Round Led by HealthCor Partners Management, L.P. and Endeavour Vision SA to Support U.S. Commercialization of ReShape™ Integrated Dual Balloon System Following Recent Approval by the FDA
SAN CLEMENTE, Calif., August 26, 2015 – ReShape Medical® today announced that it has completed a Series D financing of $38 million led by HealthCor Partners Management, L.P. with participation from Endeavour Vision SA and existing investors, SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners and Venture Investors. The announcement follows the recent approval of the ReShape™ Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure, by the U.S. Food and Drug Administration (FDA). The ReShape Procedure provides a non-surgical option for adults with a BMI of 30-40 and a related health condition who haven’t succeeded at diet and exercise alone, and do not want or do not qualify for bariatric surgery. The new capital will be used to support U.S. commercialization of the ReShape Integrated Dual Balloon System.
“With more than one-third of U.S. adults considered to be obese and with very limited non-surgical weight-loss options, the market potential for the ReShape Procedure is significant,” said Michael Mashaal, MD of HealthCor Partners Management, L.P. “We are impressed by data from the ReShape clinical trial and look forward to working with the company’s experienced management team to fill the sizeable, unaddressed need in the global obesity market with this new treatment option.”
The ReShape Integrated Dual Balloon System was evaluated in the REDUCE pivotal trial, the results of which were presented at the 2014 ObesityWeek, the annual meeting of the American Society for Metabolic and Bariatric Surgery and published in the journal Surgery for Obesity and Related Diseases. In that study, patients that had the ReShape Procedure lost 2.3 times as much weight as a control group that received diet and exercise coaching only. There were also measurable and sustained improvements in co-morbidities and strong patient satisfaction. In a study of the ReShape Procedure in commercial use in Europe, ReShape patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year. Following approval by the FDA on July 28, 2015, the ReShape Procedure is becoming available in select markets across the country, with several physicians already offering it to patients.
“The outlook for the ReShape Procedure has never been more promising, with the recent FDA approval followed by this demonstration of support by our investor partners,” said Richard Thompson, President and CEO of ReShape Medical, Inc. “With this momentum and the positive feedback we are receiving from physicians across the country, the Company is in a strong position to make the ReShape Procedure available to U.S. patients in need of a non-surgical option for weight loss and to achieve global leadership in non-surgical obesity treatment in the future.”
The ReShape Procedure is designed to help patients lose weight and facilitate healthy behavior change. The ReShape Integrated Dual Balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months. The balloons take up space in the stomach and help 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 and helps reinforce new habits for lasting results.
About ReShape Medical, Inc.
ReShape Medical, Inc. 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.ReShapelifesciences.com. The ReShape Procedure has been available in the European Union since December 2011.
Rachel Gross or Kirsten Swenson