Clinical Data from European Commercial Use

Clinical Data from European Commercial Use

ReShape Medical® Announces Additional Clinical Data for ReShape Procedure at ObesityWeek 2014

November 6, 2014

Data from Spain Showing Excellent and Sustained Weight Loss with ReShape’s Non-Surgical Weight Loss Device as reported in one of the Top 15 Posters at ObesityWeek

BOSTON & SAN CLEMENTE, Calif., November 6, 2014 (Booth # 721) – ReShape Medical® today announced that data on the clinical experience with the ReShape™ Integrated Dual Balloon in Spain is featured in a Top 15 Poster at ObesityWeek 2014, currently taking place in Boston. The study evaluated both single and sequential dual balloon use. The results, being presented today during the Scientific Session, found that patients experienced exceptional results with a single dual balloon, and sequential implantation of the dual balloon was safe and not associated with any unanticipated adverse events.

Results with a single dual balloon at six months demonstrated:

  • Mean total body weight loss of 17.1 kg
  • Mean percent total body weight loss of 16.0%
  • Mean percent excess weight loss of 48.8%
  • Additionally, patients receiving one dual balloon with continued counseling for a mean of 7.4 months after balloon removal maintained 94% of their weight loss.

“The results we have seen in the clinical setting in Spain continue to underscore the benefits of the ReShape Procedure,” said the study’s investigator Gontrand López-Nava, MD, Director de la Unidad de Tratamientos Endoscópicos de la Obesidad del Hospital Universitario Sanchinarro. “Our experience shows that the Reshape dual balloon offers patients a non-invasive alternative that is proven to achieve clinically significant weight loss in a relatively short period of time. We have also demonstrated that patients receiving a single dual balloon, coupled with continued counseling, can maintain almost all of their weight loss.”

“While the results presented today clearly show that one balloon helps most patients achieve significant weight loss, we also showed that a second balloon placed sequentially is a safe option,” said Dr. López-Nava.

“The positive results coming out of Europe in the commercial setting continue to support the ReShape Procedure as a new option to help many of the millions of patients currently struggling with obesity,” said Richard Thompson, President and CEO of ReShape Medical. “We are very pleased to see the recognition awarded this Top 15 poster presentation and the Top 10 presentation of our pivotal trial data at ObesityWeek.”

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.

Dr. López-Nava will present the poster, Prospective Evaluation of Initial and Repeat Use of a Novel Dual Intragastric Balloon, on November 6 at 2:35 p.m. ET during the Main Scientific Sessions.
 

About ReShape Medical

ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.ReShapeReady.com. The ReShape device has been available in the European Union since December 2011.

Caution: Investigational device. Limited by Federal (United States) law to investigational use.