Dynamics, Inc. (ASX: GID), a medical device company
developing innovative treatments for type 2 diabetes and obesity,
announced that Mark C. Twyman is leaving his position as chief
commercial officer, effective today. GI Dynamics has launched a search
for a president and chief operating officer to augment its leadership
team and oversee the global sales and marketing efforts for EndoBarrier®
Therapy. In the interim, other members of senior management will assume
Mr. Twyman's responsibilities.
"On behalf of the Company's Board, I want to thank Mr. Twyman for his
service to the Company and wish him well in his future endeavors,"
stated Stuart A. Randle, chief executive officer of GI Dynamics.
The Company also advises that it is experiencing challenging business
conditions in certain key self-pay commercial markets. Preliminary
revenues for the second quarter are estimated to be slightly below first
quarter 2014, in part due to less than expected sales in Chile, as well
as delayed regulatory approval in Brazil. Further information on second
quarter financial results will be provided with the filing of the
Appendix 4C and Form 10Q, for the period ended June 30, 2014.
The EndoBarrier device is currently under investigation in the U.S. in a
multicenter, pivotal clinical trial (The
ENDO Trial) for the treatment of patients who have uncontrolled type
2 diabetes and are obese. EndoBarrier Therapy has been approved in
select countries internationally since 2010 and is available in Chile,
Australia and select countries in Europe and the Middle East.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®,
the first endoscopically-delivered device therapy approved for the
treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and
commercially available in multiple countries outside the U.S.
EndoBarrier is not approved for sale in the U.S. and is limited by
federal law to investigational use only in the United States. GI
Dynamics is conducting a pivotal clinical trial of EndoBarrier in
the U.S. for the treatment of patients who have uncontrolled type 2
diabetes and are obese. Founded in 2003, GI Dynamics is headquartered in
Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains forward-looking statements concerning: our
development and commercialization plans; our potential revenues, costs,
profitability and financial performance; our ability to obtain
reimbursement for our products; our clinical trials, and associated
regulatory submissions and approvals; the number and location of
commercial centres offering the EndoBarrier®; and our
intellectual property position. These forward-looking statements are
based on the current estimates and expectations of future events by the
management of GI Dynamics, Inc. as of the date of this announcement and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those indicated
in or implied by such forward-looking statements, including those
described in our filings with the U.S. Securities and Exchange
These risks and uncertainties include, but are not limited to: risks
associated with the possibility that clinical trials will not be
successful or confirm earlier results; risks associated with obtaining
funding from third parties; risks relating to the timing and costs of
clinical trials, results of clinical trials, the timing of regulatory
submissions, the timing and receipt of regulatory approvals, the timing
and amount of other expenses; execution risks; competition; risks
related to market acceptance of products; intellectual property risks;
and assumptions regarding the size of the available market, benefits of
our products, product pricing, timing of product launches, future
financial results and other factors. Given these uncertainties, you
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,
future events or otherwise, unless required by law.
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