Hemostemix begins face-to-face sales program in Florida

Executive Summary

• Hemostemix Inc. has launched a direct-to-clinician sales program ("boots on the ground") in Florida, targeting Miami, Naples, and Tampa, to drive adoption of its autologous stem cell therapy, VesCell (ACP-01).
• The initiative leverages Florida’s right-to-try statute (SB 1768) to allow physicians to treat patients with life-threatening conditions who have exhausted standard care options.
• The company is leveraging data from 498 treated patients and seven completed clinical studies to build a statewide network of participating clinics and gather data for future FDA engagement.

Key Details

• Commercial Strategy: Launch of face-to-face sales program led by CEO Thomas Smeenk and CCO Croom Lawrence.
• Target Audience: Clinicians, clinic owners, and former Phase II clinical trial investigators in Florida.
• Regulatory Context: Utilization of Florida’s right-to-try statute (SB 1768) for compassionate use access.
• Clinical Evidence Base:
  • 498 patients treated to date.
  • Seven clinical studies completed involving 318 subjects.
  • 11 peer-reviewed publications validating safety and efficacy.
• Targeted Indications under Florida Law:
  • Peripheral arterial disease (PAD)
  • Chronic limb-threatening ischemia (CLTI)
  • Angina
  • Ischemic cardiomyopathy
  • Non-ischemic dilated cardiomyopathy
  • Congestive heart failure
  • Total body ischemia
• Specific Clinical Results Cited:
  • Podiatry/Vascular: In three published trials (including Phase II), VesCell generated new blood vessels, restored circulation, healed ulcers, and reduced amputation rates.
  • Cardiology: In studies of 41, 106, and 53 subjects, VesCell was safe and clinically relevant, improving ejection fraction, exercise capacity, and quality of life.
  • Angina: In a study of 24 subjects with chronic stable angina, VesCell reduced severe symptoms, improved exercise capacity, improved six-minute walk test results, and generated clinical improvement in all patients.
  • CLTI Mortality Data: University of British Columbia and University of Toronto reported 0% mortality (compared to 50% five-year mortality in general population), cessation of pain, and wound healing in 83% of patients followed for up to 4.5 years.
• Future Regulatory Path: Data collection from the Florida rollout is intended to support engagement with the U.S. Food and Drug Administration (FDA) for regulatory approval.

Notable Quotes

• "Florida is one of the most advanced U.S. jurisdictions for right-to-try and compassionate use access," said Mr. Smeenk. "By putting boots on the ground, we're ensuring physicians and clinic leaders have direct engagement with our leadership team as we expand access to VesCell for patients in need."
• "Our priority is building deep relationships with the clinical community, many of whom already have first-hand experience with ACP-01 from earlier trials," added Mr. Lawrence. "Florida represents a significant opportunity to align world-class expertise with our mission to bring VesCell to those with no remaining treatment options."