[May 24, 2016] |
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GI Windows Announces Data from First-Ever Clinical Study on a New Non-surgical Procedure to Treat Type 2 Diabetes with Self-Assembling Magnets at Digestive Disease Week® 2016
GI Windows, Inc., a clinical-stage medical device company, today
announced the presentation of six-month results of the first-ever
clinical study evaluating the endoscopic creation of a dual-path enteral
diversion using the company's Incision-less Anastomosis System (IAS) at
Digestive Disease Week® 2016 (DDW), in San Diego, Calif. The
data support the safety and efficacy of GI Windows' IAS as a treatment
option for Type 2 diabetes in obese patients.
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For more than 20 years, studies have confirmed that obese patients with
Type 2 diabetes can experience significant and lasting metabolic
improvements through bariatric surgeries, such as the gastric bypass1.
The GI Windows technology enables a non-surgical procedure that can
divert a portion of ingested food from the proximal to distal small
bowel, providing a less-invasive approach to achieve comparable
long-term metabolic benefits as those seen in bariatric surgery.
Click Here
to See Self-assembling Magnets Used to Create The Dual-path Enteral
Diversion
Click Here
to Listen to Christopher C. Thompson, MD, discuss The Dual-path Enteral
Diversion at DDW 2016
The study reported on the safety and metabolic impact of a dual-path
enteral diversion using GI Windows' Incision-less Anastomosis System.
The procedure was performed on 10 obese patients, with a mean body mass
index of 41. Four patients had Type 2 diabetes and three more patients
were in the pre-diabetic range.
The study found that the dual-path enteral diversion was safely created
in all patients, and the IAS devices were expelled without incident. At
six months, investigators observed that all patients experienced
significant reductions in HbA1c and fasting blood glucose levels. For
patients with pre-diabetes, HbA1c levels were reduced from a mean
baseline of 6.1 percent to 5.25 percent at six months, and fasting blood
glucose levels decreased from 119 mg/dl to 105 mg/dl. Patients with Type
2 diabetes showed a decrease of HbA1c from a mean baseline of 7.8
percent to 6.0 percent at six months, with a decrease in fasting blood
glucose leels from 177 mg/dl to 111mg/dl. All patients had fasting
blood glucose levels move from the diabetic or pre-diabetic range to the
normal range at six months. The mean weight loss for all patients was
approximately 28 pounds (12.9 kg), representing a 10.6 percent decrease
in total weight loss.
"Type 2 diabetes is a global pandemic and non-surgical treatment options
are needed to effectively help the millions of patients manage this
chronic condition," said Evžen Machytka, MD, PhD, Ostrava University
Hospital, a study investigator. "The results from this six-month
study are promising and suggest that the IAS, which relies on mechanisms
of action proven in surgical approaches, has the potential to markedly
reduce HbA1c, fasting blood glucose levels, and weight in obese patients
with Type 2 diabetes. These findings warrant further investigation of
the IAS technology."
Click Here
to Listen to Evžen Machytka, MD, PhD, about the First in Human Clinical
Study at DDW 2016
The dual-path enteral diversion was created with a flexible endoscope,
as smart, magnetic devices are deployed from the scope and self-assemble
in the small bowel. The devices transform from a linear shape to an
octagonal geometry and then couple to form an anastomosis -- a
connection between two hollow or tubular structures or organs. Coupled
devices are eventually expelled naturally, leaving behind an anastomosis
without residual foreign material. Patients enrolled in the study were
restricted to a two-week post-op liquid/soft diet, underwent an upper GI
series to confirm anastomotic patency (the degree of openness or
exposure) at two weeks post implant, and received follow-up endoscopies
at two and six months to visualize the anastomosis.
"Based on this study's findings, we believe the dual-path enteral
diversion, created with the IAS system, may be a viable treatment option
for obese patients living with Type 2 diabetes," said James Wright,
President and CEO of GI Windows. "Durability of effect, with
non-surgical delivery, is at the core of the GI Windows value
proposition. We are pleased with the results we are seeing at 6 months
and look forward to presenting 12-month data with the self-assembling
magnets in an upcoming publication."
According to the American Diabetes Association, approximately 30 million
children and adults in the United States have diabetes, of which almost
95 percent have Type 2 diabetes.2 In addition, 86 million
U.S. adults are pre-diabetic, according to the Centers for Disease
Control and Prevention.3 Of those with pre-diabetes, 15-30
percent will develop Type 2 diabetes within five years without weight
loss and moderate physical activity.4
To learn more about GI Window, please visit GIWindows.com.
About GI Windows, Inc.
GI Windows is a clinical-stage medical device company developing an
incision-less anastomotic system that can be used to create non-surgical
therapies to treat Type 2 diabetes. The company's technology is designed
to enable durable, intestinal bypasses to address chronic diseases, such
as Type 2 diabetes and obesity, without the cost and invasiveness of
surgical interventions. For more information, visit http://giwindows.com/.
1 Resolution of Type 2 Diabetes Following Bariatric Surgery:
Implications for Adults and Adolescents. Accessed in May 16. 2016: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936261/ 2
American Diabetes Association Website. Accessed on May 11, 2016: http://www.diabetes.org/diabetes-basics/statistics/infographics.html 3
CDC's 2014 National Diabetes Statistics Report. Accessed in May 11,
2016: http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html 4
CDC's 2014 National Diabetes Statistics Report. Accessed in May 11,
2016: http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html
View source version on businesswire.com: http://www.businesswire.com/news/home/20160524005683/en/
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