The aim of the StrokeCap project is to close a central gap in preclinical stroke diagnostics. Strokes are among the most common causes of death and often result in permanent neurological impairments in survivors. Early initiation of therapy is crucial for treatment success, because “time is brain”.

Modern therapies such as mechanical thrombectomy require rapid and precise diagnosis.  To date in emergency medical services suitable technical solutions are still lacking: decisions are usually based on unspecific clinical scores which leads to misdiagnoses, delays, and unnecessary transport to non-specialized hospitals.

StrokeCap is a portable measurement system designed to assess cerebral blood flow in real time without radiation, using a measuring cap. The technology is based on magnetic particle imaging (MPI) using already approved magnetic nanoparticles. After the cap is placed on the patient’s head and the particles are injected, the cap should detect perfusion disturbances in the brain. This could potentially enable a decision about the appropriate destination hospital directly at the emergency scene - comparable to the role of the ECG heart attacks.

In recent years, initial demonstrators have been developed to prove the technical feasibility of the concept. Currently, with the support of the Medical Valley Award, a functional prototype is being developed. However, for the next steps in particular adaptation to regulatory requirements and preparation for clinical trials, require specialized regulatory expertise.

This is where the applied ForTra funding from the Else Kröner-Fresenius Foundation comes in. By financing regulatory consulting services, especially for the preparation and conduct of consultations with the Federal Institute for Drugs and Medical Devices (BfArM), it enables early and reliable regulatory decisions. This targeted support accelerates the transition from technical development to clinical application of StrokeCap with the long-term goal of making fast, safe, and well-founded stroke diagnostics available in emergency medical services and thereby improving patient care.