Cynosure Receives FDA Clearance For Smartlipo(TM) System

Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 10 Nov 2006 - 0:00 PDT

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Cynosure, Inc. (Nasdaq: CYNO), a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, today announced it has received clearance from the U.S. Food and Drug Administration for its Smartlipo(TM) system for laser assisted lipolysis, or LaserBodySculpting(SM), a procedure that disrupts fat cells and causes coagulation of the tissue leading to skin tightening. The Smartlipo system provides aesthetic surgeons a new, less- invasive method for reducing fat cells.

Cynosure believes the demand for liposuction and body sculpting procedures that remove or reduce fat cells is increasing. For example, nearly 500,000 liposuction procedures were performed in the U.S. in 2005, making it the number one surgical cosmetic procedure among both women and men according to the American Society for Aesthetic Plastic Surgery (ASAPS).

"I believe that the Smartlipo system is particularly useful for treating areas with localized fat deposits. In addition to disrupting fat, it coagulates and tightens tissue," said Bruce Katz, MD, Clinical Professor at Mt. Sinai School of Medicine and Medical Director of JUVA Skin and Laser Center in New York City. "We have seen excellent results with this new laser lipolysis procedure."

The LaserBodySculpting uses a small cannula, or tube, containing a laser fiber that is inserted into the skin and passed throughout the treatment area. The laser's energy is applied directly to the fat cells, causing them to rupture and drain away. Treatments with the Smartlipo system generally result in less swelling and bleeding as compared to traditional liposuction methods and can usually be performed in one 45-minute session.

"The Smartlipo laser lipolysis is a minimally invasive procedure that is well suited for the treatment of small areas," said Karen Kim, MD, a board- certified dermatologist at the Laser Skin and Surgery Center of New York. "Our early clinical trials suggest that patients experience rapid healing with little tissue trauma. Post-operative results can be seen as soon as one week, with continued improvement over several months."

Cynosure Chairman and Chief Executive Officer Michael R. Davin said, "We are pleased with receiving the FDA clearance ahead of our projected timeline. We are excited to have the exclusive North American distribution rights for this product and expect to launch the Smartlipo system in 2007. The addition of the Smartlipo system to Cynosure's award-winning product suite furthers our ability to provide the aesthetic treatment systems market with diverse tools to enhance our customers' businesses and practices. We believe there will be continued growth in the laser body sculpting and liposuction market as innovative technologies, such as the Smartlipo system, is introduced to meet this growing market."

About Cynosure, Inc.

Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive procedures to remove hair, treat vascular lesions, rejuvenate skin through the treatment of shallow vascular and pigmented lesions and temporarily reduce the appearance of cellulite. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulsed 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 http://www.cynosurelaser.com/.

Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., including statements about the growth in the laser body sculpting and liposuction market, market acceptance and consumer demand for LaserBodySculpting, Cynosure's ability to successfully market and sell the Smartlipo system, and 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 our history of operating losses, our reliance on sole source suppliers, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure's Annual Report on Form 10-K filed with the SEC. 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.

Cynosure, Inc
http://www.cynosurelaser.com/

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