Hemostemix Receives FDA Support for Its Basket Protocol Approach

Calgary, Alberta–(Newsfile Corp. – January 16, 2026) – Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous stem cell company treating those who suffer in pain from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, dilated cardiomyopathy, and vascular dementia, in Florida, Canada, The Bahamas, announces the successful completion of its pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA).

Hemostemix’ team included Thomas Smeenk, CEO; Dr. Ina Sarel, Chief Scientific Officer; Dr. Fraser Henderson, Chief Medical Officer, Professor of Neurosurgery and a practicing neurosurgeon; Dr. Ernst von Schwarz, a triple board-certified transplant surgeon, cardiologist and renowned stem cell researcher; and Dr. William Shankle, a neurologist specializing in the prevention, diagnosis, and management of vascular dementia and Alzheimer’s.

Basket Protocol

The FDA provided guidance indicating that the Company’s basket protocol approach is acceptable, subject to the inclusion of clearly defined eligibility criteria, appropriate handling of patient heterogeneity, and rigorous clinical and statistical design. The basket protocol is designed to evaluate ACP-01 across multiple ischemic and vascular-related conditions that share common underlying pathophysiology, while maintaining clinically meaningful cohort definitions and appropriate analytical methods. Hemostemix will address the FDA’s guidance in its IND submission; in its clinical practice, and guidelines.

Real World Evidence (RWE)

The Company also received the FDA’s guidance on its plan to capture ACP-01 real-world data in jurisdictions such as Florida, Canada, and The Bahamas. The guidance supports the collection of RWE that is structured in a manner consistent with FDA’s publications, which addresses patient privacy, safety and data integrity.

Next Regulatory Milestones

“The FDA’s guidance supports Hemostemix’ basket protocol strategy, and collection of RWE, enabling the Company to advance across multiple ischemic diseases,” stated Thomas Smeenk, CEO. “We are incorporating the FDA’s feedback in our IND submission, data models and statistical analyses of patients treated with ACP-01,” Smeenk said.

Hemostemix is proceeding with the filing of its IND, including the submission of product comparison validation studies. The Company will news release updates throughout the process.

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 selling autologous (patient’s own) blood-based stem cell therapy, VesCell™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant 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.

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 a non brokered private placement and the treatment of conditions of ischemia including via the Phase I basket protocol clinical trial of ACP-01 as a treatment for multiple indications of ischemia including Vascular Dementia, and the treatment of pain in Florida related related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, with Angiogenic Cell Precursors (ACP-01), in furtherance of sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. 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”); 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 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.

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