Kamen, DEKA develop pump as alternative to surgery for obese
A startup company based in Pennsylvania has obtained approvals in Europe and is hoping to get FDA approval in the U.S. for the AspireAssist, a do-it-yourself stomach pump developed by DEKA in cooperation with a team of doctors and scientists who came up with the idea.
Key components of the AspireAssist are now among the more than 400 U.S. and foreign patents held by Kamen and his DEKA associates.
Ventures into health-care devices are nothing new for Kamen, who also holds patents on the widely used insulin pump. So when a group of doctors came up with an idea to help dangerously obese patients avoid bariatric surgery, they naturally turned to DEKA and its engineers based in the Manchester Millyard.
"At least two or three years ago, we were contacted by an investor who worked with a couple of doctors who recognized a clinical need to help people who are really morbidly obese," he said. "The doctors came up with this concept, and they had most of the idea described. They needed us to do the engineering, to make it safe and practical."
The result was a device built around the same type of tubing used to feed patients, only instead of putting food in, it's designed to take food out before calories can be absorbed.
The tube is implanted in the stomach, and leads to a small, low-profile port at the surface of the skin. The AspireAssist device is attached to the port about 20 minutes after a meal to remove about a third of the calories consumed, according to the company's website, which emphasizes that, "the AspireAssist is used in conjunction with a lifestyle modification program, and requires careful and comprehensive medical monitoring."
Katherine D. Crothall is president and CEO of Aspire Bariatrics, a company started last year with $11 million in venture capital and private funding, headquartered in King of Prussia, Pa. "If you look at the therapies available for morbidly obese people, they are not very attractive," she said. "Fewer than 1 percent of the morbidly obese population takes advantage of bariatric surgery in any one year."
The company is testing the market in Europe, where the first patients are already using the device.
"We have patients in Sweden and the Czech Republic," she said, "and hopefully soon in Belgium, France, Italy and maybe Finland. So it's pretty much all over Europe. It should be available in Canada some time by the middle of this year, if not sooner."
Approval by the Food and Drug Administration in the U.S. is more challenging, she said, and not likely until 2014 or 2015.
Crothall pointed out that the device has been manufactured so that it can only be used under a doctor's supervision. After one month of use, the pump disables itself, and can only be reactivated by a physician. "It's configured so the patient can't go off and use it willy-nilly," she said.
The company has FDA approval for 176 patient trials at eight hospitals or universities, lasting one year with continued follow-ups. One of the trials will be conducted in Boston, at Brigham and Women's Hospital.
If the device goes into widespread use, it could prove a new source of revenue for DEKA in Manchester.
"There is an agreement between DEKA and the company," she said. "I would prefer to leave it at that."
Kamen said money from the Aspire patents would help the high school robotics competition he developed to foster education in math, science and engineering. "It'll be more money for FIRST," he said.