Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced the enrollment of the first patient in a multicenter, randomized, controlled, double-blind study of the efficacy and safety of Endoscopic Sleeve Gastroplasty (“ESG”) using Apollo’s OverStitch™ Endoscopic Suturing System, in patients with non-alcoholic steatohepatitis (“NASH”). The study is funded by a Beca FIS Grant awarded to the Foundation of the Hospital Universitario Puerta de Hierro Majadahonda by the Ministry of Health of the Spanish Government.
The study will involve four National Health System Hospitals, led by Professor José Luis Calleja, MD from Hospital Universitario Puerta de Hierro Majadahonda – Universidad Autónoma de Madrid, as Principal Investigator. The primary objective of the study is to compare the efficacy of ESG plus lifestyle modification to lifestyle modification alone in the resolution of NASH without worsening of fibrosis in patients with BMI greater than 30 kg/m2. View more details here.
NASH results from the accumulation of excess fat (triglyceride) in the liver causing inflammation which can lead to cirrhosis, and is a growing public health problem affecting over 5% of the global population. NASH is expected to become the most common cause for cirrhosis of the liver leading to increased risk of cardiovascular and liver-related death and higher rates of malignancy. Liver transplantation is currently the main treatment option for patients with advanced liver disease.
Given that nearly 82% of NASH patients are obese, the standard treatment is weight loss and physical exercise, with histological and biochemical improvement observed in patients achieving a 5-10% reduction in body weight. However, less than 25% of patients achieve this goal.
“The aim of this study is to evaluate a safe and effective method to improve liver histology in obese patients with nonalcoholic steatohepatitis but without the increase of bariatric surgery risks,” said Professor Jose Luis Calleja, MD. “Currently, less invasive and less costly endoscopic techniques are being widely adopted to treat obese patients that do not want surgery. Current data demonstrates that the ESG procedure achieves clinically significant weight loss with a decreased length of hospital stay and a lower complication rate than surgery.”