SculpSure submental application now FDA-cleared for patients with BMI up to 49, the highest BMI clearance on the market
MARLBOROUGH, Mass.–(BUSINESS WIRE)–#TempSure–Hologic’s (Nasdaq: HOLX) Cynosure division announced today the launch of two new products that expand the Company’s growing portfolio of innovative aesthetic treatments — the TempSure® Firm handpiece and a petite mask for SculpSure® submental treatments. SculpSure submental treatments are now cleared by the U.S. Food and Drug Administration (FDA) for patients with a body mass index (BMI) up to 49 — the highest BMI clearance on the market for submental treatments.
The TempSure Firm handpiece is the latest addition to the TempSure platform. It delivers monopolar radiofrequency energy through unique massage heads to gently heat tissue and temporarily reduce the appearance of cellulite. The new 60 mm handpiece allows practitioners to treat larger areas of the body at a faster rate, without surgery or downtime.
Cynosure also received 510(k) clearance from the FDA for its petite submental mask, which attaches to the SculpSure platform. This new product will allow practitioners to perform WarmSculpting™ Profile treatments of submental fat (known as “double chin”) on patients with a narrow jawline. The new submental mask makes the treatment accessible to an even broader audience. The FDA clearance also includes an expanded BMI range for all SculpSure submental treatments, now available to patients with a BMI up to 49 — the highest BMI clearance on the market for submental treatments.
“The WarmSculpting Profile treatment was already a game changer for addressing the double chin, and after listening to customer feedback, we are excited to introduce the petite mask — the latest evolution of the cutting-edge SculpSure device,” said Erik Anderson, Hologic’s Division President, Cynosure. “Our clinicians tell us almost 20 percent of their patients have smaller, narrow jawlines, and with the new petite mask, they can help even more men and women feel their best with non-surgical fat reduction in that area. The updated BMI clearance of 49 for all submental treatments is a clear competitive advantage and underscores our market-leader status in the body contouring category.”
“The TempSure Firm handpiece enhances the functionality and versatility of our already cutting-edge TempSure radiofrequency platform,” Anderson added. “The larger 60 mm handpiece allows practitioners to further expand and differentiate their practices, while treating more patients seeking to temporarily reduce the appearance of cellulite. These launches are prime examples of the continuous innovation we are committed to in order to best serve our patients and providers.”
WarmSculpting treatments with SculpSure are clinically proven, non-surgical body contouring (lipolysis) treatments designed to permanently eliminate fat cells in problem areas.1 The SculpSure device’s selective wavelength laser targets fat cells under the skin and raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return.1
The TempSure Firm handpiece is the latest innovation launched on the TempSure platform — an expandable technology that provides the ability to perform surgical and non-surgical aesthetic applications in one convenient 300W, 4MHz device. The TempSure platform is the ideal choice for practitioners across a variety of specialties with a broad range of needs, including plastic surgery, dermatology, gynecology and ophthalmology.
“The new offerings from Cynosure allow practitioners to meet the growing patient demand in the expanding arena of body contouring,” said Dr. Raminder Saluja of Saluja Cosmetic and Laser Center. “TempSure Firm allows me to confidently, and now more quickly, address patient needs and deliver results they’re looking for. WarmSculpting Profile treatments with SculpSure are my go-to option for patients looking for noticeable results without surgery, and now with the expanded BMI clearance and petite mask, I can treat those who might not have been candidates before.”
In conjunction with these launches, Cynosure has updated its SculpSure software to include a new, optional, guided mode feature. Developed to help clinicians treat patients more easily, it features a preset algorithm for energy titration, resulting in a controlled increase in temperature to achieve lipolysis, as well as energy setting parameters designed to guide providers into a repeatable and comfortable treatment for their patients.
To learn more about SculpSure and its applications, please visit www.cynosure.com/sculpsure.
To learn more about the TempSure radiofrequency platform, please visit www.cynosure.com/tempsure-platform.
Indications for Use
The SculpSure device is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs, and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. Individual results may vary and are not guaranteed. WarmSculpting treatments with SculpSure are not intended for weight-loss results or for people who are obese. Mild side effects may occur, including temporary tenderness, swelling, or tissue firmness in the treatment area. Please consult with your physician to see if WarmSculpting treatments are right for you.
The TempSure Firm treatment provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite. Product for use by an appropriately licensed and trained healthcare professional who remains responsible for diagnosis and treatment.
About Hologic, Inc.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
1Single treatment of average reduction in fat volume as measured by MRI; Clinical and Histological Evaluations of a 1060nm Laser Device for Non-Invasive Fat Reduction – John W. Decorato, MD., F A C S. Rafael Sierra, Ph.D., Bo Chen, Ph.D., Westford, MA, 2014.
©2019. Hologic, Inc. All rights reserved. Cynosure, SculpSure and TempSure are registered trademarks of Cynosure, LLC. WarmSculpting and TempSure Firm are trademarks of Cynosure, LLC.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.
SOURCE: Hologic, Inc.
*Dr. Saluja is a paid consultant for Cynosure, LLC
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