Hemostemix Inc. has begun commercial sales of its autologous stem cell therapy VesCell (ACP-01) in Florida following the enactment of Senate Bill 1768, which became law on July 1, 2025. The legislation enables patients and physicians to access non-FDA approved autologous stem cell therapies with informed consent, making Florida the most progressive state in the U.S. for regenerative medicine according to company CEO Thomas Smeenk.
The Calgary-based biotechnology company projects $22.5 million in sales for 2026 and plans to offer first commercial treatments by Q4 2025. The company aims to outperform this forecast through therapy convertible debentures (TCDs), payment plans, and financial assistance for economically disadvantaged individuals.
Clinical Evidence and Patient Population
ACP-01 targets pain associated with ischemic conditions, including peripheral arterial disease (PAD), chronic limb threatening ischemia (CLTI), angina, congestive heart failure, ischemic and non-ischemic dilated cardiomyopathy, and peripheral neuropathy related to total body ischemia.
The therapy has demonstrated significant clinical benefits in Phase II trials for chronic limb threatening ischemia. Patients treated with ACP-01 experienced ulcer size reduction from an average of 1.46 cm² to 0.48 mm² within three months, with a statistically significant p-value of 0.01, while the placebo group showed no significant change.
At one year follow-up, the ACP-01 group achieved a 4.8% amputation rate (1/21 patients) and 4.8% mortality rate (1/21), compared to 25% amputation (2/8) and 12.5% mortality (1/8) in the placebo group. No treatment-related complications were reported across the study population.
Safety Profile and Clinical Experience
Hemostemix has treated 498 patients to date across seven clinical studies involving 318 subjects, with results published in nine peer-reviewed publications. The company reports published results demonstrating safety, improvement in cardiac function, mobility, and pain reduction.
According to data presented to the 41st meeting of vascular surgeons by UBC and University of Toronto researchers, patients followed for up to 4.5 years showed 0% mortality, cessation of pain, and wound healing in 83% of patients, compared to a typical five-year mortality rate of 60% in the CLTI patient population.
Regulatory Compliance and Manufacturing
Under Florida SB 1768, physicians must provide patients with a state-mandated disclosure notice that VesCell is not FDA-approved, and patients must sign informed consent acknowledging the investigational nature of the therapy. Treatments must be performed in licensed medical facilities under physician supervision.
ACP-01 is produced at a GMP-certified and FDA-audited facility using a patented process to isolate, expand, and formulate angiogenic cell precursors from the patient's blood. The therapy is delivered to treating physicians in sterile ready-to-use syringes with temperature-controlled packaging and full quality assurance documentation.
Company Background and Future Strategy
Founded in 2003, Hemostemix is a World Economic Forum Technology Pioneer Award winner that has developed and patented autologous blood-based stem cell therapy. The company completed its Phase II clinical trial for chronic limb threatening ischemia and published results in the Journal of Biomedical Research & Environmental Science.
Chief Commercial Officer Croom Lawrence stated that "with 498 patients treated to-date and published results demonstrating safety, improvement in cardiac function, mobility, and pain reduction, ACP-01 is positioned to be the #1 therapy for patients with no other treatment options."
The company plans to emphasize patient follow-up data collection to fast-track FDA approval while complying with all aspects of the law and regulatory environment. Hemostemix is using Florida's progressive stance to anchor its U.S. clinical strategy as it scales its autologous stem cell therapy platform.
