FDAnews Device Daily Bulletin
Research and Development / Commercial Operations

Endomedix Receives $1.49 Million Grant for Brain Surgery Hemostat

June 3, 2014
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Newark, N.J.-based Endomedix has won a $1.49 million Phase II Small Business Innovation Research grant to develop a surgical hemostat to stop bleeding during brain surgery — a complication that can occur seven to ten times throughout the course of a procedure, the company says.

The grant, awarded by the National Institute of Neurological Disorders and Stroke, will go towards safety and in vivo performance studies.

Endomedix will get $842,000 this year and the rest in 2015, depending on funding, President and CEO Richard Russo told Devices Daily Bulletin. He said the company has raised $1.15 million from private investors, but will likely need to raise an additional $4.5 million to get the product to market.

The company also is considering applying for other available grants, such as Phase II B SBIR grant.

The brain hemostat is the first in a platform technology of surgical hemostats, sealants and stem cell tissue engineering technology, Russo said. The brain hemostat will be light-duty and not as strong as a vascular hemostat, he added.

Studies will begin in the second half of 2014, Russo said. Endomedix will pursue FDA approval and a CE mark once the studies are completed, giving priority to whichever jurisdiction can grant a speedier approval, he said. The company plans to seek an expanded indication for use on the spine or during ear, nose and throat procedures at a later date, Russo added. — Kellen Owings

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