Hemostemix Presents ACP-01 Data at University of Florida Grand Rounds: Highlights Strong Safety, Functional Gains, and Florida Access Pathway

Core Insights - Hemostemix Inc. presented data on its ACP-01 therapy, highlighting its strong safety profile and functional gains in treating conditions like chronic limb-threatening ischemia (CLTI), cardiomyopathy, and angina [1][4][12] Safety Profile - The safety profile of ACP-01 was demonstrated across more than 498 treated patients, with no cell-related complications reported [3][5] - Historical programs noted one non-related death and two responsive tachyarrhythmias, indicating a favorable safety outcome [5] Cardiovascular Efficacy - In patients with ischemic and dilated non-ischemic cardiomyopathy, ACP-01 showed a ~5% absolute increase in left ventricular ejection fraction (LVEF), translating to a 16-47% improvement in cardiac function depending on the subtype [4][12] - Significant improvements were observed in 6-minute walk tests, exercise capacity, and angina class at 3-6 months post-treatment [6][12] CLTI Treatment Outcomes - In no-option CLTI populations, ACP-01 was associated with a combined amputation/death rate of ~5% compared to ~40% in the control group over 12 months [12] - Wound-presenting patients exhibited significant healing responses compared to placebo [12] Florida Access Pathway - Under Florida SB 1768, physicians can offer autologous stem-cell therapies, including ACP-01, with informed consent and FDA-regulated manufacturing [12] - ACP-01 is now available in Florida outside of clinical trials, priced at US$37,000, excluding physician and clinic fees [12] Treatment Administration Process - The treatment process involves a blood draw, ex-vivo expansion of ACP-01 over 5 days, quality control, and local intramuscular injections on the 7th day [12] Future Steps - Hemostemix plans to schedule treatments in Florida and The Bahamas, where ACP-01 is permitted [11]