The project made significant achievements on multiple fronts.
On the WP1, we have implemented several mechanisms for grant and project control, such as 1) Project Management best practices, 2) Risk Management and mitigation, 3) Financial controls and audits. Our initiatives led to more mature operations control as we grow and progress on the grant execution.
On WP2, we achieved certification according to the ISO 13485, securing full compliance with this standard. Additionally, we have engaged with the FDA, with 1v1 meetings to understand US and other additional country-specific regulations, getting us closer to the product launch to ensure full compliance for commercialisation. After the implementation of the ISO13485, we have proceeded to CE-mark our platform, which was subsequently achieved. Further on, we pursued the deployment of the platform in 3 separate studies, in Europe, the USA and eventually Asia. We have also continued to increase our FTO, via the filing of an additional patent. Our IP portfolio is now comprised of various patents, trademarks, data sets and other assets such as trade secrets, AI Models, drawings and designs, some of them already granted in locations such as EU, the US or Japan, that assure protection for our platform.
On WP3,we have acted on the various deliverables. We have actively collected samples through ongoing collaborations with current partners, while also maintaining a strong focus on establishing new partnerships. This approach has and will be creating more opportunities to expand our network and access well-defined, well-characterised samples, which are crucial for building a comprehensive cloud-based library of optical fingerprints.
Additionally, we kept collecting one of the biggest private biobanks of Alzheimer's patients in the world, including other dementia cases, and healthy controls, allowing us to continuously refine our AI models, enhancing their accuracy and effectiveness. Furthermore, we have transitioned to an enhanced automated operation, with a new cleaning protocol and an autosampler in an enclosed fluidic system provides significant benefits.
On WP4, we collected thousands of samples from AD-confirmed patients (via CSF or PET) biomarkers with additional medical exams from patients with dementia and confirmed AD. Additionally, we further tested our platform in one of the biggest and best Neurodegenerative studies in the world, with over +30 clinical sites in North America and Europe, as in smaller studies run in partnership with leading international institutions.
