Apollo Endosurgery Announces MFDS Approval for the ORBERA® Intragastric Balloon System in South Korea, a Non-Surgical Solution to Assist Patients with Weight Loss
Public Company Information:
AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced the South Korean Ministry of Food and Drug Safety’s (MFDS) approval of the ORBERA® Intragastric Balloon System, the #1 intragastric balloon in the world, to assist adult patients who are overweight – with a body mass index (BMI) greater than 27 – in losing and maintaining weight.
The ORBERA balloon is part of a comprehensive, non-surgical two-part program. The ORBERA System includes a silicone balloon that is filled with saline after endoscopic placement into a patient’s stomach. Once in the patient’s stomach, the balloon serves to reduce stomach capacity, causing patients to consume less food following the procedure, and delay gastric emptying, the primary mechanisms of action in assisting the patient in losing weight.
Studies have shown that Asians are more vulnerable to obesity complications including type 2 diabetes, dyslipidemia and hypertension. As a result, the Asia Pacific regional guidelines of the WHO and International Obesity Task Force define obesity as BMI ≥ 25.0 [kg/m2]. Data published in 2017 from the National Health Insurance System of South Korea (NHIS) reported that more than 30% of adults in South Korea were considered moderately obese or severely obese (BMI ≥ 25.0 kg/m2). NHIS insures approximately 97% of the population in South Korea.
Shin Han Systek Co. Ltd. is the exclusive distributor for ORBERA in South Korea.
ORBERA is an incision-less, non-surgical weight loss solution designed for adult patients who are overweight or obese, 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 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 works with their physician and their staff in a formal lifestyle modification program 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 277,000 ORBERA balloons have been distributed worldwide in over 70 countries.
For additional information regarding ORBERA please visit www.orbera.com and for full safety information please visit http://apolloendo.com/patient-labeling-and-dfus/#
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal disorders. 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 Endosurgery, 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: price levels for established and innovative medical devices compared to the costs of procedures utilizing our products; developments in medical technology; regulatory approvals; reimbursement decisions by private or government payers or other government actions; physician adoption and recommendations of procedures utilizing our products; misuse or off label use of our products by physicians 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, 2016 and its Form 10-Q for the three months ended September 30, 2017. 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.
Apollo Endosurgery, Inc.
Jen Cook, +1-512-279-5158
Marketing Communication Director
Stefanie Cavanaugh, +1-512-279-5100
Chief Financial Officer
The Ruth Group
Lee Roth, +1-646-536-7000
Shin Han Systek Co., Ltd.
Daniel In Mo Chung
New Products & Business Development President
4F, DongHeung Bldg, 646, Yeongdong-daero
Samseong-dong, Gangnam-gu, Seoul, Korea
Tel: +82-2-556-4031 / 517-4031