Hemostemix Files for Ethics Approval of its Study of Vascular Dementia

Calgary, Alberta--(Newsfile Corp. - October 9, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce it has filed its Institutional Review Board (IRB) application for approval of its Phase 1 clinical trial titled "Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP-01)." The 102-page submission marks a critical milestone in expanding the therapeutic reach of ACP-01.

Plain-language summary:
Hemostemix has officially applied for ethics approval to begin a new clinical study testing its stem-cell therapy, ACP-01, for people suffering from vascular dementia — a form of memory loss caused by poor blood flow to the brain. This is an important step toward treating a disease for which no current cure exists.

Significance of the Filing

Vascular dementia (VaD) and vascular cognitive impairment (VCID) represent the second most common cause of dementia worldwide, accounting for up to 20% of all cases. With no FDA-approved therapies, VCID remains a major unmet medical need. The IRB submission positions Hemostemix at the forefront of regenerative neuroscience by proposing the first autologous intrathecal stem-cell therapy designed to restore brain perfusion and neurovascular integrity in affected patients.

Plain-language summary:
Vascular dementia is the second-most common cause of dementia after Alzheimer's. It happens when blood flow problems damage brain tissue. No approved drugs exist to stop or reverse it. Hemostemix's new trial aims to repair blood vessels in the brain using the patient's own stem cells injected safely into the spinal fluid to reach the brain directly.

ACP is Safe and Effective

ACP-01, a population of angiogenic cell precursors derived from autologous peripheral blood, has demonstrated strong safety and efficacy in clinical trials for refractory angina, ischemic cardiomyopathy, non ischemic dilated cardiomyopathy and peripheral arterial disease as chronic limb-threatening ischemia. The vascular dementia trial represents the first direct application of ACP-01 to the central nervous system, leveraging its pro-angiogenic, anti-apoptotic, and neurotrophic mechanisms.