AI-supported analyses could revolutionize the neurological treatment of dementia diseases. The Canadian stem cell company Hemostemix Inc. (TSXV: HEM; FRA: 2VF0) has now commissioned the US AI company Firefly Neurosciences (NASDAQ: AIFF) to conduct AI-supported analyses on patients as part of a clinical Phase 1 study for vascular dementia to test the effectiveness of Hemostemix’s autologous blood-based ACP-01 stem cell therapy on brain health. A growing body of clinical evidence supports the use of Firefly’s FDA-approved BNA™ platform to investigate ACP-01 as a treatment for vascular dementia.
Hemostemix’s clinical Phase 1 study on vascular dementia aligns with Firefly’s other collaborations with globally recognized companies such as Bright Minds Biosciences (CSE: DRUG), Novartis (NVS), and Takeda Pharmaceutical (TAK). As part of the collaboration, Hemostemix will utilize Firefly’s proprietary database of 77,000 EEG brain scans for twelve diseases. Hemostemix and FireFly will work together to generate scientific criteria with the aim of objectively proving that the intrathecal injection of ACP-01, applied directly to the brain or spinal cord, is a safe, preliminarily effective, and clinically relevant treatment method for vascular dementia.
Structure of Hemostemix’s Clinical Phase I Study on ACP-01 for Vascular Dementia
The Phase 1 clinical trial will investigate the safety, tolerability, and preliminary efficacy of intrathecal injection of ACP-01 directly into the cerebrospinal fluid of subjects suffering from vascular dementia.
Primary objectives include the incidence of safety and adverse events, the feasibility of administering ACP-01 through intrathecal injection, safe dosing, and tolerability.
Secondary objectives include the assessment of cognitive functions, global clinical dementia assessment, quality of life evaluation, and standardized MRI metric analyses of brain volume and blood flow.
Exploratory study endpoints include FireFly’s BNA™ readout before treatment and at 3 and 6 months after treatment.
In January 2025, Firefly presented two significant studies demonstrating the benefits of its AI-based BNA™ data analysis for advanced resting electroencephalograms (EEG) and cognitive EEG (ERP). As shown by the two studies, Firefly’s enhanced BNA™ system provided unique objective measurements for treatment efficacy and cognitive changes.
Use of Firefly’s BNA™ Technology
In the first step, Firefly’s BNA™ technology is used before and after treatment to record brain activity at rest and during the performance of visual and auditory cognitive tasks. The recorded electrophysiological data is automatically cleaned and analyzed by Firefly’s proprietary BNA™ platform. A variety of brain function measurements are compared to Firefly’s FDA-approved age-appropriate normative database. Each score is evaluated in relation to the relevant reference normal range. The analyses compare the change in various brain measurements over time within the treated population relative to the expected normative change over a six-month period based on the Firefly database.
Subsequently, quality of life and brain function are measured using the Firefly BNA™ assessment.
Dr. Fraser Henderson, CMO, Hemostemix added: “There is limited data on the use of ACP-01 in dementia; however, the specificity of ACP-01 in promoting angiogenesis, the molecular upregulation of neurotrophic factors in the brain, and specific chemokines strongly suggest that ACP-01 could be effective as a treatment for vascular dementia.”
Greg Lipschitz, CEO of Firefly commented: “We are proud that BNA™ continues to be at the forefront of EEG innovation, and we agree with Hemostemix that the dose-response study of ACP-01 in patients with vascular dementia has the potential to illustrate how our proprietary technology can transform complex brain data into actionable insights for clinicians and researchers.”
Thomas Smeenk, CEO of Hemostemix, referred to previous positive feedback from patients treated with ACP-01: “Listen to a patient who was treated with ACP-01 for vascular dementia – 10 years after treatment. Mrs. L. had lost her daily living skills and was to be admitted to a long-term care facility. Ten years after ACP-01 treatment, she spoke for 12 minutes about her professional career, the time she raised her children, the annulment of her first marriage and her wonderful second marriage, her driving ability, and the benefits of ACP treatment, including that she no longer suffers from ocular migraines. She then scheduled a lunch appointment with the doctor who had treated her for vascular dementia to celebrate her cognitive health.” Smeenk continued: “Given BNA™’s results on ACP’s efficacy, I expect Hemostemix and Firefly will set the objective standard for successful diagnosis and treatment of vascular dementia. Family members of those suffering from vascular dementia can contact me (tsmeenk@hemostemix.com) to understand the evaluation, inclusion, and exclusion criteria.”
About Hemostemix Inc.
Hemostemix Inc., an autologous angiogenic stem cell company that has safely treated 498 patients for various forms of cardiovascular disease, including vascular dementia.
About Firefly Firefly (NASDAQ: AIFF) is an artificial intelligence (‘AI’) company developing innovative solutions to improve brain health for patients with neurological and cognitive disorders. Firefly’s Brain Network Analytics (BNA™) technology, developed and FDA 510(k) cleared, is revolutionizing diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, secured patent protection, and obtained FDA approval. The company is bringing BNA™ to market, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as physicians for clinical use. Brain Network Analytics is based on standardized, high-resolution longitudinal electroencephalograms (EEGs) from over 17,000 patients representing twelve disorders, as well as data from clinically normal patients.
