ELIGIBILITY

1. Is the call limited to micro and small enterprises or can medium enterprises, large companies and other entities participate?

The Transformative Health Instrument call is limited for micro, small and medium enterprises to participate. The applicant need to be a for-profit SME according to the European Commission’s SME definition. The financial sustainability mechanism used is the “Grant to Options to Equity” model. After the selection process, applicants will need to reach an agreement with EIT Health based on the “Grant to Options to Equity” model to be granted.

2. In the call document, why are there exclusion criteria?

For the Transformative Health Instrument call, it is crucial that the solutions are focused on adaptable innovations that place patients at the core of their efforts, ensuring that healthcare delivery becomes more personalized, sustainable, and effective. The exclusion criteria in the call document outlines all the areas and solutions that this call is not focused on.

3. Are there any restrictions regarding resubmissions from previous calls? How many times can a project be resubmitted?

There are no restrictions for re-submissions.

4. My company is currently participating in another project funded by EIT Health. Can my company still apply for the Transformative Health Instrument Call?

Yes, however, we encourage applicants to consider their internal resources and capacity before deciding to apply for more project grants from EIT Health. There must be a clear distinction between project activities to ensure that the same project activities are not funded by different EU grants, this is known as double funding and is strictly prohibited. The maximum amount of financial support provided to individual entities within the 3-year duration of the Grant Agreement between EIT Health and EIT, namely 2023-2025 should not exceed €6,000,000.

5. The call document states that a Qualified Investment Round successfully closed in year 2023 or 2024 is one of the eligibility criteria. What does this mean?

The applying company must have successfully closed an equity funding round in 2023 or 2024 that meets all of the conditions stated in the call document.

The equity funding round must fulfil the following:

• It was a priced round with a set valuation. Simple Agreement for Future Equity (SAFE) or convertibles do not apply.
• It was closed in 2023 or 2024.
• Total equity capital reached minimum value of 4 million Euros.
• The total equity capital was received within 12 consecutive months.
• The round incorporated at least one new professional investor, matching the description outlined in the call document.

Below are four non exhaustive examples to help illustrate this particular eligibility criteria.

• Example A: if a company raised 2 million Euros funding in February 2023 and 3 million Euros funding in May 2024, this company will not be eligible for this call, because none of these funding events reached the minimum value of 4 million Euros on its own. On top of this, the two events are more than 12 months apart from each other.
• Example B: if a company raised 4 million Euros funding in 2023, with the same group of investors from their last round, and no new investors had invested in this 4-million round. This company will not be eligible for this call, because there were no new investors participating.
• Example C: if a company raised 1 million SAFE in 2023, and then raised 3 million Euros funding in 2024, this company will not be eligible for this call, because SAFEs or convertibles do not count as part of Qualified Investment Round in this call, and the funding raised in 2024 alone does not reach minimum value of 4 million Euros on its own.
• Example D: if a company raised 4 million Euros priced round with a set valuation in February 2024 with one new professional investor, and then raised 1 million Euros convertible notes in September 2024. This company is eligible for this call, because the company has a Qualified Investment Round in February 2024 that meets all of the conditions stated in the call document, regardless of the subsequent convertible notes raised.

6. Can a proposal be made with non-EIT Health members?

Yes. This is a single-beneficiary call, aimed at SMEs. Companies can apply and do not have to be members of the EIT Health.

7. Can medium enterprises apply?

Yes, medium enterprises that are for-profit enterprises according to European Commission SME definition can apply to the THI call.

8. Can large enterprises apply?

 No, the Transformative Health Instrument call only calls for-profit enterprises according to European Commission SME definition to apply.

9. Can an SME apply for the call if it has IPO’ed?

 No. The applying entity must be a privately held company that has not issued any publicly traded securities or initiated any public offering process.

10. There has been a development regarding the UK´s association to the Horizon Europe programme. Does this change UK Partners´ eligibility to receive funding from EIT Health?

Yes, UK entities will now be eligible to directly receive EIT funding, if selected and will be treated as all other participants from Horizon Europe participating and associated countries. Further information on this topic can be found on the UK Research and Innovation website or by reaching out to the EIT Health Ireland-UK Co-location Centre.

11. Are entities based in Switzerland eligible to receive EIT funding following a successful application to the Transformative Health Instrument Call?

Swiss start-ups or small and micro enterprises (SMEs) are eligible to apply.

However, Switzerland and the European Commission are negotiating a transitional arrangement for the 2025 Horizon Europe programme. As a result, Swiss SMEs can prepare applications for Horizon Europe funding as potential beneficiaries.

