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.
