The St. Paul, Minn.-based company’s vBloc system is designed to intermittently block the vagus nerve using high-frequency, low-energy electrical impulses.
The therapy is approved in the U.S., Europe and Australia to aid weight loss in people with a body mass index of 40 to 45 or a body mass index of 35 to 39.9 with a related health condition.
The 28-patient study evaluated the safety and efficacy of the vBloc therapy by measuring average percentage excess weight loss, blood sugar, fasting plasma glucose and blood pressure following device activation. After 3 years, no deaths, unanticipated adverse device effects or life-threatening complications occurred, EnteroMedics reported.
Results from the study showed that average percentage excess weight loss was 21% with reductions in blood sugar of 0.6% from a baseline of 7.8%. Nearly 40% of participants either lessened or stopped their diabetes medications as a result of the reduction in blood sugar.
“In addition to maintaining weight loss over time, successful management of comorbid conditions such as diabetes is critical,” Dr. Charles Billington, from the University of Minnesota, said in prepared remarks. “The 3-year data from the vBloc DM2 study continue to demonstrate that vBloc Therapy not only provides durable improvements in weight loss through 3 years, but also improved glycemic control in obese patients with Type II diabetes who do not wish to undergo anatomy-altering weight-loss procedures.”
“We are encouraged by the strong 3 year results seen in the vBloc DM2 study, as the data provides additional evidence of the benefit that vBloc Therapy can offer to patients battling obesity and Type II diabetes,” president & CEO Dan Gladney added. “Obesity and Type II diabetes are two of the most serious societal health concerns throughout the world today, and innovative treatments like vBloc Therapy have the potential to stem the tide against these dangerous and debilitating conditions.”
ETRM shares were trading at $7.38 in mid-morning activity, up +9.6%.
In December, the company released a real-world assessment of weight loss data from patients using its vBloc therapy device and associated programs, touting between 9% and 10% total weight loss at 6 and 9 months, respectively.