Apollo Endosurgery Surges on FDA Approval

By Chris Lange Updated Jan 12, 5:58AM EST · Published Nov 28, 10:15AM EST

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Apollo Endosurgery Surges on FDA Approval — © Thinkstock

Shares of Apollo Endosurgery Inc. (NASDAQ: APEN) saw a healthy gain early on Tuesday after the company announced it had received 510k clearance from the U.S. Food and Drug Administration (FDA). Specifically, this is dealing with Apollo’s OverStitch Sx, a new, full-thickness flexible endoscopic suturing system that will work on a broad range of single-channel flexible endoscopes.

Essentially, flexible endoscopic suturing using Apollo’s current version of OverStitch is an important tool for both surgeons and gastroenterologists. However, it is currently only compatible with a limited number of dual channel endoscopes, and physicians without access to this specific capital equipment cannot leverage the benefits of endoscopic suturing.

OverStitch Sx removes this access limitation, and it will be compatible with most single channel endoscopes with diameters ranging from 8.8 mm to 9.8 mm.

Once available, the combination of the current version of OverStitch and OverStitch Sx will provide most physicians with access to the benefits of full-thickness flexible endoscopic suturing regardless of their hospital’s selection of endoscopic capital equipment or endoscope manufacturer.

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Christopher Gostout, MD, chief medical officer at Apollo Endosurgery, commented:

Endoscopic suturing is quickly becoming a global standard of care for a variety of endoscopic procedures backed by a growing level of clinical evidence. The launch of OverStitch Sx will allow suturing technology to be available to nearly any physician with access to an endoscope. Broader physician access to endoscopic suturing allows for greater patient access to a variety of minimally invasive endoscopic treatments.

Shares of Apollo were last seen up about 55% at $6.30, with a consensus analyst price target of $11.50 and a 52-week range of $2.00 to $21.88.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.