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Press and Publications
Recent & Upcoming Events
Clinical Validation
Our 2024 clinical study at Scientific LLC, a CLIA-certified lab in Charleston, SC, wrapped early 2025. That was the first of several upcoming US-based studies, intended to reproduce the results of previous studies conducted in Australia.
As we wrap up the 2024 study analysis, we are already gearing up for our 2026 clinical validation study. This study will use fresh blood samples provided by some of the leading Alzheimer's Disease Research Centers in the nation. We are proud to collaborate with Vanta Diagnostics to bring this project to life and with Pentara Corporation, our trusted biostatistical analysis provider, for quality results.
The rigorous validation process is essential to provide data for our FDA application, NIH grant applications, and to start commercializing our test with confidence and safety.
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 510(k) SaMD application to the FDA and expect a response regarding the designation in the following months.
What is the Breakthrough Devices Program?
Patent Application
We have applied for a patent in the United States and about 75% of the worldwide market.
We have recently received a Notice of Allowance from the United States Patent and Trademark Office, a major milestone achievement in our commercialization process.
We also have a patent issued in Japan, a hub for cutting-edge research and therapeutic development.
AAIC
We were excited to attend AAIC 2025 (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 had the opportunity to discuss our progress with industry experts, exchange theories, breakthroughs, and practices. We attended fascinating lectures and gained many valuable insights. We can't wait to apply everything while working on NeuroScreen®.
AAIC took place July 27-31, 2025, in Toronto, Canada.
Funding
We have recently secured a $250k investment from SC Launch, Inc., the South Carolina Research Authority investment affiliate.
While we continue our fundraising journey, we also seek other growth opportunities, including NIH grants, research collaborations, and strategic partnerships with relevant organizations.
We expect to close the current round in 2026.
Listen to our CEO, Jason Maxwell, talk about our fundraising efforts on South Carolina Public Radio




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