Minnesota medical device maker EnteroMedics (NSDQ:ETRM) appeared unfazed by the FDA’s response to the company’s premarket approval application, anticipating no slowdown in the regulatory process for its landmark Maestro weight-loss implant.
"We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely manner," president & CEO Mark Knudson said in prepared remarks. "We believe that the company continues on track for a panel in late Q4 2013/Q1 2014 with approval decision in the 1st half of 2014."
EnteroMedics submitted its FDA application earlier this year, 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 FDA’s recent response asked the company to provide more information on device testing and clinical data, the company said, including user training and post-approval studies.
"The company anticipates responding to the FDA’s questions within the coming weeks," according to a statement.
Despite EnteroMedics’ optimism, ETRM shares dropped 1.7% by the early afternoon, trading at $1.19 as of about 1:50 p.m.
EnteroMedics’ Maestro device stimulates the Vagus nerve, located between the stomach and the esophagus, in order to alter a patient’s eating habits by modifying their physiological cravings. Maestro delivers VBLOC therapy through 2 laparoscopically implanted leads that intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. The therapy is powered by an internal battery, which is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.