Tissue Dynamics and Galmed Pharmaceuticals to Develop Human-Centered Chronic Cardiac Fibrosis Platform to Advance Aramchol-Based Therapeutics

Rhea-AI Summary

Galmed (NASDAQ: GLMD) and Tissue Dynamics announced a collaboration to build a human-centered chronic cardiac fibrosis platform to accelerate Aramchol-based therapeutics. The platform uses vascularized, multichambered cardiac organoids with embedded metabolic sensors, AI, and automation to test >20,000 organoids in parallel.

The model targets post-MI remodeling and HFpEF, links SCD1-driven lipid metabolism to fibrosis and impaired repair, and aims to support preclinical evaluation of dosing, combinations, and disease-stage interventions.

Positive

• Platform designed to test more than 20,000 human organoids in parallel
• Focus on chronic post-MI remodeling and HFpEF, key areas with unmet therapies
• Integration of embedded metabolic sensors and AI for longitudinal functional and molecular readouts
• Applies Galmed's SCD1 biology expertise to cardiac fibrosis-relevant metabolic pathways

Negative

• No clinical efficacy or human trial data reported; work is preclinical and model-developmental
• Therapeutic impact on patient outcomes is unproven until Aramchol-based candidates advance beyond model testing
• Regulatory acceptance of model readouts for approval remains contingent on authorities and validation

Key Figures

2024 net loss: $7.5 million 2025 net loss: $10.3 million Accumulated deficit: $210.8 million +5 more

8 metrics

2024 net loss $7.5 million Losses attributable to ordinary shareholders in 2024 (Form 20-F)

2025 net loss $10.3 million Losses attributable to ordinary shareholders in 2025 (Form 20-F)

Accumulated deficit $210.8 million Accumulated deficit as of Dec 31, 2025 (Form 20-F)

Net working capital $15.8 million Net working capital as of Dec 31, 2025; expected to fund >12 months

Cash and equivalents $4.0 million Cash and cash equivalents as of Dec 31, 2025 (Form 20-F)

Short-term deposits $7.1 million Short-term deposits as of Dec 31, 2025 (Form 20-F)

Marketable debt securities $7.0 million Marketable debt securities as of Dec 31, 2025 (Form 20-F)

Organoids throughput more than 20,000 human organoids DynamiX platform testing capacity in cardiac fibrosis model

Market Reality Check

Price: $0.6278 Vol: Volume 65,338 is at 0.01x...

low vol

$0.6278 Last Close

Volume Volume 65,338 is at 0.01x the 20-day average of 9,318,846, showing very light trading ahead of this collaboration news. low

Technical Shares at $0.59 are trading below the 200-day MA of $1.04 and remain 74.79% under the 52-week high of $2.34.

Peers on Argus

Biotech peers show mixed moves, with VYNE flagged in momentum data down 4.49% wh...

1 Down

Biotech peers show mixed moves, with VYNE flagged in momentum data down 4.49% while other close peers (CYCN, APRE, DWTX, TSBX) have varied directions, suggesting no clear synchronized sector reaction to this GLMD cardiac-fibrosis collaboration.

Historical Context

5 past events · Latest: Apr 14 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 14	Oncology collaboration	Positive	-6.7%	Collaboration with Tel Aviv University to evaluate Aramchol in metastatic brain cancers.
Apr 09	Formulation milestone	Positive	+26.1%	Announcement of brain-penetrating Aramchol formulation with planned Parkinson PoC trial.
Mar 31	Annual report filing	Negative	+8.2%	20-F detailing continued losses, going-concern doubt and strategic refocus of Aramchol.
Jan 30	Nasdaq compliance risk	Negative	-6.3%	Nasdaq notice for trading below $1.00 minimum bid with 180-day cure period.
Dec 08	Conference abstract	Positive	+8.0%	Late-breaking HEP-DART abstract on Aramchol plus regorafenib in liver cancer.

Pattern Detected

Recent GLMD news often ties to expanding Aramchol into new indications. Price reactions have been mixed, with positive alignment on some scientific milestones, but divergences on certain collaborations and risk disclosures.

Recent Company History

Over the last six months, Galmed has repeatedly highlighted Aramchol’s repositioning beyond NASH into oncology and cardiometabolic indications. Key updates include a brain-penetrant Aramchol formulation for CNS disorders on Apr 9, 2026 and a metastatic brain cancer collaboration on Apr 14, 2026. Regulatory filings on Mar 31, 2026 detailed ongoing losses and going-concern risks but also funding for more than 12 months. Today’s cardiac fibrosis organoid collaboration continues this strategy of leveraging SCD1 biology across high-unmet-need indications using advanced human-relevant models.

