Betalin's EIC Accelerator Project: Human Trials Against Mouse Data

Betalin Therapeutics told the European Commission in 2020 that a single injection of its Micro Pancreas would free people with diabetes from insulin, needles and glucose monitoring. The Jerusalem company was selected in the March 2020 round of the Horizon 2020 EIC Accelerator pilot, grant only, and received an EU contribution of €2,452,625 towards a €3,503,750 project that ran from 1 September 2020 to 29 February 2024, according to CORDIS. Its closing report says the clinical trial planned for the UK was postponed and that a switch to stem cells "hindered our progress in achieving Phase IB as outlined in the project plan". In September 2026 the company was raising money from the public on the Israeli platform ExitValley, still describing itself as preclinical.

Betalin is listed under its own name, and as the only company of its project, in the Commission's list of EIC Accelerator winners for the March and May 2020 cut-offs. CORDIS adds a UK subsidiary, BetalinUK Limited, as a linked third party that received €164,500 of the grant.

Where Betalin Stands Now

Betalin is an active company. The Israeli Corporations Authority lists it as active, with its address at the Jerusalem Bio Park and its last annual report filed for 2026, according to the authority's open register data; OpenCorporates shows the same status and address. Israeli private companies do not publish their accounts, so revenue, losses and cash are not public.

The clearest recent signal is a crowdfunding round on ExitValley that opened on 1 September 2026. With six days to go it had raised ₪1,618,855, of which ₪671,774 came from a preliminary angel round, against a minimum of ₪300,000 and a maximum of ₪4,760,000, at a company value of ₪48,803,287, according to the offer page. The same page states three employees. The company's August 2026 presentation says it needs $5 million to complete IND-enabling studies, move to GMP manufacturing and start a first-in-human trial, and about $100 million to take the product through approval.

The UK arm is gone. BetalinUK Limited, incorporated on 12 August 2020, applied to be struck off on 1 September 2025 and was dissolved by voluntary strike-off on 25 November 2025, according to Companies House. Its company record gives an address at the Canary Wharf offices of Skytax at the end, not the Leeds laboratory hub it moved into in 2020.

The Technology: A Scaffold From Pig Lungs

The established cell treatment for severe type 1 diabetes, the Edmonton Protocol, transplants donor islets, the insulin-producing clusters of the pancreas, into the liver alongside immune-suppressing drugs; Betalin's EIC report describes it as used for "most severe cases in few highly specialized medical centres". Betalin's approach starts from pig lung tissue that is cut into thin sections and stripped of its own cells, leaving a natural three-dimensional matrix it calls the Micro-Organ Matrix. Insulin-producing cells are seeded onto it and the result, the "micro pancreas", is injected under the skin, where it is meant to sense blood sugar and release insulin, according to the company presentation and its website. The scaffold technology was developed by Prof. Eduardo Mitrani at the Hebrew University and licensed to Betalin in 2015, as ISRAEL21c and Hayadan reported.

The idea is to give the cells the surroundings they lose when they are taken out of a pancreas, so that more of them survive and keep working. Under EU law, a product made of cells or tissue modified to repair or replace human tissue is a tissue-engineered advanced therapy medicinal product, which needs a central marketing authorisation from the European Medicines Agency. The regulatory contacts Betalin has reported so far are with the US Food and Drug Administration: a pre-IND exchange in 2019 and a request for guidance on human trials described in 2025.

What the EIC Project Promised, and What CORDIS Shows

The CORDIS objective promised a product that "eliminates insulin dependency in diabetes patients", built from donor human islets, mesenchymal stem cells and the scaffold, and it followed a €50,000 SME Instrument Phase 1 feasibility study, Io-EMP, from November 2017 to February 2018. The final periodic report, covering March 2022 to February 2024, lists what the first period achieved: a manufacturing process in line with ISO guidelines, an automation analysis, suppliers of human islets and clinical centres for the trials, regulatory documents for trial approval, and the set-up of BetalinUK on the University of Leeds campus. It says the first period "suffered badly" from COVID-19 delays.

