Innovation, influence and business in America's medical cities.

Let’s do it again.EnteroMedics Inc., based in Roseville, Minnesota, said Monday that the Food and Drug Administration has approved a new clinical trial for its Maestro anti-obesity device that uses electricity to suppress hunger.The news represents a major victory for EnteroMedics whose previous study ended in failure. Last October, initial results from the EMPOWER studies [...]

Ernie Andberg has a little more free time on his hands these days.The long-time “emerging medical device companies” equity analyst for Feltl & Co. in Minneapolis has not seen a lot of companies emerging lately.In fact, they’ve been disappearing all together. Case in point: Medtronic Inc.’s (NYSE: MDT) deal last week to acquire ATS Medical [...]

University Enterprise Laboratories (UEL), the St. Paul-based bioscience incubator that never quite lived up to expectations, is planning an ambitious $20 million expansion project.UEL plans to add 40,000 square feet of lab and office space on 3.5 acres of land next to the facility, according to documents obtained by MedCity News.The project is in its [...]

Someday, in the not-so-distant future, EnteroMedics Inc. officials might look back at late 2009 and laugh. Or cry.That ultimately depends on whether the Food and Drug Administration ultimately approves or rejects the company’s groundbreaking Maestro device. Approval means enormous financial success, the only implantable neurostimulation device in the United States designed to treat obesity. Rejection [...]

Patients will measure their vital signs such as blood pressure, pulse and weight, and respond to questions related to their diseases on a daily basis. A clinical care team will review the data, and will be able to use videoconferencing to further evaluate the patients.

EnteroMedics and Leptos are both developing a device that uses electricity to treat obesity. But that’s where the similarities end, EnteroMedics CEO Mark Knudson told me in a quick phone call.

After discussions with the U.S. Food and Drug Administration, EnteroMedics will apply for approval to conduct another human trial to supplement results from an earlier study, which showed the company’s Maestro’s device did not perform any better than the control group.

Last November, Nasdaq threatened to delist EnteroMedics because its stock failed to trade above $1.00 for ten consecutive days. The company has until May 12, 2010 to comply with the rule or face expulsion- again.

EnteroMedics is dangling precariously off a cliff. Last fall, initial results from its Empower clinical study failed to meet the company’s goals.