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Hemostemix to Sell VesCell (ACP-01) in Florida After Senate Bill 1768 Becomes Law
Calgary, Alberta - July 2, 2025 - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), a biotechnology company specializing in autologous stem cell therapies for cardiovascular diseases, has announced that Florida Senate Bill 1768 is now law, effective July 1. This legislation allows for the commercial sale of VesCell (ACP-01) in Florida.
The company plans to offer its first commercial treatments by Q4 2025 and projects sales of $22.5 million in 2026. Hemostemix aims to exceed this forecast by continuing to sell therapy convertible debentures (tcds), offering payment plans, and providing financial assistance to economically disadvantaged individuals.Florida SB 1768 protects the rights of patients and their physicians to access autologous stem cell therapies that have not yet received FDA approval, provided that patients give informed consent and physicians disclose the investigational nature of the treatment.
Under the new law, licensed Florida physicians can administer ACP-01 (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 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 and soon offer payment plans and financial assistance to those in need. We will emphasize following each patient to collect data to fast-track FDA approval, while complying with all aspects of the law and regulatory surroundings."
to comply with Florida SB 1768, physicians must provide patients with a state-mandated disclosure notice that VesCell is not FDA-approved, and patients must sign an informed consent form. The treatment must be performed in licensed medical facilities under the supervision of a physician.
ACP-01 is produced at a GMP-certified and FDA-audited facility 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 QA/QC documentation and traceability.
Clinical data from a Phase II trial on Chronic Limb Threatening Ischemia showed promising results:
Ulcer Size Reduction: Patients treated with ACP-01 experienced a reduction in ulcer sizes from an average of 1.46 cm to 0.48 mm within three months (p=0.01).
Amputation and Mortality Rates: At one year, the ACP-01 group had a 4.8% amputation rate and a 4.8% mortality rate, compared to 25% amputation and 12.5% mortality in the placebo group.
Safety Profile: No treatment-related complications were reported.
Hemostemix is focusing on Florida to anchor its U.S. clinical strategy.
About Hemostemix
Hemostemix is an autologous stem cell therapy platform company founded in 2003.The company has developed, patented, and is scaling and selling its autologous 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.
For more data, visit www.hemostemix.com.
Medical Contact:
Croom Lawrence, CCO, clawrence@hemostemix.com, (540) 878-6754
Neither the TSX Venture Exchange nor its Regulation Service Provider accepts responsibility for the adequacy or accuracy of this release.*
Forward-Looking Information
This news release contains forward-looking information subject to risks and uncertainties. Actual results may differ materially from those anticipated.
