VesCell
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Hemostemix Submits FDA Filing 1517 for ACP-01 (VesCell™) Basket Protocol Targeting Multiple Ischemic and Vascular Indications
Hemostemix (HMTXF) filed an FDA Pre-IND application for a Phase I basket trial of ACP-01 (VesCell™) to evaluate its safety and early efficacy across vascular dementia, peripheral arterial disease, angina, cardiomyopathy, and congestive heart failure. Hemostemix aims to use real-world evidence from Florida, where ACP-01 is available, to support regulatory advancement. The company has completed 498 safe treatments and has 11 peer-reviewed publications. The basket protocol seeks to accelerate development and expand target markets.
