ANVISA Approval Awarded to Cutera’s truSculpt Body Sculpting Systems

CUTERA Inc. announced that Brazil’s healthcare regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), recently granted regulatory approval for truSculpt iD and truSculpt 3D systems. The truSculpt family of devices use innovative monopolar radiofrequency technology to elevate tissue temperature for fat reduction and are approved by ANVISA for body sculpting and contouring, circumferential reduction, the treatment of skin laxity, and for the improvement in the appearance of cellulite.
 
“Brazil is a large and fast-growing aesthetic market, and we are pleased to add this to our product offerings in Brazil and selected markets throughout South America,” said Cutera CEO David Mowry.

“truSculpt is enormously popular for patients seeking body contouring treatments in the United States. This ANVISA clearance allows us to further partner with our South American physician customers to enhance their practices,” added Jason Richey, Cutera’s president.
 
Sao Paulo-based Endocrinologist, Dr. Elaine Dias Jakubowski, is the first provider to introduce the truSculpt technology into her practice in Brazil. “We’ve been monitoring the progress of body sculpting technologies from Cutera in the U.S. for some time now and have researched the options for the best body shaping device. We are pleased with truSculpt’s clinical results, its ability to treat all different patient body types, as well as its best-in-class design and functionality. With radiofrequency (RF) technology, we are excited to begin offering this service to patients looking to reduce body fat in stubborn areas, where diet and exercise alone don’t achieve the desired results. We look forward to growing our practice in Sao Paulo through truSculpt.”
 
Research shows the Latin American market for energy-based devices (EBD), including body shaping and aesthetics, was $211 million in 2018, with a projected five-year compound annual growth rate (CAGR) of 10 percent.¹
 
Commercial shipments of truSculpt systems to Brazil have already begun. The company launched truSculpt iD in the United States in 2018, and truSculpt 3D in 2017.
 
truSculpt is a non-surgical fat reduction treatment that uses monopolar radiofrequency (RF) technology. truSculpt offers two options for non-surgical monopolar radiofrequency body sculpting. Both systems are clinically proven to get rid of stubborn fat cells permanently by an average of 24 percent,² even in areas that are resistant to diet and exercise.
 
The truSculpt iD is clinically proven to eliminate fat in as little as one 15-minute hands-free treatment, completely personalized to an individual’s needs. truSculpt 3D gives individuals the power to reshape dimension, improve definition, and reduce overall depth in one simple 60-minute provider hand-held treatment.
 
Brisbane, Calif.-based Cutera provides laser and other energy-based aesthetic systems for practitioners worldwide. Since 1998, Cutera has been developing products that enable physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients.
 
References
¹ Medical Insight, Inc.
² Amy Taub, MD, Study ASDS 2017 Poster