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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...
About this update from Hemostemix Inc
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, incl...