As we approach the holidays, many of us are looking at shopping catalogs, plates full of cookies and expanding waistlines. A California healthcare startup has an obesity treatment that could provide non-surgical weight loss to patients who are slightly overweight. ReShape Medical‘s deceptively simple medical device–a saline-filled dual-balloon–paired with behavioral experts and nutrition therapy could help patients with a BMI between 30 and 40, or who are about 20 to 40 pounds overweight, lose 5 to 15 percent of their overall weight.
More than a third of the American population have a BMI above 30, principal investigator for the ReShape Duo clinical trial Dr. Jaime Ponce said. “We’re gonna be able to offer more treatment to more patients in that category of BMI,” he said.
The patient is under conscious sedation when the physician inserts the ReShape Duo into the stomach using an endoscope. There, the two balloons, which are independently valved, are both inflated. The whole procedure takes between 15 and 20 minutes. The intragastric, saline-filled balloon stays in the patient’s stomach for six months. Like gastric bypass surgery, it restricts the amount of food that can be eaten before feeling full. But there are no sutures, no incisions. Because the balloon occupies such a large volume of the stomach, the patient will be eating small portions, meaning fewer calories, and lose weight, CEO Rick Thompson said. Meanwhile, they are receiving therapy from a team of nutritionists, dietitians and behavioral experts so they come to associate small portions with weight loss, he said.
Once the device is drained, deflated and removed, the patient continues the therapy portion of the treatment for an additional six months. The idea is the balloon jump-starts the patient into behaviors everyone already recognizes are healthier. It provides an alternative for those patients who aren’t candidates for surgeries as well as those who are put off by surgical risks. Ponce couldn’t comment on the ongoing trials, but said patients maintained 60 percent of weight loss in an earlier study.
This isn’t just a cosmetic issue. The bottom line may be it takes the cost out of care–preventing patients from moving toward severe obesity.
“We know that obese patients do carry a higher healthcare cost because they do tend to develop a lot of medical problems,” Ponce said. The more obese, the higher the risk for diabetes, heart disease and sleep apnea. “That drives healthcare cost.”
The device has been available in Europe for several years, and is meeting endpoints in pivotal trials in the U.S. now. Thompson said the company plans to file for premarket approval with the FDA after those trials end in Q1 of 2014. The medical device company’s next big milestone?
“(There is) such a large opportunity in the U.S., our main goal for the next few years is going to be satisfying this market,” Thompson said. That said, he added the company is interested in exploring the European markets “more fully,” then moving to Asian and Middle Eastern markets.
The six-year old medical devices company is revving up for another round of fundraising–this time Series D to get it through the PMA process. The company hasn’t decided on a dollar amount yet, Thompson said, because it’s trying to clarify how far beyond PMA approval that funding should stretch.
In a tough investment economy, venture capital has funded ReShape throughout its history. Venture capital for the startup comes from SV Life Sciences, New Leaf Ventures, U.S. Venture Partners and Madison, Wisc.-based Venture Investors, Thompson said.
He said “dealing with one of the most important underserved markets in healthcare, being obesity,” meeting clinical endpoints and having strong management make the company attractive to investors. Thompson came to ReShape about two years ago, when the VCs wanted a new management team; he was familiar with the diabetes space and knew some of the board members well. Thompson, a self-proclaimed “serial entrepreneur,” co-founded and ran LifeScan, which is now a division of Johnson & Johnson (JNJ).
The intragastric balloon availability in the US will be very exciting. The coupling of this procedure, pre and post procedurally, with a solid nutritional and behavioral program is paramount to the longterm success. Certainly, prospective studies will ultimately show whether or not the ideal weight loss goals can be met. Our group looks forward to their implementation. AA Starpoli, MD
Patients can't maintain almost half of a 5/15% weight loss? That's about 15 lbs for a lot of people that turns into less than 10 lbs after less than a year. Weight Watchers has a better record.
That sounds like no "re-shape" is going on. Just as "Regain" had to change its name to Rogaine, I predict this product will have to change its name to get that PMA approved.
@Edmundo Inga Zapata Hi. The expected weight loss is between 5 and 15 percent of total weight. The balloon stays in six months. But the therapeutic treatment--frequent interaction with behavioral experts and dieticians, etc.--last six months beyond the treatment.