Stereotaxis, Inc. Announces First Procedures Successfully Performed With Recently Re-introduced Magnetic Irrigated Catheter

ST. LOUIS, Sept. 8 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. announced today that the first atrial fibrillation procedures using its re-introduced partnered magnetic irrigated catheter were successfully performed in Europe last week. The catheter received CE Mark approval in the last week of August following its resubmission to European regulators by the Company’s partner in July 2008, and these first cases are part of the standard pre-release evaluation.

Also in July, the Company’s partner submitted a PMA Supplement to the U.S. Food and Drug Administration (FDA) for use of the magnetic catheter in the U.S. with the expectation that U.S. approval would be obtained subsequent to the European CE Mark.

Prof. Carlo Pappone MD, PhD, FACC, performed the first procedures last week at San Raffaele University Hospital in Milan, Italy. He said, “I am delighted with the results of my first procedures performed successfully with the newly available Biosense magnetic irrigated catheter. I am extremely happy with its performance, and believe that Biosense did an excellent job. Contact stability, lesion quality and overall mechanical performance are excellent, and I believe safety is likely to be exemplary.”

“We are very pleased with the successful initial experience of our partnered magnetic catheter following its recent re-introduction in Europe,” said Bevil Hogg, CEO of Stereotaxis. “We remain optimistic regarding the timing for re-approval of this catheter in the U.S. and look forward to the completion of its initial evaluation prior to commercial release in Europe. Most importantly, we anticipate that the commercial re-introduction of this catheter, which is used primarily for complex procedures in the left atrium of the heart, will mark a point of inflection in the utilization of our installed base of Niobe(R) systems, resulting in a substantial increase in procedure volume over time and a concomitant acceleration of system sales.”

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.

This press release includes statements that may constitute “forward- looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.

CONTACT: Jim Stolze, Chief Financial Officer of Stereotaxis, Inc.,
+1-314-678-6105; or Investors, Doug Sherk or Jenifer Kirtland,
+1-415-896-6820, or Media, Steve DiMattia, +1-646-201-5445, all of EVC
Group, Inc.

Web site: http://www.stereotaxis.com/

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