|Chris Rowland, CEO of IntraPace|
Based: Mountain View, CA
The Scoop: About as big as a typical pacemaker, the Abiliti anti-obesity medical device is implanted laparoscopically in a tissue pocket on top of the stomach, and connected to a lead that attaches to the stomach in two places (similar to how cardiac pacemakers and defibrillators are structured). Powered by batteries that can be replaced every 5 years, the device emits preprogrammed electrical pulses, tailored to an individual person, to create a feeling of fullness so a patient eats less and loses weight. It is also armed with a sensor that captures meal and exercise data to help patients customize their weight-loss plans.
What Makes It Fierce: Obesity is increasingly viewed as a global pandemic. IntraPace's Abiliti device stands ready to tackle that reality with a device that is showing promise as a potential game-changer and won a CE mark in Europe in 2011.
A small investor army backs the company, including Boston Scientific ($BSX), Johnson & Johnson ($JNJ), L Capital Partners, Oxford Bioscience Partners, ePlanet Capital, Vulcan Capital, InCube Ventures, The Halo Fund and The Angels Forum.
In recent months, IntraPace has accelerated its focus on the demanding U.S. regulatory pathway, with high hopes for success. As Bloomberg has previously reported, it appears to be both effective and also far less likely to leave patients with health problems faced through more invasive methods such as Lap-Band surgery (Allergan's band that tightens around a patient's stomach, quelling appetite) and gastric bypass, where patients can struggle to absorb nutrients and face other issues. New company President Chris Rowland, formerly chief commercial officer, says Abiliti also stands out from the pack because it can gather data on diet and exercise that patients can use to customize their weight-loss plans.
"I see it more as an integration of stimulation therapy and behavioral change, and you really need both to be successful with weight loss," Rowland tells FierceMedicalDevices. "A lot of the gastric bands and bypasses, what happens is patients regain much of that lost weight so there is a behavioral element, really, that is really important." He replaces Chuck Brynelsen, a veteran Medtronic ($MDT) executive who had run IntraPace since its 2005 founding. (Brynelsen, who left for personal reasons to move back to Minnesota, will remain as an adviser, Rowland says.)
Thus far, a study of 25 Abiliti patients in Germany after 18 months showed an average 30% drop in excess weight above what is considered ideal, similar to gastric banding. IntraPace has also completed enrollment in a multicenter randomized post marketing study in Europe involving 161 patients, with results expected later next year. There's no investigational device exemption in the U.S., yet, but IntraPace hopes to move forward on a premarket approval pathway. Rowland wouldn't speculate as to when the company might make an FDA submission. Bloomberg reports that an FDA application could come up to 5 years after IntraPace's CE mark, taking into account added safety and efficacy requirements.
What To Look For: Next year will be all about finalizing the company's U.S. regulatory pathway, and also likely pursuing another funding round. Plans call for closing another round by mid-November, hopefully in the $6 million to $7 million range, Rowland says.
Whether IntraPace continues to stay on its own, form partnerships or seek to be acquired remains an open question. After results from the larger study are released next year, Rowland says the company will face "a decision time." Success at that point will breed the need to make some major choices.
"What we found with the product, is it is a market development product that requires a considerable amount of effort in the behavioral side of post-procedural [weight-loss] therapy," he said. "We are trying to define what the commercial scalability looks like. Can we do this ourselves, or with a partner, or are we better off having a larger company take care of that for us?" To be determined.
-- Mark Hollmer (Twitter | email)
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