GI Dynamics Inc. is once again touting positive data from clinical trials of its EndoBarrier gut liner, confirming earlier data showing that the device helps reduce the symptoms of Type II diabetes and helps obese patients lsoe weight.
The Lexington, Mass.-based startup cited a pair of studies, one involving obese patients and another involving obese Type II diabetics, examining its EndoBarrier gastrointestinal liner. The device is a plastic sleeve that’s inserted via endoscope into the small intestine, where it slows the absorption of food nutrients.
The studies enrolled 61 patients and monitored them for weight loss or gain and also monitored 22 diebetic patients for a common measure of the amount of glycated hemoglobin, or HbA1c. Those patients, who entered the study with a mean body mass index of 44.9 and mean baseline blood sugar levels of 8.9 percent HbA1c, showed a drop of 1.5 percent HbA1c after 24 weeks, with 58 percent achieving HbA1c levels of 7 percent or less. All patients in the studies showed a mean weight loss of about 33 pounds.
One patient’s device migrated during the study before the end of 24 weeks, which GI Dynamics called "a significant improvement" over the first-generation design of the device, according to a press release. Eight other EndoBarriers were removed early due to "device-related adverse events such as GI discomfort," according to the release.
It’s the latest round of positive clinical data for GI Dynamics, which in March announced that its first batch of patients passed the one-year mark. The results showed that patients lost an average of 35 pounds and showed an average 2.5-point drop in HbA1c, one year into using the device.
The company announced similarly positive results in November 2009, when a group of 19 patients passed the 24-week mark. The EndoBarrier won CE Mark approval the next month, clearing the way for sales to begin within the European Union this year. Earlier in 2009 GI Dynamics also closed on $15 million in Series C funding from a host of investors, including Waltham, Mass.-based Polaris Venture Partners and Johnson & Johnson Development Corp., the private-equity arm of the healthcare giant J&J (NYSE:JNJ). And early this year Medtronic Inc. (NYSE:MDT) put $15 million into GI Dynamics’ coffers.