Hologic Receives CE Mark to Market SculpSure® for Non-Invasive Body Contouring (Lipolysis) of the Submental Area (Under the Chin)
Patients in Clinical Studies Report 100% Satisfaction
MARLBOROUGH, Massachusetts, Oct. 17, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that it has received an additional European Medical Device Directive (MDD) certification for SculpSure®, a state-of-the-art body contouring laser treatment. The device is now certified to treat a double chin (also known as the submental area), marking the product's sixth certified body treatment area. SculpSure® is also certified to treat the abdomen, love handles (flanks), back, and inner and outer thighs.
The certification allows Hologic to place the CE Mark on SculpSure® double chin (submental) treatments for use in the European Union (EU) and its member states. The double chin (submental) treatment requires practitioners to purchase a simple laser attachment, which will allow the treatment applicators to fit seamlessly onto the area. Hologic's Cynosure sales force will begin distribution immediately to interested practitioners.
"Most patients in the 57-person submental clinical trial received two brief treatments six weeks apart," said Dr. Lawrence Bass, board certified plastic surgeon and a principal investigator in the SculpSure clinical trials. "The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area."
SculpSure® is an advanced, non-invasive body contouring treatment that helps patients achieve a natural-looking, slimmer appearance. The fully customizable treatment uses a laser to raise the temperature of body fat to precisely disrupt and destroy fat cells under the skin. The fat cells are then naturally eliminated over time and do not return. Each treatment lasts approximately 25 minutes and requires no surgery or downtime.
"The receipt of the CE Mark to treat double chin is an important growth milestone for SculpSure®," said Kevin Thornal, Divisional President of Cynosure at Hologic. "The laser's proven effectiveness rate coupled with the fact that SculpSure® is certified to treat patients with a wider BMI range than our competition in the submental area will provide healthcare professionals with a distinct treatment advantage that can drive demand and widen their patient communities."
To learn more about SculpSure® or visit 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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