Minnesota-based EnteroMedics will meet on May 29 with the FDA’s expert panel, hoping to land approval for its flagship Maestro implant, which uses mild electrical pulses to stimulate the vagus nerve located between the stomach and the esophagus. Clinical studies have shown that stimulating the vagus nerve may help modify physiological cravings and help patients form better eating habits.
The panel date is good new for EnteroMedics, which hit some hurdles on the road to pre-market approval for its landmark device. The FDA last year asked the company to provide more data on its device testing and clinical data, including information on user training and post-approval studies. EnteroMedics said at the time that the additional requests would not hamper its progress or hurt its estimated time-lines.
EnteroMedics submitted its FDA application in June 2013, hoping to land indication to treat obesity, metabolic diseases and other gastrointestinal disorders. The Maestro system has been on the European market since winning CE Mark approval in 2011.
The company announced the FDA panel date alongside the release of its Q4 and full-year 2013 financial report, in which the company posted continued, but narrowing, losses as it pursued several clinical trials.
EnteroMedics reported losses of $6.6 million, or 11¢ per share, during the 3 months ended December 31, falling just a penny shy of analysts’ consensus expectations for the quarter. That compared with losses of $7 million, or 17¢ per share, during the same period the previous year.
For the full year, EnteroMedics reported losses of $25.8 million, or 47¢ per diluted share, right on target with Wall Street’s estimate. That compared with losses of $23.5 million, or 59¢ per share, during 2012.
"Operating expenses were primarily associated with the cost of supporting multiple ongoing clinical trials, including the ReCharge Study, the Company’s VBLOC vagal blocking therapy Premarket Approval (PMA) application, and the continued development of VBLOC Therapy delivered through the company’s Maestro Rechargeable System," according to a press release.
ETRM shares jumped early this morning, opening at $2.43, a 12.5% bump over last night’s close of $2.16. Shares settled down by the afternoon and were flat at $2.16 as of about 1:45 p.m.