EnteroMedics (NSDQ:ETRM) revealed results for the 1st 18 months of its 5-year ReCharge pivotal trial for its VBLOC therapy, an implanted neurostimulator designed to help prevent obesity.
VBLOC therapy limits signals from vagus nerve, which regulates gastrointestinal and metabolic mechanisms such as expansion of the stomach as food enters. The pacemaker-like device Maestro device stimulates the nerve to alter perceptions of hunger and fullness.
The prospective double-blind, sham-controlled clinical trial involved 239 randomized patients at 10 sites in the U.S. and Australia. Researchers reported that patients in the VBLOC group lost 25% of excess weight compared to 12% for the sham group; 54% of patients in the VBLOC group achieved at least 20% excess weight loss, compared to 26% for the sham control group at the 18-month interval, according to a press release.
“Durable weight loss over time is a critical, if challenging, goal in bariatric medicine, one that plays a significant role in achieving long-term health benefits," president & CEO Dr. Mark Knudson said in prepared remarks. "These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety, underscoring the attractive benefit risk profile of VBLOC Therapy. If approved, VBLOC may help to address the lifelong challenges associated with obesity by offering a treatment option that supports safe, long-term weight loss and a healthy lifestyle."
The St. Paul, Minn.-based company rose 51.4% on release of the results, as stocks closed at $2.24 on Dec. 3rd. Shares were up another 3.6% today, trading at $2.01 as of about 2:30 p.m.