ReShape Lifesciences® Receives Health Canada Approval for its Next-Generation Lap-Band® 2.0 FLEX
November 12 2024 - 8:31AM
ReShape Lifesciences® (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced that Health Canada has
updated the Medical Device License granting approval for the
company’s next generation, enhanced Lap-Band® 2.0 FLEX and Tubing
Kit.
“Approval by Health Canada for the Lap-Band® 2.0
FLEX is yet another significant milestone for ReShape and an
important growth catalyst for the company’s Lap-Band® franchise,”
stated Paul F. Hickey, President and Chief Executive Officer of
ReShape Lifesciences. “As a reminder, the enhanced Lap-Band® 2.0
FLEX was designed with physician feedback with the goal of
improving the patient experience. Like the current Lap-Band,
Lap-Band® 2.0 FLEX can be adjusted postoperatively to increase or
decrease the band opening, thus optimizing eating habits and
comfort. Additionally, Lap-Band® 2.0 FLEX has a new feature called
Flex technology, which acts as a relief valve, enabling larger
pieces of food to pass through the narrowed passage more easily.
Specifically, the band momentarily relaxes before returning to its
resting diameter, while minimizing discomfort caused by swallowing
large food pieces. Recently, we have successfully completed the
limited market release of the Lap-Band® 2.0 FLEX in the U.S., and
initial surgeon feedback has been overwhelmingly positive, we are
analyzing data and metrics that will be used to support our U.S.
commercial launch. Additionally, we now look forward to launching
the product in Canada in the near future.”
About ReShape Lifesciences®
ReShape Lifesciences® is America’s premier weight loss and
metabolic health-solutions company, offering an integrated
portfolio of proven products and services that manage and treat
obesity and metabolic disease. The FDA-approved Lap-Band® System
provides minimally invasive, long-term treatment of obesity and is
an alternative to more invasive surgical stapling procedures such
as the gastric bypass or sleeve gastrectomy. The investigational
Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system utilizes a
proprietary vagus nerve block and stimulation technology platform
for the treatment of type 2 diabetes and metabolic disorders. The
Obalon® balloon technology is a non-surgical, swallowable,
gas-filled intra-gastric balloon that is designed to provide
long-lasting weight loss. For more information, please visit
www.reshapelifesciences.com.
Forward-Looking Safe Harbor
Statement This press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Actual results could differ materially from
those discussed due to known and unknown risks, uncertainties, and
other factors. These forward-looking statements generally can be
identified by the use of words such as "expect," "plan,"
"anticipate," "could," "may," "intend," "will," "continue,"
"future," other words of similar meaning and the use of future
dates. Forward-looking statements in this press release include
statements about the company’s expected commercial launch of the
Lap-Band® 2.0 in the U.S. and Canada. These and additional risks
and uncertainties are described more fully in the company's filings
with the Securities and Exchange Commission, including those
factors identified as "risk factors" in our most recent Annual
Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
We are providing this information as of the date of this press
release and do not undertake any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or otherwise, except as required
by law.
CONTACTSReShape Lifesciences Investor
Contact:Paul F. HickeyPresident and Chief Executive
Officer949-276-7223ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael
Miller(917)-633-6086mmiller@rxir.com
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