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’s presentation of results from Mayo Clinic’s prospective open-label study of the ORBERA® Intragastric Balloon in patients with Nonalcoholic Steatohepatitis (“NASH”) at Digestive Disease Week 2018.
The FDA-approved study demonstrated the significant benefits of weight loss with the ORBERA Intragastric Balloon in patients with NASH and nonalcoholic fatty liver disease (NAFLD).
- 65% of patients achieved resolution of NASH on biopsy
- 80% of patients had a ≥2 point improvement in NAFLD activity score
- 15% had tissue evidence indicating regression of fibrosis (scarring), despite the relatively short period of the study
Liver scarring is a feared complication that constitutes the driving force behind the development of the cirrhosis syndrome, which can only be adequately treated by liver transplantation when the organ decompensates.
These benefits were also coupled with significant weight loss and improvements in other key risk factors for cardiovascular disease and diabetes. On average, patients achieved total body weight loss of 12% in the 6 months with their ORBERA balloon. Eighty percent of patients were able to achieve the minimum recommended weight loss of 7.0% total body weight loss (“TBWL”). Additionally, there were notable and statistically significant improvements in key metabolic factors such as diabetes related HbA1c and waist circumference.
“The disease improvement seen in this study is very significant and was achieved in the majority of patients. These types of results are rare because fatty liver disease and NASH are difficult to treat, with weight loss being the primary treatment option. Typical weight loss efforts only help a small percentage of patients achieve the 7-10% TBWL required to see improvements in the disease. Furthermore, the authors found a very significant decrease in mesenteric fat thickness, which was robustly associated with severity of the liver inflammation. Mesenteric fat represents the fat around the actual visceral organs, and is thought to be a culprit in the development of inflammation in fatty liver disease. The results from this study highlight that the ORBERA balloon and weight management programs can safely provide substantial clinical value for liver disease patients,” said Dr. Christopher Gostout, MD, Chief Medical Officer at Apollo.
The accumulation of excess fat (triglyceride) in the liver plays a role in the development of NASH, 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 liver cirrhosis in 2030, leading to increased risk of liver-related death and higher rates of malignancy. Liver transplantation is currently the main treatment option for patients with advanced liver disease. The standard treatment is weight loss and physical exercise, with histological and biochemical improvement observed in patients achieving a 7-10% reduction in body weight. However, less than 25% of patients achieve this goal.
This study was led by Dr. Barham Abu Dayyeh M.D. MPH FASGE, a Gastroenterology Consultant and director of the bariatric and metabolic endoscopy program at the Mayo Clinic (Rochester, MN) and presented by Dr. Fateh Bazerbachi. A copy of the full abstract can be found at ddw.org.
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 295,000 ORBERA balloons have been distributed worldwide in over 70 countries.
For additional information regarding ORBERA, please visit www.orbera.com.
For full safety information please visit www.orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.
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.
© 2018 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
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.