Hemostemix Announces ACP-01 Treatment-Purchase Available with Social Media Campaign Underway

Calgary, Alberta–(Newsfile Corp. – November 25, 2024) – Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Company“) is pleased to announce that, focusing on revenue, it has retained social media experts to educate and sell caregivers and individuals suffering from Chronic Limb Threatening Ischemia (“CLTI”), Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy, and Congestive Heart Failure, an ACP-01 treatment, available under special access programs.

ACP-01 is a break-through treatment for no-option cardiovascular disease patients. Sourced from the patient’s blood and cultured in the patient’s serum, ACP-01 is proven safe in 498 treatments. In each of the six clinical trials and one retrospective study, 318 subjects, ACP-01 treatment was statistically significant. For example, in dilated cardiomyopathy subjects, cardiac function as measured by left ventricle ejection fraction percent (LVEF%) increased up to 47.1 percent following one treatment (Stem Cell Research & Therapy, November 2023), and was most marked in patients who had the most severe dilated cardiomyopathy (LVEF% < 20%).

As compared to the five-year mortality rate of 60% in no-option CLTI patients, the University of Toronto and University of British Columbia posted at, and reported to, the 41^st meeting of vascular surgeons: “Healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients followed for up to 4.5 years.”

The results of no-option subjects who started the Phase II trial with an ulcer that would otherwise not heal, as published in the Journal of Biomedical Research & Environmental Science, February 2024 detailed: “Ulcer size in the treated group decreased from a mean of 1.46 cm2 to 0.48 mm2 (p = 0.01) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54). At one year there were no complications related to treatment. The treatment group had one amputation (4.8%) and one death (4.8%); the placebo group had 2 amputations (25%) and 1 death (12.5%).”

In September 2024, the Canadian Institute of Health Information (CIHI) published a report examining diabetes-related lower limb amputations in Canada, using data from 2020 to 2023. The report’s findings contrast the significant differences between ACP-01 treatment to amputation in terms of mortality, quality of life, and significant costs to the Canadian healthcare system.

The report’s key findings are as follows:

• Of the 31,220 hospitalizations for diabetes-associated lower limb complications in Canada, 19,100 were for unique patients. The remaining 12,120 were repeat visits within the year.

• There were 7,720 hospitalizations for lower limb amputations associated with diabetes, including 3,080 leg amputations.

• Within 12 months, 19 percent of leg amputees were readmitted for a second amputation, or treatment of ulcers, gangrene and infections.

• Patients who received a leg amputation spent an average of 19 days in hospital, often require multiple procedures during their stay and have a high risk of readmission and in-hospital death.

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  Approximately 8 percent of patients died in hospital within 30 days of a hospitalization for a leg amputation.

• Average hospitalization cost: $47,000; Annual cost: $750 Million; Noting, however, that $750 Million reflects only a fraction of the total system costs associated with diabetic foot ulcers and amputations. The full CIHI Report and findings can be found at this link https://www.cihi.ca/en/equity-in-diabetes-care-a-focus-on-lower-limb-amputation.

“Globally, the published five-year mortality rate for no-option CLTI patients is 60%. 236 million suffer from peripheral arterial disease (PAD) worldwide; approximately 10% (23.6 million) degenerate into CLTI; a further 5 million degenerate into no-option CLTI and face limb amputation each year” stated Thomas Smeenk, CEO. “Yet, ACP-01 is a safe, efficacious, ethical and a cost-effective treatment for no-option CLTI, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy, and Congestive Heart Failure. Our outreach will engage with these individuals, and describe how ACP-01 neovascularizes the leg or heart, and regenerates it and quality of life. Our campaign will generate sales, and treatments in the priority purchased,” Smeenk said.

About Hemostemix

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient’s blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. For more information, please visit Hemostemix.com.

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 sales of its lead product ACP-01, the commercialization of ACP-01 via the sale of compassionate treatments Special Access Program. 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 the 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 Hemostemis 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.sedar.com. 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/231308