Hemostemix Announces its 10th Publication: A Molecular Strategy for the Treatment of Heart Failure: Response to BioCardia's Cardiamp Heart Failure Trial
Hemostemix (OTCQB: HMTXF) has published its 10th scientific paper detailing ACP-01's molecular strategy for treating heart failure, specifically focusing on non-ischemic dilated cardiomyopathy (DCM). The publication highlights how ACP-01's unique characteristics differentiate it from traditional bone marrow-derived cell therapies.
The company's previous studies demonstrated that cardiac function improved by up to 47.1% after one ACP-01 treatment in DCM patients. ACP-01's effectiveness is attributed to three key mechanisms: precise migration to injured tissue through CXCR4 expression, attraction of Natural Killer cells to reduce inflammation and fibrosis, and improved microcirculation through angiogenesis.
Following Florida's new law permitting non-FDA approved stem cell treatments, Hemostemix is now offering ACP-01 therapy to no-option DCM patients in Florida.
Hemostemix (OTCQB: HMTXF) ha pubblicato il suo decimo articolo scientifico che descrive la strategia molecolare di ACP-01 per il trattamento dell'insufficienza cardiaca, con un focus specifico sulla cardiomiopatia dilatativa non ischemica (DCM). La pubblicazione evidenzia come le caratteristiche uniche di ACP-01 lo distinguano dalle terapie cellulari tradizionali derivate dal midollo osseo.
Gli studi precedenti dell'azienda hanno dimostrato che la funzione cardiaca è migliorata fino al 47,1% dopo un singolo trattamento con ACP-01 in pazienti con DCM. L'efficacia di ACP-01 è attribuita a tre meccanismi chiave: la migrazione precisa verso i tessuti danneggiati tramite l'espressione di CXCR4, l'attrazione delle cellule Natural Killer per ridurre l'infiammazione e la fibrosi, e il miglioramento della microcircolazione attraverso l'angiogenesi.
In seguito alla nuova legge della Florida che consente trattamenti con cellule staminali non approvati dalla FDA, Hemostemix sta ora offrendo la terapia ACP-01 ai pazienti con DCM senza altre opzioni in Florida.
Hemostemix (OTCQB: HMTXF) ha publicado su décimo artículo científico detallando la estrategia molecular de ACP-01 para tratar la insuficiencia cardíaca, enfocándose específicamente en la miocardiopatía dilatada no isquémica (DCM). La publicación destaca cómo las características únicas de ACP-01 lo diferencian de las terapias celulares tradicionales derivadas de la médula ósea.
Los estudios previos de la compañía demostraron que la función cardíaca mejoró hasta un 47.1% tras un solo tratamiento con ACP-01 en pacientes con DCM. La efectividad de ACP-01 se atribuye a tres mecanismos clave: migración precisa hacia el tejido lesionado mediante la expresión de CXCR4, atracción de células Natural Killer para reducir la inflamación y fibrosis, y mejora de la microcirculación a través de la angiogénesis.
Tras la nueva ley de Florida que permite tratamientos con células madre no aprobados por la FDA, Hemostemix ahora está ofreciendo la terapia ACP-01 a pacientes con DCM sin opciones en Florida.
Hemostemix (OTCQB: HMTXF)는 심부전 치료를 위한 ACP-01의 분자 전략을 자세히 다룬 10번째 과학 논문을 발표했으며, 특히 비허혈성 확장성 심근병증(DCM)에 중점을 두었습니다. 이 출판물은 ACP-01의 독특한 특성이 기존 골수 유래 세포 치료법과 어떻게 차별화되는지를 강조합니다.
회사의 이전 연구들은 DCM 환자에서 ACP-01 단일 치료 후 심장 기능이 최대 47.1% 개선되었다고 입증했습니다. ACP-01의 효과는 세 가지 주요 메커니즘에 기인합니다: CXCR4 발현을 통한 손상된 조직으로의 정확한 이동, 염증과 섬유증을 줄이기 위한 자연 살해 세포(Natural Killer cells)의 유인, 그리고 혈관신생을 통한 미세순환 개선입니다.
