Conference Call Scheduled for Friday, August 11, 2017 at 8:30 AM (EDT)
to Discuss Letter
AUSTIN, Texas–(BUSINESS WIRE)–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:
|Link to FDA MAUDE Data|
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
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.
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, 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.
Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
Lee Roth or Zack Kubow, 646-536-7000