Start-up Time is Brain monitors brain function after stroke

Stroke victims frequently face lasting disabilities. Recognizing this, the start-up "Time is Brain" has pioneered a portable device for early stroke detection. This innovation empowers doctors to tailor therapeutic decisions throughout a patient's journey, ensuring continuous, real-time brain monitoring from the moment a stroke begins.

In this MEDICA-tradefair.com interview, Alicia Martínez dives deep into the benefits of the BrainN20 portable medical device and shares insights on navigating the medical market as a start-up.

What is the Time is Brain origin story?

Martínez, PhD: Time is Brain was born from a scientific project developed by the Department of Neurosciences of the Germans Trias Pujol University Hospital (HGTP) whose objective was to improve the prognosis of people who suffer an acute stroke. Despite having state-of-the-art treatments such as endovascular thrombectomy, 50 percent of people affected by a stroke remain with permanent disability that prevents them from resuming their normal activities.

For this reason, Time is Brain founders, neurologists from HGTP, started a line of research in 2013 to find new diagnostic tools that would improve the devastating impact of this disease. Thanks to a clinical study that we carried out between 2018 and 2020 (ClinicalTrials.gov: NCT04099615), our team has discovered and validated the advantages of an electrical signal that is generated in our brain, the N20 response. With it, we have a greater capacity to diagnose if the brain is still viable and to predict whether a person will respond satisfactorily to treatment, surpassing the capabilities of current available technologies.

How does the BraiN20 product work?

Martínez: Time is Brain has developed BraiN20®, a portable and non-invasive medical device that we consider the "stroke electrocardiogram." It consists of a tablet-shaped device and single-use electrodes that are placed on the head and hands of stroke patients. BraiN20® enables real-time monitoring of brain function from the onset of a stroke and throughout the entire patient journey until patients are transferred to the Stroke Unit or Intensive Care Unit.

BraiN20® incorporates advanced algorithms that automatically record and analyze N20, an electrical signal that has been validated and patented by Time is Brain in more than 200 patients.

How does it improve treatment options and the diagnosis of stroke?

Martínez: With BraiN20®, we reduce the time to access, and increase the number of patients eligible, for the gold-standard treatment, endovascular thrombectomy (EVT). For the first time, we can monitor brain function in real-time during EVT, guiding the physician and improving the procedure's outcome.

According to our health economics assessment, the implementation of BraiN20® could increase up to 7 QALYs (Quality-Adjusted Life Years) per EVT and save 2.6 billion euros per year in direct hospital costs in Europe alone.

What was the biggest obstacle in starting Time is Brain?

Martínez: The founders and team of Time is Brain are highly motivated and fully committed to bringing BraiN20® to the market to enhance stroke patients' outcomes. However, BraiN20® faces the challenge of navigating a dynamic regulatory landscape. Medical devices marketed in the EU, USA, LATAM, Canada, and Australia are subject to regulatory controls, that involve demonstrating safety and effectiveness.

Each country has its own regulatory process with distinct steps and required documents that must be submitted and approved before market access is granted.

What are the next steps for Time is Brain?

Martínez: We plan to start a second clinical trial, the PROMISE20 study, in September 2023. The aim is to validate the accuracy and safety of the BraiN20® device and obtain the CE mark between Q4 2024 and Q1 2025, enabling us to begin market penetration. Additionally, we are on track to finish manufacturing the BraiN20® pre-series during Q4 2023.

How do you assess the opportunities for start-ups in the medical market?

Martínez: The medical market is highly competitive and complex, with significant barriers in areas such as research and development, regulatory compliance, and more. However, we firmly believe that our product possesses a breakthrough technology capable of enhancing outcomes for Acute Ischemic Stroke (AIS) patients worldwide.

Since establishing Time is Brain we are preparing the market launch of our product by conducting several tasks: a) to design a global dissemination/communication plan across key opinion leaders, neurologists and other health care personnel, b) expert panels and market access research to identify the pains of our stakeholders and the ability of BraiN20® to relieve them, c) analysis of the willingness to pay, d) validation of our business model, d) analysis of reimbursement models in the targeted markets and e) HTA assessment. We have a potential diversification of the intended use of our product and we already have contact to hospitals in Europe and the US to carry out pilot studies.

What do you expect as an exhibitor from MEDICA 2023?

Martínez: We are convinced that the MEDICA trade fair will provide Time is Brain with the opportunity to interact with medical distributors, suppliers, and stakeholders, thereby facilitating the access of BraiN20 to various markets. Undoubtedly, our participation in MEDICA 2023 will be a turning point for our company.