BrainsGate
Minimally Invasive Treatment for Central Nervous System Diseases
Company Overview
Snapshot
Founded in July 2000, BrainsGate operates with 11–50 employees. The company has raised $98.5M across 6 funding rounds from 11 investors. In December 2020, BrainsGate secured funding from BNP Paribas and Elron Ventures.
Business overview
BrainsGate is a medical device company focused on developing therapies for central nervous system diseases, particularly acute ischemic stroke. Its core technology involves electrical stimulation of the sphenopalatine ganglion to increase cerebral blood flow. The company's primary product is the Ischemic Stroke System (ISS), a miniature electrode implanted in the roof of the mouth through a minimally invasive procedure. BrainsGate serves the healthcare industry, targeting patients and providers within the Health Tech & Life Sciences sector.
Strategic signal
In December 2021, BrainsGate faced a negative FDA panel outcome, partly attributed to low U.S. enrollment in its clinical trials. This signals potential challenges in regulatory approval and market penetration within the critical U.S. healthcare landscape, indicating a need for strategic re-evaluation of its clinical trial approach and market entry strategy.
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- What is BrainsGate's primary focus?
- BrainsGate develops therapies for patients suffering from central nervous system diseases, with a particular focus on the treatment of acute ischemic stroke.
- What is the Ischemic Stroke System (ISS)?
- The Ischemic Stroke System (ISS) is a device developed by BrainsGate that involves a miniature electrode implanted in the roof of the mouth in a minimally invasive bedside procedure, designed to treat acute ischemic stroke.
- When did BrainsGate complete its pivotal trial for acute ischemic stroke?
- In 2011, BrainsGate completed a 300-patient RCT pivotal trial that substantiated the safety and efficacy of its treatment for acute ischemic stroke patients.
- What was a key finding from the ImPACT-1 pilot clinical trial?
- BrainsGate completed the ImPACT-1 pilot clinical trial for acute ischemic stroke in 2008, which showed promising results.
- What was the outcome of the FDA panel for BrainsGate in December 2021?
- In December 2021, BrainsGate received a negative FDA panel outcome, with low U.S. enrollment cited as a contributing factor.