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News

Johnson & Johnson Medical Israel to distribute TopSpin's IVMRI catheter in Israel

TopSpin Medical Israel : 30 July, 2007  (New Product)
TopSpin Medical has signed an agreement with Johnson and Johnson Medical Israel for distribution, marketing and joint-funding of clinical trials of its intravascular MRI (IVMRI) catheter.
The agreement appoints J&J Medical Israel as the exclusive distributor for IVMRI in Israel for a period of three years, with an option to extend the period by mutual agreement. The IVMRI catheter, developed by TopSpin Medical, can image the tissue composition of coronary artery walls from within the artery during cardiac catheterisation, without the need for a bulky and expensive MRI setup.

As part of the agreement, J&J Medical Israel will participate, through its Cardiovascular Division - Cordis, in funding clinical trials that the two companies will initiate in Israel. The trials will study the potential clinical use of TopSpin's IVMRI as a new modality for the diagnosis and therapy guidance in patients that are at high risk for heart attacks.

To date TopSpin has successfully tested its IVMRI Catheter in 160 patients, in Europe, US and Israel, as part of two clinical trials: a First In Man (FIM) study, which allowed the company to obtain CE-Mark by end of 2006, and the TOP-IMAGE-2 study, which the company plans to submit to the FDA as part of a 510k market clearance. The company has also announced that it has received the CE-Mark for its second generation IVMRI catheter, which offers a lower Catheter profile and multiple sensors for longer segment coronary imaging.

Erez Golan, TopSpin's CEO: 'We are happy to announce this collaboration between Johnson and Johnson Medical Israel and TopSpin. It reinforces our joint commitment to offer physicians and patients the most advanced technology available and to validate it as a means for early diagnosis of coronary plaque that can lead to heart attacks. We are already working with our physician and distribution partners in Europe on studies that would further validate the potential application of IVMRI in diagnosing and guiding treatment of unstable plaques. This agreement with J&J Medical Israel will now allow us to offer key Israeli cardiologists to become our partners in developing this exciting field. Our plan is to extend this type of collaboration into other parts of Europe, US and the Far-East as a means to establish IVMRI as a useful, evidence-based tool for routine use in interventional cardiology.'


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