BrainsGate Ltd. has obtained US Food and Drug Administration (FDA) approval for the clinical trial protocols for a study that the company began in June 2011 on its ischemic stroke treatment. The clinical trial includes 176 patients at 57 medical centers around the world. The FDA approval means that the company can recruit patients for the trial in the US.
BrainsGate's technology uses electrical neurostimulation of the Spheno-Palatine Ganglion (SPG), a nervous center known to increase cerebral blood flow. It is designed to treat ischemic strokes with 24 hours of an event. Current pharmaceutical treatments, which include tPA proteins, are permitted only within 3-4.5 hours of a stroke.
BrainsGate expects to complete the trial on 450 patients in the fourth quarter of 2013.
BrainsGate has raised $70 million to date. Investors include IDB Holding Corp. Ltd. (TASE:IDBH) unit Elron Electronic Industries Ltd. (TASE: ELRN), which owns 30% of the company, Johnson & Johnson (NYSE: JNJ) investment arm J&J Development Corporation, Boston Scientific Inc. (NYSE: BSX), Pitango Venture Capital, Infinity Private Equity, Agate Medical Investments LP, and Cipio Partners.
The World Health Organization estimates the direct cost of ischemic strokes at $73.7 billion, and that 15 million worldwide suffer strokes every year. Ischemic stroke is a leading cause of long-term disability. Due to the short treatment window of current treatments, only 5% of victims receive medical treatment, a proportion that could increase thanks to the longer treatment window that BrainsGate's technology offers.
Published by Globes [online], Israel business news - www.globes-online.com - on July 26, 2012
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