Tissue Dynamics and Galmed Partner to Develop Novel Cardiac Fibrosis Platform Using Human Organoids and AI
核心洞察
Tissue Dynamics (搜索) and Galmed Pharmaceuticals announced a collaboration to develop a human-centered chronic cardiac fibrosis (搜索) model using vascularized cardiac organoids with embedded sensors to advance Aramchol-based therapeutics.
The platform will focus on chronic post-myocardial infarction (搜索) remodeling and heart failure with preserved ejection fraction (搜索), targeting the SCD1 (搜索) enzyme pathway that links lipid metabolism to cardiac fibrosis (搜索).
The DynamiX® platform can test over 20,000 human organoids in parallel with real-time monitoring, addressing the lack of effective models for chronic cardiac fibrosis (搜索) research.
Tissue Dynamics (搜索) Ltd. and Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced a collaboration to develop a novel human chronic cardiac fibrosis (搜索) model designed to accelerate the discovery and development of new Aramchol-based therapeutic approaches for complex fibrotic heart diseases. The partnership addresses a critical unmet medical need, as cardiovascular disease (搜索) remains the leading cause of death globally, responsible for an estimated 20.5 million deaths in 2025, with no approved therapies that directly and durably reverse cardiac fibrosis.
Targeting Metabolic Dysfunction in Cardiac Fibrosis
Cardiac fibrosis (搜索) is a major driver of chronic heart failure (搜索), including long-term remodeling after myocardial infarction (搜索) (MI) and heart failure with preserved ejection fraction (搜索) (HFpEF). The disease is increasingly understood as a failure of tissue repair rooted in metabolic dysfunction, where disturbed lipid uptake, oxidation, storage, and signaling can drive lipotoxicity, mitochondrial dysfunction, inflammation, fibroblast activation, and impaired regenerative remodeling.
The collaboration focuses on SCD1 (搜索), a key enzyme controlling monounsaturated fatty-acid synthesis and membrane-lipid composition that sits at the center of this biology. Studies have shown SCD1 upregulation in experimental heart failure (搜索) and linked cardiac SCD activity to lipid overload, collagen gene expression, hypertrophy, and cardiac dysfunction, while SCD also influences angiogenesis and energy metabolism in the hypoxic myocardium after myocardial infarction (搜索).
Advanced Human Organoid Platform
The partnership will combine Tissue Dynamics (搜索)' highly physiological vascularized, multichambered cardiac organoids with embedded metabolic sensors, massive automation, and continuous real-time monitoring. Tissue Dynamics' DynamiX® platform is designed to test more than 20,000 human organoids in parallel, capturing real-time functional kinetics through embedded metabolic sensors and generating longitudinal human-relevant data across metabolism, fibrosis, electrical conduction, inflammatory signaling, lipid handling, and stress pathways.
A central obstacle in cardiac fibrosis (搜索) research has been the lack of models capable of reproducing chronic, multicellular, mechanically active, metabolically dynamic human disease. Animal models and short-term in vitro assays often fail to capture the long-term transition from injury response to persistent fibrosis, particularly in diseases such as MI and HFpEF where human metabolism, vascular function, inflammation, and tissue mechanics interact over time.
Regulatory Support for Human-Relevant Models
Regulators are now explicitly encouraging more human-relevant approaches. The U.S. Food and Drug Administration (FDA) has described a 'transformative shift' toward advanced human-relevant methods, including AI-powered models and human organ-on-chip systems, and has stated that New Approach Methodologies (NAMs) can improve predictivity, identify mechanisms of action, and support safer clinical development. The FDA has also announced plans to promote human organoids and organ-on-chip systems that mimic human organs, including heart models, while the EMA supports regulatory acceptance of scientifically sound NAMs and provides interaction routes for developers through its Innovation Task Force.
Therapeutic Development Strategy
In the new cardiac fibrosis (搜索) program, the companies intend to apply Galmed's expertise in SCD1 (搜索) biology and metabolic-pathway modulation to human cardiac disease settings where lipid imbalance may impair vascular repair, cardiomyocyte function, fibroblast behavior, and extracellular-matrix remodeling. By monitoring thousands of organoids over time and applying AI-driven analysis to functional, metabolic, structural, and molecular endpoints, the model is expected to support rapid evaluation of Aramchol-based candidates, combinations, dosing strategies, and disease-stage-specific interventions.
"We believe that combining Tissue Dynamics (搜索)' human cardiac organoid technology, embedded sensors, automation, and AI with Galmed's expertise in modulating fibrotic pathways gives us a unique opportunity to change how cardiac fibrosis (搜索) therapies are developed," said Dr. Avner Ehrlich, CEO of Tissue Dynamics. "The ability to model chronic human fibrosis in real time and at scale could allow us to investigate interventions that do more than delay disease progression. If we can identify approaches that improve tissue repair and help resolve fibrosis by correcting the underlying metabolic dysfunction, this has the potential to be a game changer for patients and for drug development in this field."
Prof. Yaakov Nahmias, Founder and CSO of Tissue Dynamics (搜索), added: "This model is one of a kind. By combining vascularized, multichambered human cardiac organoids with continuous metabolic sensing and AI, we can investigate human fibrotic processes with unprecedented precision. This is especially important for metabolic processes such as lipid remodeling and SCD1 (搜索) activity, where human relevance, timing, and tissue context are essential to understanding disease and therapeutic response."
Company Backgrounds
Tissue Dynamics (搜索) is a next-generation human-focused CRO delivering predictive preclinical data using human organoid systems, real-time metabolic analytics, and explainable AI. Its platform is designed to replace uncertain animal studies with human-relevant mechanistic insight, improving the probability of clinical success and accelerating development timelines for biotech and pharmaceutical partners.
Galmed is a biopharmaceutical company focused on the development of Aramchol. Galmed has focused almost exclusively on developing Aramchol for the treatment of liver disease, and it is currently seeking to advance the development of Aramchol for oncological indications beyond NASH (搜索) and fibrosis. As part of its growth strategy, Galmed is actively pursuing opportunities to expand and diversify its product pipeline, specifically targeting cardiometabolic indications and other innovative product candidates that align with its core expertise in drug development.