ReShape Medical said about a year ago that it had positive U.S. pivotal obesity data for its ReShape Integrated Dual Balloon. Now it has offered a glimpse of that data for the first time, ahead of an FDA review that's expected to come during the first half of 2015.
The startup is presenting its U.S. REDUCE pivotal data on Nov. 4 as a Top 10 Paper at the ObesityWeek conference in Boston, MA. On Nov. 6 at the conference, it will also present additional data from a study in Spain that it has previously reported on. ReShape Medical was a Fierce 15 pick for 2014.
It expects to position the device for potential bariatric patients who aren't interested in invasive surgery. ReShape pegs the portion of bariatric patients who are eligible for surgery and actually receive it at only about 1%. It expects to get a U.S. label for obese patients with a body mass index (BMI) of 30 to 40, which was the population for the pivotal study.
Reimbursement isn't even on the table for ReShape; it expects to achieve ample U.S. self-pay sales through established bariatric programs. That's despite the fact that the Lap-Band from Apollo Endosurgery has become much more reimbursable in recent years.
"For the foreseeable future, we will be self-pay for a while," ReShape President and CEO Richard Thompson told FierceMedicalDevices in an interview.
In Thompson's view, the device, which is placed endoscopically in an outpatient procedure, is for patients who seek more than the moderate weight loss that drugs can provide, but who are not interested in surgical intervention. He bills it in part as a behavior modification scheme to teach patients to consume smaller portions regularly during the 6-month period it can be used.
Thompson added that ReShape hasn't established U.S. pricing for the device yet, but he expects it to be "consistent with the fact that it's a significant weight loss program. So it will cost more than a food-supplement plan, but will be less severe and cost less than a surgical procedure."
The device has been marketed in Europe under a CE mark received in 2007. ReShape has already released impressive postmarketing data, which it attributes largely to the unusual motivation and dedication of the patients and healthcare providers. It expects to release more EU postmarketing data later this week.
In the REDUCE pivotal data, patients receiving the device lost an average of 28% of their excess weight. The device is paired with nutrition, exercise and behavior modification during the 6 months of use, with an additional 6 months of follow-up after the device is removed. Placebo patients, treated with medically supervised diet and exercise alone, lost 12% of their excess weight on average. The study was conducted at 8 U.S. sites and included 326 patients.
In data from patients in Spain that will also be reported at ObesityWeek, device users had an average excess weight loss of 48.8% with a mean weight loss of 17.1 kg. Even at a mean of 7.4 months after balloon removal, these motivated patients retained an astonishing 94% of their weight loss.
In the pivotal trial, more than half of treated ReShape patients lost at least one-quarter of their excess weight. But treated patients slipped up somewhat; after 6 months without the device but with ongoing counseling they had already regained one-third of the weight they previously lost with the device.
Significant improvements in comorbidities were observed throughout the 24-week treatment phase. These included reductions in triglycerides, high- and low-density lipoproteins, and systolic and diastolic blood pressures as well as waist and hip circumferences. Even during the 24-week follow-up period after the balloon was retrieved, these improvements lasted.
Thompson said that treated patients also reported quality-of-life improvements such as increased activity and improved sex life at 24 and 48 weeks.
Patients didn't seem to mind the treatment experience. No migrations or obstructions were reported. In a follow-up survey, two-thirds of treated patients said they would do it again and 75% said they would recommend the device to a friend.
"Bariatric surgeons see firsthand the struggles our patients face when surgery is not an option and diet and exercise alone have failed," Dr. Jaime Ponce, principal investigator in the REDUCE trial and medical director of the Bariatric Surgery Program at Hamilton Medical Center in Dalton, GA, said in a statement.
"The ReShape Procedure's ability to deliver clinically significant, safe weight loss and strong patient satisfaction shows it is well poised to serve as a new treatment option for patients with a BMI of 30 to 40, helping them achieve their weight loss goals and providing them with weight management skills that can be used in the long-term," he concluded.