SAN CLEMENTE, Calif.,
April 24, 2018 /PRNewswire/
-- ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of
minimally invasive medical devices to treat obesity and metabolic
diseases, announced today that the ReShape Balloon™ was
granted registration by the National Health Regulation Authority
(NHRA) in the Kingdom of Bahrain
and the Company has signed a distribution agreement with Yousuf
Mahmood Husain CO W.L.L. of Bahrain.
It was reported in Bahrain
This Week, which quotes the latest Health Ministry statistics,
that almost half of the Bahraini adult male population and
one-third of Bahraini women are overweight or obese. According to
Renew Bariatrics, as much as 75% of the population in the Middle
East Region is overweight or obese, which is over twice the
worldwide obesity rate of 30%.
Yousuf Mahmood Husain CO W.L.L is one of Bahrain's largest and most broad-based health
care companies and one of the leading suppliers of products to
Bahrain Ministry of Health, Bahrain Defense Force and private
hospitals. The company was established over 75 years ago and
is one of the largest distributors of medical supplies in the
Middle East and Bahrain.
About ReShape Lifesciences Inc.
ReShape Lifesciences™ is a medical device company focused on
technologies to treat obesity and metabolic diseases. The
FDA-approved ReShape Balloon™ System involves a non-surgical weight
loss procedure that uses advanced balloon technology designed to
take up room in the stomach to help people with a 30-40
kg/m2 Body Mass Index (BMI) and at least one
co-morbidity lose weight. ReShape vBloc™ Therapy, delivered by an
FDA-approved pacemaker-like device called the ReShape vBloc System,
is designed to help patients with a 40-45 kg/m2, or a
35-39.9 kg/m2 BMI and at least one co-morbidity feel
full and eat less by intermittently blocking hunger signals on the
vagus nerve. The ReShape Vest™ System is an investigational,
minimally invasive, laparoscopically implanted medical device that
wraps around the stomach, emulating the gastric volume reduction
effect of conventional weight-loss surgery, and is intended to
enable rapid weight loss in obese and morbidly obese patients
without permanently changing patient anatomy.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. 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. These
forward-looking statements are based on the current expectations of
our management and involve known and unknown risks and
uncertainties that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others: risks and uncertainties related to our acquisitions
of ReShape Medical, Inc. and BarioSurg, Inc.; risks related to the
U.S. Food and Drug Administration's announcement to alert health
care providers of unanticipated deaths involving the ReShape
Balloon; our proposed ReShape Vest product may not be successfully
developed and commercialized; our ability to continue as a going
concern if we are unsuccessful in our pursuit of various funding
options; our limited history of operations; our losses since
inception and for the foreseeable future; our limited commercial
sales experience; the competitive industry in which we operate; our
ability to maintain compliance with the Nasdaq continued listing
requirements; our dependence on third parties to initiate and
perform our clinical trials; the need to obtain regulatory approval
for our ReShape Vest and any modifications to our vBloc system or
ReShape Balloon; physician adoption of our products; our ability to
obtain third party coding, coverage or payment levels; ongoing
regulatory compliance; our dependence on third party manufacturers
and suppliers; the successful development of our sales and
marketing capabilities; our ability to raise additional capital
when needed; international commercialization and operation; our
ability to attract and retain management and other personnel and to
manage our growth effectively; potential product liability claims;
the cost and management time of operating a public company;
potential healthcare fraud and abuse claims; healthcare legislative
reform; and our ability to obtain and maintain intellectual
property protection for our technology and products. These and
additional risks and uncertainties are described more fully in the
Company's filings with the Securities and Exchange Commission,
particularly those factors identified as "risk factors" in our
annual report on Form 10-K filed April 2, 2018. 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.
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SOURCE ReShape Lifesciences Inc.