Weight loss: EnteroMedics names new operating chief ahead of FDA bid

EnteroMedics logo

Minnesota weight-loss devices maker EnteroMedics (NSDQ:ETRM) announced today that CFO and senior vice president Greg Lea had also been appointed chief operating officer.

Lea will help the company get through its 2013 objective to make progress on its pre-market approval application for the Maestro vagal blocking system, an implanted neurostimulator designed to stimulate the Vagus nerve in order to alter a patient’s eating habits by modifying physiological cravings.

"Greg has been a member of EnteroMedics’ strategic management team since joining the company over 5 years ago," president & CEO Mark Knudson said in prepared remarks. "With our attention now fully on the U.S. regulatory process and its associated activities, his leadership and depth of knowledge provide a strong basis for successful management of the critical period the company’s operations are now entering."

The company may have some hurdles ahead in convincing FDA regulators to put the stamp of approval on the Maestro system. The device failed to meet pre-defined endpoints in its recent ReCharge pivotal trial, EnteroMedics announced earlier this month.

The company is hoping that the demonstrated rates of excess weight-loss achieved with the Maestro system, as well as the device’s safety profile, will be enough to get through the premarket approval process.

The company’s shares have yet to recover from the dramatic drop following news of the failed trial. ETRM shares opened at $2.97 on Thursday, Feb. 7, 2013, prior to the release of the study results, and had sunk 57.6% over the weekend to open at $1.26 on Monday, Feb. 11.

Shares continued to drop during the month, and were trading at $1.15 as of about 12:20 p.m. today.

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