Hemostemix talks work in Florida

Executive Summary

• Hemostemix Inc. is expanding its commercial and operational footprint in Florida to accelerate patient access to its autologous angiogenic-cell-precursor therapy, ACP-01, leveraging Florida Senate Bill 1768 (SB 1768).
• The company has deployed a dedicated field team to engage vascular surgeons and podiatrists, focusing on physician education, compliance with SB 1768, and establishing clinic partnerships for compassionate use of ACP-01 for chronic limb-threatening ischemia (CLTI).
• Upcoming activities include a grand rounds presentation at the University of Florida on November 12, 2025, and the development of patient education materials, alongside ongoing clinical trial data reviews.

Key Details

• Regulatory Framework: Expansion is driven by Florida Senate Bill 1768 (SB 1768), enacted this year, which allows licensed Florida physicians to deliver unapproved stem-cell-based therapies for pain management and wound care under specific safety, consent, and ethical safeguards.
• Product Indication: ACP-01 is an autologous angiogenic-cell-precursor therapy targeting chronic limb-threatening ischemia (CLTI), pain relief, and wound healing.
• Commercial Outreach:
  • Led by Chief Commercial Officer Croom Lawrence, a Florida-focused field team has met with dozens of vascular surgeons and podiatrists in Miami, Tampa, Orlando, Jacksonville, Naples, and Boca Raton since August.
  • Focus areas include SB 1768 education, patient screening, referral workflows, and emerging clinic partnerships.
• Physician Training:
  • Implementation of a dedicated SB 1768 curriculum training physicians on ACP-01 protocols, patient-consent standards, and monitoring (treated as an open-label phase 1 clinical trial).
  • Emphasis on scope adherence, documentation, and legal/ethical transparency.
• Clinical Trial & Research:
  • University of Florida, Gainesville, is a principal investigator site in Hemostemix's FDA-authorized randomized phase II clinical trial.
  • A grand rounds presentation on November 12, 2025, will review Phase I and II results for CLTI, ischemic/dilated cardiomyopathy, and angina.
  • The company is fielding interest for its Basket clinical trial, currently under Institutional Review Board (IRB) review.
• Operational Infrastructure:
  • Establishment of clinical liaisons to coordinate patient eligibility and regulatory documentation.
  • Development of patient and community education materials regarding regenerative options for CLTI.
  • Ongoing social media outreach and continuing webinars for physician engagement.
• Clinical Data Highlights (from About Section):
  • ACP-01 has been studied in seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed publications.
  • Midpoint results from the University of British Columbia and University of Toronto (presented to the 41st meeting of vascular surgeons) reported 0% mortality, cessation of pain, and wound healing in 83% of CLTI patients followed for up to 4.5 years, compared to a 50% five-year mortality rate in the general CLTI population.

Notable Quotes

• "SB 1768 beacons compassionate innovation, tackling pain and wounds in CLTI and similar conditions... Our Florida expansion ensures physicians can provide ACP-01 safely, effectively and ethically under state law, transforming lives while upholding regulatory integrity." — Thomas Smeenk, Chief Executive Officer