GI Windows' technology delivers magnetic parts via endoscope that then self-assemble in the small bowel, forming an anastomosis before passing out of the body.
Diabetes drugs abound, but many startups are taking the device approach to manage type 2 diabetes, an expensive and chronic condition.
There's Fractyl Laboratories, based in Waltham, MA, that is testing an endoscopic procedure to ablate a portion of the duodenum mucosa in a bid to provide better glycemic control for the patient.
And now another company that believes in the anti-diabetic effect of bariatric-surgery like Fractyl is also developing an endoscopic procedure.
GI Windows, based in West Bridgewater, MA, presented the data this week at Digestive Disease Week in San Diego, CA, for the new treatment that uses self-assembling magnets that showed that at six months there was significant reduction of A1c levels and fasting glucose levels.
So, how does the procedure work?
The dual-path enteral diversion is created with a flexible endoscope through which smart, magnetic devices are deployed from the scope. These magnets then assemble themselves 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," according to a news release. These coupled devices are eventually expelled from the body naturally thereby leaving behind an anastomosis but without any residual foreign implants or materials.
The 10 obese patients who were enrolled in the study had a mean BMI of 41 and were restricted to a two-week liquid/soft diet following the procedure. These patients underwent an X-ray of the upper GI tract to confirm "anastomotic patency" (the degree of openness or exposure) at two weeks after the magnets were introduced. They also received follow-up endoscopes at two and six months so physicians could see the anastomosis.
At six months the results were as follows: For patients with pre-diabetes, HbA1c levels were reduced to 5.25% from a mean baseline of 6.1%. Fasting blood glucose levels decreased to 105 mg/dl from 119 mg/dl. Patients with Type 2 diabetes showed a decrease of HbA1c to 6.0% from a mean baseline of 7.8%, with a decrease in fasting blood glucose levels to 111mg/dl from 177 mg/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 about 28 pounds (12.9 kg) or a 10.6% decrease in total weight loss.
The strong results warrants further trials involving GI Windows' Incision-less Anastomosis System as an option to treat type 2 diabetes in obese patients.
"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," said Ev?en Machytka, MD, a study investigator from Czech Republic's Ostrava University Hospital, in the news release. "These findings warrant further investigation of the IAS technology."
Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.
Arundhati Parmar is a senior editor at UBM.
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