How to secure follow-on funding for your finished H2020/HORIZON project in regenerative medicine: new call topic HLTH-2026-01-TOOL-05
5th December 2025 at 12:13 pm
Many regenerative medicine projects funded under Horizon 2020 and Horizon Europe have already delivered promising breakthroughs. Yet too often, strong scientific results stall at TRL 5 before reaching clinical development or market uptake. The HORIZON-HLTH-2026-01-TOOL-05 call topic aims to change that. By piloting a follow-on funding mechanism, the European Commission (EC) wants to help researchers and innovators bridge the critical gap between research and deployment, moving high-potential health technologies closer to patients.
With the 16 April 2026 deadline still months away, now is the ideal moment to define how your previous EU project can evolve into a compelling, impact-driven follow-on proposal. Under this Innovation Action (IA), four projects with an EU contribution between six and eight million euros are expected to be approved. In this blog, we break down what the EC expects and share tips for designing a strong application that showcases the translational value of your regenerative medicine innovation.
Who is eligible for this follow-on funding call topic?
To be eligible for the HORIZON-HLTH-2026-01-TOOL-05 call topic, the following eligibility conditions apply:
- Proposals must be based on results generated within a prior multi-beneficiary project funded under Horizon 2020 or Horizon Europe Framework Programme.
- The project must have been 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. Projects funded under co-funded European Partnerships or ERANETs are considered eligible.
- Ongoing projects are not considered eligible.
Expected outcomes: Why this call matters for regenerative medicine
Regenerative medicine holds the promise to repair, replace or restore tissues and organs affected by disease, ageing or trauma. It is a key component of the EU’s “Strategy for European Life Sciences” and is recognised as a critical enabling technology. Through this call, Horizon Europe aims to:
- Strengthen the competitiveness of the EU biotechnology sector.
- Leverage outcomes of previous EU-funded work for greater impact.
- Support innovators in securing funding for late-stage development.
- Bring regenerative solutions to patients faster.
This is not a standard research call. It specifically targets mature innovations at TRL 5 that have already demonstrated preclinical validation in earlier EC-funded projects.
For applicants submitting a proposal for this call topic, the following five points are stated in the call topic and expected to be included in the scope of the project:
1. Start with evidence: proving your innovation is ready
Applicants must demonstrate that the technology has already been validated at preclinical level within a previous EU-funded project. The follow-on funding aims to take the next steps: prototyping, demonstrating, validating, scaling or preparing for clinical development or manufacturing. The EC expects a clear and concise technology maturity narrative.
You should provide qualitative and quantitative proof of maturity, such as:
- Peer-reviewed publications
- Patent, trademark or design applications
- Start-up or spin-out development
- Regulatory interactions (scientific advice, classification)
- Venture capital pitches or investments
- Manufacturing steps already underway
Additionally, it might be a good idea to include a timeline that shows how the innovation progressed during the prior project and why now is the right moment for follow-on funding.
2. Build a consortium that fits the next stage
Your consortium should not be a simple copy of your previous one. It must reflect the skills, partners and infrastructure needed for translational progress, such as clinical trials, regulatory alignment, manufacturing, business development or patient access.
Tips for applicants:
- Justify every new partner based on the new project’s ambitions.
- Include clinical partners early, especially if clinical studies are expected.
- Consider SMEs or industry partners for manufacturing, regulatory strategy or commercialisation.
- Involve patient groups to demonstrate clinical relevance and strengthen patient-centred design.
3. Protect your idea and ensure freedom to operate
Applicants must prove that they have protected their intellectual property (IP) effectively or have ensured freedom to operate for the intended further development. This means, for example:
- Present an updated IP landscape analysis.
- Clarify ownership between all partners, especially if the consortium changed.
- Demonstrate how IP risks are managed (e.g. licensing, background IP agreements).
- Highlight how IP strategy supports commercial or clinical pathways.
4. Define the pathway to patients and route to market
A strong proposal must articulate a clear route to patient access or market entry, including regulatory considerations. Proposals must define milestones and KPIs that are verifiable, realistic and linked to TRL progression.
- Describe how your design, validation or manufacturing steps align with regulatory expectations.
- Define specific milestones together with concrete and verifiable Key Performance Indicators (KPIs) to assess progress towards the market or healthcare settings.
As stated in the call topic, the EC expects proposals to distinguish whether their innovation follows a commercialisation pathway or a non-commercial, high patient benefit pathway. Our tip: Be explicit. Evaluators want to see that you understand your innovation’s economic and clinical positioning.
5. Identify the patient groups and product development milestones
Understanding who will benefit from your regenerative medicine innovation and how the development will progress is essential for convincing evaluators of both feasibility and impact. Proposals should clearly describe the target patient groups, outline the expected reach of the innovation and present a structured plan, supported by realistic financial projections. The EC expects applicants to:
- Clarify the patient groups who will benefit, including population size and unmet needs.
- Indicate how many patients will be treated during the project.
- Define product development milestones linked to each clinical or technical stage.
- Include a financial plan for each milestone, outlining required resources, funding gaps and expected cost drivers (manufacturing, regulatory, clinical validation)
As stated in the call topic, proposals must consider sex, gender, age and socio-demographic factors to ensure scientific robustness and real-world applicability.
Our tip: Present recruitment strategies for clinical studies that reflect patient diversity, and provide justification if exclusions are necessary.
Looking for proposal writing support from experts with biomedical experience?
Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. At accelopment, we have been supporting consortia in the HORIZON Health projects GENEGUT, EXPOSIM, EU PAL-COPD, GLIOMATCH, COVend and MyPath and have been a partner in numerous H2020 projects such as VANGUARD. Additionally, our support extends to many more health-focused ITNs, including MITGEST and MobiliTraIN, as well as Pathfinder-Open projects related to health, such as POLINA and BoneOscopy.
The HORIZON-HLTH-2026-01-TOOL-05 call offers a valuable opportunity to advance regenerative medicine innovations that have already shown promise in previous EU-funded projects. If you are preparing a proposal for this call topic, contact our Horizon Health experts for strategic support on proposal design, consortium planning and translational readiness. Together, we can help you turn your regenerative medicine breakthrough into a strong and competitive Horizon Europe proposal.
