Hemostemix Files FDA Submission For Basket Protocol (Filing 1517) To Advance ACP-01 (Vescell(TM" Across Multiple Ischemic And Vascular Indications Simultaneously

(MENAFN- Newsfile Corp) 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 VesCellTM (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 (VesCellTM) .

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 (VesCellTM) 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, VesCellTM (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 .

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