Medical Device Daily Associate

Proving that things often are better when the fruit doesn't fall too far from the tree, EnteroMedics (St. Paul, Minn-esota), a developer of medical devices for the treatment of obesity and gastrointestinal disorders, reported that it has entered into an exclusive collaborative obesity device research and development agreement with the nearby Mayo Foundation for Medical Education and Research, which is affiliated with the Mayo Clinic (both Rochester, Minnesota).

Through this arrangement, EnteroMedics will collaborate with a group of Mayo Clinic physicians and researchers in the field of obesity.

Under the terms of the five-year agreement, Entero-Medics and this group of Mayo specialists will collectively work toward the development of new medical devices for the treatment of obesity. The agreement also includes a similar collaboration for the development of products to address a wide variety of disorders susceptible to treatment by electrically blocking neural impulses on the vagus nerve.

The accord provides EnteroMedics with exclusive rights to obesity-related device inventions developed through this collaboration. As part of this agreement, EnteroMedics also has in-licensed several obesity-related patent applications from the Mayo Clinic. These patent applications cover a number of what the company termed "novel concepts" (including novel gastric by-pass concepts) for treating obesity with medical devices.

EnteroMedics' lead product candidate is an implantable system for the treatment of obesity. Based on the company's Vagal Smart Modulation (VSM) therapeutic platform, the product is designed to down-regulate (controllably block) the activity of the vagus nerve.

If successful, the company said the versatility of the VSM platform would make it the first technology to simultaneously control multiple major biological functions related to obesity, including food intake, hunger perception and digestion.

By acting on these key functions, the VSM technology will allow patients to avoid major surgery, while also providing significant advantages as compared to current drug or device treatments that only address one or two such causes of obesity. Additionally, VSM treatment is fully reversible and can be adjusted and programmed to meet an individual patient's treatment needs.

Mark Knudson, PhD, president and CEO of EnteroMedics, said he has worked with the Mayo Clinic while employed by a couple of other companies. "So I really know the Mayo system and really appreciate the quality of institution that it is," he told Medical Device Daily.

Knudson said that when the company, which originally was part of a search incubator fund in 2002, really got going on the VSM platform, it started talking to thought leaders in the gastrointestinal field. Many of these leaders were affiliated with the Mayo Clinic. "They got quite excited about what we were doing," he said. At the same time, he noted that the clinic had begun an initiative to really focus its resources on future obesity initiatives. "So they had started working on some potential obesity devices that could be implanted endoscopically."

The company also had a Mayo gastroenterologist on its medical advisory board.

"One thing led to another and [the Mayo Clinic] said they'd really like to work with us as their device partner for obesity therapy along with some other gastrointestinal disorders," Knudson said.

He noted that the Mayo Clinic is one of the world's premier healthcare organizations and a leading authority on obesity and obesity therapeutic devices. "We believe that our relationship with the Mayo Clinic in the field of gastrointestinal disorders, including obesity, will provide valuable insight and resources, with the ultimate goal of helping people who suffer from such conditions."

Knudson also noted that the company is very fortunate to have such an incredible institution as the Mayo Clinic virtually in its back yard, less than 100 miles away. "That's one of the major advantages of starting device companies in Minnesota," he said.

He also pointed out that the infrastructure resources that a fledgling company needs are also readily available. He said that EnteroMedics can utilize the same companies that build leads for Guidant (Indianapolis) and Medtronic (Minneapolis) in the development of its systems. Knudson also noted that the company was able to do its pre-clinical studies a stone's throw away at the University of Minnesota (Minneapolis).

He emphasized that VSM technology "is not a stimulator," but rather controllably blocks vagus nerve stimulation where it enters the abdominal cavity. "We realized there were so many side effects to stimulation therapies. We needed to look at the first principles of control of the gastrointestinal tract by the vagus, and we invented a way to down-regulate, by blocking it."

The effect, he said, is to control the nerves related to obesity and modify not one but three primary factors: "food intake, hunger perception and digestive efficiency," by controlling impulses sent from the brain to the intestines, 20%, and the reverse flow to the brain, 80%. "Basically you modify the way your brain perceives whether you're hungry or not," he said.

Knudson added that the vagus "also controls the release of digestive enzymes from the pancreas to the intestines. By blocking the vagus, you control how much food you can put in your stomach, how rapidly it is processed and the efficiency by which it is digested." By contrast, he said that other drug and device options work on only one or two of the factors controlling hunger and digestion.

He said that VSM does essentially all the things a gastric bypass does, "but it's a simple laparoscopic procedure that's controllable, reversible and titrateable."

Knudson said the company closed on its most recent financing round, a Series B preferred stock financing valued at $16.9 million, in November (Medical Device Daily, Nov. 30, 2004). EnteroMedics previously received $2 million in a Series A round from MPM Capital.

He noted that the company probably would have to raise a Series C round when it launches a pivotal trial, which is expected to begin sometime in 2006.