Hemostemix Adds the Treatment of Refractory Angina to Its Phase 1 Basket Protocol
Hemostemix (OTCQB: HMTXF) completed a Phase 1 basket-trial protocol titled Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01) dated October 15, 2025. The multi-center, open-label, non-randomized study will enroll 20–100 adults aged 40–90 with refractory severe angina to assess feasibility and safety after intracoronary ACP-01 delivery in an outpatient catheterization setting.
Secondary endpoints include chest-pain frequency, six-minute-walk distance, QoL and Karnofsky scores, emergency-care use, LVEF, and functional class; exploratory endpoints compare one versus two treatments (Day 0 and Day 90) and analyze BNP as a predictor.
Hemostemix (OTCQB: HMTXF) ha completato un protocollo di trial di fase 1 basket intitolato Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01) datato 15 ottobre 2025. Lo studio multicentrico, in singola mascherata? open-label, non randomizzato valuterà 20–100 adulti di età compresa tra 40 e 90 anni affetti da angina refrattaria severa per valutare la fattibilità e la sicurezza dopo la somministrazione intracoronaria di ACP-01 in un contesto di cateterismo ambulatorio.
Gli endpoint secondari includono frequenza del dolore toracico, distanza percorsa in sei minuti, QoL e punteggi di Karnofsky, uso di cure d'emergenza, frazione d'eiezione (LVEF) e classe funzionale; gli endpoint esplorativi confrontano una terapia versus due terapie (Giorno 0 e Giorno 90) e analizzano BNP come predittore.
Hemostemix (OTCQB: HMTXF) ha completado un protocolo de ensayo de fase 1 tipo basket titulado Tratamiento de la angina refractaria con precursores celulares angiogénicos (ACP-01) con fecha del 15 de octubre de 2025. El estudio multicéntrico, abierto y no aleatorizado inscribirá entre 20–100 adultos de 40 a 90 años con angina refractaria severa para evaluar la viabilidad y la seguridad tras la administración intracoronaria de ACP-01 en un entorno de cateterismo ambulatorio.
Los endpoints secundarios incluyen frecuencia de dolor torácico, distancia recorrida en la prueba de caminata de seis minutos, calidad de vida (QoL) y puntuaciones de Karnofsky, uso de atención de emergencia, LVEF y clase funcional; endpoints exploratorios comparan un tratamiento frente a dos tratamientos (Día 0 y Día 90) y analizan BNP como predictor.
Hemostemix (OTCQB: HMTXF) 은 2025년 10월 15일자 ACP-01라는 제목의 1상 바스켓 시험 프로토콜을 완료했습니다. 다기관, 공개 라벨, 비무작위 연구로 40–90세의 20–100명 성인을 모집하여 난치성 심근허혈성 협심증에 대한 ACP-01의 관상동맥 내 투여 후 외래 카테터 검사 환경에서의 타당성과 안전성을 평가합니다.
보조 평가 변수에는 흉통 빈도, 6분 보행 거리, 삶의 질(QoL) 및 Karnofsky 점수, 응급의료 이용, LVEF, 기능 등급이 포함됩니다. 탐색적 종단은 한 번 치료 대 두 번 치료(Day 0 및 Day 90)를 비교하고 BNP를 예측 변수로 분석합니다.
Hemostemix (OTCQB: HMTXF) a terminé un protocole d essai de phase 1 basket intitulé Traitement de l'Angine Réfractaire avec des Précurseurs Cellulaires Angiogéniques (ACP-01) daté du 15 octobre 2025. L'étude multicentrique, ouverte et non randomisée recrutera 20–100 adultes âgés de 40 à 90 ans souffrant d'une angine réfractaire sévère afin d évaluer la faisabilité et la sécurité après administration intracoronarienne ACP-01 en milieu de cathétérisme ambulatoire.
Les critères secondaires incluent la fréquence de la douleur thoracique, la distance parcourue lors du test de marche de six minutes, la qualité de vie et les scores de Karnofsky, l'utilisation des soins d'urgence, le LVEF et la classe fonctionnelle; les critères exploratoires comparent une versus deux traitements (Jour 0 et Jour 90) et analysent le BNP comme prédicteur.
