About a third of the 22 obese patients using a gastro-intestinal liner as an alternative to gastric bypass surgery have shown positive results in both losing weight and reducing amounts of glycated hemoglobin one year into a clinical trial, according to GI Dynamics.
The Lexington, Mass.-based firm, which is developing a non-surgical “sleeve” that is placed in the upper intestine, released 12-month results from six of its study group of 22 obese patients with Type II diabetes.
The results showed that patients lost an average of 35 pounds and showed an average 2.5-point drop in a common measure of the amount of glycated hemoglobin, or HbA1c, one year into using the device. The clinical trial is being conducted by Dr. Eduardo Moura of Hospital das Clinicas at the University of Sao Paulo, Brazil.
Company officials were bullish on the results. GI Dynamics CEO Stuart Randle called them “a landmark achievement” in a prepared release.
GI Dynamics released similarly positive results back in November, when a group of 19 patients passed the 24-week mark.
The company has used those positive results to attract considerable attention in recent months in both the financial and medical circles. In January, the company closed a $15 million strategic investment from Minneapolis, Minn.-based medical device giant Medtronic Inc. (NYSE:MDT).
In addition, the EndoBarrier digestive tract liner won CE Mark approval in December 2009, 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).