플로리다주의 새로운 법률에 따라 FDA 승인받지 않은 줄기세포 치료가 허용됨에 따라 Hemostemix는 현재 플로리다에서 치료 옵션이 없는 DCM 환자들에게 ACP-01 치료를 제공하고 있습니다.
Hemostemix (OTCQB : HMTXF) a publié son dixième article scientifique détaillant la stratégie moléculaire d'ACP-01 pour le traitement de l'insuffisance cardiaque, en se concentrant spécifiquement sur la cardiomyopathie dilatée non ischémique (DCM). La publication met en avant comment les caractéristiques uniques d'ACP-01 le distinguent des thérapies cellulaires traditionnelles dérivées de la moelle osseuse.
Les études précédentes de la société ont démontré que la fonction cardiaque s'est améliorée jusqu'à 47,1 % après un traitement unique d'ACP-01 chez des patients atteints de DCM. L'efficacité d'ACP-01 est attribuée à trois mécanismes clés : une migration précise vers les tissus lésés via l'expression de CXCR4, l'attraction des cellules Natural Killer pour réduire l'inflammation et la fibrose, et une amélioration de la microcirculation par angiogenèse.
Suite à la nouvelle loi de Floride autorisant les traitements par cellules souches non approuvés par la FDA, Hemostemix propose désormais la thérapie ACP-01 aux patients atteints de DCM sans autre option en Floride.
Hemostemix (OTCQB: HMTXF) hat seine zehnte wissenschaftliche Veröffentlichung veröffentlicht, die die molekulare Strategie von ACP-01 zur Behandlung von Herzinsuffizienz beschreibt, mit besonderem Fokus auf nicht-ischämische dilatative Kardiomyopathie (DCM). Die Publikation hebt hervor, wie sich die einzigartigen Eigenschaften von ACP-01 von herkömmlichen, aus dem Knochenmark gewonnenen Zelltherapien unterscheiden.
Frühere Studien des Unternehmens zeigten, dass die Herzfunktion nach einer einzigen ACP-01-Behandlung bei DCM-Patienten um bis zu 47,1 % verbessert wurde. Die Wirksamkeit von ACP-01 wird drei wesentlichen Mechanismen zugeschrieben: präzise Migration zum verletzten Gewebe durch CXCR4-Expression, Anlocken von natürlichen Killerzellen zur Reduzierung von Entzündungen und Fibrose sowie Verbesserung der Mikrozirkulation durch Angiogenese.
Nach dem neuen Gesetz in Florida, das nicht von der FDA zugelassene Stammzelltherapien erlaubt, bietet Hemostemix nun ACP-01-Therapie für DCM-Patienten ohne weitere Optionen in Florida an.
- Previous clinical studies showed up to 47.1% improvement in cardiac function (LVEF%) after one treatment
- ACP-01 demonstrates superior targeting mechanism compared to traditional therapies
- New opportunity to treat patients in Florida under recent stem cell treatment law
- Autologous nature of treatment reduces rejection risks
- Treatment is not yet FDA approved
- Limited to Florida market under current regulations
- Success depends on individual patient cell characteristics
Calgary, Alberta--(Newsfile Corp. - July 3, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) is proud to share the Journal of Biomedical Research and Environmental Science published Autologous Angiogenic Cell Precursors-A Molecular Strategy for The Treatment of Heart Failure: Response to BioCardia's Cardiamp HF Trial.
Recent research has revealed the importance of choosing the right patients and the right type of stem cell to effectively treat inflammatory heart disease. Many traditional approaches using bone marrow-derived cells have failed in large trials, especially when applied broadly to patients with different forms of heart failure. However, Hemostemix's ACP-01 stands apart, due to its specific molecular characteristics and its ability to precisely target the root causes of non ischemic dilated cardiomyopathy (DCM): inflammation, fibrosis, and poor blood flow.
