BrainsGate News
6 articles
Low U.S. enrollment helped drive negative FDA panel outcome for Brainsgate
Brainsgate Ltd. faced a negative outcome in an FDA advisory hearing for their Ischemic Stroke System (ISS) despite positive safety numbers. The small enrollment of study subjects in the U.S. was a key issue, highlighting the risks of relying on non-U.S. study data in FDA applications.
Customers
Elron medical device portfolio co Brainsgate raises $14m
Brainsgate, a medical device company, has raised $14 million in funding, including $6 million from new investors BNP and SPERO. The company is developing a device for treating strokes through electrical stimulation of nerve centers. While a trial in 2018 did not fully achieve its end-point aims, Brainsgate considered the results successful and filed for FDA and EU CE mark marketing approval. The product has been approved for marketing in Europe, and Brainsgate expects to submit the requested information to the FDA in the first half of 2021. The funds raised will be used for expanding production and filing for indemnity from US government health insurers. Brainsgate plans to market the product in Europe after receiving FDA approval.
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BrainsGate narrowly misses trial endpoint
Israeli stroke treatment developer BrainsGate plans to submit its stroke treatment product for approval, despite missing the targets in its trial. The trial did not find that using the device was beneficial in comparison with the control group, but an effect was found in cortex stroke patients. BrainsGate now plans to consult with the US Food and Drug Administration (FDA) in the hope of submitting its product for approval. The FDA must decide whether the results published by BrainsGate are convincing, even though they did not meet the official target.
Customers
CNS treatment co BrainsGate raising $26m
Medical device company BrainsGate is raising $26 million at a company value of $70 million. Elron Electronic Industries Ltd. will invest $8 million in two stages of the investment round. A global health sector company is leading the round, but the name is not disclosed. BrainsGate has raised $70 million to date, including Elrons $21 million investment. The company is developing a stroke treatment using electrical stimulation to reinforce blood flow to the brain. As of the end of Q3 2014, BrainsGate had $4.4 million in cash.
Investment
Stroke treatment device co BrainsGate raises $20m
BrainsGate Ltd., a stroke treatment company, has raised $20 million in a funding round led by main investor Elron. Elron provided $7.1 million of the round, increasing its stake in the company to 30%. Pitango Venture Capital also participated in the round. The funding will enable BrainsGate to complete the clinical trial on its ischemic stroke treatment, which aims to include 600 patients. 300 patients have already participated in the trial.
Investment
BrainsGate raises $4M from financing
Tel Aviv-based startup BrainsGate has completed a $4 million seed financing round. The funds will be used to develop its device line and embark on clinical trials. BrainsGate is developing technology to facilitate the transfer of medications into the brain, bypassing the blood-brain barrier.
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