Cutera Announces Regulatory Clearance of truSculpt® iD in Canada
September 06 2018 - 7:00AM
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 iDJaggi
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 iDA 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.
Additional Resources
- truSculpt iD Product Page
- truSculpt iD Patient Microsite
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.
Investor RelationsMatthew ScaloVP, Investor Relations and
Corporate Development
415-657-5500mscalo@cutera.com
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