Hemostemix to Present Its Clinical Data of the Treatment of Severe Angina

Rhea-AI Summary

Hemostemix (OTCQB: HMTXF) has announced the upcoming presentation of significant clinical data for its VesCell™ (ACP-01) therapy in treating severe angina. The study demonstrated remarkable improvements in patients with chronic stable angina who had exhausted traditional treatment options.

Key clinical findings include: 24% increase in six-minute walk distance (from 333.65 to 414.95 meters), 26% improvement in exercise capacity (from 5.62 to 7.09 METs), and a 45% reduction in heart muscle perfusion defects. The Canadian Cardiovascular Society angina score improved significantly from 2.1 to 1.05, indicating substantial pain relief.

The company plans to offer this treatment in Florida under SB 1768, using the revenue and real-world data to fund a future double-blind randomized clinical trial for global approval.

Positive

• Clinical trial showed statistically significant improvements in all key metrics
• Treatment demonstrated 45% reduction in heart muscle perfusion defects
• Therapy uses patient's own blood cells, minimizing rejection risks
• Revenue opportunity through Florida's SB 1768 treatment program

Negative

• Global approval still requires additional double-blind randomized clinical trials
• Treatment currently limited to Florida market under SB 1768

Calgary, Alberta--(Newsfile Corp. - September 16, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading 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, in Florida under Florida's SB 1768, announces that Croom Lawrence will present Hemostemix's data on the treatment of Severe Angina Pectoris at the company's weekly webinar on Thursday, September 18, 2025.

The presentation, entitled "Treatment of Patients with Severe Angina Pectoris Using Intracoronarily Injected Autologous Blood-Borne Angiogenic Cell Precursors," compares the current standard of care—described as a "slippery slope" of limited options—to published results from a clinical pilot study of VesCell™ (ACP-01, Angiogenic Cell Precursors), reported in Circulation, Volume 114, Number Suppl_18.

Study Highlights

The clinical trial evaluated the safety and efficacy of intracoronary injection of autologous Angiogenic Cell Precursors (ACPs) in patients with chronic stable angina who had exhausted maximal drug therapy. Key findings included:

• Improved Exercise Tolerance: Six-minute walk distance increased from 333.65±26.56 meters at baseline to 414.95±28.54 meters at 3 months (P<0.001) and 413.25±33.17 meters at 6 months (P<0.001).

  • Plain terms: Patients could walk about 80 more meters in six minutes after treatment—roughly the length of a football field—showing they had more stamina and less chest pain when walking a greater distance.

• Enhanced Exercise Capacity: Exercise capacity, measured in Metabolic Equivalents (METs)—a standard way of expressing how much energy the body uses during physical activity—rose from 5.62±0.52 at baseline to 6.73±0.64 at 3 months (P<0.004) and 7.09±0.79 at 6 months (P<0.04). (1 MET = sitting quietly, while higher numbers show ability to do harder activities.)

  • Plain terms: Before treatment, most patients could only handle light to moderate activity. After treatment, they were able to do activities like climbing stairs or walking uphill without much discomfort.

• Reduction in Ischemia: SPECT-MIBI perfusion defects (a measure of poor blood flow in the heart muscle) decreased from 38.46±6.19% at baseline to 23.89±5.79% at 3 months (P<0.004) and 21.05±5.16% at 6 months (P<0.005).

  • Plain terms: Scans of the heart showed that blocked or under-supplied areas were reduced by almost half, meaning blood was flowing better to the heart muscle after treatment.

• Symptom Relief: Canadian Cardiovascular Society (CCS) angina score improved from 2.1±0.19 at baseline to 1.05±0.05 at 3 months and 1.18±0.13 at 6 months (P<0.001). (The CCS scale ranks angina severity from 0 = no chest pain to 4 = severe chest pain with minimal activity or rest.)

  • Plain terms: Patients moved from having chest pain during everyday activities—like walking—to having little or no chest pain at all.

Conclusion

The study concluded that VesCell™ (ACP-01) therapy for chronic stable angina worked safely and gave patients meaningful improvements in their ability to move, exercise, and live with less chest pain.

Quote from Management

"The painful, severe angina we are treating is caused by ischemia, a condition where blood flow is restricted to the heart muscle," stated Thomas Smeenk, CEO. "The results of our study are a significant step forward because our ACP-01 therapy uses a unique approach: we harvest angiogenic stem cells from the patient's own blood. These patented cells are then able to seek out the ischemic injury, improve blood circulation, and reduce the disease's impact. The therapy is demonstrated safe, clinically relevant, and statistically significant—including a better quality of life and less chest pain. Thus, ACP-01 offers renewed hope for patients who have exhausted traditional medical options. This study is a strong foundation for our continued research and development. We are eager to move forward with a treatment of angina in Florida under SB 1768." We will use that revenue, and the data generated from real world patients' experiences tracked liked a clinical trial, to fund a double blind randomized clinical trial to get it approved for global use," Smeenk said.

Presentation Details

• Presenter: Croom Lawrence

• Title: Treatment of Patients with Severe Angina Pectoris Using Intracoronarily Injected Autologous Blood-Borne Angiogenic Cell Precursors

• Date: Thursday, September 18, 2025

• Conference Link: Click here to register.

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, 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 a webinar related to VesCell.Health and hemostemix.com in furtherance of the sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale and financing 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/266673

FAQ

What are the key results of Hemostemix's (HMTXF) VesCell therapy for angina treatment?

The therapy showed a 24% increase in walking distance, 26% improvement in exercise capacity, and 45% reduction in heart muscle perfusion defects. Patients' angina pain scores improved significantly from 2.1 to 1.05.

How does Hemostemix's VesCell (ACP-01) therapy work for angina patients?

The therapy harvests angiogenic stem cells from the patient's own blood, which are then injected intracoronarily. These cells target ischemic injury, improve blood circulation, and reduce disease impact.

When will Hemostemix present its angina treatment clinical data?

Hemostemix will present the clinical data on Thursday, September 18, 2025 during the company's weekly webinar, featuring presenter Croom Lawrence.

Where is Hemostemix's VesCell therapy currently available?

The VesCell therapy is currently available in Florida under Florida's SB 1768 legislation, while the company works toward global approval through additional clinical trials.

What are the safety results of Hemostemix's VesCell therapy for angina?

The clinical trial demonstrated that VesCell (ACP-01) therapy is safe and provides clinically relevant improvements in patient mobility and pain reduction, with statistically significant results.