Periodic Reporting for period 1 - BPET (The Next-Generation of Small, Cost-Effective and Mobile Brain Scanner for an Early Detection of Alzheimer’s Disease) Reporting period: 2019-02-01 to 2019-05-31 Summary of the context and overall objectives of the project Global aging societies have a higher incidence of neurodegenerative diseases, e.g. dementia (50 M people), but early diagnosis for a prompt intervention and to avoid adverse outcomes is an unmet need. Currently, there are near 70 disease-modifying drugs in trial for Alzheimer’s disease (AD), but without efficient early detection they will not prove useful. Brain imaging to detect AD biomarkers using positron emission tomography (PET) is the gold standard for early neurodegeneration assessment, but traditional whole-body PET scanners are big, expensive, and therefore not routinely used. Positrigo is a Swiss start-up, with the aim to offer CortEx as a new dedicated PET brain scanner. It is a small, mobile and affordable device that occupies 5x less space and can deliver results at a fraction of today’s costs. It has the potential to become a game-changer in brain imaging and make AD diagnosis widely accessible. We have built a first functional prototype and achieved pre-clinical proof of concept. Now we need to optimize our scanner, obtain market access through regulatory processes, prepare manufacturing scaling-up, refine our commercialization strategies, engage with key stakeholders and plan market launch. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far CortEx first prototype was designed, developed and preliminary tested, and our intellectual property rights initially protected by means of a patent application and trademark. During the feasibility study, we identified main needs at the technical, marketing and financial level and we were able to describe potential partners and users as well as target markets. We also build-up a roadmap to clinical validation of CortEx and regulatory approvals and a plan for IP management. Finally, we defined main strategies to commercialize our brain scanners in Europe, USA and other key regions, estimate our growth potential and preliminary propose a work plan with main actions to be performed during the next 2 years until market launch. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) CortEx is a mobile brain scanner 5x smaller and 10x cheaper. By user-centered design and development, it achives the desired spatial resolution and sensitivity to measure Aβ and tau proteins (hallmarks of AD). It will greatly increase access to diagnosis, allowing prompt treatment and monitoring, and help to accelerate drug development. This improved capacity makes the healthcare systems more efficient in care quality, will generate large cost savings on the nursing home sector, and enhance the life of patients and their families. Company logo
