ORANGEBURG, N.Y., Nov. 28 /PRNewswire/ -- MetaCure Limited, today announced that it began patient enrollment in a national diabetes clinical trial of its TANTALUS(R) System, an investigational device being tested in patients with type 2 diabetes who are overweight. The study is being conducted in up to 30 sites in the United States.
The 300-patient trial will evaluate the TANTALUS, an implantable device that delivers electrical pulses to the stomach when a person eats. The primary objective of the randomized, double-blind controlled study is to evaluate the TANTALUS System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other clinical and metabolic parameters will be studied. To be considered for the trial, patients must meet certain inclusion criteria, including a diagnosis of type 2 diabetes with a body mass index (BMI) between 28 and 45 kg/m2 and ages 18 to 70.
"Even with current medications and lifestyle changes, controlling blood glucose levels in type 2 diabetes patients who are overweight can be difficult," said Naji N. Abumrad, MD, MetaCure's Medical Director and John L. Sawyers Professor of Surgery and Chairman, Department of Surgery at Vanderbilt University Medical Center, Nashville, TN. "We are excited to have this trial underway as a potential alternative treatment for patients where we have been unsuccessful in managing their type 2 diabetes and weight."
Glandular Diseases Center of San Antonio, Texas, is the first trial site to enroll patients. "We are delighted to be participating in this trial and to be the initial center to implant the TANTALUS System in study patients," said Mark Kipnes, MD, of the Glandular Diseases Center.
"The TANTALUS System is currently CE marked and available to patients in Europe for the indication to treat type 2 diabetes with obesity. It has been clinically evaluated in more than 100 patients world wide," explained Dr. Irit Yaniv, MetaCure's Chief Operating Officer. "We look forward to potentially being able to make it accessible in the future to U.S. patients as well."
For more information about the study, please go to www.metacure.com.
More About the TANTALUS System
The TANTALUS System includes a pulse generator and leads that are implanted through a minimally invasive laparoscopic procedure that can be performed in an outpatient setting. The leads are implanted in the gastric muscle and the device is implanted in a subcutaneous pocket.
The system is based on new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment during meal times.
MetaCure Limited was founded in 2003 and is developing minimally invasive solutions for today's most pressing global epidemic, type 2 diabetes. Its flagship product, the TANTALUS System, has already been granted the CE mark in Europe. The company's corporate U.S. offices are based in Orangeburg, New York, and Mt. Laurel, New Jersey. For more information, visit www.metacure.com.
MetaCure (USA) Inc.
30 Ramland Road South, Suite 101
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CONTACT: Erich Sandoval of Lazar Partners, +1-212-867-1773,
firstname.lastname@example.org, for MetaCure Limited
Web site: http://www.metacure.com/