Cutera Receives CE Mark for Its New Laser, Pearl
Cutera, Inc.® (Nasdaq:CUTR), a leading provider of laser and other light-based aesthetic systems for practitioners worldwide, today announced it received CE Mark approval for its new laser, Pearl, with proprietary YSGG technology. Pearl received its FDA clearance in March 2007 and represents the first application of the 2790 nm wavelength for cosmetic dermatology.
“Receiving the CE Mark means that Pearl has satisfied the safety, health and environmental standards required by the European Union,” said Kevin Connors, President and CEO of Cutera. “We will immediately begin shipping Pearl into the EU community and other countries that recognize the CE Mark.”
Cutera will market Pearl, a minimally invasive laser, in Europe to improve the appearance of wrinkles, uneven texture, age spots and sun damage with only one or two treatments and minimal downtime. Clinical data supports that Pearl’s controlled thermal effect creates residual heat in the upper dermis that stimulates new collagen production. Pearl is expected to become a leading skin-rejuvenation procedure because of its patient-friendly approach and excellent clinical results.
Pearl is available on Cutera’s multi-application Xeo platform, as an upgrade to all existing customers, and as a standalone unit.
About Cutera, Inc.
Brisbane, Calif.-based Cutera is a leading provider of laser and other light-based aesthetic systems to the professional aesthetic market. Since 1998, Cutera has been developing innovative, easy-to-use products that enable dermatologists, plastic surgeons, gynecologists, primary care physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients. For more information, call 1-888-4CUTERA or visit www.cutera.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the anticipated success of obtaining regulatory clearances, compiling effective clinical studies and making, marketing and selling new products are forward-looking statements within the meaning of the Safe Harbor. Forward-Looking statements are based on management’s current, preliminary expectations and are subject to risks and uncertainties, which may cause Cutera’s actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect Cutera’s business and its financial results include its ability to improve sales productivity and increase sales performance worldwide; its ability to successfully develop and market new products; unforeseen events and circumstances relating to its operations; government regulatory actions; general economic conditions; and those other factors described in the section entitled, “Risk Factors,” in its most recent Form 10-Q as filed with the Securities and Exchange Commission on May 7, 2007. Undue reliance should not be placed on forward–looking statements which speak only as of the date they are made. Cutera undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.