Calgary, Alberta--(Newsfile Corp. - August 26, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), an autologous (patient's own) stem cell therapy company offering VesCell (ACP-01) to individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, under Florida's SB 1768, announces the launch of its face-to-face sales program, with boots on the ground in Miami, Naples, and Tampa, Florida.
Florida's law authorizes the use of advanced cell therapies such as VesCell in patients with life-threatening or severely debilitating conditions who have exhausted standard-of-care treatment options. To drive rapid adoption, Hemostemix is executing a "boots on the ground" strategy, led by Thomas Smeenk, CEO, and Croom Lawrence, CCO, who are meeting directly with clinicians, clinic owners, and former Phase II clinical trial investigators, across the state.
"Florida is one of the most advanced U.S. jurisdictions for right-to-try and compassionate use access," said Thomas Smeenk, CEO of Hemostemix. "By putting boots on the ground, we're ensuring physicians and clinic leaders have direct engagement with our leadership team as we expand access to VesCell for patients in need."
"Our priority is building deep relationships with the clinical community, many of whom already have firsthand experience with ACP-01 from earlier trials," added Croom Lawrence, CCO. "Florida represents a significant opportunity to align world-class expertise with our mission to bring VesCell to those with no remaining treatment options."
Scientific and Clinical Results
Hemostemix has treated 498 patients and completed seven clinical studies of 318 subjects, resulting in 11 peer-reviewed publications that validate the safety and efficacy of VesCell. This evidence base is now being leveraged to establish a statewide network of treatments in participating clinics.
The Florida rollout strategy includes data collection for FDA Engagement: All Results add to the Company's safety and efficacy profile to obtain Regulatory Approval.
- Direct engagement with podiatrists, cardiologists, and vascular specialists.
- On-site meetings with former Phase II trial sites to transition trial experience into clinical adoption.
- Educational outreach to clinic owners and healthcare providers on patient eligibility, treatment protocols, and data collection (outcomes of treatments).
- Ongoing follow-ups with regulators, including the FDA, with respect to the data generated from treatment outcomes.
A New Chance to Live Better, Longer
Under Florida's Right-to-Try statute SB 1768, physicians-including podiatrists, cardiologists, vascular surgeons, and other specialists treating no-option patients-can now offer VesCell (ACP-01) to patients suffering in pain from:
- Peripheral Arterial Disease (PAD)
- Chronic Limb-Threatening Ischemia (CLTI)
- Angina
- Ischemic Cardiomyopathy
- Non-Ischemic Dilated Cardiomyopathy
- Congestive Heart Failure
- Total Body Ischemia
Clinical Results to Date
- Podiatrists & Vascular Surgeons
- In three published trials, including Phase II, VesCell generated new blood vessels, restored circulation, healed ulcers, and reduced rates of amputation.
Ulcer size in the treated group decreased from a mean of 1.46 cm2 (the size of a wild strawberry) to 0.48 mm2 (p = 0.01) (the size of a grain of sand) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54).
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/5065/263935_4dbb1d5964bbd9af_002full.jpg
- Cardiologists and Thoracic Surgeons
- In three published studies of 41, 106, and 53 subjects, respectively, VesCell was safe, and clinically relevant. It improved overall ejection fraction significantly, improved exercise capacity and quality of life.
- In the treatment of chronic stable angina (24 subjects), VesCell reduced severe angina symptoms, improved exercise capacity, improved six minutes walk test results, and generated clinical improvement in all patients.
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, VesCell (ACP-01). A recent peer-reviewed article in Cells (June 29, 2025) provides the scientific foundation for how ACP-01 and NCP-01 may enhance brain-computer interface performance by reducing inflammation, fostering angiogenesis and synaptic plasticity, and potentially extending implant longevity. 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 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 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 the Company's boots on the ground sales strategy in furtherance of sales 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/263935
SOURCE: Hemostemix Inc.
