ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system. The data were impressive: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.
The startup already said in November 2013 that the pivotal data met its primary endpoints for weight loss and responder rates. In July, it submitted a PMA with the FDA that was subsequently accepted for filing.
It's hoping to get FDA approval for the device during the first half of next year. Given the dearth of efficacious drug or device weight-loss options and Americans' dire need for them, the FDA is likely to give a seemingly effective, safe device the benefit of the doubt. If the device is approved, ReShape will reevaluate its status as a private company at that time, the company's president and CEO, Rick Thompson, said in an interview.
The newly released data is from 60 patients in Spain, so not a very big data set. The ReShape Integrated Dual Balloon System has been available in the EU since December 2011, but the company hasn't actively marketed it there, instead focusing on U.S. approval, and it's used at only two sites there. The data is being presented at the International Federation for the Surgery of Obesity and Metabolic Disorders 2014 World Congress in Montreal, Canada, from Aug. 26-30.
In the study, mean weight loss was 14.4 kg ± 7.4 kg (31.7 lbs. ± 16.3 lbs.). FDA guidance calls for weight-control products to demonstrate a mean difference equal to or greater than 5% between treatment and control groups. It also calls for at least 35% of the treatment group to lose 5% or more of their baseline body weight.
In this study, patients lost 13.5% of their total body weight during the typical 6-month placement of the device, with a range of ±6.4%. Fewer than 2% of patients were intolerant of the device, and 84% said they were highly or very satisfied with the procedure. The patients had a starting BMI of 30 to 45.
Thompson said that weight loss in this study is "quite a bit more than what will be reported in pivotal trial data." He pointed to an unusually high level of physician, staff and patient commitment in the postapproval data. The trial included nutrition, exercise and behavior modification, which was also part of the pivotal trial for both treatment and control arms.
The company didn't release long-term implications for weight loss once the device is removed. But Thompson said, "We see a pretty effective retention long-term for lost weight." He noted that some other approaches allow patients to eat normally, not retraining them on their behaviors.
He expects ReShape's device could be the only medical device for weight loss in the U.S. for 18 to 36 months until competitive devices, many of them also in use in Europe, start to make their way through the stricter FDA regulatory process.
ReShape will present results from the REDUCE U.S. pivotal trial at Obesity Week in November. Another study on repeat use of the ReShape balloon will also be presented at that conference.
- here is the release