Hemostemix Announces the Incorporation of Hemostemix PR Inc: 50% Reimbursement of R&D Expenses in Cash

Calgary, Alberta–(Newsfile Corp. – January 6, 2025) – Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Company”) is pleased to announce it has incorporated Hemostemix PR Inc., in Puerto Rico, as a wholly owned subsidiary and a domestic for profit corporation.

Under Puerto Rico’s ACT 60 program, Hemostemix PR Inc. is eligible to file applications for cash reimbursement of up to 50% of its research and development expenses, including clinical trials, economic impact assessments of ACP-01 in terms of healthcare budget savings, and feasibility analyses, for example. Hemostemix PR Inc.’s first ACT 60 Application is now completed. Its submission will take place this week.

The following information highlights the healthcare drivers and financial impacts that are available to Hemostemix PR Inc., our partner CytoImmune, and the people of Puerto Rico for one of seven medical indications Hemostemix has treated safely, with clinical relevancy, and statistically significant efficacy.

Annual Addressable Market: Treatments of 8,681 Diabetic Foot Ulcers

Based on its 2020 census, Puerto Rico has a population of 3,285,874. The prevalence of diabetes in Puerto Rico (19-20%) has been increasing over the years. Various studies highlight this trend: Abarty’s Health and the Puerto Rico Diabetes Association Analysis (2021) estimated a diabetes prevalence of over 19.3% among adults aged 20 and above. The International Diabetes Federation (IDF) 2021 Report estimated a diabetes prevalence of 20.1% among adults in Puerto Rico, equating to approximately 413,400 cases.

The annual incidence of foot ulceration in patients with diabetes varies between 1.2% and 3.0%, a mean of 2.1% per year (Diabetes Journals). At the mean, Hemostemix estimates its annual total addressable market in Puerto Rico for diabetic foot ulcers (DFUs) treatment is approximately 8,681 cases at USD $37,000 each. The lifetime risk of developing a foot ulcer for patients with diabetes is estimated to be between 19% and 34% (RACGP, 78,546 – 140,556 cases). The 2024 Canadian Institute for Health Information study, Equity in diabetes care: A focus on lower limb amputation, highlighted that in Canada, 31,220 hospitalizations cost $750 Million annually; however, the report noted, that cost reflected a fraction of the total system costs associated with diabetic foot ulcers and amputations.

DFU Before Treatment

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After Treatment with Hemostemix ACP-01

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We presented these figures and our solution to Puerto Rico’s Governor Elect during her campaign” stated Thomas Smeenk, CEO. “Together with the Government, our partner CytoImmune, and physicians who may treat under special access programs, ACP-01 may heal ulcers, mitigate pain for no-option diabetic foot ulcer patients, and save the healthcare budget 4-5 years of hospitalization costs per patient treated. Leveraging our Phase II results, we will complete an economic analysis of the significant cost savings for the healthcare system of Puerto Rico. ACT 60 is why Puerto Rico is the best jurisdiction in the world to complete clinical trials and R&D,” Smeenk said.

Globally, 236 million suffer from peripheral arterial disease. 23 million degenerate into chronic limb threatening ischema (“CLTI”), and face a 60% mortality rate in five years. In contrast, the University of Toronto and University of British Columbia posted their interim results during Hemostemix’s Phase II randomized double blind clinical trial that 83% of patients followed for up to 4.5 years experienced healing of ulcers and resolution of ischemic rest pain.

Precision Healthcare (ACP-01) Regenerates Circulation and Restores Quality of Life

ACP-01 is sourced from the patient’s blood and cultured in the patient’s serum. It is demonstrated to be safe, clinically relevant, and statistically effective. For example:

• In the Journal of Biomedical Research & Environmental Science, February 2024, The Company’s phase II chronic limb threatening ischemia (CLTI) clinical trial results detailed that ulcer size decreased significantly in the treated group from a mean of 1.46 cm² to 0.48 mm², p = 0.01 within three months.
• In the Journal Stem Cell Research & Therapy, October 2023, the Company published its seventh peer reviewed study. This was the third independent study of ACP-01 as a treatment for end stage heart failure (53 subjects). Two previous clinical trials of ischemic cardiomyopathy and non ischemic dilated cardiomyopathy( 106 subjects, 41 subjects), achieved clinically relevant results that were statistically significant. For example, in 53 subjects, ACP-01 regenerated and improved cardiac function by up to 24.1% at 12 months in ischemic cardiomyopathy subjects; and, up to 47.1% at 12 months in non ischemic dilated cardiomyopathy subjects.

Follow Hemostemix:

• Instagram: https://www.instagram.com/hemostemix.inc?utm_source=ig_web_button_share_sheet&igsh=ZDNlZDc0MzIxNw==
• Facebook:https://www.facebook.com/profile.php?id=61571076998595
• LinkedIn:https://www.linkedin.com/in/thomas-smeenk-03b9213/
• YouTube:https://www.youtube.com/@hemostemix3830
• X: @heartrepairguy

About Hemostemix

Founded in 2003, Hemostemix is a clinical-stage biotechnology company and winner of the World Economic Forum Technology Pioneer Award. The Company has developed and patented a blood-based stem cell therapeutics platform that includes angiogenic cell precursors (ACP), neuronal cell precursors (NCP), and cardiomyocyte cell precursors (CCP)

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 under Special Access Program, and social media programs targeted to generate sales. 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.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.

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