Hemostemix (OTCQB: HMTXF) hat ein Phase-1-Basket-Studienprotokoll mit dem Titel Behandlung der refraktären Angina mit angiogenen Zellvorläuferzellen (ACP-01) datiert vom 15. Oktober 2025 abgeschlossen. Die multizentrische, offene, nicht-randomisierte Studie wird 20–100 Erwachsene im Alter von 40–90 Jahren einschließen, die an refraktärer schwerer Angina leiden, um die Machbarkeit und Sicherheit nach intrakoronarer ACP-01-Verabreichung in einer ambulanten Katheterisierungsumgebung zu bewerten.
Zu den sekundären Endpunkten gehören Brustschmerzfrequenz, Distanz beim Sechs-Minuten-Gehen, QoL und Karnofsky-Scores, Notfallversorgung, LVEF und Funktionsklasse; explorative Endpunkte vergleichen eine versus zwei Behandlungen (Tag 0 und Tag 90) und analysieren BNP als Prädiktor.
Hemostemix (OTCQB: HMTXF) أتمت بروتوكول تجربة من المرحلة الأولى من نوع Basket بعنوان علاج الذبحة الصدرية المقاومة باستخدام أسلاف الخلايا التوليدية للأوعية (ACP-01) المؤرخ في 15 أكتوبر 2025. ستجري الدراسة متعددة المراكز، مفتوحة التسمية، غير عشوائية، وشاملة 20–100 بالغاً تتراوح أعمارهم بين 40 و90 عاماً مصابين بذبحة صدرية شديدة مقاومة لتقييم الجدوى والسلامة بعد إعطاء ACP-01 داخل الشريان التاجي في إطار قسطرة خارج المستشفى.
تشمل النقاط الثانوية تكرار ألم الصدر، المسافة المقطوعة في اختبارات المشي لمدة ست دقائق، جودة الحياة وتقييم Karnofsky، استخدام الرعاية الطارئة، معدل الإفراغ القلبي EF-L؟، والفئة الوظيفية؛ تقارن النقاط الاستكشافية بين علاج واحد مقابل علاجين (اليوم 0 واليوم 90) وتحلل BNP كمؤشر تنبئي.
Hemostemix (OTCQB: HMTXF) 已完成名为 治疗难治性心绞痛的血管生成细胞前体（ACP-01） 的阶段1篮子试验协议，日期为 2025 年 10 月 15 日。该多中心、开放标签、非随机研究将招募 40–90 岁之间的 20–100 名成人，患有难治性严重心绞痛，以评估在门诊导管检查环境中经冠状动脉给药 ACP-01 的可行性和安全性。
次要终点包括胸痛频率、六分钟步行距离、生活质量（QoL）和 Karnofsky 评分、急诊护理使用、左心室射血分数（LVEF）及功能等级；探索性终点比较单次治疗与两次治疗（第 0 天和第 90 天），并将 BNP 作为预测因子进行分析。
- Planned enrollment of 20–100 adults 40–90 years
- Primary endpoints explicitly set to feasibility and safety
- Delivery method intracoronary infusion in outpatient catheterization with same-day discharge
- Exploratory two-dose arm comparing Day 0 versus Day 0 and Day 90 treatments
- Early-phase design (Phase 1) focuses on safety, not definitive efficacy
- Open-label, non-randomized design limits ability to control bias and measure causal efficacy
- No quantitative efficacy data reported in the protocol (no effect sizes or powered endpoints)
Calgary, Alberta--(Newsfile Corp. - October 15, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida under Florida's SB 1768, is pleased to announce that it has completed the drafting of its clinical trial protocol titled "Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01)".
The second protocol for its basket Phase 1 clinical trial, the protocol advances Hemostemix's regenerative-cardiology program toward addressing patients who suffer persistent chest pain despite maximal medical and surgical therapy.
Plain-language summary:
Hemostemix will officially apply for ethics approval to begin a new clinical trial testing its ACP-01 stem-cell therapy in people with severe chest pain (angina) who no longer responds to standard drugs or surgery. This marks the next step in bringing a new option to patients who live with constant, disabling heart pain.
Significance of the Filing
Scientific paragraph:
Angina pectoris — chest pain from insufficient blood supply to the heart - is a major symptom of ischemic heart disease and affects roughly five percent of adults over 40 in developed countries (Rinaldi 2025; Vos 2020). Refractory angina, defined as angina that persists despite optimal therapy, causes marked reductions in quality of life and functional capacity, frequent emergency visits, and substantial healthcare costs (Fox 2020; Manolis 2019). Although one-year mortality is only about four percent, many patients live with disabling pain due to limited revascularization options. Current management focuses on symptom relief rather than cure.
