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Hemostemix's VesCell Sales are Legal in Florida as it Pivots to Allow Non-FDA Approved Stem Cell Treatments!
Florida SB 1768 Becomes Law: Hemostemix Inc. Begins Commercial Offering of ACP-01 (VesCell) for I...
About this update from Hemostemix Inc
[{"type":"text","content":"Hemostemix's VesCell Sales are Legal in Florida as it Pivots to Allow Non-FDA Approved Stem Cell Treatments!Florida SB 1768 Becomes Law: Hemostemix Inc. Begins Commercial Offering of ACP-01 (VesCell) for Ischemic Pain Treatments in Florida.Calgary, Alberta--(Newsfile Corp. - July 2, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), a clinical-stage biotechnology company focused on autologous stem cell therapies for cardiovascular diseases, is pleased to announce that Florida Senate Bill 1768 has officially become law on July 1, 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 Q4 2025 and now projects sales of $22,500,000 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 FDA-approved, provided patients give informed consent and physicians disclose the investigational nature of the treatment.Under the new law, licensed Florida physicians may administer ACP-01 (VesCell) to treat pain associated with conditions of ischemia, including:Peripheral Arterial Disease (PAD)Chronic Limb Threatening Ischemia (CLTI)AnginaCongestive Heart FailureIschemic and Non-Ischemic Dilated CardiomyopathyPeripheral Neuropathy related to Total Body Ischemia\"This landmark legislation makes Florida the most progressive state in the U.S.A. for regenerative medicine,\" said Thomas Smeenk, CEO of Hemostemix Inc. \"We are proud to provide VesCell (ACP-01), 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,\" Smeenk said.Legal Compliance RequirementsTo comply with Florida SB 1768:Physicians must provide patients with a state-mandated disclosure notice that VesCell is not FDA-approved.Patients must ...