BRISBANE, Calif., January 27, 2009 — Cutera, Inc. (Nasdaq: CUTR), a leading provider of laser and other light-based aesthetic systems for practitioners worldwide, today announced Health Canada approval for its Pearl Fractional laser for skin resurfacing and the treatment of wrinkles.
"Pearl Fractional shipments are commencing immediately into the Canadian market," Cutera President and CEO Kevin Connors said.
"This approval confirms that Pearl Fractional meets all health, safety, and environmental standards required by Canada’s Ministry of Health."
"Pearl Fractional is designed to safely and effectively repair deep dermal imperfections in just one treatment with an average recovery of five days," Connors continued. And our customers outstanding clinical results and histology data support that it’s working.
A recent study revealed that 94 percent of patients were pleased to extremely happy with their treatment results and 95 percent of patients would recommend a Pearl Fractional treatment.
"Pearl Fractional can be used on the entire face or just problem areas. It is especially good for treating the periorbital, perioral and jawline areas," said Brian Biesman, M.D., medical director of the Nashville Centre for Laser and Facial Surgery in Nashville, TN and current president of the American Society for Laser Medicine and Surgery.
Biesman continued, "When combined with Cutera's Pearl laser for full epidermal renewal, I have a unique solution for a deep and full coverage treatment. My patients are thrilled to see improvements in not only their wrinkles, but also with their uneven skin texture, pigmentation and sun damage. Pearl and Pearl Fractional offer a unique and outstanding option for skin rejuvenation."
Pearl Fractional is the only fractional ablative laser based on the 2790 nm wavelength with proprietary YSGG technology. Due to its specific water absorption characteristics, 2790 nm is an optimal laser wavelength for providing the dual benefit of deep dermal ablation with a controlled zone of thermal coagulation to maximize results while minimizing post-operative downtime.
Pearl Fractional received FDA clearance and CE Mark approval in 2008.
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 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.
Potential risks and uncertainties that could affect Cutera’s business and its financial results and cause them to differ materially from the forward-looking statements herein include the global economic crisis, which may reduce consumer demand for its products, cause potential customers to delay their purchase decisions and make it more difficult for some potential customers to obtain credit financing; its ability to successfully develop and acquire new products and applications and market them to both its installed based and new customers; the length of the sales cycle process; unforeseen events and circumstances relating to its operations; government regulatory actions; 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 November 3, 2008. 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.