Topspin Medical Announces First Commercial Installation of the Cathamaran(TM) Intravascular MRI System |
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By: TopSpin Medical Israel Ltd Posted: 2008-01-30 03:24:32 |
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TopSpin Medical, Inc. (TASE: TOPMD) announces first commercial installation of the Cathamaran(TM) Intravascular MRI System at ZOL Hospital, Genk, Belgium, with the first procedures performed on January 16th.
"We are pleased to be the first site to install the Cathamaran(TM) IVMRI System. This 6F compatible technology represents a major breakthrough in our ability to detect and quantify lipid present in coronary lesions. We are very excited to be among the first centers to participate in the MIRACLE Study to further evaluate the clinical role for IVMRI in both diagnostic and interventional coronary catheterization procedures. The identification of high risk, lipid -rich lesions that may be prone to rupture is of paramount importance, and the IVMRI System may potentially help address this unmet need," stated Dr. M. Vrolix from ZOL hospital, Belgium. The company and the distributor are currently in advance negotiation for similar agreements with additional medical centers in the Benelux territory. The company is expecting to install additional Cathamaran(TM) Intravascular MRI systems in the Benelux territory in the course of the current quarter. The Cathamaran(TM) IVMRI System will be used in a post-market Study of coronary plaque lipid characterization by IVMRI performed during diagnostic or interventional catheterization [MIRACLE Study]. The multi-national prospective MIRACLE Study is designed to collect data on a widespread post-market clinical experience to evaluate how lipid quantification with the IVMRI System may be used to guide patient treatment. Yaron Tal, President and Chief Executive Officer of TopSpin Medical, said: "The introduction of our unique Cathamaran(TM) Intravascular MRI System and the initiation of the MIRACLE Registry represent major milestones for our company. We are committed to advancing investigation into vulnerable plaque with the goal of improving diagnosis of these high-risk lesions and aiding development of appropriate therapeutic solutions. We are very excited to collaborate with ZOL hospital in this important investigation." About TopSpin Topspin Medical(TASE: TOPMD), Inc. founded in 1999 and headquartered in Lod, Israel, is a publicly traded company focused on developing and commercializing real time therapy guidance systems based on a novel magnetic resonance imaging technology. The company's technological development is unique because of the miniaturization of the device, its ability to characterize soft tissues in greater precision and resolution and to provide the physician results in real-time. The use of the novel technology may constitute a platform in many fields where characterizing soft tissues in high resolution is of critical importance for diagnosing and treating the disease. In addition, the innovation allows greater access to MRI technology thanks to the size of the device, the simplicity of its use and its low cost. The technology's first application in the cardiology field is targeted to aid the diagnosis and treatment of vascular disease. The company has developed the only 6F compatible MRI probe designed for intravascular delivery in the coronary arteries. The company has recently submitted a 510K with the FDA and received the CE Mark for its second generation in August 2007. In 2006 TopSpin Medical began to develop its technology for imaging prostate cancer by an integrated endo-rectal MRI and ultrasound probe. For more information about Topspin Medical, visit the company's website at http://www.Topspin.co.il Forward-looking Statements Statements in this press release which are not historical data are forward-looking statements which involve known and unknown risks, uncertainties or other factors not under the company's control, which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the company's periodic filings with the securities authorities. Contact: Eyal Kolka CFO & Senior Vice President, Business Development +972-8-920-0033 |
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