Pilot actions for follow-on funding: Leveraging EU-funded collaborative research in regenerative medicine

The grant opportunity HORIZON-HLTH-2026-01-TOOL-05, titled "Pilot actions for follow-on funding: Leveraging EU-funded collaborative research in regenerative medicine," is part of the Horizon Europe Programme under the Health Cluster. It aims to support the development and deployment of health innovations within the field of regenerative medicine.

Eligible applicants include legal entities from EU member states, EEA countries, and associated countries. This includes biotech SMEs, large enterprises, universities, research institutions, spin-outs, and start-ups that have successfully validated preclinical health innovations from previous EU-funded projects. Notably, entities from the United States are also eligible, while those controlled by Chinese entities are excluded.

The funding type is a grant, specifically through Horizon Innovation Actions (HORIZON-IA) with a lump sum grant format. This process outlines that eligible costs will be paid as lump sums, ensuring financial support for advancing biotech innovations without the burden of traditional cost reimbursement requirements.

A multi-stakeholder consortium is mandatory for application submissions. This must consist of various sectors, including businesses, research institutions, and healthcare providers, arguing the need for interdisciplinary collaboration to achieve success. Proposed projects should be built on results from prior EU-funded projects under Horizon 2020 or Horizon Europe, completed no more than three years before the submission deadline.

The geographic eligibility covers all EU and EEA countries, with specific restrictions in place for entities from non-eligible countries, mainly China. The focus is primarily on regenerative medicine, including Advanced Therapy Medicinal Products (ATMPs) and other innovative health biotechnology areas.

Projects must be at Technology Readiness Level (TRL) 5 and above, aimed at prototyping, validating, demonstrating clinical developments, and scaling up manufacturing processes. The total budget allocated for this initiative is €29.5 million, with each project expected to receive between €6 million to €8 million, funding around four projects.

The application process is single-stage, with a submission period opening on February 10, 2026, and closing on April 16, 2026, at 17:00 CEST. Proposals will be evaluated on excellence, impact, and implementation, with a set of criteria to meet minimum thresholds for consideration. There is no explicit co-funding requirement; however, proposals should ideally showcase other financial commitments and market readiness.

HORIZON-HLTH-2026-01-TOOL-05 aims to fill the financial gap between early-stage research findings and practical applications, thereby enhancing the EU's biotechnology sector's competitiveness. It underscores the role of collaborative innovations and aims to facilitate the swift translation of promising research into products that benefit patients, while ensuring the sustainability of funded interventions. The initiative also aligns with broader EU strategies to bolster research innovation and technology in critical sectors.

This EU grant opportunity, HORIZON HLTH 2026 01 TOOL 05, falls under the Horizon Europe Programme, specifically the Cluster 1 Health calls for proposals. It is a Horizon Innovation Action (HORIZON IA) with a single stage application process. The planned opening date is February 10, 2026, and the deadline for submission is April 16, 2026, at 17:00 Brussels time. The grant type is a HORIZON Lump Sum Grant.

The primary objective of this topic is to bolster the competitiveness of the EU biotechnology sector by supporting the advancement of health innovations that are closer to deployment. It aims to leverage previous EU funding in regenerative medicine to maximize the impact of the EU's Research and Innovation (R&I) Framework Programmes. The goal is to enable EU innovators to secure additional funding needed to finalize the last stages of development, ultimately benefiting patients by providing faster access to solutions that improve their health and wellbeing.

The scope of this initiative recognizes the crucial role of R&I in driving economic growth and enhancing the competitiveness of the EU's life sciences sector. It builds upon the foundation laid by the Horizon 2020 and Horizon Europe Framework Programmes, which have supported projects that have significantly impacted health through scientific discoveries and the development of new solutions. The importance of collaboration among businesses, research institutions, and healthcare providers is highlighted, as is the need for sustained funding throughout the entire value chain to ensure that more products reach patients more quickly.

This topic aims to pilot a follow on funding mechanism that supports the stepwise development of biotech innovations through collaboration, leveraging previously supported EU R&I actions in the field of health. This initiative contributes to strengthening the R&I ecosystem within the EU and supports the implementation of the Strategy for European Life Sciences. Given the importance of biotechnology as a critical technology, this topic aims to ensure that promising research results are efficiently taken further along the value chain, speeding the time to market or patient through stepwise funding and increasing the EU’s competitiveness.

The chosen area of focus is regenerative medicine, which has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to normalize congenital defects. Proposals should focus on prototyping, demonstrating, and validating health innovations from Technology Readiness Level (TRL) 5, moving beyond early stage research to clinical development, testing, or eventual large scale manufacturing. The previously funded EU research on which the proposal is built should be applicable to the field of regenerative medicine and should have clear exploitation potential and/or socio economic benefits for the patients.

Applicants are expected to:

Demonstrate in their proposal that the health product, therapy, or service has been successfully validated at the preclinical level in the prior EU funded project and provide justification of the innovation potential with qualitative and quantitative data (e.g., publications, patent/trademark/design applications, spin out/start up track record, regulatory procedures, venture capital pitches, funds raised, etc.).

Justify the proposed composition of the consortium and explain how this differs from the previous grant, and demonstrate how the health product, therapy, or service to be developed further qualifies as regenerative medicine.

Demonstrate adequate protection of the idea or Intellectual Property Rights (IPR) or ensure freedom to operate until full deployment.

Have a clear vision on the intended pathway to patients and/or route to market, including regulatory compliance. This includes defining specific milestones together with concrete and verifiable Key Performance Indicators (KPIs) to assess progress towards the market or healthcare settings.

Identify the target patient group(s) (how many patients to be treated during the project and the potential patient population that could benefit) and product development milestones including a financial plan (for each milestone).

