The 239-patient pivotal Recharge trial examined weight-loss differences between patients who were implanted with the Maestro device, which provides vBloc therapy, and patients who were implanted with a similar neuroregulator that did not.
At 12 months, patients treated with vBloc therapy demonstrated 25.8% excess weight loss, 8.9% greater than the excess weight loss achieved by patients in the sham group. At 18 months, vBloc patients sustained 23.5% excess weightloss, versus 10.2% in the sham group.
“Because of the cyclical nature of obesity, sustainable weight loss is a critical measure of success in the treatment of this disease. Results at 18 months from the ReCharge Study demonstrate both the sustainability of weight loss using vBloc Therapy, a distinct contrast to the weight regain experienced by the sham control group, and the unique safety profile of the device over time. Publication of these results underscores vBloc Therapy’s important new position within the obesity treatment spectrum, where, historically, options such as anatomy altering or restricting surgery have required substantial tradeoffs in lifestyle, nutrition and safety,” lead author and EnteroMedics chief medical officer Dr. Scott Shikora said in a press release.
The Maestro device functions by stimulating the vagal nerve, which is associated with hunger and satiety, in a specific manner that St. Paul, Minn.-based Enteromedics says helps patients lose weight. To control for differences between groups, the sham devices contained a similar neuroregulator that dissipated charge into a resistor at a rate similar to the active device.
The study will continue to track patients up to 5-years. Additional long-term data and continued follow-up data are needed to further evaluate the safety and effectiveness of vBloc therapy, according to the study.
Earlier this month, Enteromedics closed a $14.7 million follow-on offering it initially hoped would gross $35 million. The company initially planned to float 40.2 million shares at 87¢ apiece,for gross proceeds of $35 million. That offering was to have consisted of 1 ETRM share, plus Series A and Series B warrants. But the company was forced to cancel the issue after the NASDAQ Capital Market said wouldn’t approved the transaction.
Instead, EnteroMedics retooled the offering to 32 million shares at 50¢ apiece, comprised of 1 ETRM share plus Series A warrants.