GI Dynamics, Inc. - ASX Announcement
GI Dynamics, Inc. Announces Commercial Availability of the EndoBarrier® for the Treatment of Type 2 Diabetes and/or Obesity in the NetherlandsLexington, Mass., United States and Sydney, Australia - January 4, 2012 - GI Dynamics, Inc. (ASX: GID) today announced the transition of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), a novel, non-surgical device for the treatment of type 2 diabetes and/or obesity, from clinical research to commercial use in the Netherlands. To date, nearly 100 patients have been treated with the EndoBarrier in clinical trials conducted in the Netherlands.
"We have studied the EndoBarrier for several years and are
very happy with the improvements in blood sugar and weight
loss our patients have achieved," said Ignace Janssen, M.D.,
clinical study investigator and bariatric surgeon, Vitalys
Obesitas Centrum, Rijnstate Hospital,
Arnhem, Netherlands. "Our clinical experience has given us a
keen understanding of the type
2 diabetes patients and/or obese patients who would be good
candidates for EndoBarrier therapy. Additionally, it has
helped us develop the optimal treatment program that will
help ensure successful outcomes for our patients."
Martin Kirch, director of Vitalys Clinics added, "The
EndoBarrier is filling a gap in our treatment paradigm. In
particular, we believe it can help obese diabetic patients in
the lower BMI range. The EndoBarrier provides an approach to
better manage type 2 diabetes and related comorbidities for
these patients."
The EndoBarrier has received European CE mark approval and is
commercially available
in Chile, Germany, the United Kingdom, the Netherlands and
Austria. The EndoBarrier has also received TGA approval and
will soon be available in Australia.
"We are delighted that the EndoBarrier is now being offered
commercially through this Center of Excellence in the
Netherlands," said Stuart A. Randle, president and chief
executive officer, GI Dynamics. "In particular, the success
this center has had implanting the EndoBarrier under
conscious sedation is very exciting and could potentially
translate into reduced costs and even more rapid recovery.
These are important milestones for the company as we expand
from clinical to commercial use in key European markets."
The EndoBarrier is a thin, flexible, tube-shaped liner that
forms a physical barrier between food and a portion of the
wall of the intestine. It has been clinically proven to lower
HbA1c levels,
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