In the case of innovations with commercial potential, proposals should present the investor and market readiness towards commercialisation and deployment (market research, value proposition, business case and business model, prospects for growth, intellectual property protection, competitor analysis etc.) as well as aspects of regulation, certification and standardisation and reimbursement.

In the case of innovations with evidenced limited commercial potential but high patient benefit, proposals should contain a deployment and sustainability plan including aspects related to regulations, certification and standardisation and patient access through healthcare providers.

Proposals should take into account sex, gender, age and other relevant socio demographic variables to ensure the scientific robustness, clinical value and applicability of the targeted regenerative medicine innovation.

Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.

The admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. The proposal page limits and layout are described in Part B of the Application Form available in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non EU/non Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.

Other eligibility conditions include that proposals must be based on results generated within a prior multi beneficiary project funded under Horizon 2020 or Horizon Europe Framework Programme, completed maximum 3 years before the submission deadline. Applicants must explicitly state in their proposal the prior multi beneficiary project concerned. Projects funded under Marie Sklodowska Curie Actions are not considered eligible, while projects funded under co funded European Partnerships or ERANETs are considered eligible. Ongoing projects are not considered eligible. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. If projects use satellite based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS. In line with the restriction on control in innovation actions in critical technology areas, entities established in an eligible country but which are directly or indirectly controlled by China or by a legal entity established in China are not eligible to participate in the action.

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.

The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme. Legal and financial set up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates include the standard application form (HE RIA, IA) and the standard evaluation form (HE RIA, IA). Guidance documents include the HE Programme Guide, Model Grant Agreement (MGA), Lump Sum MGA, call specific instructions, information on clinical studies (HE), detailed budget table (HE LS), guidance on lump sums, and an ownership control declaration. Additional documents include the HE Main Work Programme 2026 2027, HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, Decision authorising the use of lump sum contributions under the Horizon Europe Programme, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA Annotated Model Grant Agreement, Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

The total budget for the HORIZON HLTH 2026 01 call is 29,500,000 EUR. The opening date is February 10, 2026, and the deadline is April 16, 2026. The estimated contribution per project ranges from 6,000,000 to 8,000,000 EUR, with an indicative number of 4 grants to be awarded.

This funding opportunity is designed to provide crucial follow on support to promising regenerative medicine projects that have already demonstrated preclinical success through prior EU funding. It aims to bridge the gap between research and real world application, accelerating the development and deployment of innovative health solutions for the benefit of patients and the European biotechnology industry. By focusing on projects at TRL 5 and above, the grant seeks to translate research findings into tangible products and services, ensuring that EU investments in health research have a lasting impact.

Eligible Applicant Types: The opportunity targets a collaborative effort, implying that consortia of multiple applicants are preferred. The eligible applicants can include businesses, research institutions, and healthcare providers. The focus is on entities capable of developing and deploying health innovations, particularly in regenerative medicine. Legal entities established in the United States of America are also eligible to receive Union funding. Entities established in an eligible country but directly or indirectly controlled by China or by a legal entity established in China are not eligible to participate in the action.

Funding Type: The funding type is a grant, specifically a HORIZON Innovation Action (HORIZON-IA) with a HORIZON Lump Sum Grant (HORIZON-AG-LS) mechanism. This implies that eligible costs will take the form of a lump sum. There are also HORIZON Public Procurement of Innovative Solutions (HORIZON-PPI), HORIZON Research and Innovation Actions (HORIZON-RIA) and HORIZON Coordination and Support Actions (HORIZON-CSA).

Consortium Requirement: A consortium is required, as the opportunity emphasizes collaboration and the need to justify the proposed composition of the consortium, explaining how it differs from the previous grant. The proposals must be based on results generated within a prior multi-beneficiary project funded under Horizon 2020 or Horizon Europe Framework Programme.

Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically biotechnology and regenerative medicine. The program aims to support the development and deployment of health innovations, with a focus on prototyping, demonstrating, and validating innovations from Technology Readiness Level (TRL) 5 onwards.

Mentioned Countries: The United States of America and China are explicitly mentioned. The opportunity is primarily focused on the EU and associated countries, as it builds upon previous EU-funded research.

Project Stage: The project stage should be at TRL 5 or higher, focusing on prototyping, demonstrating, and validating health innovations, moving towards clinical development, testing, or large-scale manufacturing.

Funding Amount: The funding amounts vary depending on the specific HORIZON action. For HORIZON-PPI, the contributions range from 3,000,000 to 8,000,000 EUR. For HORIZON-RIA, the contributions vary from around 1,900,000 EUR to around 10,000,000 EUR. For HORIZON-IA, the contributions range from 6,000,000 to 8,000,000 EUR. For HORIZON-CSA, the contributions range from 1,500,000 to 3,900,000 EUR.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves a single stage.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight into the potential success rate.

Co-funding Requirement: The text does not explicitly state a co-funding requirement.

Summary: This Horizon Europe funding opportunity aims to bolster the EU's biotechnology sector by providing follow-on funding for projects in regenerative medicine that have already received EU funding through Horizon 2020 or Horizon Europe. The goal is to accelerate the development and deployment of health innovations, ensuring that promising research results are efficiently translated into products and services that benefit patients. The funding supports activities from prototyping to clinical development and large-scale manufacturing, targeting innovations at TRL 5 or higher. Applicants must demonstrate the innovation potential of their project, justify the composition of their consortium, ensure adequate intellectual property protection, and have a clear vision for the pathway to patients and/or market. The opportunity is open to a range of entities, including businesses, research institutions, and healthcare providers, with a focus on collaborative projects that strengthen the EU's R&I ecosystem and enhance its competitiveness in the global life sciences sector. The funding is provided as a lump sum, and the application process involves a single stage.