MARLBOROUGH, Mass.,
Sept. 27, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq:
HOLX) announced today that the U.S. Food and Drug
Administration (FDA) has granted an expanded FDA 510(k) clearance
for Cynosure's non-invasive body contouring
product, SculpSure®. The state-of-the-art body contouring
laser treatment is now cleared to treat a double chin (also known
as the submental area), marking the product's sixth cleared body
treatment area. SculpSure® is also cleared to treat the abdomen,
love handles (flanks), back, and inner and outer thighs.
"Most patients in the 57-person 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.
"We are encouraged that our chin treatment was proven effective
on patients with a body mass index (BMI) up to 43, while our
competition in the non-invasive arena is only FDA-cleared to treat
patients with a BMI up to 30," said Kevin Thornal, Divisional
President of Cynosure at Hologic. "We are excited to provide our
customers with a competitive advantage that can further widen their
patient communities."
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.
Media Contact
Jane Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact
Michael Watts
858.410.8588
michael.watts@hologic.com
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SOURCE Hologic, Inc.