Stereotaxis (STXS) Stock up 228% on FDA Clearance
Shares of Stereotaxis Inc. (STXS) closed up +4.07 or +228.7 percent on Tuesday after news that the FDA had granted the company 501K clearance to begin marketing its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography catheter manipulator in the United States. The company's Vdrive products have been in use in Europe since 2011, the clearance for their marketing by the FDA is the first for this type of product.
Stereotaxis derives its name from stereotaxy, a minimally invasive type of surgical intervention, which uses a three dimensional coordinate system for locating targets inside the body for biopsy, lesion, implantation, injection etc. Daily Chart
St. Louis, Missouri based Stereotaxis Inc. was founded in 1990 and is involved in the design and manufacture of robotic instrument navigation systems used in cardiology surgery. Its best known products are the NIOBE ES Remote Magnetic Navigation System, used to navigate guidelines and catheters through blood vessels and heart chambers, and the NAVIGANT system, which allows physicians to visualize and keep track of cardiology procedures. The company is a leader in the development of robotic instrument navigation systems in the field of cardiology, used to enhance the treatment of coronary disease and arrhythmias. The company also specializes in information management solutions for interventional laboratories. Stereotaxis own more than a hundred patents uses in hospital interventional surgery, as well as the Odyssey portfolio of lab optimization, a networking system for patient management. The company also produces the Vdrive Robotic Mechanical Navigation system. The V family of products includes the Vdrive with the V-Sono system, used for the remote control of ultrasound or ICE compatible catheters for insertion into the right atrium. The Vdrive system was originally released in Europe in 2011 and has already been used in more than 20,000 clinical cases of which 100 have made use of the V Sono disposable, launched in 2012. Stereotaxis' Chairman and Interim Chief Executive Officer, William Mills stated after the announcement that, "This is an exciting milestone for Stereotaxis, the Vdrive platform has added significant clinical value to a growing number of Niobe ES labs in Europe, and this V-Sono clearance should accelerate procedure growth in our U.S. installed base as well as open up an untapped, expanding electrophysiology (EP) market where ICE catheters are widely utilized. More than 68,000 ICE catheters are used in U.S. EP labs each year, a number that is growing at an annual rate of 15%." Stereotaxis stock gapped higher on the opening Tuesday and traded as high as $6.90 - a new all-time high - per share in a volatile trading session with extremely high volume. With a market cap of 47.7 million shares, the company had an EPS of -1.09 that could very well turn around in the next few quarters in light of the FDA clearance. With the FDA approval, the company's United States business will increase significantly boosting Stereotaxis share price. In addition, the dollar amount for shares is still low, which could attract even more investment. Other News About STXS STEREOTAXIS, INC. Files SEC form 8-K, Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation
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Published on Jul 31, 2013
By Jay Hawk