EnteroMedics (NSDQ:ETRM) today released a real-world assessment of weight loss data from patients using its Maestro vBloc therapy device and associated programs, touting between 9% and 10% total weight loss at 6 and 9 months, respectively.
St. Paul, Minn.-based EnteroMedic’s Maestro device is an implantable neurostimulation device designed to intermittently block the vagus nerves using high-frequency, low-energy impulses. The therapy, which the company calls “vBloc,” is approved in the U.S., Europe and Australia to aid in weight loss in obese adults with a body mass index of 40 to 45 or a related health condition and a BMI of 35 to 39.9.
The company said it gathered the data for the assessment from its US vBloc institutes, and that results mirrored those from the ReCharge pivotal trial of the device, which also reported 9% and 10% at 6 and 9 months, respectively.
“The patients who received their vBloc Therapy implant at vBloc Institutes and participated in the Company’s vBloc Achieve support program achieved total weight loss comparable with the patients in the ReCharge Pivotal Trial, which utilized a very demanding patient follow-up protocol and was used to secure FDA approval. The corroboration of our clinical trial results in an everyday environment provides additional support for vBloc as a revolutionary treatment option for morbidly obese patients who do not wish to undergo anatomy-altering weight-loss procedures. These data are yet another important proof point in the advancement of our commercialization strategy and efforts to secure broad reimbursement coverage to make vBloc Therapy widely available to all patients. The commercial results appear to be equal to the solid results from our clinical trial and we will be submitting these data for presentation at a future medical meeting and for journal article publication as appropriate,” CEO & chair Dan Gladney said in a press release.
The FDA granted pre-market approval for the Maestro device in January 2015.
In October, EnteroMedics said it cancelled a special meeting of stockholders it had scheduled to vote on increasing stock numbers and initiating a reverse stock split after a lack of support from shareholders.
The company sought to increase the number of shares of common stock to 650 million in its 1st proposition, and was looking for approval to initiate a 1-for-10 or 1-for-20 reverse stock in the second, according to an SEC filing.