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Hemostemix Files FDA Submission for Basket Protocol (Filing 1517) to Advance ACP-01 (VesCell(TM)) Across Multiple Ischemic and Vascular Indications Simultaneously
Calgary, Alberta--(Newsfile Corp. - September 23, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMT...
About this update from Hemostemix Inc
[{"type":"text","content":"Hemostemix Files FDA Submission for Basket Protocol (Filing 1517) to Advance ACP-01 (VesCell(TM)) Across Multiple Ischemic and Vascular Indications SimultaneouslyCalgary, 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)AnginaIschemic cardiomyopathyNon-ischemic dilated cardiomyopathyCongestive heart failure (CHF)Total body ischemiaStrategic Importance of FDA Filing 1517This 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 ShareholdersRegulatory Pathway Clarification: Filing 1517 is the essential first...