Periodic Reporting for period 2 - promise (BraiN20®: A paradigm shift in Acute Ischemic Stroke (AIS) patient management)
Reporting period: 2024-05-01 to 2025-04-30
Acute Ischemic Stroke (AIS) represents 85% of all strokes and is the leading cause of disability and the second of mortality worldwide. Every year, 3.3 million people died from AIS, globally. “Time is Brain”: every hour of delay from stroke onset until receiving a treatment reduces by 20% the chance of a successful recovery. Today, the journey from stroke onset until the best treatment, the Endovascular Thrombectomy (EVT), is long and open to mistaken decisions due to lack of real-time data of brain function and viability.. Thus, critical decisions are based on momentaneous brain image and score test which results in 190.000 brain cells lost every minute, yielding high mortality and morbidity rate. The current standard of care lacks robust tools to monitor in real-time brain viability, and results in 54% of patients undergoing EVT do not respond to the treatment, with significant costs associated (€45B/year in Europe alone). The aim of the PROMISE project is to develop, validate and implement BraiN20®, the first medical device which provides real-time brain monitoring through the entire acute stroke patient journey (from pre-hospital management to post-treatment care) to enable accurate and fast decision-making. BraiN20® is considered as “the stroke electrocardiogram”.. We are used to seeing how the state of the heart is monitored from the first moment a symptom of angina or acute myocardial infarction occurs, but there is nothing similar in the case of AIS. BraiN20® will be a paradigm shift in AIS since it will standardise and accelerate patient triage, enable real-time monitoring and increase access to EVT treatment. With BraiN20®, 15% more patients could benefit from EVT treatment, we can reduce time-to-treatment up to 140 minutes and improve its results in 26% of cases.
An updated version of the BraiN20® medical device was designed and developed from June 2024 to April 2025. It incorporates an upgrade of the neurostimulation system to optimize its usability and facilitates a large-volume manufacturing process. The BraiN20® electronics have being redesigned to substitute the device charging base by a medical-certified charger. The mechanical enclosure is more ergonomic and robust and streamline the assembly during the manufacturing process. BraiN20® firmware and software have also been upgraded, including a novel detection algorithm for our proprietary biomarker, the N20 signal, taking into account the data obtained from clinical investigations. . Time is Brain has frozen the design of BraiN20® V2.1. medical device and proceed to its assembly, calibration, and quality check (QC). It has successfully passed the ElectroMagnetic Compatiblity (EMC) and Electrical Safety (ES) testing according to the applicable standards for our product (IMQ certification laboratories). The transfer to production to manufacture a pre-series of 25 units of the final system started in March 2025 and it is expected to be completed in June 2025.
Time is Brain has completed the development and manufacturing of BraiN20® V2.0 fulfilling all the requirements according to the regulations for medical devices. Therefore, we provide, for the first time, a tool to enable real-time brain monitoring from acute stroke onset and during the entire patient journey. BraiN20® clinical validation isbeing tested in Spanish University hospitals. For the first time, BraiN20® enables real-time brain monitoring through the entire stroke patient journey accessible to anyone, anywhere, anytime. Both healthcare systems/hospitals and AIS patients are the ones that are genuine interested in having solutions capable of solving the main problems of AIS management. Considering that the current tools are limited to a snapshot providing a brain image, they are eager to test a solution promising to accelerate triage and provide real-time brain monitoring during AIS. Furthermore, BraiN20® can significantly reduce time-to-treatment since it is a portable and bedside tool and its setting and recording time takes less than 5 minutes. Thus, the director of the Mobile Stroke Unit (MSU) and stroke research institute in Texas (US), James C.Grotta states that “The BraiN20® system has the potential to have a major impact on the way stroke patients are managed, throughout the world”. The BraiN20® engage him and other stroke Key Opinion Leaders (KOLs) worldwide, who are prompt to support Time is Brain with BraiN20® validation and implementation. During 2025, two clinical trials are going to be launched: the PROMISE20 RELOADED and the PULSO AUSTRALIA, involving 3 Spanish and 5 Australian hospitals, respectively, aiming to validate the BraiN20® V2.1.Nonetheless to ensure further uptake and success, it is also needed to deploy marketing and commercialisation activities, such a establishing a robust and wide network of specialized distributors and strategic partners in our targeted markets and to design and carry out an awareness campaign addressed to patients and relatives, healthcare systems and corporates involved with the stroke management. It is also mandatory to obtain the regulatory approvals to operate in those targeted markets (e.i. CE-certificate, FDA and TGA approvals). On the other hand, it is also needed to continuously introduce technical innovations in our BraiN20® system always aimed at satisfying the needs of its users. In this sense, Time is Brain is taking the first steps towards expanding the potential impact of BraiN20® beyond AIS, responding to the demands received from physicians and healthcare staff.