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InsideLook: Can EnteroMedics Gain Access to the Neural Pathway to Manage Weight?


Posted by Heather Thompson on December 17, 2010

EnteroMedics doesn't have a product on the market, but its still getting attention for its plans to fight obesity.


Obesity is a complex disease—one that medicine, psychology, and countless life-coach efforts have not been able to cure with any satisfactory consistency. Different methods work (or don’t work) for different people, some work temporarily, and some have actually proved far more dangerous than acceptable limits allow.

Obesity Facts
 

19

percentage of all Americans over the age of 20 designated as obese in 1997.
 

30

percentage of all Americans classified as obese in 2005.
 

23 million

number of Americans considered severely or morbidly obese.
 

100,000

number of deaths associated with obesity in the United States each year.

Nonetheless, this hasn’t stopped the scientific community from working to find a solution to the complicated problem, and in many respects, the medical device industry (through bariatric surgical techniques) has shown greater efficacy than decades of self-help books, OCT drugs, and even pharmaceuticals.

But even the device industry’s best efforts could be improved, because these procedures demand high maintenance postsurgery (restrictions on eating habits, supplement injections, etc.)

By tapping into the vagus nerve rather than changing the physiology of the stomach, one company is trying to make the process less invasive than gastric banding or bypass techniques.

EnteroMedics Inc. is a start-up company that is clinically investigating VBLOC, vagal blocking therapy, to address the large unmet need for a procedure that may offer weight loss while minimizing the morbidity, mortality, and other side effects associated with current surgical treatments. To date, the company has no earnings, and does not expect to have a product on the market until the second half of 2013.

Research shows that the vagus nerve regulates multiple digestive functions. According to EnteroMedics, VBLOC therapy is a noninvasively adjustable implantable treatment for obesity. These devices are undergoing clinical investigation for obesity. The company delivers the therapy via its Maestro RC systems, which uses laparoscopically implanted leads to intermittently block the vagus nerve signals using high-frequency, low-energy electrical impulses. The therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

Preliminary results from a feasibility study conducted outside the United States, which includes 38 patients, indicate that the Maestro System may provide durable and ongoing weight-loss for people with obesity. Follow up data show excess weight loss of 37.6% in 9 patients after 18 months of therapy and 28.1% in 17 patients at 12 months of therapy. To date, the company says that no deaths or unanticipated adverse device events have been reported.
In March, the company submitted an investigational device exemption (IDE) application to FDA for its Maestro RC system. This next-generation system improves on the original design by including a rechargeable battery.

“This IDE submission marks an important next step in advancing our Maestro RC System toward a pivotal study in obesity,” said president and CEO Mark B. Knudson in a statement. “We look forward to working through the IDE review process with the FDA. We expect to be in a position to provide an update on our strategy after this process has reached a conclusion.”

In EntroMedics’s 2010 annual report, Knudson said that the integrated rechargeable battery “is designed to significantly improve patient compliance and increase the percentage of patients who use the device for the prescribed daily hours of use.”

In December 2010, the company announced that it is offering 14.8 million shares of the Company’s common stock together with warrants to purchase an additional 14.8 million shares of common stock at an aggregate price of $1.75 per share and corresponding warrant. The net proceeds, approximately $24.0 million, will go toward gaining regulatory approval of the Maestro RC. The funds should also help the firm with international commercialization and clinical and product development activities. “We have taken steps to strengthen our balance sheet through two equity financings, raising a total of nearly $10 million and repaying half of our outstanding debt,” said Knudson.


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