|Obesity startup CEO hopes to be first to bring non-surgical alternative to weight loss in the U.S.|
For years gastric bypass surgery has been the gold standard when it comes to dramatic weight loss in severely obese patients.
Even when compared with Allergan's Lap-Band system, in which adjustable band is placed on the top of the stomach creating a small space that can hold limited amount of food, the gastric bypass procedure came out on top.
|The ReShape Duo|
But a new breed of startups are trying to provide a non-surgical alternative to weight loss. None of them are approved for sale in the U.S. and therefore remains to be seen if they are both clinically effective and safe.
Of those, ReShape Medical, an obesity startup based in San Clemente, California claims to be ahead of its competition in terms of commercializing its intragastric balloon. The company has completeled enrolling 326 patients in a pivotal trial taking place in eight U.S. medical centers, while other are still enrolling says CEO Richard Thompspn. Thompson believed that patients with BMI in the range of 30 to 40 who are obese but not morbidly so are looking for non-surgical options because they do not want to lose control over their body and believe they can lose the weight but with a little help.
That's where the ReShape Duo can come in.
The ReShape Duo, a pair of intragastric balloons, is placed endoscopically through the mouth inside a person's stomach is intended to help patients with a BMI of 30 to 40 see successful and sustained weight loss.It works by filling up space inside the person's stomach so that by eating small meals, the patient feels satisfied, Thompson explains.
The temporary device is inside a patient for a period of six months when the company works with each patient to make them understand the principles of portion control, diet and exercise. After the device is removed six months later, the company continues to work with those patients to drive home the importance of eating small meals, Thompson says.
In pilot trials, the results have been positive, Thompson says. Right at the six month mark, on average patients lose about a third of their excess weiight. Excess weiight is the weight that is higher than what their normal BMI is, which is in the range of 18.5- 24.9. In other words, if a person has a BMI of 30, the excess weight he or she is carrying around is around 5 to 11.5 BMI points.
So, people on the ReShape Duo, were found to have lost one-third of their excess weight and at the 12 month period the results were a bit different. One third of patients had regained most or all of the weight they had lost at the six-month mark, another third had maintained the weight loss while the final third were continuing to lose weight, ReShape Medical executives found.
"We consider that to be 2/3rd successful and 1/3rd unsuccessful, which in the diet and exercise world, is a very good result," Thompson says.
Now the company is focused on proving itself in the pivotal trial. To date the company which is venture backed with investors like SV Life Sciences, New Leaf Venture Partners, US Ventures and Venture Investors, has raised $45 million. That money will help them through the picotal trial, but to commercialize the product would require more cash infusion, Thompson says.
He does not expect to get a PMA approval from the FDA in 2015. But what about competitors?
Thompson said ReShape is ahead of direct competitors like Obalon, which is still enrolling patients in its pivotal trial. Obalon, like ReShape, employs intragastric balloons to aid in weight loss, but the company has a faster treatment period - 12 weeks instead of six months. Also depending on the patient, one-to-three balloons may be placed over a 12-week period. The method of placement is also different - whereas the ReShape Duo is placed under consocious sedation endoscopically, the Obalon balloon is placed inside a capsule with a tubethat is swallowed. Once inside, the capsule opens up and releases the balloon. A physician confirms its placement through X-Ray and then inflates the balloon througha device inserted through the mouth using the tube and then removes the tube leaving the balloon in place in the stomach.
There are other companies in Europe that provide non-surgical alternatives to weight loss, but they don't sell products in the U.S., Thompson says.
Both Obalon and ReShape Medical have their products approved in Europe. However, Thompson says that ReShape is using Europe more as a laboratory than as a place to generate revenue.
"We are learning what does it take to attract the consumer to the product and persuade them that this is a good option for them and to get them to actually make the decision," he says. "And then on the delivery side learning what des it take to put the systems and procedures in place to safely and effectively privide the product to the patient with all of the counseling and aftercare we believe they need to have."
By Arundhati Parmar, Senior Editor, MD+DI