Plain-language summary:
Angina happens when the heart doesn't get enough blood. For many people, medicine or bypass surgery helps, but some continue to have severe chest pain every day. These patients often cannot work, exercise, or even sleep comfortably. Hemostemix's trial targets this group, offering hope where conventional treatments have failed.
Scientific Rationale
Scientific paragraph:
ACP-01 cells, derived from a patient's own hematopoietic lineage, are programmed to form endothelial cells that release vascular endothelial growth factor (VEGF) and angiogenin, promoting new blood-vessel formation and micro-circulatory repair. The cell population is rich in CD34⁺ progenitors known to drive angiogenesis. ACP-01 expresses the CXCR4 receptor, which enables the cells to home toward CXCL12, a chemokine released by ischemic myocardium. Hemostemix's previous open-label trial in refractory angina and ischemic or dilated cardiomyopathy reported improved left-ventricular ejection fraction (LVEF), longer six-minute-walk distances, and better New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class (Chaithiraphan 2009; Arom 2008; Schubart 2023).
Plain-language summary:
ACP-01 comes from the patient's own blood. These cells naturally grow into new blood-vessel tissue and release healing proteins that improve circulation in the heart. Earlier studies showed patients could walk farther, had increased heart function as measured by the volume of blood ejected with each heart beat, and needed fewer emergency treatments after ACP-01 therapy.
Study Design and Objectives
Scientific paragraph:
This Phase 1, multi-center, open-label, non-randomized study will enroll 20 to 100 adults aged 40–90 years with recurrent or refractory severe angina. ACP-01 will be administered by intracoronary injection in an outpatient cardiac-catheterization setting. The study's primary endpoints are feasibility and safety, including incidence of adverse events. Secondary endpoints include improvement (decrease) in chest-pain frequency, increased six-minute-walk distance, increased quality-of-life (QoL) and Karnofsky performance scores, reduced need for emergency care, improved LVEF, and enhanced NYHA and CCS functional classifications. Exploratory endpoints will compare outcomes from one versus two ACP-01 treatments (Day 0 and Day 90) and analyze serum brain natriuretic peptide (BNP) levels as predictors of response.
Plain-language summary:
The trial will test whether giving ACP-01 cells directly into the heart via the arteries is safe and practical. Up to 100 men and women will take part. Doctors will look for fewer chest-pain attacks, better stamina, stronger heart function, and improved day-to-day quality of life. Some patients will get a second dose at three months to see if two treatments work better than one dose.
Mechanism of Delivery
Scientific paragraph:
ACP-01 will be infused through an intracoronary route under fluoroscopic guidance. Direct intracoronary delivery allows cells to localize precisely to ischemic territories while minimizing systemic exposure. Prior Hemostemix experience in ischemic cardiomyopathy and non ischemic dilated cardiomyopathy demonstrates the procedure's safety and feasibility in outpatient interventional settings with no procedure complications.
Plain-language summary:
Doctors will use a thin catheter—similar to an angioplasty—to place the patient's own stem cells straight into the heart's arteries. The procedure is done under local anesthesia, takes about an hour, and patients can usually go home the same day.
Safety Oversight
Scientific paragraph:
All interventions will be conducted by qualified interventional cardiologists with continuous ECG and hemodynamic monitoring. A Data Safety Monitoring Board (DSMB) will review all adverse events and procedural data. All prior ACP-01 trials have reported no serious product-related toxicities.
Plain-language summary:
The study will be closely supervised by heart specialists and an independent safety board. Every patient's heart rhythm and blood pressure will be monitored during and after the procedure to make sure the treatment is safe.
Executive Commentary
"Completing our Phase 1 refractory-angina protocol builds directly on more than two decades of real-world data showing ACP-01's ability to regrow blood vessels and restore circulation," said Thomas Smeenk, President & CEO of Hemostemix. "For patients living with daily chest pain who have no other options, this trial represents a meaningful step toward a restorative, rather than purely palliative, therapy."
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
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 completion of the Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01) Phase 1 clinical trial protocol in furtherance of 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.
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FAQ
What does Hemostemix (HMTXF) aim to test in the October 15, 2025 Phase 1 refractory angina protocol?
How many patients will Hemostemix enroll in the HMTXF refractory angina Phase 1 trial?
How is ACP-01 delivered in the HMTXF refractory angina study and where is it performed?
Will Hemostemix (HMTXF) test multiple doses in the refractory angina trial?
What are the primary endpoints for Hemostemix's HMTXF Phase 1 refractory angina protocol?
