Ovalum is launching this July its Multicenter study to evaluate the performance of the CiTop™ ExPander™ Guidewire in crossing CTOs in the coronary arteries. Dr. Farrel Hellig from the Sunninghill Hospital in Johannesburg, South Africa, has concluded that "…the CiTop™ was successful with an excellent result" after an initial experience with the CiTop™ ExPander™ Guidewire.
The company has submitted the CiTop™ ExPander™ Guidewire to its notified body in the European Economic Area and is expecting to receive its CE marking during the fourth quarter of 2008. In addition, the company has completed the CiTop™ ExPander™ Guidewire 510K application to the FDA which will be submitted next month.
The CiTop™ ExPander™ Guidewire provides a simpler and more efficient means to open the Chronic Total Occlusion, thus avoiding the need for coronary bypass surgery. Noam Shamay, founder and CEO of Ovalum Ltd. said: "I am enthusiastic about the opportunity to introduce a significantly less invasive therapeutic option for coronary CTO patients".
Ovalum Ltd. was founded in March 2005 by Noam Shamay and Eitan Finkelstein. Located in Rabin Science Park Rehovot, Israel, OVALUM Ltd. Develops, manufactures and markets breakthrough products for the minimally invasive cardiology and interventional radiology markets designed specifically for the most challenging arterial procedures.
Ovalum Ltd. investors: Ziegler Meditech equity Partners LP and Smithfield Fiduciary LLC, represented by Eitan Machover (Director) and Pontifax LP represented by Tomer Kariv (Director).
CiTop™, CoBra™, TraVerse™ are all trademarks of Ovalum Ltd.
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