Hemostemix’s Boots on the Ground in Florida

Calgary, Alberta – August 26, 2025 – Hemostemix Inc. (TSX-V: HEM; OTCQB: HMTXF; FSE: 2VF0), an autologous (patient’s own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, under Florida’s SB 1768, announces the launch of its face-to-face sales program, with boots on the ground in Miami, Naples, and Tampa, Florida.
Florida’s law authorizes the use of advanced cell therapies such as VesCell™ in patients with life-threatening or severely debilitating conditions who have exhausted standard-of-care treatment options. To drive rapid adoption, Hemostemix is executing a “boots on the ground” strategy, led by Thomas Smeenk, CEO, and Croom Lawrence, CCO, who are meeting directly with clinicians, clinic owners, and former Phase II clinical trial investigators, across the state.
“Florida is one of the most advanced U.S. jurisdictions for right-to-try and compassionate use access,” said Thomas Smeenk, CEO of Hemostemix. “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 firsthand experience with ACP-01 from earlier trials,” added Croom Lawrence, CCO. “Florida represents a significant opportunity to align world-class expertise with our mission to bring VesCell™ to those with no remaining treatment options.”
Scientific and Clinical Results
Hemostemix has treated 498 patients and completed seven clinical studies of 318 subjects, resulting in 11 peer-reviewed publications that validate the safety and efficacy of VesCell™. This evidence base is now being leveraged to establish a statewide network of treatments in participating clinics.
The Florida rollout strategy includes data collection for FDA Engagement: All Results add to the Company’s safety and efficacy profile to obtain Regulatory Approval.
-
Direct engagement with podiatrists, cardiologists, and vascular specialists.
-
On-site meetings with former Phase II trial sites to transition trial experience into clinical adoption.
-
Educational outreach to clinic owners and healthcare providers on patient eligibility, treatment protocols, and data collection (outcomes of treatments).
-
Ongoing follow-ups with regulators, including the FDA, with respect to the data generated from treatment outcomes.
A New Chance to Live Better, Longer
Under Florida’s Right-to-Try statute SB 1768, physicians—including podiatrists, cardiologists, vascular surgeons, and other specialists treating no-option patients—can now offer VesCell™ (ACP-01) to patients suffering in pain from:
-
Peripheral Arterial Disease (PAD)
-
Chronic Limb-Threatening Ischemia (CLTI)
-
Angina
-
Ischemic Cardiomyopathy
-
Non-Ischemic Dilated Cardiomyopathy
-
Congestive Heart Failure
-
Total Body Ischemia
Clinical Results to Date
-
Podiatrists & Vascular Surgeons
Ulcer size in the treated group decreased from a mean of 1.46 cm2 (the size of a wild strawberry) to 0.48 mm2 (p = 0.01) (the size of a grain of sand) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54).
-
In three published trials, including Phase II, VesCell™ generated new blood vessels, restored circulation, healed ulcers, and reduced rates of amputation.
-
Cardiologists and Thoracic Surgeons
-
In three published studies of 41, 106, and 53 subjects, respectively, VesCell™was safe, and clinically relevant. It improved overall ejection fraction significantly, improved exercise capacity and quality of life.
-
In the treatment of chronic stable angina (24 subjects), VesCell™reduced severe angina symptoms, improved exercise capacity, improved six minutes walk test results, and generated clinical improvement in all patients.
-