In the second period the plan changed. The report says the team "identified numerous challenges associated with the utilization of human islets", postponed the UK clinical trials and the planned UK activities, and decided to seed the scaffold with stem cell-derived beta cells instead. It then completed a manufacturing process adjusted to those cells, identified GMP-compliant reagents and a supplier of stem cell-derived beta cells, and ran preclinical studies showing efficacy in a diabetic mouse model. Betalin's website dates the pivot to outsourced cells to January 2023.

1. Industrial scaffold manufacturingDeliveredProcess in line with ISO guidelines, then adapted to stem cell-derived cells, per the CORDIS report.
2. Efficacy in animalsDeliveredDiabetic mouse study, published in December 2025 (see below).
3. Donor islet supply for the productDroppedAbandoned for stem cell-derived beta cells during the project.
4. Phase Ib clinical trial in the UKNot achievedPostponed; no human trial announced by October 2026.
5. UK subsidiary as clinical baseNot achievedBetalinUK dissolved in November 2025.
6. An injectable product that ends insulin dependenceNot achievedStill preclinical in the August 2026 offer.

The project ran its full term and closed on schedule in February 2024, but its central milestone, the first test in people, was not reached. The work that was done is real: a manufacturing route and animal data. A grant of this size funds development rather than market success, yet the EIC selected Micro Pancreas as a clinical-stage step, and the clinical step did not happen.

What Betalin Has Achieved Since the Award

The main scientific output is a mouse study. In December 2025 Betalin researchers, with co-authors from Kadimastem Ltd. of Jerusalem and from Dresden, Edmonton, London and Zurich, reported in Hormone and Metabolic Research that their "endocrine micro-pancreata", seeded with embryonic stem cell-derived islets, released 1.4 times more insulin in response to glucose than free islets in the dish, and that grafts placed under the skin of diabetic mice improved glucose tolerance by 46%, against 31% when placed in the abdomen, over three months, according to the PubMed record and the TU Dresden research portal. Those are animal results; no human data exist.

Betalin's other EU project, Cells in Matrix, a Fast Track to Innovation consortium with the cell-culture plate developer Kugelmeiers, TU Dresden and University Hospital Zurich, received €2,640,417.50 from March 2020 to February 2023, €1,233,750 of it for Betalin. Its final report says it produced "two potential products", one of them a Betalin research tool for diabetes drug testing. No sale of that tool has been announced.

The private money is modest and partly unusual. Betalin's August 2026 cap table shows Shai Sapir Investments with 80,689 of 229,813 issued shares (35.11%), Yissum, the Hebrew University's technology transfer company, and three Beijing life-science companies among the holders. The company's presentation claims $16 million of total funding, $6 million of it non-dilutive and $10 million equity; no independent source confirms these totals.

The EIC Fund Stake

Betalin's 2020 award was grant only, yet the EIC Fund is a shareholder. Betalin appears among the EIC Fund's invested companies, with its own portfolio page, and the 2026 cap table lists the EIC Fund with 15,821 ordinary shares, 6.88% of issued shares and 6.31% fully diluted. A 2025 promoted article that Betalin placed in Haaretz also refers to EU equity. When the EIC Fund invested, and how much, is not public.

A Decade of Promised Trials

The gap between announced and actual clinical timelines is the thread through Betalin's record. In December 2015 Prof. Mitrani said the company aimed to "start our first human trials within a year", according to ISRAEL21c, while Globes reported a horizon of "a year and a half or two years". In November 2019 then chief executive Nikolay Konicher told Hayadan that the FDA had responded positively to a pre-IND submission and named trial centres in Germany, China and the United States. In August 2020 the British Friends of the Hebrew University reported that the company would ask that month for permission to start human trials, and in October 2020 BusinessCloud reported its move into the University of Leeds Nexus hub. By July 2023 The Media Line described the therapy as still preclinical, with stem cell results needed before human trials.

Why Europe Should Care

Diabetes is one of the five strands of the Commission's Healthier Together initiative on non-communicable diseases, launched in December 2021, and cell therapies for it would be regulated as advanced therapies through the EMA. Betalin's European links were real: research partners in Dresden and Zurich, a German industrial partner and a UK subsidiary. None of that European activity has turned into a trial site or a product, and the UK base has closed.

The Verdict

Betalin Therapeutics has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.