Apollo Endosurgery Receives FDA Breakthrough Device Designation for the Orbera(R) Intragastric Balloon for Treatment of Patients with NASH

Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that it has received a Breakthrough Device Designation from the U.S. Food and Drug Administration for the Orbera® Intragastric Balloon, specifically for the indication for use in treating patients with BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.