Flexicath receives FDA approval for first product

The company raised $3 million at the beginning of the year from a group of investors led by the Zitelman Group.

Medical device company FlexiCath Ltd., a former Misgav Technology Center incubator company, has received US Food and Drug Administration (FDA) approval to market its first product, Firm Grip 15, in the US.

FlexiCath was co-founded in 2004 by medical adviser Prof. Paul Froom, R&D director Shai Amisar, and general manager Ronen Radomski. The company has developed a catheter which is encased in a sterile sleeve and has a special silicon insertion unit, enabling it to be inserted without being touched, and obviating the need for it to be sterilized first. The catheter is only removed from its sleeve once inside the patient's body, and it can be left in place for up to 29 days. Long-term catheters are inserted by doctors in a surgical procedure. FlexiCath's product can be inserted by any medical staff member, thanks to its innovative sleeve.

In January FlexiCath raised $3 million from a group of investors led by Maryland-based investment group The Zitelman Group Inc. Misgav Technology fund Trendlines Israel also participated in the round. The FDA approval will enable the product to be marketed in the US, but in order to generate significant sales, FlexiCath will still need to recruit distributors or build its own sales network, and obtain cover for the procedure from insurance companies. The company aims to raise a further $2 million, which it will use for these purposes.

Published by Globes [online], Israel business news - www.globes.co.il - on May 31, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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