Mr. Thomas Smeenk reports

HEMOSTEMIX COMMERCIALIZES ITS VASCULAR DEMENTIA CLINICAL TRIAL OF VESCELL UNDER LARTA

Hemostemix Inc. has noted greater than 130 participants have enrolled to hear the special presentation by Dr. William R. Shankle, MS, MD, FACP, entitled: "Vascular Cognitive Impairment and Vascular Dementia: Recognizing the Vascular Cause and Exploring the Clinical-Trial Application of VesCell." The presentation will begin at 12 p.m. EST and is available through on Zoom.

Dementia debilitates an estimated 50 million to 57 million people worldwide, representing one of the largest unmet needs in neurology. Vascular dementia accounts for up to 15 per cent of all dementia cases. Approximately 70 million people worldwide were living with the consequences of ischemic stroke in 2021. Cognitive impairment occurs in up to 60 per cent of stroke survivors during the first year, implying that as many as 42 million ischemic stroke survivors may experience some degree of cognitive impairment. There are currently no approved therapies designed to regenerate the damaged microvasculature responsible for cognitive decline, or vascular dementia.

During the presentation, Dr. Shankle is expected to discuss:

• The differences and overlap between Alzheimer's disease, vascular cognitive impairment and vascular dementia;
• The relevance of endothelial cell physiology and pathophysiology;
• How VesCell, as an autologous (patient's own) lineage-specific endothelial progenitor cell population (the patient's own DNA), may leverage the patient's own migration, angiogenesis, blood vessel formation and tissue regeneration signalling processes, to support circulation renewal, endothelium repair, tissue and organ regeneration;
• How small vessel cerebrovascular disease contributes to memory loss and cognitive decline;
• The importance of identifying a vascular contribution to cognitive impairment at an early stage;
• MCI screen: a practical approach to patient screening, diagnosis and functional assessment;
• The clinical trial of VesCell for treatment of vascular cognitive impairment.

Dr. Shankle is a board-certified neurologist specializing in the prevention, diagnosis and management of Alzheimer's disease, vascular dementia and related cognitive disorders. He co-founded the Alzheimer's Disease Clinical Research Center at the University of California, Irvine, received the National Alzheimer's Association's zenith pioneer award and co-discovered neurogenesis of the human cerebral cortex after birth, which presaged the era of stem cell therapy. Dr. Shankle is the founder of the Shankle Clinic in Newport Beach, Calif., where his clinical work focuses on identifying the causes of cognitive decline and providing individualized treatment and disease management strategies.

Dr. Shankle said: "Vascular cognitive impairment is frequently missed because cognitive decline is too readily assumed to be Alzheimer's disease. MCI screen can be administered efficiently and has demonstrated a very high accuracy in distinguishing normal aging from mild cognitive impairment in published validated studies. When combined with a focused Hachinski vascular assessment -- including questions concerning stroke history, abrupt or stepwise decline, fluctuating symptoms, and focal neurological findings -- it provides a practical and highly informative method of identifying patients whose cognitive impairment is likely to have a vascular cause or significant vascular contribution. In appropriately selected patients, this approach may provide up-to-90-per-cent clinical confidence that a meaningful vascular component is present. Of course, MCI is only a diagnostic tool. The final diagnosis must incorporate the patient's history, neurological examination, laboratory assessment and appropriate brain imaging."

Endothelial cells form the continuous, single-cell lining of every artery, arteriole, capillary, venule and vein in the human body. Rather than simply forming the walls of blood vessels, the endothelium is a vast, biologically active organ. Endothelial cells regulate vascular tone and blood flow, coagulation, inflammation, vascular permeability, angiogenesis, and the delivery of oxygen and nutrients to tissues. In the brain, specialized endothelial cells also form the foundation of the blood-brain barrier and regulate cerebral microcirculation. Because of them being the most numerous cells in the human body, understanding their role is key to treating cerebrovascular disease at its root cause.

There is currently no Food and Drug Administration-approved drug or biologic specifically indicated to treat vascular cognitive impairment or vascular dementia. That is a profound unmet medical need. Based on 498 treatments, seven clinical trials including two phase 2 trials, VesCell may be a safe treatment of vascular dementia as it promotes generation of new blood vessels while repairing existing ones.

VesCell is derived from the patient's own blood, which avoids the pitfalls of immune incompatibility and rejection risks. It promotes healing of the blood vessels' endothelial wall by migrating to the site of damage, engrafting within it, and recruiting other endogenous stem cells from the patient's blood to join in the regeneration of the damaged endothelium, tissue and organs.

"Mrs. L. had experienced a loss of executive function, short- and long-term memory, judgment, and the ability to independently perform the activities of daily living. Four physicians and I spoke with her seven years post-VesCell treatment in a telephone call. At 87, Mrs. L reported that, within six months of her VesCell treatment, she regained her ability to live independently. She recalled her wonderful treatment experience; her career, her child-bearing years and family, and her active social calendar, with the ease of a cognitively healthy individual," said Thomas Smeenk, chief executive officer. "While one case study does not make a statistically significant result, it is the first documented in-human use of VesCell that generated a significant cognitive improvement as measured by the Montreal cognitive assessment pre and posttreatment," Mr. Smeenk said.

"The MCI screen test is only $179. I invite families to contact Hemostemix's director of patient services and clinical operations, Shaune Harding (sharding@hemostemix.com, telephone: 226-504-4357) to complete it confidentially. MCI screen will enable all participants to know where they are on the spectrum and whether or not they qualify for the clinical trial," Smeenk said.

Proposed VesCell vascular dementia clinical trial

Hemostemix developed a clinical trial protocol to evaluate the safety, feasibility and preliminary efficacy of VesCell in patients with vascular cognitive impairment or vascular dementia.

The proposed program is designed to use standardized baseline and follow-up assessments of cognition, daily function, quality of life and vascular risk. Enrolment is now under way. The clinical trial is subject to the final approvals now in progress under the Bahamas Longevity and Regenerative Therapy Act.

VesCell is investigational and has not been approved by the U.S. Food and Drug Administration or Health Canada for the treatment of vascular cognitive impairment or vascular dementia.

Presentation information

Speaker:  Dr. William R. Shankle, MS, MD, FACP

Topic:  vascular cognitive impairment and vascular dementia: recognizing the vascular cause and exploring the clinical trial application of VesCell

Date:  Tuesday, Aug. 20, 2026

Time:  12 p.m. EST

Please register.

Audience:  physicians, health care professionals, patients, caregivers, researchers, investors and members of the public interested in vascular cognitive impairment and regenerative medicine

About Hemostemix Inc.

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, has patented, is scaling and is selling autologous (patient's own) blood-based stem cell therapy, VesCell an investigational autologous stem cell therapy developed to support circulation in areas affected by diseases of ischemia. VesCell is derived from a patient's own blood and evaluated through structured clinical research. Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer-reviewed publications. ACP-01 is safe, and appears clinically relevant 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 2 clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared with a five-year mortality rate of 50 per cent in the CLTI diabetes-based patient population, the University of British Columbia and the University of Toronto reported to the 41st meeting of vascular surgeons: 0 per cent mortality, cessation of pain and wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.

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