Calgary, Alberta, March 17, 2025: Hemostemix Inc. (‘Hemostemix’ or ‘HEM’) (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), an autologous angiogenic stem cell company that has safely treated 498 patients for various forms of cardiovascular disease, presented the treatment of vascular dementia with ACP-01 to Wall Street.
“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,” explained Dr. Fraser Henderson, Neurosurgeon, CMO, Hemostemix Inc.
“The Phase 1 clinical trial is designed for up to 100 patients who meet the inclusion criteria, each of whom will pay Hemostemix $37,000 ($3,700,000, CAD 5,365,000) for ACP-01. We will examine the effects of ACP-01 using FireFly’s BNA™ readouts,” said CEO Thomas Smeenk. “Listen to what a patient treated with ACP-01 for vascular dementia has to say ten years after treatment. Her dementia was reversed by treatment with ACP-01. She has gained more than ten years of life, love, and joy with her family from a single ACP-01 treatment,” Smeenk added.
The 100-patient clinical trial will complement Firefly’s proprietary database of 77,000 EEG brain scans across twelve diseases. The scans could objectively prove that intrathecal injection of ACP-01 is a safe, effective, and clinically relevant treatment for vascular dementia. In January 2025, Firefly presented two compelling studies demonstrating the benefit of its AI-based BNA™ data analysis for advanced resting electroencephalograms (EEG) and cognitive EEG (ERP). As the two studies show, Firefly’s BNA™ system uniquely provided objective measurements of treatment efficacy and cognitive changes.
Design of Hemostemix’s Clinical Phase I Study on Vascular Dementia of ACP-01
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.
The primary endpoints include the incidence of safety and adverse events, the feasibility of administering ACP-01 by intrathecal injection, safe dosing, and tolerability.
The secondary endpoints include assessment of cognitive functions, global clinical dementia assessment, quality of life assessment, and standardized MRI metric analyses of brain volume and blood flow.
The exploratory endpoints include FireFly’s BNA™ readout before treatment and at 3 and 6 months post-treatment.
How Hemostemix Plans to Use BNA™ in Its Clinical Phase I Study on Vascular Dementia
1. Firefly’s BNA™ technology will be used pre-treatment for assessment and post-treatment to record brain activity at rest and during the performance of visual and auditory cognitive tasks. The broad range of functional brain measurements will be compared to Firefly’s FDA-cleared age-appropriate normative database. Each score is evaluated relative to the relevant reference normal range. The analyses will compare the change in various brain measurements over time within the treated population to the expected normative change over a six-month period based on the Firefly database.
2. Quality of life and brain function will be measured using the BNA™ assessment.
ABOUT HEMOSTEMIX
Hemostemix is a company founded in 2003 that specializes in autologous stem cell therapies. The company, which has been awarded the World Economic Forum’s Technology Pioneer Award, has developed, patented, scaled, and sold autologous (patient’s own) blood-based stem cell therapies that include angiogenic cell precursors (ACP-01), late neural cell precursors (NCP-01), and cardiomyocyte cell precursors (CCP-01). Hemostemix has completed seven clinical trials with 318 subjects and published the results in nine peer-reviewed publications. ACP-01 is safe, clinically relevant, and statistically significant in treating peripheral arterial disease, chronic limb-threatening ischemia, non-ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix has completed its Phase II clinical trial for chronic limb-threatening ischemia and published the results in the Journal of Biomedical Research & Environmental Science. Compared to a 5-year mortality rate of 60% in the CLTI patient population, UBC and U of T reported at the 41st Vascular Surgeons Meeting: 0% mortality, pain relief, wound healing in 83% of patients observed for up to 4.5 years. For more information, visit www.hemostemix.com.