Market Pulse Summary

This announcement extends Galmed’s strategy of applying its SCD1 inhibitor Aramchol beyond liver dis...

Analysis

This announcement extends Galmed’s strategy of applying its SCD1 inhibitor Aramchol beyond liver disease into cardiometabolic and fibrotic indications. The collaboration with Tissue Dynamics leverages a vascularized cardiac organoid platform testing over 20,000 organoids in parallel, aiming at post-MI remodeling and HFpEF. Against a backdrop of $7.5M and $10.3M annual losses and a $210.8M accumulated deficit, investors may focus on how quickly this human-relevant model can generate data that supports partnering, clinical entry, or non-dilutive funding.

Key Terms

myocardial infarction, HFpEF, cardiac organoid, SCD1, +4 more

8 terms

myocardial infarction medical

"long-term remodeling after myocardial infarction (MI) and heart failure..."

Myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked and heart muscle is damaged—like a garden hose being pinched so a patch of lawn starts to die. For investors, heart attacks matter because they drive demand for drugs, devices, hospitals and rehabilitation, affect health-care costs and workforce productivity, and can lead to regulatory actions, litigation or shifts in insurance and pricing that impact company earnings.

HFpEF medical

"heart failure with preserved ejection fraction, or HFpEF."

Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart pumps out a normal percentage of blood but has trouble relaxing and filling, so overall blood flow to the body is reduced. For investors, HFpEF matters because it represents a large, growing patient population with substantial hospital costs and unmet treatment needs, making it a focus for drug development, clinical trials, and medical device opportunities.

cardiac organoid medical

"novel vascularized, sensor-embedded cardiac organoid model will focus..."

A cardiac organoid is a tiny, lab-grown cluster of heart cells that forms a miniature, beating heart-like structure used to study heart biology. Investors should care because these small models act like a rapid, lower-cost testbed—similar to a scale model of a building—for screening drug effects, spotting safety problems, and shortening development timelines, which can reduce risk and cost for therapies and diagnostics.

SCD1 medical

"SCD1, a key enzyme controlling monounsaturated fatty-acid synthesis..."

SCD1 is an enzyme that acts like a factory machine inside cells, converting certain solid fats into softer, more usable fats that influence energy storage, cell membranes, and signaling. Investors pay attention because drugs or diagnostics that block or measure SCD1 activity are pursued for conditions such as metabolic disease, cancer and skin disorders; success or failure in clinical trials, safety issues, or regulatory decisions around SCD1-targeted therapies can materially affect company value.

angiogenesis medical

"while SCD also influences angiogenesis and energy metabolism..."

Angiogenesis is the biological process where the body builds new blood vessels, like laying new roads to deliver oxygen and nutrients to tissues. Investors care because many drugs aim to block or encourage this process to treat cancer, eye diseases, or chronic wounds; success or failure in controlling angiogenesis often determines a therapy’s effectiveness, regulatory approval, safety profile, and commercial potential.

organ-on-chip technical

"advanced human-relevant methods, including AI-powered models and human organ-on-chip systems..."

A small laboratory device that recreates key functions of a human organ on a micro scale by using living cells and tiny channels to mimic blood flow and tissue structure. Like a flight simulator for drugs, it lets developers test safety and effectiveness faster and cheaper than full clinical trials, reducing development risk, time and cost and potentially improving the odds and timing of a product reaching the market—information investors use to value biotech and medical-technology companies.

New Approach Methodologies (NAMs) regulatory

"stated that New Approach Methodologies (NAMs) can improve predictivity..."

New approach methodologies (NAMs) are modern testing tools and strategies—such as computer models, advanced cell-based assays, and lab-grown tissues—that replace or supplement traditional animal tests to evaluate safety, toxicity, and biological activity of drugs, chemicals and products. For investors, NAMs can shorten development timelines, lower testing costs, and reduce regulatory uncertainty, much like switching from slow manual inspection to faster automated quality checks in a factory.

organoids medical

"plans to promote human organoids and organ-on-chip systems that mimic human organs..."

Miniaturized, simplified versions of human organs grown in the lab from stem cells that mimic key structure and function of real tissues. Like scale models used by architects, organoids let researchers test drugs, study disease and predict how human tissues will respond without using whole patients, which can speed development, reduce costs and lower risk for investors evaluating biotech pipelines and therapies.

AI-generated analysis. Not financial advice.

