Mr. Thomas Smeenk reports

HEMOSTEMIX'S BOOTS ON THE GROUND IN FLORIDA

Hemostemix Inc. has launched 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, chief executive officer, and Croom Lawrence, chief commercial officer, 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 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."

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 U.S. Food and Drug Administration (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 health care providers on patient eligibility, treatment protocols and data collection (outcomes of treatments);
• Continuing 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 and vascular surgeons:

• 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-minute walk test results and generated clinical improvement in all patients.

About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell (ACP-01). A recent peer-reviewed article in Cells (June 29, 2025) provides the scientific foundation for how ACP-01 and NCP-01 may enhance brain-computer interface performance by reducing inflammation, fostering angiogenesis and synaptic plasticity, and potentially extending implant longevity. Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer-reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non-ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure and angina. Hemostemix completed its phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared with a five-year mortality rate of 50 per cent in the CLTI patient population, the University of British Columbia and University of Toronto reported to the 41st meeting of vascular surgeons: mortality of 0 per cent, cessation of pain, wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.

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