Cleveland-backed Israeli device firm gets FDA clearance

Israeli company Navotek Medical, which is backed by a Cleveland venture firm, has received U.S. regulatory clearance for its radiation therapy monitoring system.

Navotek’s RealEye system obtained 510(k) clearance from the U.S. Food and Drug Administration for the treatment of patients with prostate cancer. The company says the system helps doctors more precisely monitor the delivery of radiation therapy, which helps reduce the risk of collateral damage to healthy tissue.

Navotek has already received regulatory clearance to commercialize the RealEye system in the European Union.

The company has raised more than $10 million in investment capital since its 2005 inception, with about $1 million of that coming from Cleveland-based Bridge Investment Fund. Bridge’s model is to invest in Israeli device firms that are looking to break into the U.S. market. Bridge’s portfolio companies have had a good run recently, with IceCure raising $10 million in an initial public offering on the Tel Aviv Stock Exchange in February and EarlySense raising $20 million last year.

Navotek’s other investors include Israeli venture capital firms Wanaka Capital Partners, Giza Ventures and Agate Medical Investments.

Like EarlySense and IceCure, Navotek is considering establishing Northeast Ohio as the base of its U.S. operations, but Navotek CEO Giora Kornblau said it’d likely be about a year before any decision is made.

“Cleveland is of course one of the options being considered,” Kornblau said. “We have connections in the area — both medical and financial.”

One of Navotek’s Northeast Ohio connections is co-founder David Neustadter, who received a doctorate in biomedical engineering from Case Western Reserve University.

Navotek is in discussions with several unidentified U.S. hospitals regarding clinical trials of the device for use with patients suffering from breast or lung cancers. Kornblau expects the trials to begin in a year or two.

Among the company’s next key steps is to seek FDA clearance for an implantable fiducial marker, an object used as a point of reference by monitoring systems such as the RealEye.

Navotek’s RealEye device is a large piece of equipment that attaches to a linear accelerator, a device used to deliver radiation to cancer patients.

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