Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure® for Non-Invasive Body Contouring (Lipolysis) of Back, Inner and Outer Thighs
SculpSure Now Cleared to Treat Five Areas of the Body
Jun 15, 2017, 08:00 ET
MARLBOROUGH, Mass., June 15, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for Cynosure's non-invasive body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treatment of the abdomen and love handles (flanks).
SculpSure is a clinically proven, non-surgical body contouring (lipolysis) treatment designed to permanently eliminate fat cells in problem areas. Developed by Cynosure, a world leader in medical aesthetics and division of Hologic, SculpSure utilizes a selective wavelength laser that precisely targets fat cells under the skin. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return. Patients are able to achieve desired results – without downtime or surgery – through customized treatment plans, each lasting only 25 minutes.
"The approval of SculpSure to treat back fat and the inner and outer thighs is a direct response to the growing needs of our consumers, who are looking to achieve a slimmer appearance and enhance the body they work hard to maintain," said Michael Davin, Divisional President of Cynosure at Hologic. "Cynosure is a leader in medical aesthetics and pioneer in light-based fat reduction, and we expect the addition of three known body problem areas to SculpSure's already advanced, versatile treatment to further drive demand and pave the way for future innovations."
To learn more about SculpSure, please visit www.SculpSure.com.
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.
Hologic, The Science of Sure and SculpSure are registered trademarks of Hologic, Inc. in the United States and/or other countries.
Forward-Looking Statements
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.
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SOURCE Hologic, Inc.