AI Study Tracks Unexpected Cognitive Gains in Vascular Dementia Trial

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Hemostemix Inc. (HEM:TSXV; HMTXF:OTCQB; 2VF0:FSE) has announced a collaboration with Firefly Neuroscience Inc. (AIFF:NASDAQ) to advance its Phase 1 clinical trial studying ACP-01 as a potential treatment for vascular dementia. FireFly's Brain Network Analytics (BNA™) platform, which has received clearance from the U.S. Food and Drug Administration (FDA), will be used to assess brain wave activity in trial participants before and after treatment.

The Phase 1 study will enroll up to 100 patients, monitoring changes at baseline, three months, and six months following ACP-01 treatment. The trial will assess the safety, tolerability, and preliminary efficacy of ACP-01 through intrathecal injections, which deliver the therapy directly into the cerebrospinal fluid. Primary endpoints include monitoring adverse events and determining safe dosage levels, while secondary endpoints will measure cognitive function, quality of life, and brain imaging results. The study also incorporates FireFly's BNA™ technology as an exploratory endpoint, analyzing electrophysiological data against its database of 77,000 EEG brain scans.

Hemostemix's CEO, Thomas Smeenk, cited past patient experiences as motivation for further research. "Mrs. L lost her daily function-abilities and was to be admitted to a long-term care facility. Ten years after ACP-01 treatment, she discussed her career path, family-raising-time, and scheduled a lunch appointment with the physician who treated her for vascular dementia, to celebrate her cognitive health ten years post treatment," Smeenk stated in the news release.

FireFly Neuroscience, which has previously partnered with companies such as Bright Minds, Novartis, and Takeda, is providing its proprietary AI-based analysis for the trial. "We are proud that BNA™ continues to be at the forefront of EEG innovation," said FireFly's Executive Chairman Greg Lipschitz. "We agree with Hemostemix that its study of ACP-01 dose response in subjects suffering from vascular dementia has the potential to exemplify how our proprietary technology may transform complex brain data into actionable insights for clinicians and researchers."

Technical Analyst Clive Maund rated Hemostemix as "an Immediate Strong Buy," emphasizing that the company was at "a very favorable entry point" for investors. 

According to Hemostemix's Chief Medical Officer, Dr. Fraser Henderson, ACP-01's mechanism of action supports the potential for efficacy in vascular dementia.

"There is limited data on the use of ACP-01 in dementia; however, the specificity of ACP-01 in promotion of angiogenesis, the molecular up-regulation of brain neurotrophic factors, and specific chemokines strongly suggest ACP-01 may be efficacious as a treatment for vascular dementia," Henderson said.

The trial follows Hemostemix's previous work in stem cell therapies for cardiovascular conditions. The company has treated 498 patients across various forms of cardiovascular disease, including chronic limb-threatening ischemia and ischemic cardiomyopathy, with ACP-01. The company's Phase 2 clinical trial for chronic limb-threatening ischemia showed an 83% wound healing rate and 0% mortality among patients tracked for up to 4.5 years.

Regenerative Medicine Sector Sees Rapid Growth Amid Innovations in Stem Cell Therapies

An industry report from BioSpace highlighted the financial growth of the U.S. regenerative medicine market, stating that it was valued at US$17.19 billion in 2023, had reached US$20.07 billion in 2024, and was projected to grow to US$80.74 billion by 2033 at a compound annual growth rate (CAGR) of 16.73%. The report explained that regenerative medicine integrates engineering and life science principles to promote tissue and organ regeneration, with the potential to "revolutionize the treatment of tissues and organs damaged by age, disease, or trauma, and to correct congenital defects." Advances in regulatory support, such as collaboration between the National Institute of Standards and Technology (NIST) and the FDA's Center for Biologics Evaluation and Research (CBER), have also contributed to the sector's momentum.

A January 8 Research and Markets report focused on the human embryonic stem cell (hESC) market, projecting its growth from US$2.26 billion in 2024 to US$6.76 billion by 2035 at a CAGR of 10.47%. The report attributed this expansion to the "growing prevalence of chronic diseases, advances in stem cell research, government funding and support, the growing need for regenerative medicine, and the increased emphasis on personalized medicine." The same report noted that research-grade hESCs accounted for the largest revenue segment in 2024 due to their widespread use in preclinical studies, drug discovery, and disease modeling.

