Mr. Thomas Smeenk reports
HEMOSTEMIX'S BOOTS ON THE GROUND IN FLORIDA OCTOBER UPDATE
Hemostemix Inc. has made major progress in Florida as it builds upon the success of its weekly webinar series, which, since August, has drawn strong interest from vascular surgeons statewide. These efforts mark the next phase of the company's boots-on-the-ground initiative, accelerating patient access to ACP-01, Hemostemix's autologous angiogenic-cell-precursor therapy for chronic limb-threatening ischemia (CLTI), pain relief and wound healing, under Florida Senate Bill 1768 (SB 1768).
Florida opens the door to compassionate innovation
SB 1768, enacted this year, establishes one of the most forward-looking regenerative-medicine frameworks in the United States. It empowers licensed Florida physicians to deliver unapproved stem-cell-based therapies specifically for pain management and wound care, provided safety, consent and ethical safeguards are met. For no-option CLTI patients -- those suffering severe ischemic pain and non-healing wounds at risk of amputation -- this statute provides a pathway to receive potentially limb-saving therapies such as ACP-01.
Hemostemix's approach centres on physician enablement and statutory compliance, including licensure verification, disclosure of expected outcomes, adverse-event reporting and integration with continuing clinical protocols.
"SB 1768 beacons compassionate innovation, tackling pain and wounds in CLTI and similar conditions," said Thomas Smeenk, chief executive officer of Hemostemix. "Pain defines ACP-01's indications -- from heart failure, angina and cardiomyopathy to wound care and CLTI -- while cognition defines our dementia work. Our Florida expansion ensures physicians can provide ACP-01 safely, effectively and ethically under state law, transforming lives while upholding regulatory integrity."
Grand rounds at the University of Florida -- Nov. 12, 2025
As part of its educational leadership in regenerative medicine, Hemostemix will headline a grand rounds presentation at the University of Florida in Gainesville on Nov. 12, 2025, led by Dr. Fraser Henderson, neurosurgeon.
The University of Florida, Gainesville -- a principal investigator site in Hemostemix's FDA-authorized (U.S. Food and Drug Administration) randomized phase II clinical trial -- played a key role in evaluating ACP-01 for the treatment of critical limb ischemia. This coming session will review Hemostemix's phase I and II clinical trial results across CLTI, ischemic and dilated cardiomyopathy, and angina. The event underscores the company's commitment to physician education, ethical integration of ACP-01 under SB 1768 and collaboration with Florida's medical community.
Key actions driving ACP-01 access in Florida
- Dedicated sales and outreach team: Led by chief commercial officer Croom Lawrence, Hemostemix deployed its Florida-focused field team, which has met with dozens of vascular surgeons and podiatrists in Miami, Tampa, Orlando, Jacksonville, Naples and Boca Raton since August. These sessions focus on SB 1768 education, patient screening and referral workflows, resulting in several emerging clinic partnerships.
- Physician training programs: A dedicated SB 1768 curriculum trains physicians on ACP-01's protocols for pain and wound outcomes, patient-consent standards and monitoring of patients as if they are in an open-label phase 1 clinical trial. The in-person discussions emphasize scope adherence, documentation, legal and ethical transparency.
- Compassionate-use access expansion: Under SB 1768's pain/wound provisions, Hemostemix has streamlined access for Rutherford 4-5 CLTI patients with intractable pain and wounds while fielding interest for its Basket clinical trial (now under IRB (institutional review board) review.
- Collaborative network building: Hemostemix is establishing formal ties with Florida's vascular surgeons to co-ordinate success-story documentation, adverse-event reporting and compliance tracking per SB 1768.
- Patient and community education: SB 1768-information materials are now being developed for patients exploring regenerative options. The educational content highlights ACP-01's record in pain relief and wound healing for CLTI.
Operational infrastructure and momentum
With boots on the ground, Hemostemix's Florida operations will include:
- Continuing grand rounds presentations;
- Outreach through social media to patients who suffer in pain with CLTI;
- Clinical liaisons co-ordinating patient eligibility and regulatory documentation;
- Continuing webinars and in-person sessions for physician engagement and patient education.
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 autologous (patient's own) blood-based stem-cell therapy, VesCell (ACP-01). 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 the University of Toronto reported to the 41st meeting of vascular surgeons: 0-per-cent mortality, 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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