Hemostemix's Pitch to Wall Street: ACP-01 Vascular Dementia Trial will Generate $5,365,000, Capture Data, as a Phase 1 Clinical Trial

Rhea-AI Summary

Hemostemix (HMTXF) has announced a Phase 1 clinical trial for treating Vascular Dementia with ACP-01, targeting up to 100 patients. Each patient will pay USD $37,000 for the treatment, potentially generating USD $3.7M (CAD $5.36M) in revenue.

The trial will evaluate the safety, tolerability, and preliminary efficacy of intrathecal ACP-01 injection directly into cerebrospinal fluid. Primary endpoints include safety assessment and ACP-01 delivery feasibility, while secondary endpoints focus on cognitive function, dementia rating, and quality of life measurements.

The study will utilize FireFly's BNA™ technology for brain activity monitoring, comparing results against their FDA-cleared database of 77,000 EEG brain scans. The company reports a successful case study of a patient treated with ACP-01 showing positive results 10 years post-treatment.

Calgary, Alberta--(Newsfile Corp. - March 17, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or "HEM"), an autologous angiogenic stem cell company that has safely treated 498 patients for various forms of cardiovascular disease, pitched the treatment of Vascular Dementia with ACP-01 to Wall Street.

"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," stated Dr. Fraser Henderson, neurosurgeon, CMO, Hemostemix Inc.

"Designed as Phase 1 clinical trial for up to 100 patients who meet the inclusion criteria, and who will each pay Hemostemix USD $37,000 for ACP-01 (USD $3,700,000, CAD $5,365,000), we will study ACP-01's impacts using FireFly's BNA™'s readouts," stated Thomas Smeenk, CEO. "Listen to a Patient treated with ACP-01 for Vascular Dementia 10 Years Post-Treatment. It reversed Mrs. L's dementia. She has gained greater than ten years of life, love and the joy of family from one ACP-01 treatment," Smeenk said.

The clinical trial of 100 patients will add to Firefly's proprietary database of 77,000 EEG brain scans across twelve disorders. The scans may objectively prove that intrathecal injection of ACP-01 is a safe, efficacious, and a clinically relevant treatment for vascular dementia. In January 2025, Firefly highlighted two impactful studies that demonstrated the utility of its AI-based BNA™ advanced Resting Electroencephalograms (EEG) and Cognitive EEG (ERP) data analytics. As illustrated by the two studies, Firefly's BNA™ system uniquely provided objective measures of the efficacy of treatment and cognitive change.

Design of Hemostemix's Vascular Dementia Phase I Clinical Trial of ACP-01

The Phase 1 clinical trial will evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of ACP-01 directly into the cerebrospinal fluid of subjects who suffer from vascular dementia.

• Primary endpoints include incidence of safety and adverse events; feasibility of ACP-01 delivery via intrathecal injection; safe dosage; and tolerability.

• Secondary endpoints include cognitive functional assessment; global clinical dementia rating; quality of life assessment; and, standardized MRI metric analyses of brain volume and blood flow.

• Exploratory endpoints include FireFly's BNA™ readout pre-treatment and at 3-months, and 6-months post-treatment.

How Hemostemix Plans to Use BNA™ in its Phase I Vascular Dementia Clinical Trial

1. Firefly's BNA™ technology will be used pre-treatment as an assessment, and post-treatment to record brain activity at resting state and during the performance of visual and auditory cognitive tasks. The wide range of functional brain measures will be compared against Firefly's FDA-cleared age-matched normative database. Each score will be assessed relative to the relevant reference normal range. The analyses will compare the change in different brain measures over time within the treated population, relative to the expected normative change over a range of six months based on Firefly's database.

2. Quality of life and brain function will be measured with the BNA™ assessment.

ABOUT HEMOSTEMIX

Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapies that include angiogenic cell precursors (ACP-01), later neural cell precursors (NCP-01), and cardiomyocyte cell precursors (CCP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in nine peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 60% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years. For more information, please visit www.hemostemix.com.

For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder
EM: tsmeenk@hemostemix.com PH: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the use of FireFly's BNA™ technologies, the sales of ACP-01 as a treatment for vascular dementia, including the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete  clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; general business, economic, competitive, political and social uncertainties; general capital market  conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and  financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression;the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at www.sedarplus.ca. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law. 

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/244840

FAQ

What is the expected revenue from Hemostemix's (HMTXF) Vascular Dementia trial?

The trial is expected to generate USD $3.7 million (CAD $5.365 million) from 100 patients paying USD $37,000 each for ACP-01 treatment.

How many patients will be enrolled in HMTXF's Phase 1 Vascular Dementia trial?

The Phase 1 clinical trial will enroll up to 100 patients who meet the inclusion criteria for ACP-01 treatment.

What technology will HMTXF use to monitor treatment effectiveness in the Vascular Dementia trial?

Hemostemix will use FireFly's BNA™ technology to monitor brain activity pre-treatment and at 3 and 6 months post-treatment.

What are the primary endpoints of HMTXF's Vascular Dementia Phase 1 trial?

Primary endpoints include safety and adverse events monitoring, feasibility of ACP-01 delivery via intrathecal injection, safe dosage determination, and tolerability assessment.