ReShape Lifesciences™ Receives FDA 510(k) Clearance for the GIBI HD™ Calibration Tubes for use in Gastric and Bariatric Procedures
August 10 2022 - 12:05PM
ReShape Lifesciences™ (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health solutions company, today announced it has received U.S. Food
and Drug Administration (FDA) 510(k) clearance for the disposable,
Gastro Intestinal Balloon Indicator (GIBI HD™) calibration tube for
use in gastric and bariatric surgical procedures. The company
expects U.S. commercial sales to begin in September 2022.
The GIBI HD™ includes three new sizes – 32, 36,
and 40 Fr – all designed to simplify bariatric procedures such as
laparoscopic sleeve gastrectomy, gastric bypass and adjustable
gastric banding. The large diameter and blunt tip design of the new
calibration tube allows for confident placement and rapid
decompression to ensure greater visibility and provide guidance to
allow for straighter staple lines. Additionally, compared to
reusable bougies and disposable gastric tubes, ReShape
Lifesciences’ GIBI HD™ is a multifunctional device. The GIBI HD™ is
also less traumatic to the patient, as it is intended to fit to the
lesser curvature of the stomach more easily and quickly reach the
pylorus.
“FDA clearance of our GIBI HD™ calibration tube,
which supports bariatric procedures across the spectrum, marks an
important addition to our suite of physician led weight loss
solutions and we look forward to formally introducing this
important new product at the International Federation for the
Surgery of Obesity and Metabolic Disorders – IFSO 2022 World
Congress in Miami, later this month,” stated Michael Bordainick,
Senior Vice President, Commercial Operations at ReShape
Lifesciences. “The GIBI HD™ is a valuable tool for physicians, with
a balloon feature that helps bariatric surgeons better visualize
the anatomy, making it easier to identify potential defects. As we
have communicated to the market, we continue to innovate our
pipeline of physician prescribed, insurance reimbursed weight loss
solutions including the Lap-Band® Program, supportive
reshapecare™ Virtual Health Coaching Platform and
the ReShape Optimize™ line of supplements by ProCare Health,
available on ReShape Marketplace™. It is truly an exciting time for
ReShape as we solidify our position as the premier physician-led
weight loss and metabolic health-solutions company.”
About ReShape
Lifesciences™ReShape Lifesciences™ is the premier global
weight loss and metabolic health-solutions company, offering an
integrated portfolio of physician-led, proven products and services
that manage and treat obesity and metabolic disease. The
FDA-approved Lap-Band® Program 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 ReShape Vest™ System is an investigational
(outside the U.S.) minimally invasive, laparoscopically implanted
medical device that wraps around the stomach, emulating the gastric
volume reduction effect of conventional weight-loss surgery. It
helps enable rapid weight loss in obese and morbidly obese patients
without permanently changing patient anatomy.
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. The recently launched ReShape
Marketplace™ is an online collection of quality wellness products
curated for all consumers to help them achieve their health goals.
For more information, please visit www.reshapelifesciences.com
Forward-Looking Safe Harbor
StatementThis 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 that the company expects U.S. commercial sales of the
GIBI HD™ to begin in September 2022. 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
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