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.
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.