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 47.1% following one treatment (Stem Cell Research & Therapy, November 2023), with the most marked improvements observed in patients with severe dilated cardiomyopathy (LVEF% < 20%).
| 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 | 18-25% | 35-45% | 3-12 months | Improved NYHA class, 6MWT |
| Compassionate Use Cases | End-stage DCM | <=20% | by 10-25% points | 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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SOURCE: Hemostemix Inc.
