ST. PAUL, Minn., July 31, 2017 /PRNewswire/ -- EnteroMedics Inc.
(NASDAQ:ETRM), a developer of minimally invasive medical devices to
treat obesity, metabolic diseases and other gastrointestinal
disorders, today announced that the company has received approval
from the Ministry of Health, Social Services, and Equality (MHSSE)
in Spain through the Agency of
Medicines and Medical Devices, and the CEIC Ethics Committee to
initiate a clinical trial for the Gastric Vest™ System in
Spain.
"We are thrilled to have reached this significant clinical
milestone, which supports our plans for CE Mark approval and takes
us one step closer to bringing our Gastric Vest product to market,"
said Dan Gladney, EnteroMedics
President, Chief Executive Officer, and Chairman of the Board. "We
believe that the Gastric Vest, which is designed to allow rapid
excess weight loss over a short period of time through a minimally
invasive, non-anatomy-changing procedure, will offer a novel
solution for the obesity continuum of care."
EnteroMedics expects the safety and performance CE Mark study
for the Gastric Vest to include a total of between 50-100 patients
at up to four sites within the European Union. This approval by the
MHSSE in Spain represents the
first country approval for the Gastric Vest CE Mark trial.
The clinical trial in Spain will
be conducted under the supervision of Principal Investigator, Dr.
Jordi Pujol Gebelli, and Co-Investigator, Dr. Amador Garcia Ruiz de
Gordejuela at Hospital Universitari de Bellvitge, in Barcelona, Spain. Enrollment is expected to
begin by early 2018.
About the Gastric Vest System
The Gastric Vest System (GVS) is an investigational, minimally
invasive, laparoscopically implanted medical device being studied
for weight loss in obese and morbidly obese patients. The device
wraps around the stomach, emulating the effect of conventional
weight-loss surgery, and enables gastric volume reduction without
permanently changing patient anatomy.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the
development and commercialization of technology to treat obesity
and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by
an FDA-approved pacemaker-like device called the vBloc® System, is
designed to help patients feel full and eat less by intermittently
blocking hunger signals on the vagus nerve. EnteroMedics recently
acquired the Gastric Vest System™ through its acquisition of
BarioSurg, Inc.
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. Forward-looking
statements in this release include our plans for CE Mark approval
and bringing our Gastric Vest product to market, our belief that
the Gastric Vest will offer a novel solution for the obesity
continuum of care, and our expectation that the safety and
performance CE Mark study for the Gastric Vest will include a total
of 50-100 patients at up to four sites within the European Union
with enrollment expected to begin by early 2018. 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: our limited history of operations; our losses since
inception and for the foreseeable future; our limited commercial
sales experience with our vBloc® System for the treatment of
obesity in the United States or in
any foreign market other than Australia and the European Community; the
competitive industry in which we operate; our ability to maintain
compliance with the Nasdaq continued listing requirements; our
ability to commercialize our vBloc® System; our dependence on third
parties to initiate and perform our clinical trials; the need to
obtain regulatory approval for any modifications to our vBloc®
System; physician adoption of our vBloc® System and vBloc®
Neurometabolic Therapy; 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 the annual report on Form
10-K filed March 8, 2017, the
quarterly report on Form 10-Q filed May 15,
2017 and the current report on Form 8-K filed July 26, 2017. 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/enteromedics-receives-approval-for-gastric-vest-system-clinical-study-in-spain-300496260.html
SOURCE EnteroMedics Inc.