In Hemostemix' two earlier studies of DCM patients, cardiac function as measured by left ventricle ejection fraction percent (LVEF%) increased by up to
| Study/Case Series | Patient Type | Baseline LVEF | Post-ACP-01 LVEF | Time Frame | Key Outcomes |
Previous Dilated Cardiomyopathy Study Results for ACP-01
| Hemostemix Phase 1 Data | Ischemic/Non-ischemic | 18 | 35 | 3-12 months | Improved NYHA class, 6MWT |
| Compassionate Use Cases | End-stage DCM | ≤ | ↑ by 10 | 6-12 months | Reduction in CHF symptom |
A Molecular Strategy for the Treatment of Heart Failure
The Science of ACP-01: Targeted Repair at the Cellular Level
ACP-01 is made from autologous cells, taken from the patient's blood, reducing the risk of rejection or immune attack-response. ACP-01 consists of angiogenic cell precursors, which are biologically programmed to migrate to the site of injury, attract NK cells to reduce inflammation and fibrosis, and drive angiogenesis to improve microcirculation,
Migrate Precisely to Areas of Injury
Unlike other cell therapies, ACP-01 maintains high expression of CXCR4, a receptor that guides cells to injured tissue by following CXCL12 chemokine signals. This homing mechanism ensures ACP-01 migrates exactly to where the damage is occurring; and, it supports tissue repair through paracrine signaling, which is the communication between cells that stimulates healing in neighbouring cells.
Attract Natural Killer (NK) Cells to Reduce Inflammation and Fibrosis
Dilated cardiomyopathy is associated with excessive inflammation and scarring (fibrosis) of the heart muscle. ACP-01 produces high levels of CXCL8, a chemokine that attracts NK cells, a type of immune cell. NK cells help by:
Suppressing fibrotic activity in cardiac fibroblasts (the cells that produce scar tissue).
Blocking the buildup of inflammatory cells in the heart.
Protecting the heart from viral damage, a known trigger for DCM.
Scientific studies have shown that when NK cells are active in the heart, they reduce collagen buildup (a key component of scar tissue), and support anti-inflammatory signalling.
Drive Angiogenesis to Improve Microcirculation
ACP-01 helps repair the heart by improving blood supply. These cells:
Are programmed to form blood vessels
Express high levels of VEGF and angiogenin, two key molecules in the formation of new blood vessels.
Contain CD34+ cells, which are essential for organizing and guiding new vessel growth.
Mobilize more CD34+ cells through CXCL8 signaling to amplify vascular repair.
Restoring microcirculation is critical for reducing the size of the damaged heart area, and for preventing further loss of function in the surrounding healthy heart tissues.
Why ACP-01 Succeeds Where Others Fail
Unlike bone marrow-derived therapies, ACP-01 is designed specifically to address the molecular drivers of DCM-chronic inflammation, fibrosis, and poor perfusion. Its mechanism of action and precision is driven by its composition and each patient's innate cellular communication pathways. Additionally, being autologous, ACP-01 avoids the complications of immune rejection, and it improves the consistency of cell survival and function.
Next Step: Treatment of nao-option patients in Florida
Building on Florida's new law that permits the use of non FDA approved stem cell treatments and Hemostemix's scientific findings, the Company is offering its therapy to patients with non-ischemic dilated cardiomyopathy, offering a life-changing, less invasive solution.
"ACP-01 is a personalized, biologically intelligent solution for the problem of dilated cardiomyopathy," said Dr. Fraser Henderson, CMO, Hemostemix. " Robust expression of specific cytokines by ACP create a cellular mileau that increases blood vessel formation and blood flow, while modulating inflammatory response to injured heart, countering scar and fibrosis. Moreover, receptor driven migration of ACP-01 cells to injured heart muscle promote local growth factor influences, preventing cardiac cell death. DCM patients who have run out of options now have a new path forward to regenerate heart function."
"With ACP-01, we're not just treating symptoms- it rebuilds the heart itself," said Thomas Smeenk, CEO of Hemostemix. "This is personalized medicine in action that is safe, targeted, and rooted in real science."
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 molecular composition of ACP-01, 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
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