TEL AVIV, Israel, November 27 /PRNewswire-FirstCall/ -- TopSpin Medical (TASE: TOPMD) announced today that it has raised $11 million in convertible bonds from institutional investors on the Tel Aviv stock exchange in Israel.
TopSpin Medical has developed a unique technology platform, which for the first time enables MRI to be conducted with no external magnets. The ability to perform high-resolution local MRI with no external magnets is a breakthrough in medical imaging as it enables the extension of MRI technology to a wide range of applications, in which conventional MRI cannot get to the required resolution or is simply too bulky and expensive.
The primary application developed by TopSpin is high-resolution imaging of coronary artery walls during cardiac catheterization by a single-use, IntraVascular MRI (IVMRI) catheter. The IVMRI catheter has demonstrated accurate characterization of the lipid composition of atherosclerotic plaque - the most important factor in determining plaque instability.
TopSpin has successfully completed its First In Man (FIM) clinical trial, which, the company anticipates, would allow it to obtain CE-Mark for the IVMRI system by end of this year (2006). An additional clinical study is now ongoing in more than ten centres in Europe, Israel and the US, with Drs. Martin B. Leon and William Wijns as principle investigators. To date, about 100 patients have been enrolled in TopSpin’s studies with good safety and performance results. TopSpin plans to use the data to obtain FDA market clearance, which the company expects to receive by mid 2007.
In parallel, as announced in June of this year, TopSpin has made significant technological progress with the development of an advanced generation IVMRI catheter having a lower profile and multiple sensors for longer segment coronary imaging. Last month the company also updated on significant progress made on the development of a prototype trans-rectal MRI probe for prostate cancer imaging in Urology.
“We are very happy to conclude this significant financing”, says Erez Golan, TopSpin’s President and CEO. “The $11M raised will allow us to launch our IVMRI catheter in Europe and in the US, while continuing to invest in an extensive post-marketing clinical program that would help build our market. We intend to continue working with leading cardiologists, as well as industry partners, to further demonstrate the usefulness of IVMRI in diagnosing and guiding therapy to vulnerable plaque. At the last TCT conference in Washington DC this October we first announced our plan to initiate a large global registry of IVMRI users based on investigator driven protocols. The successful completion of the financing will allow us to move ahead with this ambitious plan, while further developing our technology, in Cardiology, Urology and beyond.”
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: Contact: Eyal Kolka, CFO & Senior Vice President, BusinessDevelopment, (+972)8/920-0033, eyal@topspin.co.il
