TEL AVIV, Israel, July 6 /PRNewswire-FirstCall/ -- TopSpin Medical (TASE: TOPMD) announced it has received FDA approval to start conducting clinical trials in the US with its IntraVascular MRI (IVMRI) catheter, intended for the characterization of lipid-rich lesions in the coronary arteries. TopSpin IVMRI catheter technology enables MRI to be performed in the clinic for the first time with no external magnets. To date the company conducted clinical trials with its IVMRI catheter in more than 70 patients in Europe and Israel, and following the FDA approval TopSpin intends to extend the clinical trials to leading US clinical sites.
In addition, TopSpin Medical announced it has completed the development of a prototype of its advanced generation IVMRI catheter, in accordance with the planned schedule. This advanced generation IVMRI catheter prototype is a further technological breakthrough in the miniaturization of the sensors and in the ability to integrate a number of sensors for imaging longer arterial segments in a short acquisition time.
The company projects that it will receive marketing clearance in Europe (CE Mark) by the end of 2006, and aims to receive marketing clearance in the US by the middle of 2007.
"We're encouraged by the technological breakthrough achieved in the development of our advanced generation IVMRI catheter" said Erez Golan, TopSpin Medical's President and CEO, "The completion of the advanced prototype development in parallel to substantial progress in our clinical trials will enable us to get the marketing clearance and launch the IVMRI catheter in Europe and in the US as planned. Subsequently we will be able to offer cardiologists advanced generations of the IVMRI catheter using the same imaging console".
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 eyal@topspin.co.il
Caution: TopSpin IVMRI system is not available for sale and is currently in clinical trials.
TopSpin Medical, Inc.CONTACT: Eyal Kolka, CFO & Senior Vice President, Business Development,+972-8-920-0033, eyal@topspin.co.il
