During this first period, the project made significant significant advancements in 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 will lead to a more mature operations control as we grow and progress on the grant execution.
On WP2, we have moved to adhere to ISO 13485. We are currently working towards achieving compliance with these standard as part of our initial phase. Additionally, a plan is in place to explore any additional country-specific regulations closer to the product launch to ensure full compliance for commercialization. After the implementation of the ISO13485 we will be ready to proceed to CE-mark, as with the product development file. We additionally enlisted a specialized partner to assist us on both ISO 13.485 CE Mark and future tentative FDA Breakthrough designation. Further on, we are currently working to deploy the platform in 3 separate studies, in Europe, USA and eventually Asia. We have also continued to increase our FTO, via filling 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 that assure protection for our platform.
On WP3,we have delivered on the deadline for achieving an "Optimized Biosensor", acting on the goal of "Enhance iLoF platform screening performance reducing measurement variability and extending probe lifecycle to improve technology robustness and cost efficiency". We have additionally been actively collecting samples through ongoing collaborations with current partners, while also maintaining a strong focus in establishing new partnerships. This approach has and will be creating more opportunities to expand our network and access well-defined, well-characterized samples, which are crucial for building a comprehensive cloud-based library of optical fingerprints. These samples, representing thousands of Alzheimer's patients, other dementia cases, and healthy controls, will allow us to continuously refine our AI models, enhancing their accuracy and effectiveness. Furthermore, we have transitioned to a enhanced automated operation, with a new cleaning protocol and an autosampler in an enclosed fluidic system provides significant benefits.
On WP4, we continued to collecting samples from AD-confirmed patients (via CSF or PET) biomarkers with additional medical exams from patients with dementia and confirmed AD. Aditionally, we are further testing our platform in a world-leading study, as in smaller studies run in partnership with leading international institutions.
