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Recent & Upcoming Events
AAIC
We were proud to present NeuroScreen® at the 2024 AAIC (Alzheimer's Association International Conference), where the leading global medical and scientific dementia researcher community comes together every year "to learn about the latest research, products, and solutions available in the treatment of Alzheimer’s and related dementias."
We are excited for the 2025 conference, where we can discuss our progress with industry experts, exchange theories, breakthroughs, and practices. AAIC is taking place July 27-31, 2025, in Toronto, Canada.
Clinical Validation
We recently completed our 2024 clinical study at Vikor Scientific LLC, a CLIA-certified lab in Charleston, SC. The next step is completing a biostatistical analysis, for which we are collaborating with Pentara Corporation and should have the results by the end of 2025.
As we wrap up the 2024 study analysis, we are already gearing up for our Fall 2025 clinical validation study. This study will use 2,000 blood samples provided to us by the groundbreaking AHEAD Study, which tests "whether an investigational treatment can slow or stop the earliest brain changes due to Alzheimer’s disease in people with a higher risk of developing the disease later in life."
The validation process is essential to provide data for the FDA application, NIH grants, and to start commercializing our test.
FDA Application
We are working on a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Once the clinical validation process is completed, we will submit a De Novo SaMD application to the FDA and expect a response regarding the designation in the following months.
Funding
We will close the current funding round once we raise enough capital or non-dilutive funding. We have recently secured a $250,000 investment from SC Launch, Inc., the South Carolina Research Authority (SCRA) investment affiliate.
We are also aiming to be part of Johns Hopkins' BioCard Study, which could qualify us for a supplemental NIH (National Institutes of Health) grant to include us in their long-term research. The process is expected to take approximately 4-6 months.