Hemostemix Files FDA Submission for Basket Protocol (Filing 1517) to Advance ACP-01 (VesCell(TM)) Across Multiple Ischemic and Vascular Indications Simultaneously

Rhea-AI Summary

Hemostemix (OTCQB: HMTXF) has filed FDA Pre-IND Application 1517 for a basket protocol Phase I clinical trial of its lead therapy ACP-01 (VesCell™). The trial aims to evaluate safety, feasibility, and early efficacy of ACP-01 across multiple conditions including vascular dementia, peripheral arterial disease, angina, cardiomyopathy, and congestive heart failure.

The company plans to integrate real-world evidence from Florida, where ACP-01 is legally available under SB 1768, to support IND advancement and expedited regulatory designations. Hemostemix has completed 498 safe treatments to date and has 11 peer-reviewed publications demonstrating safety and efficacy.

Positive

• Filing of FDA Pre-IND Application 1517 enables evaluation of multiple indications under one unified trial design
• Company has completed 498 safe treatments and published 11 peer-reviewed papers demonstrating safety and efficacy
• Real-world evidence from Florida treatments can support expedited regulatory designations
• Basket protocol approach could accelerate development timeline and expand addressable markets

Negative

• Multiple indications still require Phase I clinical trials, indicating early development stage
• Success of basket protocol strategy depends on pending FDA feedback
• Complex regulatory pathway across multiple therapeutic areas may increase development risks

Calgary, Alberta--(Newsfile Corp. - September 23, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida under Florida's SB 1768, is pleased to announce that it has filed FDA Pre-IND Application 1517, seeking regulatory feedback on a basket protocol Phase I clinical trial of its lead therapy, ACP-01 (VesCell™).

The proposed basket protocol is designed to evaluate safety, feasibility, and early efficacy signals of ACP-01 in patients with:

• Vascular dementia (earliest medically validated subtype)
• Peripheral arterial disease (PAD)
• Angina
• Ischemic cardiomyopathy
• Non-ischemic dilated cardiomyopathy
• Congestive heart failure (CHF)
• Total body ischemia

Strategic Importance of FDA Filing 1517
This filing marks Hemostemix's formal engagement with the FDA to align on the regulatory path for ACP-01 in multiple high-unmet-need conditions. By pursuing a basket protocol, the Company aims to:

• Accelerate development by studying multiple indications under one unified trial design;
• Maximize the breadth of ACP-01's therapeutic potential in ischemia-related diseases;
• Generate pivotal safety and exploratory efficacy data across cardiology, neurology, and vascular medicine.

Incorporating Real-World Evidence (Florida SB 1768)
As part of its strategy, Hemostemix will present to the FDA its plan to integrate systematically collected real-world evidence (RWE) from Florida, where ACP-01 (VesCell™) is legally available under SB 1768. Patients treated in Florida will be followed prospectively and documented as if they were in a Phase I open-label clinical trial, with standardized endpoints and monitoring. This dataset will be positioned as supportive evidence for IND advancement and expedited regulatory designations such as RMAT (Regenerative Medicine Advanced Therapy).

Implications for Shareholders

• Regulatory Pathway Clarification: Filing 1517 is the essential first step in securing FDA guidance on ACP-01's accelerated development pathway, including RMAT designation, Fast Track, or Breakthrough Therapy eligibility.
• Expansion Potential: A successful basket protocol enables Hemostemix to pursue multiple billion-dollar markets in parallel, significantly expanding the Company's addressable market.
• Value Creation: Positive FDA feedback could shorten timelines to pivotal trials and eventual commercialization, positioning Hemostemix as a first-mover in autologous stem cell therapies for ischemia and vascular dementia.

Management Commentary
Thomas Smeenk, CEO of Hemostemix, stated:"This FDA filing is a transformational milestone for Hemostemix. By proposing a basket trial that spans cardiology, vascular disease, and vascular dementia, we are unlocking ACP-01's full potential as a regenerative therapy. Layering in real-world evidence from Florida strengthens our case for expedited pathways and positions Hemostemix to deliver shareholder value through accelerated regulatory approval."

Hemostemix has established itself as the world's #1 autologous stem cell therapy company, backed by:

• 11 peer-reviewed publications demonstrating safety and efficacy,
• 498 safe treatments completed to date,
• Clinically relevant efficacy in no-option patients with severe angina, ischemic and non-ischemic dilated cardiomyopathy, and related co-morbidities, including congestive heart failure, peripheral arterial disease (PAD), and chronic limb-threatening ischemia (CLTI).

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). A recent peer-reviewed article in Cells (June 29, 2025) provides the scientific foundation for how ACP-01 and NCP-01 may enhance brain-computer interface performance by reducing inflammation, fostering angiogenesis and synaptic plasticity, potentially extending implant longevity. Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 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.

For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder: EM: tsmeenk@hemostemix.com / PH: 905-580-4170

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 webinar related to VesCell.Health and hemostemix.com in furtherance of the sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale and financing 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/267606

FAQ

What is the significance of Hemostemix's FDA Pre-IND Application 1517?

The FDA Pre-IND Application 1517 allows Hemostemix to pursue a basket protocol clinical trial for ACP-01 across multiple conditions including vascular dementia, PAD, and heart conditions, potentially accelerating development timelines.

How many treatments has Hemostemix (HMTXF) completed with ACP-01?

Hemostemix has completed 498 safe treatments with ACP-01 (VesCell™) and has published 11 peer-reviewed publications demonstrating safety and efficacy.

What medical conditions will Hemostemix's ACP-01 basket trial target?

The basket trial will target vascular dementia, peripheral arterial disease (PAD), angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure (CHF), and total body ischemia.

How does Florida's SB 1768 law benefit Hemostemix's development strategy?

Under Florida's SB 1768, Hemostemix can collect real-world evidence from ACP-01 treatments, which can support IND advancement and expedited regulatory designations such as RMAT.

What is the current development stage of Hemostemix's ACP-01 therapy?

ACP-01 is entering Phase I clinical trials through a basket protocol, while also being available in Florida under SB 1768. The company has completed 498 treatments and published 11 peer-reviewed studies.