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 Company enters into Sixth Loan Modification and Waiver Agreement with Silicon Valley Bank. Stereotaxis Earnings Call Nuggets: Procedure Side Dynamics Highlights from the company's latest earnings conference. Other Stocks in the News Has LinkedIn's Growth Kept Pace With Facebook? Article on LinkedIn's growth and how it compares to FB. Bionomics Signs Pain Treatments Deal with Merck of Up to $172 Million Bionomics strikes $172 million deal with Merck. Copyright 2013 by, Inc. InvestorGuide has no control over the sites we link to, is not affiliated with these sites, and cannot take responsibility for their quality or suitability. The news, analysis, commentary and profile information is not meant to be comprehensive, and the data provided is not guaranteed to be accurate. WebFinance Inc., the publisher of this newsletter, is not a registered investment advisor or a broker/dealer. This is not a stock recommendation newsletter but rather a source for investment ideas, and we encourage you to fully research any company before considering investing. The opinions expressed herein are those of the author and do not necessarily represent the views of nor are they endorsed by WebFinance Inc. No employee of WebFinance has owned or currently owns any shares in the company described above. The above is neither an offer nor solicitation to buy or sell any securities. The trading of securities may not be suitable for all potential readers of this newsletter, and the purchase of stocks mentioned in this newsletter may result in the loss of some or all of any investment made. We recommend that you consult a stockbroker or financial advisor before buying or selling securities or making investment decisions. We are not responsible for claims made by advertisers and sponsors. Anyone who makes decisions based on what they read here does so at their own risk and cannot hold WebFinance Inc. (DBA, Inc.) or its employees responsible.

Published on Jul 31, 2013
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

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