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Regulatory clearance triggers immediate commencement of customer shipments to Canada and Taiwan for the first and only high-powered, dual wavelength and dual pulse duration laser featuring picosecond technology
BRISBANE, Calif., Feb. 12, 2016 -- Cutera, Inc. (NASDAQ:CUTR) (“Cutera” or the “Company”), a leading provider of laser and energy-based aesthetic systems for practitioners worldwide, announced today that Canada’s medical device regulatory authority, Health Canada, and the Taiwanese Ministry of Health and Welfare recently granted regulatory clearance for its enlightenTM picosecond laser platform. Commercial shipments to Canada as well as Taiwan will begin immediately. enlighten is 510(k) cleared by the U.S. Food and Drug Administration for tattoo removal and the treatment of benign pigmented lesions.
“Canada has proven to be a key market for Cutera, so the clearance for our enlighten picosecond laser platform by Health Canada for both tattoo removal as well as the treatment of benign pigmented lesions is an important milestone. I am very pleased that we may now begin selling this leading product in Canada. Similarly, our clearance to sell enlighten in Taiwan for the same dual indications means that we may commence shipments there as well. enlighten has proven to be a globally popular platform, and we expect that the Canadian and Taiwanese clearances will meaningfully drive 2016 enlighten revenue,” said Kevin Connors, President and CEO of Cutera, Inc.
About Cutera, Inc.
Brisbane, California-based Cutera is a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide. 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 Cutera's ability to increase revenue, reduce expenses, make productivity improvements, grow the Company’s market share, realize benefits from additional investment, achieve profitability, penetrate the market, generate cash from operations, and statements regarding long-term prospects and opportunities in the laser and other energy-based equipment aesthetic market 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 cause its financial results to differ materially from those contained in the forward-looking statements include those related to the Company’s efforts to improve sales productivity, hire and retain qualified sales representatives, improve revenue growth, gross margins and profitability through leveraging operating expenses; the Company’s ability to successfully develop and launch new products and applications and market them to both its installed base and new customers; unforeseen events and circumstances relating to the Company’s 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 2nd, 2015. 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. Cutera's financial performance for the fourth quarter ended December 31, 2015, as discussed in this release, is preliminary and unaudited, and subject to adjustment.
Cutera, Inc. Ron Santilli Chief Financial Officer 415-657-5500 Investor Relations John Mills Integrated Corporate Relations, Inc. 646-277-1254 [email protected]
