Healthcare Industry News:  Combined Apex Pulse 

Devices Regulatory

 News Release - September 7, 2006

Cynosure Receives CE Mark Approval for Affirm(TM) Laser System

Micro-rejuvenation device designed to reduce the appearance of wrinkles, scars and skin discoloration

WESTFORD, Mass., Sept. 7 (HSMN NewsFeed) -- Cynosure, Inc. (Nasdaq: CYNO ), a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, today announced it has received CE mark approval for the Affirm(TM) system, the company's single-platform, multi-energy technology for skin rejuvenation, including treatments for wrinkles, skin texture and discoloration. This approval allows for the marketing of the Affirm system throughout the European Union, as well as many other countries worldwide.

"Gaining CE mark approval for the Affirm system -- our fifth flagship product -- underscores the efficacy and reliability of our award-winning technology," said Cynosure CEO Michael R. Davin. "It also validates the success of our modular construction and design, which provides greater flexibility to physician practices by supporting a diverse range of high-volume skin rejuvenation applications.

"Skin rejuvenation represents one of the fastest growing segments of the aesthetic laser marketplace," Davin continued. "The initial market response to the Affirm system has been decidedly positive, and we believe its ease of use, versatility and speed will set it apart from competing devices. Our proprietary disposable microlens array combined with the Affirm system workstation offers providers the ability to treat patients far more rapidly than other products available in the market today -- thereby increasing patient throughput for doctors, treatment centers or spas. We are enthusiastic about the long-term prospects for the Affirm system."

Cynosure remains on track to begin initial Affirm system workstation shipments in the United States and Europe in the third quarter of 2006. Pending the necessary regulatory approvals, product shipments are expected to begin in Canada and the Pacific Rim as early as the end of this year.

"We have been using the Affirm system for more than nine months and have achieved outstanding results," said Robert A. Weiss, MD, of the Laser Skin and Vein Institute in Baltimore. "Its speed and simplicity make this an ideal technology for our practice. Our patients prefer it to conventional energy delivery technologies for scar and wrinkle treatments."

The Affirm system is the only device utilizing the Combined Apex Pulse(TM) (CAP) technology for reducing the appearance of wrinkles and scars with micro-rejuvenation capabilities to create a more complete skin treatment. The proprietary CAP technology found in the Affirm system delivers light energy of varying intensity levels to provide one platform for the treatment for wrinkles, micro-rejuvenation and skin discoloration.

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 future use and market acceptance of the Affirm system, the markets in which Cynosure's products are sold, 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.


Source: Cynosure

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