Spanish start-up Time is Brain is taking the medical principle to heart by developing BraiN20, a wearable device designed to monitor brain activity throughout the stroke journey. The device aims to save lives and neurons by offering real-time data to guide treatment decisions.
Every year, nearly 800,000 people in the US suffer a stroke, with many resulting in long-term disability or death, according to the Centers for Disease Control and Prevention. One in six deaths from cardiovascular disease is due to stroke, which is a sudden blockage of blood flow to the brain. Stroke is also the leading direct cause of death in the US. Stroke incidence has been rising, even among younger adults, driven by increases in obesity, high cholesterol, diabetes and high blood pressure.
The urgency of stroke care is underscored by research from UCLA neurologist Jeffrey Saver, who found that for every minute in which a large ischemic stroke is untreated, the average patient loses 1.9 million neurons, 13.8 billion synapses, and 7 miles of axonal fibers. For every hour without treatment, the brain loses as many neurons as it does in almost 3.6 years of normal aging, according to a study by Saver.
Alicia Martínez, CEO and co-founder of Barcelona-based Time is Brain, believes the company’s non-invasive medical device opens a window to the brain that can help save lives.
Key Takeaways
- Time is Brain’s BraiN20 monitors neuronal activity in real time, aiding treatment decisions and predicting stroke recovery.
- Time is Brain anticipates European CE marking and US FDA clearance in 2025.
- In addition to its use in hospitals, BraiN20 could potentially transform ambulances into active care units, enabling earlier interventions.
“Our value proposition is to offer real-time monitoring around the brain stages during the entire stroke journey,” Martínez, a neurologist who was instrumental in developing the technology, told Medtech Insight.
She likened the device to an electrocardiogram for stroke as it can monitor brain viability in real time. BraiN20 logs and analyzes neuronal activity from acute ischemic stroke (AIS) symptom onset throughout the entire stroke care continuum.
“We have already validated that according to the signal, we know if the brain is less or more seriously damaged during the stroke journey,” she explained. “We know how the patient is going to evolve -- not only in that moment -- we can predict what is going to happen months after the stroke.”
The collected data also helps health professionals choose the best treatment and preempt complications.
While blood clot-busting injections like tissue plasminogen activator (tPA) have long been considered a gold standard treatment for eligible stroke patients, they must be used within 4.5 hours from the onset of symptoms and may not be appropriate in patients with a higher risk of bleeding. And, Martínez added, “The chance of removing the clot intravenously is low – in the range of 5%-15%.”
For certain types of ischemic strokes, another gold standard is mechanical thrombectomy (MT), a surgical procedure that involves threading a catheter into an artery to remove the clot from the blocked artery in the brain.
But Time is Brain claims that MT alone doesn’t show the full picture because of a lack of technologies that allow for proper monitoring of patients before, during and after MT.
BraiN20 aims to predict functional recovery of stroke patients undergoing endovascular thrombectomy (EVT), a broad term referring to minimally invasive procedures like MTs, by measuring N20 somatosensory potentials. These potentials represent electrical activity in various brain regions and provide key insights into cortical cerebral perfusion, the blood flow to the brain’s neural tissue.
Currently, BraiN20 is being evaluated in six hospitals in Spain: five hospitals in Catalonia, which are the Institut d’Investigació en Ciències de la Salut Germans Trias I Pujol (IGTP) hospital; Hospital Vall d’Hebron, Hospital Sant Pau, Hospital Josep Trueta and Hospital Arnau de Vilanova, as well as Hospital Universitario de La Princesa in Madrid. Time Is Brain spun off from IGTP Hospital in 2020.
The company also plans to conduct a pilot study at Hospital Sanitas CIMA Barcelona (Bupa Group) to evaluate how emergency room physicians will use BraiN20 to monitor stroke patients as well as evaluate its performance. Other trials are ongoing, including use of BraiN20 during EVT procedures, but the company declined to offer details.
Time is Brain filed for the CE marking under the EU Medical Device Regulation for BraiN20 in April, Martínez said. She expects to receive CE marking in the first quarter of 2025 and also hopes to receive US Food and Drug Administration 510(k) clearance for the device in the first half of 2025.
On the funding side, the company received €2.5m from the European Innovation Council (EIC) after taking part in the EIT Health Catapult accelerator program in 2022. To date, Time is Brain raised about €8.8m in total from government institutions and private investors.
Marketing Plans
If all goes as planned, the company plans to sell the device to hospitals and neurologists starting in Spain where it has an established network.
The business model is B2B through distributors, Blas Díaz, chief operating officer, told Medtech Insight. BraiN20 encompasses a tablet-shaped device with integrated software (priced at €29,500), and disposables, which are the headband and gloves (priced at €450).
In the future, Martínez envisions that the device could be used beyond hospitals, such as in ambulances and in the home.
“Today, the ambulance acts like a bus just transferring the patient,” she said. She hopes that in the future, paramedics will be able to use BraiN20 to monitor a patient’s vital signs, such as blood glucose and blood pressure levels, which would allow paramedics to start potentially life-saving treatment before the patient arrives in the hospital.
“Sometimes the blood glucose can rise – even for a nondiabetic patient – which is really harmful for the brain,” she explained. “If you can see that this impacts the wave [EEG], you can administer insulin or another drug to decrease the level of blood glucose.” This information could also be vital to ensure that the patient is transported to a stroke-ready hospital.