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.

July 02, 2025 3:00 AM EDT | Source: Hemostemix Inc.

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)

  • 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. 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 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 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 QA/QC documentation and traceability.

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

Pain Reduction in Chronic Limb Threatening Ischemia (Phase II).

  • Ulcer Size Reduction: Patients treated with ACP-01 saw ulcer sizes decrease from an average of 1.46 cm² to 0.48 mm² 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% amputation rate (1/21 patients) and a 4.8% mortality rate (1/21), compared to 25% amputation (2/8) and 12.5% mortality (1/8) 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. Learn more, join our community, or enrol today at www.Vescell.Health.

Medical Contact: Croom Lawrence, CCO, clawrence@hemostemix.com, (540) 878-6754

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, 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 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 60% 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 www.hemostemix.com.

For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder

EM: tsmeenk@hemostemix.com PH: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to sales in Florida of VesCell (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and, Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at www.sedarplus.ca. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/257478

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