Hemostemix's Boots On The Ground In Florida October Update
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 centers on physician enablement and statutory compliance, including licensure verification, disclosure of expected outcomes, adverse-event reporting, and integration with ongoing clinical protocols.
"SB 1768 beacons compassionate innovation, tackling pain and wounds in CLTI and similar conditions," said Thomas Smeenk, CEO 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 - November 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 November 12, 2025, led by Dr. Fraser Henderson Sr., Neurosurgeon.
The University of Florida, Gainesville - a principal investigator site in Hemostemix's FDA-authorized randomized phase II clinical trial - played a key role in evaluating ACP-01 for the treatment of critical limb ischemia. This upcoming 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 TeamLed by Chief Commercial Officer Croom Lawrence, Hemostemix deployed its Florida-focused field team that has met with dozens of vascular surgeons, and podiatrists, in Miami, Tampa, Orlando, Jacksonville, Naples, 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 review. Collaborative Network Building
Hemostemix is establishing formal ties with Florida's vascular surgeons to coordinate 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 track record in pain relief and wound healing for CLTI.
Operational Infrastructure and Momentum
With boots on the ground, Hemostemix's Florida operations will include:
- Ongoing grand rounds presentations.
Outreach via social media to patients who suffer in pain with CLTI. Clinical liaisons coordinating patient eligibility and regulatory documentation.
Ongoing webinars and in-person sessions for physician engagement and patient education.
ABOUT HEMOSTEMIX
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, VesCellTM (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven 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 to a five year mortality rate of 50% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit .
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