRNewswire/ -- Cynosure, Inc. (Nasdaq: CYNO), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced the receipt of two additional international clearances for the Company's new flagship workstations for cellulite reduction.
Cynosure has received regulatory clearance from Australia's Therapeutic Goods Administration (TGA) for its Cellulaze™ Cellulite Laser Workstation, the world's first minimally invasive surgical device for the long-term reduction of cellulite. The Company also has obtained approval to market its SmoothShapes XV, a non-invasive system for the temporary reduction in the appearance of cellulite, from the Taiwan Food and Drug Administration (TFDA). Cynosure plans to sell these products through its independent distributors in each country.
"Australia and the Asia Pacific are important and attractive markets for Cynosure as we focus on expanding the international reach of our newest products, particularly our cellulite platform," said President and Chief Executive Officer Michael Davin. "Consumer demand for aesthetic procedures in these countries is strong, and practitioners are eager to integrate new technologies capable of providing safe, efficacious treatments that result in high levels of patient satisfaction. We are encouraged about the prospects for Cellulaze and SmoothShapes XV as we grow their distribution channels and build global product recognition."
Cellulaze and SmoothShapes XV have received CE Mark certification in the European Union. SmoothShapes XV also is cleared for marketing in the United States.
Cellulaze, which uses laser thermal energy to target cellulite beneath the surface of the skin, is designed to restore the skin's normal structure and underlying connective tissue. A recently presented clinical study demonstrated the potential of Cellulaze's minimally invasive, sidelight three-dimensional optical fiber and 1440 nm Nd:YAG laser in delivering long-lasting benefits for the treatment of cellulite. The condition is marked by dimply herniations and depressions within the layers of the skin, typically on the waist, buttocks and thighs. Cellulite affects an estimated 85 percent of women over age 20(1).
The SmoothShapes XV system treats cellulite through a proprietary process known as Photomology®, which combines laser and light energy with mechanical manipulation (vacuum and massage) to produce tighter, smoother-looking skin.
About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis and reduce the appearance of cellulite. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., as well as other statements containing the words "believes," "anticipates," "plans," "expects," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's history of operating losses, its reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which are filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure's views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, while Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure's views as of any date subsequent to the date of this press release.
(1) Rawlings, A.V. Cellulite and its treatment. Int. J. Cosmet. Sci. 28, 175–190 (2006).
Contact:
Scott Solomon Vice President Sharon Merrill Associates, Inc. Phone: (617) [email protected]
SOURCE Cynosure, Inc.
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Cynosure has received regulatory clearance from Australia's Therapeutic Goods Administration (TGA) for its Cellulaze™ Cellulite Laser Workstation, the world's first minimally invasive surgical device for the long-term reduction of cellulite. The Company also has obtained approval to market its SmoothShapes XV, a non-invasive system for the temporary reduction in the appearance of cellulite, from the Taiwan Food and Drug Administration (TFDA). Cynosure plans to sell these products through its independent distributors in each country.
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"Australia and the Asia Pacific are important and attractive markets for Cynosure as we focus on expanding the international reach of our newest products, particularly our cellulite platform," said President and Chief Executive Officer Michael Davin. "Consumer demand for aesthetic procedures in these countries is strong, and practitioners are eager to integrate new technologies capable of providing safe, efficacious treatments that result in high levels of patient satisfaction. We are encouraged about the prospects for Cellulaze and SmoothShapes XV as we grow their distribution channels and build global product recognition."
Cellulaze and SmoothShapes XV have received CE Mark certification in the European Union. SmoothShapes XV also is cleared for marketing in the United States.
Cellulaze, which uses laser thermal energy to target cellulite beneath the surface of the skin, is designed to restore the skin's normal structure and underlying connective tissue. A recently presented clinical study demonstrated the potential of Cellulaze's minimally invasive, sidelight three-dimensional optical fiber and 1440 nm Nd:YAG laser in delivering long-lasting benefits for the treatment of cellulite. The condition is marked by dimply herniations and depressions within the layers of the skin, typically on the waist, buttocks and thighs. Cellulite affects an estimated 85 percent of women over age 20(1).
The SmoothShapes XV system treats cellulite through a proprietary process known as Photomology®, which combines laser and light energy with mechanical manipulation (vacuum and massage) to produce tighter, smoother-looking skin.
About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis and reduce the appearance of cellulite. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., as well as other statements containing the words "believes," "anticipates," "plans," "expects," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's history of operating losses, its reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which are filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure's views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, while Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure's views as of any date subsequent to the date of this press release.
(1) Rawlings, A.V. Cellulite and its treatment. Int. J. Cosmet. Sci. 28, 175–190 (2006).
Contact:
Scott Solomon Vice President Sharon Merrill Associates, Inc. Phone: (617) [email protected]
SOURCE Cynosure, Inc.
