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 first ORBERA® U.S. post-approval multi-center study. The study was published in Clinical Gastroenterology and Hepatology, a peer reviewed journal published on behalf of the American Gastroenterology Association.
This multi-center study presents early results of the clinical use of ORBERA in a commercial setting and is the first study of ORBERA within the U.S. population outside of clinical trials. The results are based on 321 patients treated at eight centers (three academic and five private) after FDA approval in August 2015. The primary effectiveness outcomes of the study were percent total body weight loss (TBWL) at three, six, and nine months. Key data reported includes:
- Average Body Mass Index at the time of ORBERA placement of the 321 patients was 37.6.
- Average TBWL was 11.8% at six months, which is approximately 16% greater than that reported in ORBERA’s U.S. Pivotal Study.
- Average Weight Loss of 25.1 pounds at six months.
- At six months, TBWL of 5%, 10% and 15% was achieved by 88%, 62% and 31% of patients, respectively.
Significant impact on obesity related comorbidities at six months:
- 50% of type II diabetics stopped or decreased their medications and Hemoglobin A1C (HbA1C) was significantly improved by 0.7%.
- 45% of patients with hypertension were taken off their hypertension medications.
- No spontaneous inflations, pancreatitis, gastroesophageal perforations, or deaths were reported during the duration of follow-up.
The study also highlights advances that may help improve the management of associated nausea and reduce the early removal rates due to these symptoms. The study showed a 35% reduction in the early removal rates compared to the U.S. Pivotal study (18.8% vs. 12.3%). Additionally, the analysis identified two factors, usage of selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors for management of depression and usage of Aprepitant for nausea management, which were correlated to removal rates and that will help lead to further improvements of post-placement symptom management.
“The ORBERA Intragastric Balloon is the worldwide market leading intragastric balloon and as shown in this first publication of real world clinical results from different centers in the U.S., has been delivering safe and effective weight loss for U.S. patients since its approval in August of 2015,” said Todd Newton, CEO of Apollo.
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 277,000 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 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: 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, 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.