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

Core Viewpoint - Hemostemix Inc. has filed FDA Pre-IND Application 1517 to seek regulatory feedback for a Phase I clinical trial of its lead therapy, ACP-01 (VesCell™), targeting multiple ischemic and vascular conditions, marking a significant step in its development strategy [2][3][4]. Regulatory Engagement - The filing represents Hemostemix's formal engagement with the FDA to clarify the regulatory pathway for ACP-01, aiming for expedited designations such as RMAT (Regenerative Medicine Advanced Therapy) and Fast Track [3][4][10]. - The proposed basket protocol will evaluate safety, feasibility, and early efficacy signals of ACP-01 across various high-unmet-need conditions, including peripheral arterial disease and congestive heart failure [3][6]. Real-World Evidence Integration - Hemostemix plans to incorporate systematically collected real-world evidence from Florida, where ACP-01 is legally available under SB 1768, to support its IND advancement [3][10]. - Patients treated in Florida will be monitored as if they were in a Phase I open-label clinical trial, providing standardized endpoints and data for regulatory submissions [3][10]. Market Expansion Potential - A successful basket protocol could allow Hemostemix to pursue multiple billion-dollar markets simultaneously, significantly expanding its addressable market [10]. - Positive FDA feedback could shorten timelines to pivotal trials and eventual commercialization, positioning Hemostemix as a first-mover in the autologous stem cell therapy space for ischemia and vascular dementia [10][11]. Company Background - Hemostemix is recognized as a leading autologous stem cell therapy company, having developed and patented VesCell™ (ACP-01) and completed seven clinical studies with 318 subjects [8][11]. - The company has published results demonstrating the safety and efficacy of ACP-01 in treating severe conditions, including a reported 0% mortality rate in chronic limb threatening ischemia patients over a follow-up period of up to 4.5 years [8][11].