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

March 1, 2021 6:33 AM EST

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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.

Non-alcoholic steatohepatitis (NASH) is a severe form of fatty liver disease, which is associated with liver inflammation and can progress to cirrhosis and liver failure. Patients with NASH have an increased risk of morbidity and mortality from liver-related causes, and NASH is one of the top three conditions leading to liver transplant.1 The adult US NASH population having a BMI between 30-40 kg/m2 is approximately 10 million, and while there are currently no FDA approved treatments for NASH, weight loss is the recommended treatment and essential for meaningful improvement in NASH. Current treatment guidelines aim for 7-10% Total Body Weight Loss (TBWL). With this degree of weight loss, NASH histologic characteristics improve in a significant percentage of patients, with resolution of liver inflammation, fat leaving the liver, and regression of fibrosis over time. However, patients typically fail to achieve these requisite levels of weight loss using lifestyle management programs alone.

"Orbera has consistently shown, both in the pivotal study and the post-market approval study, the ability to help patients lose an average of 7-10% TBWL over 6-12 months, which is significantly greater than lifestyle modification alone," said Dr. Christopher Gostout, Apollo Endosurgery, Chief Medical Officer. "The literature and the Mayo IDE study suggest that these levels of weight loss can have a positive effect in resolving or delaying the progression of NASH. With Breakthrough Designation, we will be able to further build the body of clinical evidence and seek label expansion for the use of Orbera for patients with NASH."

The Mayo Clinic IDE-approved (G160077) study was explicitly designed to evaluate the effects of Orbera placement on metabolic and histologic features of NASH, including NAS (indicative of resolution of fat and inflammation in the liver) and fibrosis score. There was notable improvement in these NASH outcome measures when Orbera was removed after 6 months. Specifically:

  • Non-Alcoholic Fatty Liver Disease Activity Score (NAS) improved in 18/20 patients (90%), and 16/20 (80%) of patients decreasing by ≥2 points.
  • 15% had histologic regression of fibrosis (scarring), and magnetic resonance elastography (MRE) - detected fibrosis improved in 50% (10/20) patients.2

While Orbera has been FDA approved since 2015 for weight loss, the grant of Breakthrough Device Designation is an important step forward for potentially addressing a significant unmet need of improving the health of NASH patients.

1 https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash

2 Bazerbachi F, Vargas EJ, Rizk M, Masselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK; Clin Gastroenterol Hepatol 2020 Apr 30

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