ReShape Lifesciences® Submits FDA PMA Supplement Application for the Next-Generation Lap-Band® 2.0
27 6월 2023 - 5:05AM
ReShape Lifesciences® (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced the submission of a
Premarket Approval (PMA) supplement application to the U.S. Food
and Drug Administration (FDA) for the company’s next generation,
enhanced Lap-Band® 2.0, utilizing a band reservoir technology.
“The PMA supplement submission is a significant
milestone and is consistent with our second growth pillar to
develop and, ultimately, commercialize new products and therapies,”
stated Paul F. Hickey, President and Chief Executive Officer of
ReShape Lifesciences. “This next generation, enhanced Lap-Band® 2.0
was developed with physician feedback to improve the patient
experience. Similar to our current Lap-Band, the Lap-Band 2.0 is
adjustable postoperatively to increase or decrease the opening of
the band in order to optimize an individual’s comfort, thereby
improving therapy effectiveness. However, unique to the Lap-Band
2.0 is an enhanced band reservoir technology that serves as a
relief valve, designed to alleviate discomfort from swallowing
large pieces of food, that may require in-office band adjustments.
We expect feedback from the FDA by year end. If approved, we
believe that based on discussions with physicians, that there will
be broad adoption by existing Lap-Band® surgeons and surgeons that
newly adopt the Lap-Band® 2.0.”
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. ReShapeCare™ is a
virtual weight-management program that supports lifestyle changes
for all weight loss patients led by board-certified health coaches
to help them keep the weight off over time. ReShape Marketplace™ is
an online collection of quality wellness products curated for all
consumers to help them achieve their health goals. 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 the
statements that we expect feedback on the PMA submission from the
FDA by year end, and, if approved, that we believe based on
physician feedback that there will be broad adoption of the
Lap-Band® 2.0 by existing Lap-Band® surgeons and surgeons that
newly adopt the Lap-Band® 2.0. 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:Thomas StankovichChief
Financial Officer949-276-6042ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael
Miller(917)-633-6086mmiller@rxir.com
ReShape Lifesciences (NASDAQ:RSLS)
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ReShape Lifesciences (NASDAQ:RSLS)
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