BrainsGate

BrainsGate Overview

BrainsGate is a medical device company that develops therapies for patients suffering from central nervous system diseases, with a focus on the treatment of acute ischemic stroke. The companys platform technology involves electrical stimulation of the sphenopalatine ganglion, a nerve center known to increase cerebral blood flow. Building on its technology, BrainsGate has developed the Ischemic Stroke System (ISS), in which a miniature electrode is implanted in the roof of the mouth in a minimally invasive bedside procedure performed under local anesthesia and comparable to a dental treatment. In 2008, BrainsGate completed ImPACT-1, a pilot clinical trial for acute ischemic stroke with promising results. In 2011, the company completed a 300-patient RCT pivotal trial that further substantiated the safety and efficacy of its treatment for acute ischemic stroke patients. BrainsGate is currently running the ImpACT-24b, a multinational, randomized, double-blind, sham-controlled pivotal study to assess the safety and efficacy of its treatment for stroke patients in a 24-hour window.

Cumulative Funding Raised Over Time ($)

Latest News

Dec 20, 2021 · www.bioworld.com

growth-negative

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

Dec 6, 2020 · en.globes.co.il

growth-positive

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.

InvestmentExpand

Oct 21, 2018 · en.globes.co.il

growth-negative

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

Jan 25, 2015 · www.globes.co.il

growth-positive

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

Aug 16, 2011 · en.globes.co.il

growth-positive

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

Funding

Team Members

2

Employees: 11-50

Web & Social Links

Locations

Rotem HaMidbar Street 4, Caesarea, Israel

Photos & Videos

2 item(s)

BrainsGate Internal

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