AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today 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.
For more information, see https://clinicaltrials.gov/ct2/show/NCT03426111?term=NCT03426111&rank=1
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.”
The OverStitch endoscopic suturing system enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures. For more information regarding OverStitch go to: www.apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal conditions. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 70 countries today.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol "APEN." For more information regarding Apollo, go to: www.apolloendo.com.
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Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017 and its Form 10-Q for the three months ended March 31, 2018. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.