Mr. Thomas Smeenk reports
COMMERCIALIZATION APPLICATION FILED BY HEMOSTEMIX FOR THE TREATMENT OF VASCULAR DEMENTIA, ANGINA AND PAIN
Hemostemix Inc. has filed its application under the Bahamas Longevity and Regenerative Therapies Act (LARTA) for a commercial phase I basket clinical trial evaluating VesCell in patients suffering from vascular dementia, refractory angina and pain.
Published in Circulation, Tresukosol et al. evaluated VesCell in a phase I clinical trial of 24 patients suffering from chronic stable angina. The results showed statistically significant improvements in several important measures of heart function and quality of life. Patients walked 24 per cent farther during the six-minute walk test (p less than 0.001), increased their exercise capacity at three months (p less than 0.004), experienced a 45-per-cent reduction in the area of the heart receiving inadequate blood flow as measured by SPECT imaging (p less than 0.004) and saw their angina severity cut approximately in half on the Canadian Cardiovascular Society (CCS) angina scale (p less than 0.001). In medical research, p-values less than 0.05 are generally considered statistically significant. The p-values reported in Hemostemix's study were substantially lower, providing strong statistical evidence that the observed improvements were unlikely to have occurred by chance.
VesCell vascular dementia case study: Before treatment, Mrs. L. had experienced a loss of executive function, short-term and long-term memory, judgment, and the ability to independently perform activities of daily living. Seven years posttreatment, in a telephone call with four physicians and chief executive officer Thomas Smeenk, Mrs. L. reported that within six months of her VesCell treatment, she regained her ability to live independently. During the 12-minute call, Mrs. L. clearly 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. At the conclusion of the discussion, Mrs. L. invited the treating physician to lunch, to " ... thank him again for giving me my life back." While an individual patient experience does not establish clinical efficacy, Mrs. L.'s case illustrates the functional improvements that Hemostemix is evaluating in its commercial vascular dementia clinical trial.
Vascular dementia debilitates an estimated 50 million to 55 million people worldwide, representing one of the largest unmet needs in neurology. There are currently no approved therapies designed to regenerate the damaged microvasculature responsible for cognitive decline.
Angina is experienced by approximately 110 million people globally. Despite advances in pharmaceuticals, stents and bypass surgery, each individual continues to experience debilitating chest pain and reduced quality of life.
Pain is a daily companion of 230 million people who live with peripheral arterial disease worldwide, including approximately 10 million to 12 million patients who have critical limb-threatening ischemia (CLTI). CLTI patients experience severe chronic pain, impaired mobility, non-healing wounds, amputation and a 50 per cent mortality rate within five years. During the Hemostemix phase II clinical trial, the University of British Columbia and University of Toronto reported to the 41st meeting of vascular surgeons: 0 per cent mortality, cessation of pain, wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.
"This is Hemostemix's legal commercialization milestone," stated Mr. Smeenk. "Under the Bahamas legislation, Hemostemix is recruiting patients into our clinical trial, to study the effects of VesCell as a treatment for angina, vascular dementia and pain. Conducted as a commercial phase i clinical trial, this data will form the greatest asset," Mr. Smeenk said.
The Bahamas LARTA legislation enables an ethics approved physician-led commercial regenerative medicine program. LARTA is a regulatory framework that is specifically designed to evaluate innovative therapies while maintaining patient protections through physician and regulatory oversight, ethics review and informed consent.
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, patented, and is scaling and investigating the statistically significant, clinically relevant benefits of treatment with autologous (patient's own) blood-based stem cell therapy. VesCell is an investigational autologous stem cell therapy developed to support circulation in areas affected by ischemic disease. It 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. VesCell is safe and 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 II 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 patient population, the University of British Columbia and University of Toronto reported to the 41st meeting of vascular surgeons: 0 per cent mortality, cessation of pain, wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.
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