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Cutera Announces Regulatory Clearance of truSculpt® iD in Canada
BRISBANE, Calif., Sept. 06, 2018 (GLOBE NEWSWIRE) -- CUTERA, INC., (Nasdaq: CUTR) (“Cutera” or the “Company”) a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced today that Canada’s medical device regulatory authority, Health Canada, recently granted regulatory approval for the truSculpt iD® system. Commercial shipments to Canada will begin immediately. truSculpt iD is 510(k) cleared by the U.S. Food and Drug Administration for non-surgical fat-reduction and circumferential reduction procedures.
“Canada has proven to be a key market for Cutera, and I am very excited that we can now introduce this new revolutionary aesthetic technology to our Canadian customers,” said Jason Richey, Chief Operating Officer of Cutera, Inc. “truSculpt iD offers excellent clinical results at a much faster procedure time and allows physicians to effectively treat those who might not be candidates for other contouring procedures. We expect that the Canadian approval will meaningfully drive truSculpt iD revenue going forward.”
First Centers in Canada with truSculpt iD
Jaggi Rao, MD, FRCPC, Rao Dermatology: "As well-known experts in skin care technologies and innovative laser treatments, we are proud to be one of the first centers in Canada that will be offering truSculpt iD to our community in Alberta. We are privileged to be a part of the Cutera family and are looking forward to helping our clients achieve their individual aesthetic goals with the most advanced device on the market today, truSculpt iD.”
Sachit Shah, MD, Beautiful Canadian Laser and Skin Care Clinic: “We are seeing a strong demand for aesthetic treatments at our practice and are excited to offer patients a more personalized solution. trusculpt iD treats multiple body areas at the same time which will represent a huge step forward in non-invasive body contouring, and we are very excited to be one of the first to offer this service to our patients.”
About truSculpt iD
A non-surgical body contouring system, truSculpt iD uses innovative monopolar radio frequency (RF) technology to selectively target tissue and therapeutically heat it to achieve optimal results. This platform tailors to patients’ individual needs and offers an improved patient experience. With Real-Time Temperature Control working to provide consistent results, studies have shown an average fat reduction of 24 percent1, with patients seeing improvements 6-12 weeks following the first treatment.
The launch of truSculpt iD comes at a time of significant growth for the industry. Research shows non-surgical fat reduction as the top non-surgical and non-invasive procedure in 2017, with procedures increasing by 24.7 percent. Looking ahead, the body shaping and skin tightening market is expected to expand by 14.5 percent year-over-year.
1Amy Taub Study ASDS 2017 Poster.
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.
VP, Investor Relations and Corporate Development