Sources inform ''Globes'' that BrainsGate has launched the second pivotal trial to test its electrical stimulation device of the brain for the treatment of ischemic stroke, after interim results of the trial showed that it was necessary to amend the trial structure. The new trial is scheduled to begin in early 2013.
A pivotal trial to test the safety and efficacy of a medical device is equivalent to a Phase III clinical trial of a drug. BrainsGate first trial, which included 100 patients, was a success.
BrainsGate VP business development Raveh Gill-More confirmed the report, telling "Globes", "This is not a significant change in terms of the number of patients that we will have to recruit for the trial or in the time to market."
Gill-More added that the company received the interim results of the trial a few months ago, and realized that a change was needed. "We saw that we did not sufficiently filter between real stroke patients and patients who suffered a minor brain event, which could pass without therapeutic intervention. If the trial includes too many patients who improve on their own, there will not be statistically significant differences between the trial group and the control group, and the statistics will not show the effectiveness of the treatment.
Following discussions with the US Food and Drug Administration (FDA), BrainsGate decided not to pursue the trial in its original format, but to conduct a new trial after a more meticulous recruitment of patients.
"The trial is due to include 600 patients. We opened 200 envelopes before halting the current trial. We reached agreement with the FDA to include 450 patients in the second trial, so we need only 50 more patients than we originally planned to recruit to begin" said Gill-More.
"Globes": Are strategic investors interested in your product on the basis of the interim results?
Gill-More: "Strategic parties have already invested in the company. I cannot comment beyond this." The reference is to Boston Scientific Inc. (NYSE: BSX) and and Johnson & Johnson (NYSE: JNJ).
BrainsGate was founded on the basis of an invention by serial entrepreneur Yossi Gross and Prof. David Yarnitsky, the head of the Neurological Department at Rambam Medical Center in Haifa. The company's device is implanted in the mouth cavity to electrically stimulate the Spheno-Palatine Ganglion (SPG), a nervous center known to increase cerebral blood flow.
Other investors in the company include Pitango Venture Capital, Alice Ventures, Agate Medical Investments LP, Infinity Private Equity, and IDB Holding Corp. Ltd. (TASE:IDBH) venture unit Elron Electronic Industries Ltd. (Pink Sheets: ELRNF; TASE: ELRN).
Published by Globes [online], Israel business news - www.globes-online.com - on August 9, 2011
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