Pharmacy News Article

Nov. 13A review of data from a pivotal clinical trial testing an obesity-fighting device developed by EnteroMedics Inc. might not be so dire, after all.

The Roseville-based medical device company said Thursday the device, called Maestro, may promote weight loss when combined with diet, behavioral support and exercise in morbidly obese patients.

Last month, the company announced that a 294-patient study testing a pacemaker-like device to treat obesity failed to meet its primary and secondary goals.

The company had hoped to use the study to bolster its application to the Food and Drug Administration (FDA), which would permit U.S. sales of the device. With the nation's obesity levels reaching epidemic proportions an estimated 83 million Americans will be obese by 2010 the company was seen as one of the more promising medical device start-ups in Minnesota in recent years.

EnteroMedics said the study met all of its safety goals and that the 252 patients still enrolled are being encouraged to continue using the device for at least nine hours a day. The implanted device blocks the vagus nerve by using low pulses of electricity to essentially trick the brain into thinking the stomach is full.

CEO Mark Knudson said in a statement that results from the two arms of the study, along with previous clinical trials, "suggest a pattern of positive clinical outcome when blocking the vagus nerve." Results from the control and treatment arms of the study were "statistically indistinguishable," he said.

An added finding from the company's review was that subjects in the study suffering from high blood pressure demonstrated a "statistically significant" decrease.

Knudson said the company will discuss the study with the FDA "to determine the appropriate regulatory path."

After preliminary results of the clinical trial were announced in October, the company laid off 22 people, roughly 40 percent of its workforce.

In the third quarter, EnteroMedics lost $12 million, missing Wall Street's estimates, and received a deficiency letter from the Nasdaq market, where its shares are listed. The letter indicated the company is in danger of being delisted if it does not maintain a market value of listed securities totaling $50 million. The company has until Jan. 19 to regain Nasdaq's compliance.

EnteroMedic's stock, which has plunged 87 percent over the past year, closed Thursday at 69 cents.

Janet Moore 612-673-7752

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