Hemostemix's Boots on the Ground in Florida October Update

Executive Summary

• Hemostemix announced major progress in Florida by leveraging the newly enacted Senate Bill 1768 to provide its autologous stem‑cell therapy (ACP‑01) to no‑option CLTI patients under a compassionate‑use framework.
• The company will conduct a Grand Rounds presentation at the University of Florida on November 12, 2025 and has deployed a dedicated sales and outreach team across major Florida markets to educate physicians and establish clinic partnerships.
• Hemostemix is implementing physician training programs, patient education materials, and compliance tracking to ensure ethical delivery of ACP‑01 in accordance with SB 1768.

Key Details

• Regulatory Framework: Florida Senate Bill 1768 (SB 1768) permits licensed physicians to administer unapproved stem‑cell therapies for pain management and wound care when safety, consent, and reporting safeguards are met.
• Therapy Offered: ACP‑01 (VesCell™), an autologous angiogenic‑cell‑precursor therapy targeting chronic limb‑threatening ischemia (CLTI), pain relief, and wound healing.
• Leadership Quote: “SB 1768 beacons compassionate innovation… our Florida expansion ensures physicians can provide ACP‑01 safely, effectively, and ethically under state law,” – Thomas Smeenk, CEO.
• Grand Rounds Event: University of Florida, Gainesville – November 12, 2025; presentation led by Dr. Fraser Henderson Sr., Neurosurgeon, reviewing Phase I/II trial results across CLTI, cardiomyopathy, and angina.
• Field Team Deployment: Chief Commercial Officer Croom Lawrence leads a Florida‑focused team that has met with vascular surgeons and podiatrists in Miami, Tampa, Orlando, Jacksonville, Naples, and Boca Raton since August 2025.
• Physician Training Program: Curriculum covering ACP‑01 protocols, patient consent standards, adverse‑event reporting, and documentation as if conducting an open‑label Phase I trial.
• Compassionate‑Use Access: Streamlined pathway for Rutherford 4‑5 CLTI patients with intractable pain/wounds; interest generated for the Basket clinical trial currently under IRB review.
• Collaborative Network Building: Formal ties being established with Florida vascular surgeons to coordinate success‑story documentation, adverse‑event reporting, and compliance tracking per SB 1768.
• Patient & Community Education: Development of SB 1768 informational materials for patients exploring regenerative options, highlighting ACP‑01’s track record in pain relief and wound healing.

Notable Quotes

“SB 1768 beacons compassionate innovation, tackling pain and wounds in CLTI and similar conditions,” – Thomas Smeenk, CEO, Hemostemix.