Commercialization Application Filed by Hemostemix for the Treatment of Vascular Dementia, Angina and Pain

July 08, 2026 10:08 AM EDT | Source: Hemostemix Inc.

Calgary, Alberta--(Newsfile Corp. - July 8, 2026) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) ("Hemostemix" or the "Company"), the leading autologous (patient's own stem cells) regenerative medicine company is pleased to announce that it 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% farther during the six-minute walk test (p < 0.001), increased their exercise capacity at three months (p < 0.004) , experienced a 45% reduction in the area of the heart receiving inadequate blood flow as measured by SPECT imaging (p < 0.004), and saw their angina severity cut approximately in half on the Canadian Cardiovascular Society (CCS) Angina Scale (p < 0.001). In medical research, p-values <0.05 are generally considered statistically significant. The p-values reported in Hemostemix' 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 and long-term memory, judgment, and the ability to independently perform activities of daily living. Seven years post treatment, in a telephone call with four physicians and 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 50-55 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 10-12 million patients who have critical limb-threatening ischemia (CLTI). CLTI patients experience severe chronic pain, impaired mobility, non-healing wounds, amputation, and a 50% mortality rate within 5 years. During Hemostemix Phase II clinical trial, the 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.

"This is Hemostemix's legal commercialization milestone" stated Thomas Smeenk, CEO. "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," 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 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 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 eleven 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 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 more information, please visit: Hemostemix Inc.

Thomas Smeenk
Co-Founder, President & CEO
Hemostemix Inc., 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in 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 LARTA application in furtherance of sales of VesCell™ and the commercialization of VesCell™ via the sale of treatments in The Bahamas. 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"), if any; the results of VesCell™ 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 VesCell™; 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/304397

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Source: Hemostemix Inc.

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