Hemostemix Announces 10th Publication: Molecular Strategy for Heart Failure Treatment in Response to BioCardia’s Cardiamp Trial

Calgary, Alberta — In a significant stride for regenerative medicine, Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) has announced the publication of a peer-reviewed paper in the Journal of Biomedical Research and Environmental Science. Titled “Autologous Angiogenic Cell Precursors – A Molecular Strategy for the Treatment of Heart Failure: Response to BioCardia’s Cardiamp HF Trial,” the research highlights a novel cellular therapy approach for heart failure.

The study underscores a critical insight emerging from heart disease research: precision patient selection and the right type of stem cell are paramount for effective treatment, particularly for inflammatory heart conditions. While many trials employing traditional bone marrow-derived cells have fallen short, especially when administered broadly across diverse heart failure profiles, Hemostemix’s ACP-01 therapy is positioned as a differentiated solution. Its distinct molecular profile targets the core pathologies of non-ischemic dilated cardiomyopathy (DCM) – inflammation, fibrosis, and compromised blood flow.

Earlier clinical investigations by Hemostemix involving DCM patients using ACP-01 have demonstrated substantial improvements in cardiac function. Specifically, left ventricle ejection fraction (LVEF) saw an increase of up to 47.1% following a single treatment, as detailed in a November 2023 publication in Stem Cell Research & Therapy. The most dramatic enhancements were observed in patients with severe dilated cardiomyopathy, who presented with baseline LVEF levels of 20%.

Advancing Heart Failure Treatment: A Molecular Strategy

The Science Behind ACP-01: Precision Cellular Repair

ACP-01 utilizes autologous cells, harvested directly from the patient’s blood. This inherent compatibility minimizes the risk of immune rejection, a common hurdle in cell-based therapies. The therapy is rich in angiogenic cell precursors, biologically engineered to home in on damaged tissue. Once at the site of injury, these cells combat inflammation and fibrosis while promoting angiogenesis, the creation of new blood vessels to restore microcirculation.

Targeted Migration to Injury Sites

Distinguishing itself from other cell therapies, ACP-01 boasts high expression of CXCR4, a key receptor facilitating cell navigation to injured areas via the CXCL12 chemokine. This sophisticated homing mechanism ensures ACP-01 precisely targets damaged heart muscle. Furthermore, the therapy facilitates tissue repair through paracrine signaling, a crucial cellular communication process that stimulates healing in surrounding cells.

Engaging Natural Killer (NK) Cells for Inflammation and Fibrosis Reduction

Dilated cardiomyopathy is frequently characterized by excessive inflammation and fibrotic scarring within the heart muscle. ACP-01 actively counteracts these processes by producing high levels of CXCL8, a chemokine that recruits Natural Killer (NK) cells – potent immune cells that actively:

• Inhibit fibrotic activity in cardiac fibroblasts, the cells responsible for scar tissue formation.

• Prevent the accumulation of pro-inflammatory cells within the heart.

• Offer protection against viral damage, a known trigger for DCM.

Research indicates that active NK cells in the heart can significantly reduce collagen buildup, a primary component of scar tissue, and bolster anti-inflammatory signaling pathways.

Driving Angiogenesis for Enhanced Microcirculation

ACP-01 actively contributes to cardiac repair by improving the heart’s blood supply. These therapeutic cells are specifically programmed to form new blood vessels. Their high expression of VEGF and angiogenin, critical molecules in neovascularization, combined with the presence of CD34+ cells essential for vascular development, amplify the body’s natural repair mechanisms. The CXCL8 signaling further mobilizes CD34+ cells, creating a synergistic effect that boosts vascular regeneration.

Restoring healthy microcirculation is vital for shrinking infarct size and preventing the decline of function in adjacent healthy heart tissues.

ACP-01’s Differentiated Approach to DCM Treatment

Unlike therapies derived from bone marrow, ACP-01 is engineered to directly address the molecular underpinnings of DCM – chronic inflammation, fibrosis, and impaired perfusion. Its efficacy stems from a precise mechanism of action deeply rooted in its cellular composition and the patient’s own cellular communication networks. The autologous nature of ACP-01 inherently avoids immune rejection complications, ensuring greater consistency in cell survival and functional performance.

Expanding Access: Treatment for Patients in Florida

Leveraging Florida’s recent legislation that permits the use of stem cell treatments not yet fully approved by the FDA, Hemostemix is now offering its therapy to patients battling non-ischemic dilated cardiomyopathy. This initiative provides a potentially life-changing, less invasive treatment option for individuals who have exhausted conventional avenues.

“ACP-01 represents a personalized, biologically intelligent solution for the challenges posed by dilated cardiomyopathy,” stated Dr. Fraser Henderson, Chief Medical Officer at Hemostemix. “The robust expression of specific cytokines by ACP-01 cultivates a cellular environment that fosters the formation of new blood vessels and enhances blood flow, while simultaneously modulating the inflammatory response to injured heart tissue and combating scarring and fibrosis. Moreover, the receptor-driven migration of ACP-01 cells to damaged cardiac muscle promotes localized growth factor influences, preventing cardiac cell death. For DCM patients facing limited options, ACP-01 offers a promising new pathway towards regenerating heart function.”

“With ACP-01, our focus extends beyond symptom management; we are enabling the heart to rebuild itself,” commented Thomas Smeenk, CEO of Hemostemix. “This is personalized medicine in practice – safe, targeted, and grounded in rigorous scientific data.”

This news release contains “forward-looking information” as defined under applicable Canadian securities legislation. Statements of historical fact are excluded. Specifically, this release discusses the molecular composition of ACP-01, its availability in Florida through compassionate use programs under the state’s new legislation, and the path toward commercialization. There is no guarantee that these forward-looking statements will prove accurate, and actual results could materially differ. Such information reflects Hemostemix’s current beliefs, based on available data and reasonable assumptions, but is subject to known and unknown risks and uncertainties. These assumptions include, but are not limited to, Hemostemix’s value, the outcome of litigation, research results, regulatory approvals, market trends, economic conditions, consumer interest, competition, and financing availability. Risks and uncertainties may affect actual results, including clinical trial completion, analysis filings, regulatory approvals, litigation, general economic conditions, market capital, capital market conditions, board and regulatory approvals, future operations, competition, legislative changes, timing and availability of external financing, capital requirements, labor availability, and the impact of the COVID-19 pandemic. For a detailed discussion of additional risk factors, please refer to Hemostemix’s filings on the SEDAR website at www.sedarplus.ca. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, except as required by law.

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