If you are a manufacturer dealing with a lack of real-time brain function data — this project developed BraiN20®, a device that could reduce time-to-treatment by up to 140 minutes. This allows for faster triage and better patient selection for surgery.
Real-time Brain Viability Monitoring Device for Acute Ischemic Stroke Management
Imagine if doctors had an EKG for the brain to see exactly which parts are still alive during a stroke. Instead of relying on slow scans, this device tracks a specific brain signal to tell doctors instantly if a patient can be saved. It helps them decide quickly whether to perform surgery to remove a clot.
What needed solving
Current stroke treatment relies on static imaging and scores, leading to a 54% failure rate in endovascular treatments. This lack of real-time viability data results in massive healthcare costs and preventable brain cell loss.
What was built
A Class IIb non-invasive medical device (BraiN20®) featuring a neurostimulation system, medical-certified charger, and a detection algorithm for the N20 biomarker.
Who needs this
Who can put this to work
If you are a hospital operator dealing with the fact that 54% of patients undergoing EVT do not respond to treatment — this project developed a monitoring tool that can improve results in 26% of cases. This reduces wasted resources on ineffective procedures.
If you are an EMS provider dealing with delays in patient triage — this project developed a non-invasive monitoring tool for the entire patient journey. It enables accurate decision-making from pre-hospital management to post-treatment care.
Quick answers
What is the cost or pricing of the device?
Based on available project data, the specific unit price or cost of the BraiN20® device is not disclosed.
Is the device ready for industrial scale production?
The project has redesigned the device to facilitate a large-volume manufacturing process and streamlined the assembly of the mechanical enclosure.
Who owns the intellectual property and licensing?
Time Is Brain SL holds the exclusive rights to the IPR of the N20 neurophysiological biomarker.
What regulatory approvals are being sought?
The project aims to acquire the CE-Mark and FDA clearance for the Class IIb medical device.
What is the timeline for market entry?
The project period runs from 2023-05-01 to 2026-04-30, with development of updated versions occurring through April 2025.
Who built it
The project is led by a single Spanish SME, Time Is Brain SL, with a 100% industry ratio. This lean structure suggests a highly focused commercial drive, as the company holds the exclusive IPR and is managing the entire development from engineering to clinical validation.
Contact Time Is Brain SL in Spain regarding BraiN20® licensing
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