Periodic Reporting for period 2 - NeuroLF (NeuroLF: The best small and mobile dedicated brain PET scanner for an accessible early detection of Alzheimer’s disease ) Reporting period: 2021-04-01 to 2022-09-30 Summary of the context and overall objectives of the project Among older people in Europe, dementia is the leading cause of dependency and disability. Alzheimer's disease (AD) is the most common type of dementia and early diagnosis is key to its treatment. Currently, a positron emission tomography scan, commonly known as a PET scan, is used to reveal the early microscopic changes in the brain caused by Alzheimer’s disease. However, PET scans are big and expensive, making population-wide screening difficult. The Swiss start-up Positrigo is developing the NeuroLF brain PET system, which is only a tenth of the price (reduced device, personnel and radiotracers costs) and a fifth of the size of traditional scanners. The EU-funded NeuroLF project will focus on the commercialisation of this new technology, which will make brain scanning affordable for everyone. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far In the first year of the NeuroLF project, we have started the design and development process from prototype towards the medical device NeuroLF. The process is governed by our newly established ISO 13485 quality management system and includes mechanics, electronics, and software developments.We have performed the clinical study ExploreBPET to evaluate the existing prototype in the clinic and identifies aspects to be improved for the current development of NeuroLF. Meanwhile, we have completed the development of NeuroLF and started to submit the technical documentation to TÜV Süd. With feedback and test results we are fixing the remaining bugs and aim to obtain the CE mark in 2023.We have started to be visible in the public and have showcased the company and our product NeuroLF on several fairs and congresses. First pre-sales contracts are in sight and will be signed shortly. 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) Positrigo aims to disrupt Alzheimer’s Disease diagnostic market and brain imaging field by offering the smallest and cheapest PET scanner adapted to human head. At the end of the project, we expect to have a new prototype tested, which is ready to receive the CE mark and FDA 510k clearance. NeuroLF will be a new tool with which hospitals can make five times more functional brain scans on the same space for lower cost than today. This is a stepping stone for the population-wide early detection of neurodegeneration like Alzheimer’s and subsequent effective treatments by one of the drugs that are approaching regulatory approval. The first device of the brain PET scanner NeuroLF Renderning of current design concept of the brain PET scanner NeuroLF
