Apollo Endosurgery Receives 510(k) Clearance for Polypropylene Suture-Anchor Assembly
18 Septembre 2019 - 3:00PM
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 510(k)
clearance from the U.S. Food and Drug Administration for its
Polypropylene Suture-Anchor Assembly for use specifically with the
OverStitch™ Endoscopic Suturing Systems. This proprietary
suture-anchor implant is used as part of Apollo’s OverStitch™ and
OverStitch Sx™ Endoscopic Suturing Systems to pass and anchor
suture in the gastrointestinal tract.
Apollo is currently distributing a suture anchor that is
manufactured by a third party according to Apollo design
specifications. “Obtaining 510(k) clearance for our own proprietary
suture-anchor component is expected to improve our gross margins,
and allow us greater control over the supply of our suture by
reducing our dependency on third party suppliers. This will be key
as we seek to expand into new OverStitch markets outside the United
States,” stated Todd Newton, Apollo’s Chief Executive Officer.
About OverStitch and OverStitch Sx
The OverStitch and OverStitch Sx endoscopic suturing systems
enable advanced endoscopic surgery by allowing physicians to place
full-thickness sutures from a flexible endoscope. This new
technology enables a secure approximation of tissue endoscopically
and a wide range of less invasive solutions for physicians who
treat defects in both the upper and lower GI tract of their
patients. Additionally, physicians are leveraging endoscopic
suturing to perform a variety of advanced bariatric procedures. For
more information regarding OverStitch go to:
www.apolloendo.com.
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
Balloon.
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.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking
statements under the federal securities laws, 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 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, 2018 and its Form 10-Q for the three months
ended June 30, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190918005076/en/
Apollo Endosurgery, Inc. Stefanie Cavanaugh, 512-279-5100
Investor Relations investor-relations@apolloendo.com
Apollo Endosurgery (NASDAQ:APEN)
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