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Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
[August 11, 2017]

Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons


Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, today provided an update and clarifications to a letter the U.S. Food and Drug Administration (FDA) sent to Health Care Providers dated August 10, 2017 relating to potential risks with liquid-filled intragastric balloons, including the Company's ORBERA® intragastric balloon system.

The FDA letter to Health Care Providers can be found here.

In relation to the ORBERA balloon, the facts are:

  • ORBERA is approved by the FDA as safe and effective in assisting adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight.
  • There have been five (5) reported deaths of patients who had received the ORBERA intragastric balloon in four different countries since ORBERA's FDA approval in August of 2015.
  • Apollo self-reported all five cases to the FDA as part of its Global Product Surveillance program.
  • The FDA's letter to Health Care Providers does not indicate that the patient deaths were related to the ORBERA device or the insertion procedures. While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the ORBERA device.
  • Apollo has received no product liability-related claims in connection with these five cases.
  • As stated in the ORBERA Directions For Use (updated in June 2017 and approved prior to its release by the FDA), in the period from January 1, 2006 through March 31, 2017, there have been 21 reported deaths of patients while they had an ORBERA, which is an incident rate of less than one one-hundredth of one percent (<0.01%) of the more than 277,000 ORBERA balloons distributed in the same time period.
  • Since receiving FDA approval in August 2015, the incident rate remains less than 0.01%.
  • Details of the 5 cases:


                         

Location of
Procedure

     

Date of
Event

     

Date Reported
to FDA

      Link to FDA MAUDE Data
Brazil       1/29/16       3/2/16      

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5474189&pc=LTI

United States       3/16/16       4/13/16      

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5574835&pc=LTI

Brazil       5/10/16       6/8/16      

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5706677&pc=LTI

Great Britain       Unknown       11/16/16      

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6106617&pc=LTI

Mexico       4/11/17       5/19/17      

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6579298&pc=LTI

                 

  • ORBERA remains the only intragastric balloon that meets the American Society of Gastrointestinal Endoscopy's (ASGE) threshold standards for the treatment of obesity.

Todd Newton, CEO of Apollo states: "Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so."

Dr. Christopher Gostout, MD, Chief Medical Officer of Apollo states: "The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms."

Apollo Endosurgery management will hold a conference call for investors and analysts on Friday, August 11, 2017 at 8:30 AM (EDT). To participate in the conference call dial (800) 263-8506 for domestic callers and (719) 325-4778 for international callers. The conference ID number is 9061067.

A telephonic replay of the call will be available until August 18, 2017. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. The replay conference ID number is 9061067.

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 60 countries today.

Apollo's common stock is traded on NASDAQ Global Market under the symbol "APEN." For more information regarding Apollo Endosurgery, go to: apolloendo.com.

© 2017 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.

About ORBERA®

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 60 countries.

For additional information regarding ORBERA®, please visit orbera.com.

For full safety information please visit orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.

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: product liability claims relating to our Endo-bariatric products, including ORBERA; physician adoption and recommendations of procedures utilizing our products; misuse or off-label use of our products resulting in injuries or death; continued extensive FDA regulatory oversight; potential product recalls; health care provider education and on-going training to ensure patient safety and treatment; and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC (News - Alert), including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the three months ended June 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.


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