GI Dynamics Selects Proven Process Medical Devices as Contract Manufacturer
July 25 2017 - 5:45PM
Business Wire
GI Dynamics® Inc. (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe, the Middle East and
South America for patients with type 2 diabetes and obesity, today
announced the selection of Proven Process Medical Devices, Inc.
(PPMD) as its contract manufacturing partner.
PPMD is one of the nation’s leading designers and manufacturers
of Class II and Class III medical devices. The company was founded
in 1994 to address the unmet need for an outsource provider to the
medical device industry with the in-depth technical, quality
and regulatory knowledge needed to develop and manufacture
sophisticated medical products. To ensure success, the company
founders developed a “proven process” that combines creative,
state-of-the-art research and development with exceptional design,
process and quality controls to achieve new product development and
manufacturing success.
Proven Process Medical Devices will manufacture EndoBarrier at
its facilities in Mansfield, Massachusetts. The company was
selected for its deep experience in the medical device field and
ability to support production of implantable medical device
technology.
“We are pleased to be selected by GI Dynamics for the
manufacture of EndoBarrier,” said Ken Fine, president and
co-founder of PPMD. “We look forward to continuing our relationship
with GI Dynamics to provide this important product for the
treatment of type 2 diabetes and obesity.”
“We look forward to working with PPMD as our manufacturing
partner,” said Scott Schorer, president and chief executive officer
of GI Dynamics. “We have been working towards the transfer of our
manufacturing to PPMD for the past 18 months, and expect that PPMD
will manufacture EndoBarrier to the highest quality and in a
tightly cost-contained manner.”
“The implementation of our contract manufacturing partnership is
another critical action as we move to make EndoBarrier available
around the world for patients suffering from type 2 diabetes and
obesity," said Schorer.
About GI Dynamics
GI Dynamics, Inc. (ASX:GID) is the developer of EndoBarrier, the
first endoscopically-delivered device approved for the treatment of
type 2 diabetes and obesity. EndoBarrier is not approved for sale
in the United States and is limited by federal law to
investigational use only in the United States. Founded in 2003, GI
Dynamics is headquartered in Boston, Massachusetts. For more
information, please visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains forward-looking statements. These
forward-looking statements are based on GI Dynamics management’s
current estimates and expectations of future events as of the date
of this announcement. Furthermore, the estimates are subject to
several risks and uncertainties that could cause actual results to
differ materially and adversely from those indicated in or implied
by such forward-looking statements. These risks and uncertainties
include but are not limited to, risks associated with obtaining
funding from third parties; the consequences of stopping the ENDO
trial and the possibility that future clinical trials will not be
successful or confirm earlier results; the timing and costs of
clinical trials; the timing of regulatory submissions; the timing,
receipt and maintenance of regulatory approvals; the timing and
amount of other expenses; the timing and extent of third-party
reimbursement; risks associated with commercial product sales,
including product performance, competition, market acceptance of
products, intellectual-property risk; risks related to excess
inventory; and risks related to assumptions regarding the size of
the available market, the benefits of our products, product
pricing, timing of product launches, future financial results and
other factors, including those described in our filings with the
U.S. Securities and Exchange Commission. Given these uncertainties,
one should not place undue reliance on these forward-looking
statements. We do not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information or future events or otherwise, unless we are required
to do so by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20170725006562/en/
GI DynamicsInvestor RelationsUnited States:Janell
Shields, +1 781-357-3280investor@gidynamics.com
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