Mr. Thomas Smeenk reports

HEMOSTEMIX'S VESCELL SALES ARE LEGAL IN FLORIDA AS IT PIVOTS TO ALLOW NON-FDA APPROVED STEM CELL TREATMENTS!

Hemostemix Inc. says Florida Senate Bill 1768 officially become law on July 1, 2025, which enables the commercial sales of VesCell (ACP-01) in the state of Florida.

The company is on track to offer first commercial treatments by the fourth quarter of 2025, and now projects sales of $22.5-million in 2026 with the ability to outperform the forecast by continuing to sell forward its therapy convertible debentures (TCDs), offer payment plans and offer financial assistance to economically disadvantaged individuals.

Florida SB 1768 affirms the right of patients and their physicians to access autologous stem cell therapies that are not yet approved by the United States Food and Drug Administration, provided patients give informed consent and physicians disclose the investigational nature of the treatment.

Under the new law, licensed Florida physicians may administer VesCell to treat pain associated with conditions of ischemia, including:

• Peripheral arterial disease (PAD);
• Chronic limb-threatening ischemia (CLTI);
• Angina;
• Congestive heart failure;
• Ischemic and non-ischemic dilated cardiomyopathy;
• Peripheral neuropathy related to total-body ischemia.

"This landmark legislation makes Florida the most progressive state in the USA for regenerative medicine," said Thomas Smeenk, chief executive officer of Hemostemix. "We are proud to provide VesCell as a proven therapy that restores microcirculation, reduces ischemic pain and improves patient function. We will continue to sell TCDs forward. Very soon, we will offer payment plans and financial assistance to economically disadvantaged individuals. We will put significant emphasis on following each patient to collect the data to fast-track FDA approval, as we comply with all aspects of the law and regulatory environment."

Legal compliance requirements

To comply with Florida SB 1768:

• Physicians must provide patients with a state-mandated disclosure notice that VesCell is not FDA-approved.
• Patients must sign an informed consent form acknowledging the investigational nature of the therapy.
• The treatment must be performed in licensed medical facilities under the supervision of a physician.

ACP-01 is produced at a GMP-certified (good manufacturing practices) and FDA-audited facility, a legal requirement, using a patented process to isolate, expand and formulate angiogenic cell precursors from the patient's blood. The therapy is returned to the treating physician in sterile, ready-to-use syringes, in temperature-controlled packaging with full quality assurance/quality control documentation and traceability.

"With 498 patients treated to date and published results demonstrating safety [and] improvement in cardiac function, mobility and pain reduction, ACP-01 is positioned to be the No. 1 therapy for patients with no other treatment options," chief commercialization officer Croom Lawrence stated.

Pain reduction in chronic limb-threatening ischemia (phase 2):

• Ulcer size reduction -- Patients treated with ACP-01 saw ulcer sizes decrease from an average of 1.46 square centimetres to 0.48 square millimetre within three months, with a statistically significant P value of 0.01. The placebo group showed no significant change.
• Amputation and mortality rates -- At one year, the ACP-01 group had a 4.8-per-cent amputation rate (one in 21 patients) and a 4.8-per-cent mortality rate (one in 21), compared with 25-per-cent amputation (two in eight) and 12.5-per-cent mortality (one in eight) in the placebo group.
• Safety profile -- No treatment-related complications were reported, reinforcing the therapy's safety alongside its efficacy.

Hemostemix is championing Florida's progressive stance to anchor U.S. clinical strategy.

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 and patented, and is scaling and selling, an autologous (patient's own) blood-based stem cell therapy: ACP-01. Hemostemix has completed seven clinical studies of 318 subjects and published its results in nine 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 2 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 60 per cent in the CLTI patient population, the University of British Columbia and the University of Toronto reported to the 41st meeting of vascular surgeons 0-per-cent mortality, cessation of pain, and wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.

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