ReShape Lifesciences® Receives FDA PMA Supplement Approval for its Next-Generation Lap-Band® 2.0 FLEX
12 Dezember 2023 - 10:05PM
ReShape
Lifesciences® (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced that the U.S. Food and
Drug Administration (FDA) has granted approval of a PMA supplement
for the company’s next generation, enhanced Lap-Band® 2.0 FLEX.
“PMA supplement approval for our next generation
Lap-Band® 2.0 FLEX is a historic event for ReShape that is expected
to be a key growth catalyst for the company’s Lap-Band® franchise,”
stated Paul F. Hickey, President and Chief Executive Officer of
ReShape Lifesciences. “The enhanced Lap-Band® 2.0 FLEX development
effort was physician-led with the goal of improving the patient
experience. Compared to our current Lap-Band, the Lap-Band® 2.0 has
a new feature called FLEX Technology, which acts as a relief valve,
allowing larger pieces of food to more easily pass through the
narrowed passage (or stoma), created by the band. Specifically, the
band momentarily relaxes before returning to its resting diameter,
therefore, minimizing discomfort caused by passage of large food
pieces through the stoma. The Lap-Band® system is the safest and
most durable weight loss option for obese patients and is ideal for
those who are averse to medically managed weight loss and who opt
for the only available anatomy preserving surgery. We are preparing
for our U.S. product launch of the Lap-Band 2.0 FLEX and look
forward to providing updates on our progress.”
“Based on my 20-year use of the Lap-Band®, over
time, some patients have needed adjustments, particularly when
related to urgent loosening to relieve food obstruction,” stated
Christine Ren-Fielding, M.D., Professor of Surgery at NYU Grossman
School of Medicine, Director of the NYU Langone Weight Management
Program and Chief of the Division of Bariatric Surgery. “Lap-Band
2.0® FLEX will potentially remedy this issue because of the ability
for self-correction, utilizing an internal reservoir system. In
addition, multi-modal therapy is becoming a mainstay in the
bariatric surgery field. GLP-1 agonists can be used to complement
and augment weight loss after surgery to help prevent weight
regain.”
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 the
statement that the PMA supplement approval is expected to be a key
growth catalyst for the company’s Lap-Band® franchise. 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.
Dr. Ren-Fielding receives consulting and other
compensation from ReShape Lifesciences. Her views are her own and
do not represent an endorsement by NYU Langone Health.
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
ReShape Lifesciences (NASDAQ:RSLS)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
ReShape Lifesciences (NASDAQ:RSLS)
Historical Stock Chart
Von Jul 2023 bis Jul 2024