AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in
less invasive medical devices for gastrointestinal and bariatric
procedures announced today that it has received FDA approval for its
proposed labeling updates for the ORBERA® Intragastric Balloon System.
The goal of the labeling updates is to improve patient safety and these
will take effect immediately. The updated US Orbera Directions for Use
is available here.
The labeling updates improve patient safety by providing further
definition and guidance on the appropriate use of the ORBERA®
Intragastric Balloon System and patient selection. The most notable
safety labeling updates included:
Clarification to contraindications. These changes clarified that the
previous “hepatic insufficiency or cirrhosis” contraindication related
to patients with acute liver failure and decompensated cirrhosis. The
changes also clarified the types of previous gastric surgery that are
Added precautions related to patients who are taking anti-cholinergic
or psychotropic medications that are known to delay gastric emptying.
Updated US adverse event tables based on the current market
surveillance data. There were no new categories of adverse events
added and occurrence rates did not materially change.
Other procedure technique-related edits were made to the instructions
“‘Hepatic insufficiency or cirrhosis’ has been clarified so that it is
not interpreted incorrectly as disallowing Orbera’s use in a broad
spectrum of liver disease patients including non-alcoholic fatty liver
disease (NAFLD) and its subtype non-alcoholic steatohepatitis (NASH),”
said Dr. Christopher Gostout, Apollo’s Chief Medical Officer.
Approximately 100 million individuals in the United States are estimated
to have NAFLD and weight loss is identified by the American Association
for the Study of Liver Diseases in their patient treatment guidelines as
one of the most effective treatments to stop and potentially reverse the
progression of fatty liver disease.
ORBERA® is an incision-less, non-surgical weight loss solution designed
for adult patients suffering from obesity, who are not appropriate for
or considering 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 a few hours later.
After up to 6 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 while
the balloon is in place. The program is designed to help the patient
develop sustainable, healthy habits that will help keep weight off over
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less
invasive therapies to treat various gastrointestinal conditions, ranging
from gastrointestinal defect repairs to the interventional treatment of
obesity. 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 and include the OverStitch™ Endoscopic Suturing System, the
OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric
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.
© 2019 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, outcomes of clinical studies,
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 as
well as other factors detailed in Apollo’s periodic reports filed with
the Securities and Exchange Commission, or SEC, including its Form 10-K
for the year ended December 31, 2018 and its Form 10-Q for the three
months ended March, 31, 2019. 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.
Jen Cook, 512-279-5158
John Gillings, 512-279-5100