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

Executive Summary

• Hemostemix presented extensive safety and efficacy data for its autologous cell therapy ACP‑01 at a University of Florida Grand Rounds, highlighting >498 treated patients with no cell‑related complications.
• Early clinical signals show ~5 % absolute increase in LVEF (16–47 % functional improvement) in cardiomyopathy cohorts and marked reductions in amputation/death rates (~5 % vs ~40 %) for chronic limb‑threatening ischemia (CLTI).
• ACP‑01 is now commercially available in Florida under SB 1768 at a list price of US$37,000 per treatment, with a 7‑day production cycle and IRB oversight for real‑world evidence generation.

Key Details

• Safety Profile: >498 patients treated; no cell‑related adverse events reported. Historical incidents limited to one MI‑unrelated death (ineligible subject) and two tachyarrhythmias resolved with cardioversion.
• Cardiovascular Efficacy:
• Cardiomyopathy cohorts: ~5 % absolute LVEF increase (16–47 % relative improvement), +126 m in 6‑minute walk, NYHA class improvements.
• Angina studies: Significant gains in 6‑minute walk distance, METs, SPECT‑MIBI perfusion, and CCS angina class at 3–6 months.
• CLTI Outcomes: Combined amputation/death rate ~5 % in ACP‑01 subgroup vs ~40 % historical 1‑year post‑amputation mortality; accelerated wound healing noted versus placebo.
• Florida Access Pathway (SB 1768): Effective July 1, 2025 – permits physicians to offer autologous stem‑cell therapies with informed consent and cGMP manufacturing oversight.
• Commercial Pricing: ACP‑01 therapy price set at US$37,000 (excluding physician/clinic fees).
• Production Timeline: Day 0 blood draw → Days 1‑5 ex‑vivo expansion → Day 6 QC & shipment → Day 7 intramuscular injection (≈30 × 1 cc sites).
• Regulatory Oversight: All Florida procedures to be conducted under IRB supervision, generating high‑quality real‑world evidence.
• Future Plans: Expansion of treatment scheduling in Florida and the Bahamas; continuation of Basket Phase 1 Program (Bahamas) with four of seven protocols completed and pending IRB submission.

Notable Quotes

“The autologous nature and endothelial programming of ACP‑01 distinguish it from pluripotent or broadly multipotent cell types… we consistently see a favorable safety profile paired with biologic specificity for new vessel growth and inflammation modulation.” – Dr. Fraser Henderson Sr., MD

“We walked together through the door of regenerative medicine,” – Thomas Smeenk, President & CEO, Hemostemix

Materiality Assessment: Material – Positive (the release provides substantive clinical efficacy and safety data, announces commercial availability with pricing, and outlines a regulatory pathway that could materially impact the company’s revenue prospects).