GI Dynamics Releases EndoBarrier Re-Implantation Data from German Diabetes Congress
June 05 2017 - 7:46PM
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 brought
forward data from an investigator-initiated study presented at the
German Diabetes Congress 2017 in Hamburg, Germany. Initial data was
introduced that examined the safety and efficacy of EndoBarrier
re-implantation for the treatment of patients with type 2 diabetes
and obesity.
The observational study titled “Is Re-Implantation of the
Duodenal-Jejunal Bypass Liner Viable?” explored whether it is
technically feasible to re-implant EndoBarrier in patients who
previously had the device implanted and explanted, as well as
whether the re-implantation would achieve similar weight and
metabolic effects as on patients who had received prior EndoBarrier
implantation.
Five patients participated in this study. Each patient completed
an initial course of EndoBarrier treatment for a twelve month
period. The device was explanted and the patients were monitored
for 4 months. A second EndoBarrier was then implanted for a twelve
month course of treatment and subsequently removed.
Implant 1
/
(Baseline)
Explant
1
Rest
Period
Implant
2
Explant
2
12 months --> 4 months
12 months -->
HbA1c, % 9.1%
6.7%
7.8% 7.1% Reduction, absolute %
2.4%
0.7%
from baseline:
2.0%
Total Body Weight, kg 115.8
95.0
97.3 91.1 Reduction, kg
20.8
6.2
from baseline:
24.7
BMI (kg/m^2) 33.9
32.5 Insulin, iU/day 60
19 33
20 Reduction, iU/day
41
13
from baseline: 40
“Although small, this study provided important information
regarding serial usage of EndoBarrier,” said Jurgen Stein, MD, the
Primary Investigator of this study. “Re-implantation and
re-explantation of the EndoBarrier device were performed on all
five study subjects without any complications, and the early
clinical data is promising. In addition, there was a significant
reduction in insulin.”
“The study shows early indication of efficacy to support
multiple treatments utilizing EndoBarrier. Especially encouraging
is the reduction of blood sugar and weight combined with concurrent
reduction in insulin,” said Scott Schorer, president and CEO of GI
Dynamics. “We appreciate Dr. Stein’s efforts to conduct a study
that adds such interesting insights into the growing body of
evidence proving EndoBarrier safety and efficacy.”
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 obesity. EndoBarrier is approved
and commercially available in multiple countries outside the United
States. 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 concerning
the potential for EndoBarrier as an important treatment option for
patients with type 2 diabetes and obesity. 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/20170605006303/en/
GI Dynamics, Inc.Investor RelationsUnited States:Janell
Shields, +1 781-357-3280investor@gidynamics.comorMedia
RelationsUnited States:Nicole Franklin, +1
617-657-1312nfranklin@jpa.com
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