ReShape Medical, a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss, has submitted a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for the ReShape Integrated Dual Balloon System, the first and only dual balloon for non-surgical weight loss designed for people with a 30-40 body mass index (BMI).

The ReShape Integrated Dual Balloon System is the first device to meet its primary effectiveness endpoints in a US, randomized, sham-controlled pivotal trial for weight loss. ReShape’s PMA submission includes data from the Company’s REDUCE Trial involving 326 patients at eight sites in the US that measured the safety and effectiveness of the procedure as an adjunct to diet and exercise. Subjects undergoing the ReShape Procedure lost more than twice as much weight as the sham-control subjects who received diet and exercise alone. The device had an excellent safety profile.

While an estimated 50 million Americans are classified as obese with a BMI of 30-40, many neither qualify for nor want surgery, creating a significant unmet need for additional treatment options. Obesity is a major risk factor for serious health complications, many of which are the leading causes of preventable death, including heart disease, stroke, type 2 diabetes and certain types of cancer, among others.

“With this PMA submission, ReShape Medical is on track with our regulatory timeline, achieving an important milestone in our mission to offer an effective, non-surgical treatment option to those for whom other weight loss efforts have not proven sufficient,” said Richard Thompson, President and CEO of ReShape Medical.

The ReShape Non-Surgical Weight Loss Procedure is designed to help patients lose weight and facilitate behavior change. The Integrated Dual Balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months. The balloon takes up space in the stomach and helps patients feel full. While the stomach-filling balloons are in place, patients are counseled by health care professionals on nutrition, exercise and behavior modification to help them develop a healthier lifestyle. This program continues for an additional six months after removal of the balloons to encourage new habits and lasting results.