Calgary, Alberta--(Newsfile Corp. - November 20, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell (ACP-01) to no-option patients suffering from pain, angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, is pleased to announce Dr. William R. Shankle, MS, MD, FACP will lead the Phase I clinical trial of ACP-01 as a treatment for vascular dementia (VaD).
"Across his more than 35 years of medical practice, Dr. Shankle has been featured in numerous clinical programs and public education initiatives dedicated to the prevention, early diagnosis, and management of cognitive decline," stated Thomas Smeenk, CEO. "As a leader in this filed, he has approximately 500 individuals diagnosed with cognitive impairment, and is identifying and pre-screening up to 30 patients whose condition is primarily vascular in origin to enrol in the trial. Dr. Shankle has consistently advanced the understanding of neurodegenerative and vascular contributions to vascular dementia while maintaining an active portfolio of peer-reviewed publications, clinical research, and scholarly activity that continues to influence standards of care in cognitive neurology," Smeenk said.
About Dr. William R. Shankle and the Shankle Clinic
William R. Shankle, MS, MD, FACP is a neurologist specializing in the prevention, diagnosis, and management of cognitive disorders, including Alzheimer's disease and vascular cognitive impairment/dementia. He is the founder of The Shankle Clinic (Newport Beach, CA), established in 1997, a neurology practice focused on neurodegenerative conditions and cognition care. shankleclinic.com+1
Dr. Shankle has held academic and clinical leadership roles connected to the University of California, Irvine (UCI) and Hoag's Pickup Family Neurosciences Institute, including co-founding UCI's Alzheimer's Research Center and serving as clinical/program director for memory and cognitive disorders initiatives. He has also been affiliated with UCI's Department of Cognitive Sciences.
Dr. Shankle's selected contributions to vascular dementia and cognition medicine
Early work contributed to diagnostic frameworks for ischemic vascular dementia, alongside leading figures in dementia research. Cambridge University Press & Assessment
Co-authored peer-reviewed research spanning cognition across aging and dementia - methodological and clinical perspectives. PMC
Co-authorship in the leading Neurology literature addressing vascular dementia. American Academy of Neurology
Across his career, Dr. Shankle has been featured in clinical programs and public education initiatives aimed at preventing or delaying cognitive decline, while maintaining an active portfolio of publications and scholarly activity. PR Newswire+2hoaghospitalfoundation.org+2
About ACP-01 and Vascular Dementia
ACP-01 (Angiogenic Cell Precursors) is Hemostemix's autologous, blood-derived cell therapy designed to promote angiogenesis and microvascular repair. Given the vascular underpinnings of vascular dementia, Hemostemix believes ACP-01 warrants formal clinical study to assess safety, feasibility, and preliminary efficacy in patients with vascular contributions to cognitive impairment.
Regulatory Steps and Recruitment
The Phase 1 vascular dementia protocol, co-authored by Dr. Fraser Henderson Sr. and Dr. William R. Shankle, has been formally submitted to an Institutional Review Board (IRB) for ethical review and approval. The IRB has provided its initial comments, which Hemostemix and its investigators have now addressed through a set of comprehensive revisions. The revised protocol is being resubmitted for final IRB approval.
As part of the initial recruitment phase, Dr. Shankle is reviewing his patient database of approximately 500 individuals diagnosed with cognitive impairment, to identify and pre-screen up to 30 patients whose condition is primarily vascular in origin. This cohort may form the foundation for subject enrolment and baseline characterization in the Phase 1 study, which is designed to assess ACP-01's safety, feasibility, and potential cognitive benefits in vascular dementia.
Regulatory note: ACP-01 is an investigational, autologous cell therapy. It is not approved by the U.S. FDA or Health Canada for the treatment of vascular dementia. Any future clinical use will occur strictly within applicable research, ethics, and regulatory frameworks.
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 therapy, VesCell (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven 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 50% 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, as a midpoint result. For more information, please visit www.hemostemix.com.
For further information, please contact: Thomas Smeenk, President, CEO 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 Phase I clinical trial of ACP-01 as a treatment for Vascular Dementia, and the treatment of pain related to CLTI in Florida and other jurisdictions related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) in furtherance of sales of VesCell (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. 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 successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); 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; potential litigation Hemostemix may face; 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.
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SOURCE: Hemostemix Inc.
