Periodic Reporting for period 1 - ICPstatu (Non-Invasive Technology for Intracranial Pressure (ICP) Measurement)
Période du rapport: 2019-12-01 au 2020-05-31
Traumatic Brain Injury (TBI) is the most common cause to elevated IntraCranial Pressure (ICP). Elevated ICP can be fatal: in EU 2.5+ M people suffer from TBI and 3% are estimated to die. Gold Standard to monitor ICP consists in drilling a hole in the cranium and inserting sensors in the brain, which exposes patients to infections and hemorrhage. StatuManu has developed VesselTracker: a non-invasive software to precisely measure changes in ICP to be used for clinical assessment by HealthCare Professionals (HCP).
Vesseltracker algorithm was trained and now enables estimation of ICP changes with an accuracy, that makes it acceptable for clinical use and ready for regulatory approval. An easy-to-use web app (research use only, non CE marked) is completed and a solid roadmap for maturation and launch in 2023 was outlined. We have initiated a clinical trial at Odense University Hospital to compare and validate Vesseltracker against Gold Standard. The trial will contribute to understand new indications and to document safety and efficacy and will generate data for the CE mark approval. The regulatory pathway to CE mark (as a Medical Device Class IIb) was identified and infrastructure for Quality Management System and procedures is in place. For reimbursement purpose, proper Diagnose Related Group for ICP measurement was identified. A viable business model and Go2Market plan including EU and US was defined. VesselTracker clinical relevance was verified by our early adopters/customers at neurosurgical departments and a price strategy was discussed to estimate revenues and a business case for the 5 first years of commercialization. A cross-hospital board of researchers was established and these Key Opinion Leaders will support us in new clinical trials and publications of research.
Vesseltracker is expected to obtain CE mark in 2023 and be launched in DK, SE, DE, NL with rest of EU/US to follow. Vesseltracker will be a novel non-invasive device to improve diagnosis, treatment and patient outcome for HCPs in hospitals and will reduce brain damages and implications of secondary injuries to the benefit of patient’s Quality of Life and societal economy.