ST. LOUIS, Oct. 18 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. today announced an agreement with Baylis Medical Company, Inc. (Privately held) to develop and commercialize a magnetically enabled radio frequency (RF) guidewire for chronic total occlusion (CTO) applications. The agreement includes the development of a range of magnetically enabled RF guidewires for both coronary and peripheral CTO crossing applications.
The products resulting from this collaboration will have the potential to provide physicians with the unique ability to precisely steer RF guidewires using Stereotaxis' Niobe(R) magnetic navigation system, and then to deliver vessel recanalization therapy using the Baylis Medical RF energy delivery system. Traditional manual approaches to percutaneous crossing of CTOs are often hindered by difficulty in controlling the guidewire tip within fully occluded vessels.
A review of early Stereotaxis-Baylis collaborative CTO research efforts will be presented by Professor Patrick Serruys of the Thoraxcenter, Rotterdam, during the Stereotaxis Transcatheter Cardiovascular Therapeutics (TCT) Breakfast Symposium, scheduled for 7:00 to 8:00 a.m. on Wednesday, October 25, in Room 154AB of the Washington, DC Convention Center.
"This collaboration has the potential to provide the first CTO crossing device that can enable true intra-lesion steering," said Bevil Hogg, President and Chief Executive Officer of Stereotaxis, Inc. "We look forward to working with Baylis Medical to greatly improve success rates for crossing coronary and peripheral CTOs, a pre-requisite to the delivery of stents which could potentially reduce the number of patients referred to bypass surgery. We further note that the Baylis RF PowerWire(TM) (non-magnetically enabled) is already 510(k) cleared for recanalizing totally occluded peripheral vessels 3mm or greater."
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 Baylis Medical
Baylis Medical is a world leader in the development, manufacturing, and marketing of Radio Frequency systems for cardiac applications. The Baylis Medical Radio Frequency Puncture (RFP) system is designed specifically to create controlled punctures in cardiac tissue. The pediatric and adult applications include doing transseptal punctures, treating pulmonary atresia and re-canalizing vascular occlusions.
The RFP-100 Generator is used with the Nykanen Puncture Catheter, The PowerWire(TM), the Protrack(TM) Catheter, the Toronto Transseptal Catheter, and the TorFlex(TM) Transseptal Sheath & Dilator.
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 of 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.
Stereotaxis, Inc. Noonan Russo
Jim Stolze, Chief Financial Officer Brian Ritchie (investors)