FDA approves Israeli start-up Barnevs birth monitor

The company withdrew a TASE offering in 2006 because of low demand.

Sources inform ''Globes'' that Barnev Ltd. has obtained US Food and Drug Administration (FDA) approval for its flagship product, a computerized labor monitoring system. The approval means that the company can market the product in the US, and will initiate marketing efforts there.

Barnev obtained EU CE Mark certification for its product in 2006, and it has been installed as a pilot at several medical centers. However, the company considers the US to be its main market.

In February 2006, Barnev filed a prospectus for raising $5 million on the Tel Aviv Stock Exchange (TASE) at a company value of $21 million, after money, but withdrew the offering because of low demand. The company recently raised $6 million from Israeli investors at a higher company value than for its planned offering. The company has no plans to go public at this time, although it does not rule out the possibility.

Shlomo Nevo, Prof. Ofer Barnea and Dr. Dan Farine founded Barnev in 1999 at Naiot Venture Accelerator. Nevo previously founded Slo-Flo, Barnea is chairman of the Department of Medical Engineering at Tel Aviv University, and Farine is an expert in gynecology. Barnev president and CEO Yossi Machtey previously served as VP marketing at the MRI unit of Elscint Ltd.

Jerusalem Global Ventures (JGV) InnoMed Ventures is the largest shareholder in Barnev, with a 53.37% stake according to the companys last prospectus. InnoMed invests in early-stage Israeli life sciences companies. Swiss holding company Aeris owns 24.72%, Ofer Hi Tech Ltd. owns 6.76%, and private investors have small holdings.

Barnevs computerized labor monitoring system uses proprietary ultrasound technology to provide safe, continuous and accurate measurement of cervix dilatation and fetal head descent. These measurements are currently done manually every one to four hours by a midwife. These measurements are considered inaccurate, uncomfortable, and risk causing infections. By contrast, the companys computerized system continuously and accurately monitors contractions and the fetuss heartbeat.

The ultrasound monitor includes electrodes attached to the two sides of the cervix and to the head of the fetus, three transmitters/receptors attached to the mothers abdomen, and an amplifier attached to the mothers hip. The company developed all these devices. The solutions continuous monitoring gives early warning of any problem during birth and greater precision in understanding developments, which makes it possible to prepare necessary medical procedures and avoid unnecessary ones.

Published by Globes [online], Israel business news - www.globes.co.il - on February 5, 2007

Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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