Session led by neurosurgeon Dr. Fraser Henderson and Hemostemix CEO Thomas Smeenk for the University of Florida’s Department of Surgery, Division of Vascular Surgery & Endovascular Therapy (Gainesville)
Calgary, Alberta--(Newsfile Corp. - November 13, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) today announced key highlights from its November 12, 2025 Grand Rounds presentation (to the University of Florida (UF, Gainesville) vascular team. The session, titled "Angiogenic Cell Precursors (ACP-01): Regenerating Microcirculation in CLI, Cardiomyopathy and Angina," was delivered by Fraser Henderson Sr., MD (neurosurgeon) with opening remarks and policy/operations updates from Thomas Smeenk, President & CEO.
Cannot view this video? Visit:
https://www.youtube.com/watch?v=yXog6bDxpKg
Attendees included UF vascular faculty and trainees and external clinicians, among them David Alper, DPM (Boston) and Kristina Giles (MaineHealth; formerly the UF ACP-01 trial coordinator). The discussion focused on clinical outcomes, safety, Florida's treatment pathway (SB 1768), and operational readiness to accept patients.
Session Highlights
1) Safety Profile Across >498 Treated Patients
2) Cardiovascular Efficacy Signals (Cardiomyopathy & Angina)
By allowing Hemostemix to present our clinical outcomes, mechanism of action, production-to-procedure timeline, regulatory pathway, and business model to twelve specialists in forty minutes, we quite literally walked together through the door of regenerative medicine together.
Once again, my heartfelt thanks to Dr. Shah and the Department of Surgery, Division of Vascular Surgery & Endovascular Therapy in Gainesville for their collaboration and commitment to improving patients quality of life," Smeenk said.
3) CLTI (Chronic Limb-Threatening Ischemia): Limb Salvage - Wound Healing
ACP-01 (Angiogenic Cell Precursors) is a patient-derived, blood-based cell therapy programmed to form endothelial cells, secrete VEGF and angiogenin, and home to ischemic tissue via chemokine receptor pathways (e.g., CXCR4-CXCL12). The cell population is enriched in CD34⁺ cells and is engineered to promote angiogenesis and modulate inflammation (e.g., M2 macrophage polarization), supporting tissue repair in CLTI, cardiomyopathy, angina, and related disease-based signalling pathways.
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). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven 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 treatment of CLTI, and related financing of the Company related to treatment of CLTI in Florida, and the completion of the treatment of pain related to angina, peripheral arterial disease, chronic limb threatening ischemia (CLTI), ischemic ,cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) 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/274352
Cannot view this video? Visit:
https://www.youtube.com/watch?v=yXog6bDxpKg
Attendees included UF vascular faculty and trainees and external clinicians, among them David Alper, DPM (Boston) and Kristina Giles (MaineHealth; formerly the UF ACP-01 trial coordinator). The discussion focused on clinical outcomes, safety, Florida's treatment pathway (SB 1768), and operational readiness to accept patients.
Session Highlights
1) Safety Profile Across >498 Treated Patients
- ACP-01 is autologous (patient-derived) and harvested via simple blood draw.
- No cell-related complications reported across more than 498 treated patients; ~300 are in peer-reviewed publications.
- Noted events in historical programs: one MI-unrelated death in an ineligible subject with a prior silent MI; two tachyarrhythmias responsive to cardioversion.
2) Cardiovascular Efficacy Signals (Cardiomyopathy & Angina)
- Ischemic & Dilated Non-Ischemic Cardiomyopathy: Multiple cohorts demonstrated a ~5% absolute LVEF increase, translating to ~16-47% improvement in cardiac function depending on subtype; +126 m in 6-minute walk; improvements in NYHA class.
- Angina (historical VesCell™/ACP-01 studies): Significant gains in 6-minute walk, exercise capacity (METs), perfusion by SPECT-MIBI, and CCS angina class at 3-6 months.
By allowing Hemostemix to present our clinical outcomes, mechanism of action, production-to-procedure timeline, regulatory pathway, and business model to twelve specialists in forty minutes, we quite literally walked together through the door of regenerative medicine together.
Once again, my heartfelt thanks to Dr. Shah and the Department of Surgery, Division of Vascular Surgery & Endovascular Therapy in Gainesville for their collaboration and commitment to improving patients quality of life," Smeenk said.
3) CLTI (Chronic Limb-Threatening Ischemia): Limb Salvage - Wound Healing
- In no-option CLTI populations, ACP-01 was associated with marked reductions in amputation and death over 12 months. In one dataset discussed, the combined amputation/death rate was ~5% in the ACP subgroup versus ~40% 1-year post-amputation mortality.
- Wound-presenting patients showed particularly strong responses with significant healing versus placebo.
- Given Medicare-reported burdens (10-40% 6-month amputation, ~40% 1-year post-amputation mortality, and per-patient annual costs of ~$120,000 for diabetics), the team emphasized urgent unmet need and economic rationale.
- Under Florida SB 1768 (effective July 1, 2025), physicians may offer autologous stem-cell therapies for pain within their scope of practice, with informed consent and cGMP manufacturing that is regulated by the FDA.
- ACP-01 is now available in Florida outside of trials; the current therapy price is US$37,000 (exclusive of physician/clinic fees).
- Every Florida procedure will be conducted under IRB oversight, creating high-quality real-world evidence to complement IND studies.
- A 501(c)(3) organized by Dr. Henderson will help economically disadvantaged patients access treatment.
- Day 0: Blood draw → ship to Hemostemix cGMP facility.
- Days 1-5: Ex-vivo expansion to ACP-01.
- Day 6: Quality control & shipment back.
- Day 7: Local intramuscular injections (about 30 × 1 cc), typically into the gastrocnemius, under local anesthesia with light sedation and ultrasound guidance.
- Scheduling treatments in Florida and The Bahamas, which permit ACP-01.
- Basket Phase 1 Program (Bahamas): Four of seven protocols included in the basket are completed, and are in the process of being submitted to IRBs;
- The open-label design supports 12-month follow-up and fuels later-phase studies.
- Stakeholder Materials: Hemostemix is circulating a concise program brief (mechanism + trial plan) to UF and collaborating clinicians for site onboarding.
ACP-01 (Angiogenic Cell Precursors) is a patient-derived, blood-based cell therapy programmed to form endothelial cells, secrete VEGF and angiogenin, and home to ischemic tissue via chemokine receptor pathways (e.g., CXCR4-CXCL12). The cell population is enriched in CD34⁺ cells and is engineered to promote angiogenesis and modulate inflammation (e.g., M2 macrophage polarization), supporting tissue repair in CLTI, cardiomyopathy, angina, and related disease-based signalling pathways.
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). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven 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 treatment of CLTI, and related financing of the Company related to treatment of CLTI in Florida, and the completion of the treatment of pain related to angina, peripheral arterial disease, chronic limb threatening ischemia (CLTI), ischemic ,cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) 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/274352
