Healthcare Industry News: Stereotaxis
News Release - September 11, 2007
Stereotaxis' Niobe System Used to Perform More Than 10,000 Procedures WorldwideSteady Utilization Growth Seen in Atrial Fibrillation, EP Mapping and Ablation, PCI and Additional Complex Procedures
ST. LOUIS, Sept. 11 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced today that more than 10,000 procedures have been performed using the Stereotaxis system. The Stereotaxis system utilizes advanced, magnet-guided navigational technology intended to help electrophysiologists and cardiologists treat complex arrhythmias and perform other interventional procedures, with enhanced safety and precision.
To date, clinicians at more than 60 hospitals worldwide have used the Stereotaxis system to perform over 2,000 percutaneous coronary interventions (PCI) and other guidewire-based vascular procedures; approximately 6,000 right-sided electrophysiology mapping and ablation procedures; and nearly 2,000 atrial fibrillation and other complex left-sided procedures, including 400 for ventricular tachycardia.
"As one of the largest electrophysiology practices in the country, we regard our Stereotaxis Niobe® system as an important component of our daily treatment of a broad spectrum of arrhythmias," said Dr. Raul Weiss of Ohio State University Hospital. "We are particularly impressed with the superior performance and safety of the system in challenging cases, and we believe that Stereotaxis will revolutionize the treatment of complex arrhythmias, setting a new paradigm for patient care."
"The strong growth in our technology's clinical utilization is occurring across a broad range of electrophysiology, interventional cardiology, and other vascular procedures, and we are pleased to note that nearly 500 procedures have been completed with our new partnered eight millimeter catheter, since its recent launch," said Bevil Hogg, CEO of Stereotaxis. "The Stereotaxis system is continuing to gain recognition from clinicians for its peerless safety record, reflected in the fact that Stereotaxis' incidence of all reported cardiovascular complications associated with the use of magnetic catheters for complex left-sided procedures stands at approximately 0.1%, representing what we estimate to be a greater than fifty-fold improvement over what has been reported by the Heart Rhythm Society for manual AF cases. The steady adoption of the Stereotaxis system, its increasing utilization and safety profile, are very encouraging. With additional milestones on the near-term horizon, we anticipate a favorable acceleration of our clinical usage in 2008."
"We are, for instance, looking forward to the near-term launch of our irrigated catheter in Europe, and its regulatory approval in the U.S. by year-end," added Mr. Hogg. "We are also expecting to announce at the upcoming TCT conference, a new solution for the treatment of complex vascular lesions, including chronic total occlusions, in the coronaries and peripheral vasculature. This will further demonstrate the power of the Niobe system as a platform which can be broadly expanded, with the potential to deliver simpler, safer, and less expensive treatments for complex cases across the full range of interventional practice."
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.
About Forward Looking Statements
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, 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 we will recognize revenue related to our 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 our 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.
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