Novel vascularized, sensor-embedded cardiac organoid model will focus on chronic post-MI remodeling and HFpEF, linking lipid metabolism, SCD1 activity, fibrosis, and impaired tissue repair

REHOVOT, Israel and RAMAT-GAN, Israel, May 6, 2026 /PRNewswire/ -- Tissue Dynamics Ltd. and Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, today announced a collaboration to develop a novel human chronic cardiac fibrosis model designed to accelerate the discovery and development of new Aramchol-based therapeutic approaches for complex fibrotic heart diseases. Cardiac fibrosis is a major driver of chronic heart failure, including long-term remodeling after myocardial infarction (MI) and heart failure with preserved ejection fraction, or HFpEF. Cardiovascular disease remains the leading cause of death globally, responsible for an estimated 20.5 million deaths in 2025. Despite this burden, there are no approved therapies that directly and durably reverse cardiac fibrosis. The disease is increasingly understood as a failure of tissue repair rooted in metabolic dysfunction: disturbed lipid uptake, oxidation, storage, and signaling can drive lipotoxicity, mitochondrial dysfunction, inflammation, fibroblast activation, and impaired regenerative remodeling. SCD1, a key enzyme controlling monounsaturated fatty-acid synthesis and membrane-lipid composition, sits at the center of this biology. Studies have shown SCD1 upregulation in experimental heart failure 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.

A central obstacle in cardiac fibrosis 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. 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.

Tissue Dynamics and Galmed are collaborating on the development of the new platform as a high-throughput, human-centered model of chronic cardiac fibrosis, with an initial focus on the long-term effects of myocardial infarction and the fibrotic-metabolic remodeling associated with HFpEF. The platform will combine Tissue Dynamics' 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.

The collaboration comes at a pivotal moment for Aramchol's drug development. In the new cardiac fibrosis program, the companies intend to apply Galmed's expertise in SCD1 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.

Galmed aims to use this platform to develop and investigate new Aramchol-based therapies for chronic cardiac fibrotic disease.

"We believe that combining Tissue Dynamics' 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 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, 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 activity, where human relevance, timing, and tissue context are essential to understanding disease and therapeutic response."

About Tissue Dynamics

Tissue Dynamics 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. Tissue Dynamics operates a high-throughput human organoid platform capable of testing more than 20,000 organoids in parallel and supports disease modeling, mechanistic safety and toxicology, compound profiling, custom assay development, automation, and strategic clinical design.

About Galmed Pharmaceuticals Ltd.

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 and fibrosis. In addition, 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.

Forward-Looking Statements:

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to how the collaboration is designed to accelerate the discovery and development of new Aramchol-based therapeutic approaches for complex fibrotic heart diseases. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

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SOURCE Galmed Pharmaceuticals Ltd.

FAQ

What is the goal of the Galmed (GLMD) and Tissue Dynamics collaboration announced May 6, 2026?

The collaboration aims to build a human chronic cardiac fibrosis platform to accelerate Aramchol-based therapies. According to Galmed and Tissue Dynamics, it combines vascularized organoids, sensors, automation, and AI to evaluate metabolic, structural, and functional drug effects at scale.

How many organoids can Tissue Dynamics' DynamiX platform test for GLMD research?

The DynamiX system is designed to test over 20,000 human organoids in parallel. According to Tissue Dynamics, this enables longitudinal, high-throughput monitoring of metabolism, fibrosis, conduction, and inflammatory signaling across many conditions.

What cardiac conditions will GLMD focus on with the new organoid platform?

Galmed will focus on chronic post-myocardial infarction remodeling and heart failure with preserved ejection fraction (HFpEF). According to Galmed, the platform targets fibrotic-metabolic remodeling linked to SCD1-driven lipid dysfunction in these diseases.

How does the new model use SCD1 biology to inform Aramchol development for GLMD?

The platform monitors SCD1-related lipid handling and metabolic endpoints to test Aramchol-based approaches. According to Galmed, this lets researchers study how modulating SCD1 activity may affect fibroblast behavior, angiogenesis, and extracellular-matrix remodeling.

Will results from the GLMD–Tissue Dynamics platform replace animal studies for cardiac fibrosis?

Results are intended to complement, not necessarily replace, traditional models during development. According to the companies, the human-relevant organoid data aim to improve predictivity and support safer, better-informed preclinical evaluation in regulatory pathways.

Does the May 6, 2026 announcement mean Aramchol is proven effective for cardiac fibrosis?

No; the announcement describes platform development and preclinical testing plans, not clinical proof of efficacy. According to Galmed, the platform will enable rapid evaluation of candidates but clinical trials are required to establish patient benefit.