The regenerative medicine sector has continued to expand, with advancements in stem cell therapies and tissue engineering driving innovation. According to a February 18 report from Reuters, the regenerative medicine market has been bolstered by the rising prevalence of chronic conditions and an aging population. The report noted that "the regenerative medicine market is rapidly expanding, driven by the rising prevalence of chronic conditions, demand for personalized therapies, and an aging population." As demand for innovative treatments grows, companies have increasingly focused on leveraging regenerative technologies to address a wide range of medical needs, from neurodegenerative diseases to cardiovascular conditions.

Also, on February 18, Startus Insights report projected even higher global market growth, estimating the regenerative medicine industry would expand from US$24.88 billion in 2025 to US$148.42 billion by 2033, with an annual growth rate of 7.54%. The report highlighted that "the market has concluded 3,430+ funding rounds with an average investment value of US$19.8 million per round," demonstrating strong investor confidence in the sector's long-term potential. In addition, global patent filings have increased, with over 1,510 patents submitted by 680 applicants in the past year, further signaling a competitive landscape driven by research and development.

The role of artificial intelligence (AI) in regenerative medicine has also grown, with companies integrating AI-driven platforms to enhance research and treatment outcomes. AI applications have been particularly influential in optimizing stem cell therapies, tissue engineering, and predictive analytics for patient response to regenerative treatments. According to BioSpace, AI has the potential to "significantly enhance and expedite various aspects of regenerative medicine research," allowing for better learning, reasoning, and problem-solving in the field.

Hemostemix's Path to Commercialization and Regenerative Breakthroughs

Hemostemix's investor presentation outlines multiple catalysts for the company's progress, including the potential expansion of ACP-01's applications beyond vascular dementia. The company has patented and developed a portfolio of autologous stem cell therapies, including neural cell precursors (NCP-01) and cardiomyocyte cell precursors (CCP-01), indicating a broader pipeline of regenerative treatments.

The company has entered a production agreement with CytoImmune, which includes US$1.1 million in revenue and a plan to scale production capacity. Hemostemix is also leveraging Puerto Rico's Act 60 legislation to receive cash rebates on research and development expenses while benefiting from a 4% tax rate on profits.

With plans to achieve regulatory approval for ACP-01 in cardiovascular and neurological applications, Hemostemix's trial results could play a role in future commercialization efforts. The company anticipates forward sales of ACP-01 for no-option patients, with agreements in place to process up to 226 critical limb ischemia referrals per month. Additionally, a joint venture model is being pursued to expand ACP-01's availability through regional production hubs.

FireFly Neuroscience's involvement in the trial represents an expansion of its BNA™ platform into vascular dementia research. The technology has already demonstrated value in prior studies, providing objective measures of cognitive function and treatment efficacy. The trial's results may further validate the use of EEG-based AI analysis in neurological and psychiatric conditions.

With the Phase 1 trial underway, Hemostemix and FireFly's collaboration marks a step toward developing a data-driven approach to treating vascular dementia, an area with significant unmet medical need.

Technical Analysis Signals Strong Buy for Hemostemix After Breakout

According to Technical Analyst Clive Maund, Hemostemix was positioned for significant upward momentum following its breakout from a base pattern in January 2025. In his March 3, 2025, analysis, he highlighted that the stock had entered "a powerful upleg driven by strong volume," describing this movement as "clearly very bullish." Maund observed that the stock's reaction to the breakout was supported by "resilient On-balance Volume," indicating strong investor interest. He stated that "another upleg is likely to start very soon that is likely to be sizable."

Maund's analysis of Hemostemix's two-year chart revealed that the stock had formed "a large Head-and-Shoulders bottom," a pattern typically associated with long-term trend reversals. He noted that while the stock could theoretically retrace toward its breakout level, strong upside volume suggested continued momentum instead. Reviewing the six-year chart, he identified a broader Cup base pattern, suggesting that even within a potential short-term trading range, the stock could more than double from its current levels.

Based on these technical indicators, Maund rated Hemostemix as "an Immediate Strong Buy," emphasizing that the company was at "a very favorable entry point" for investors. At the time of his report, Hemostemix traded at US$0.08 on March 11.

Ownership and Share Structure

Refinitiv lists Hemostemix as having three individual investors totaling 10.39%. Those three are Peter Alan Lacy with 6.44%, Thomas Smeenk at 2.59%, and Loran Swanberg with 1.36%. The rest are retail.

Hemostemix has a market capitalization of CA$12.91 million, 133.03 million free float shares, and a 52 week range of CA$0.0350 - 0.4250.