Medical equipment company Allium Medical Ltd. (TASE: ALMD), which specializes in minimally invasive technologies, today announced that it had obtained approval from the US Food and Drug Administration (FDA) to market Gardia Medical's WIRION EPD system for indication of catheterization in the common carotid arteries (the two main arteries that bring blood to the brain). The company's share responded to the news with a 45% leap.
The company obtained FDA approval according to the timetable it had announced. The approval followed the company's success in meeting all the targets for the clinical trial conducted with the WIRION EPD system in order to obtain approval at the preliminary stage of recruiting half of the patients (120 out of 240).
Allium CEO Asaf Alperovitz said, "Receiving FDA approval to market the WIRION EPD system in the US for clinical indication of protection against embolisms in catheterization of the common carotid arties is a very significant achievement for Allium. This the most important milestone in carrying out Allium's business strategy of leveraging Gardia's unique technology and solution, while extending the range of relevant medical indications and the potential business market, and penetrating the US market, while combining forces with a leading strategic partner.
"The company plans to promote an agreement with a globally deployed strategic partner with proven marketing capabilities for marketing products in Gardia's field of business that will make it possible to maximize the clinical and commercial potential of the system."
Published by Globes [online], Israel business news - www.globes-online.com - on June 7, 2015
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