In the context of this call, if an association agreement between Switzerland and the European Commission is signed before the final results notification is sent, Swiss SMEs that pass the selection phase will be eligible for funding. However, if no agreement is in place by the time the final results notification is sent, applications from Swiss SMEs will be considered ineligible and will not be considered for grant awards. Further information is available from the State Secretariat for Education, Research and Innovation (SERI) of Switzerland, on the call FAQs page, or by reaching out to the EIT Health Germany-Switzerland Co-location Centre.

12. Are all Hungarian entities eligible to receive EIT funding following a successful application to the Transformative Health Instrument Call?

Yes, Hungarian SMEs can apply and receive funding for this call.

Due to a decision by the Council of the European Union, published on and effective as of 15 December 2022, certain Hungarian institutions designated as “public trust foundations” are currently not eligible to receive funding under the Horizon Europe and Erasmus programmes. These Hungarian entities can still participate without receiving EIT funding, as an Associated partner, if allowed by the call conditions. Further information can be found on the EU Commission Funding and Tenders FAQ website. EU Commission Funding and Tenders FAQ website.

FINANCIAL SUSTAINABILITY

13. What is the financial sustainability model ‘grant to options to equity’? and how does it work? 

The ‘grant to options to equity’ model is designed to facilitate EIT Health as a neutral investor that supports the applicant SME and shares long term risk, while minimising operational interference in the SME’s day to day. The SME’s potential and fit with ‘grant to options to equity’ model will be assessed during the due diligence process. Please see the call document for more details.

14. When will the due diligence take place?

Applicants will be notified of the quality evaluation outcomes on 27 January 2025. Applicants that are successful in the remote evaluation outcome will then be invited to the due diligence process. Applicants will be asked to upload their documents as part of the due diligence process between 27 January 2025 and 03 February 2025. Failing to do so within this timeframe may result in disqualification. The documents will then be reviewed by EIT Health and external experts between 03 February 2025 and 27 February 2025.

15. Is the grant to option to equity model a convertible note?

No, while the model closely resembles a convertible note, it is not a convertible note, as the ‘investment’ is provided as a grant rather than debt. Although it has a maturity date where the investment converts to equity, it does not carry any interest like traditional convertible.

16. Will EIT Health become a shareholder of entities that successfully receive funding right away?

No, EIT Health will not become a shareholder upon signature of the grant to option to equity agreement. The investment will convert only at the maturity date 15 January 2027. Please refer to call document for details.

17. Can companies select other financial sustainability models in the Transformative Health Instrument call?

Transformative Health Instrument call is only allowing one financial sustainability model, which is the grant to option to equity model.

CALL BUDGET

18. How many projects will be funded in Transformative Health Instrument?

The number of potential funded activities is outlined in the call document. The final number of selected applications will depend on the quality of proposals received and the final budget available from EIT.

19. How much funding can projects request?

 Projects can request a minimum of €400,000 and a maximum of €500,000 Grant for the 2025 project. There is a co-funding requirement of at least 30%. This means that EIT Health will fund 70% of the budget costs (within the amounts stated above) and 30% of total budget costs must be funded by the applicant.

20. Can co-funding be in terms of Full Time Equivalents (FTEs)?

Yes. When developing the project costing, applicants can include personnel costs such as FTEs, as well as other relevant and eligible costs.

Co-funding is the part of a cost that is not supported by the EIT Health grant i.e. some part of the costs must be covered by the company’s own resources. A 30% co-funding rate means that after the whole costs are claimed (costs that are already paid), EIT Health will reimburse 70% of these costs in the form of grant.

21. Regarding co-funding, should the company have capability to co-finance at the time of submission or at the actual start date of the project?

Companies should have sufficient funding at the time of application submission until pre-financing is launched. Pre-financing is triggered when all required agreements are signed before project starts.

22. Can projects have indirect costs? If so, what percentage?

Yes, the same percentage as in Horizon Europe, which is 25%.

23. Where can information be found regarding eligible costs?

We follow Horizon Europe cost eligibility rules for all our programmes and activities. The Annotated Model Grant Agreement (AMGA) is the backbone of all Horizon Europe grant agreements. Please see   https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/aga_en.pdf to download the AMGA, which provides the description of eligible costs for Horizon Europe projects.

24. How can we have synergies with other EU funding without falling in the double funding trap?

If the funding is not supporting the same cost of the project, it will not be considered as double funding.

ACTIVITY AND PROJECT

25. What are the requirements in relation to innovation maturity levels (IML)?

Innovations must be at pre-defined IML per sector at the time of application submission.

• IML ≥ 5 for Biotech (Safety/Tox study stage)
• IML ≥ 6 in Medtech (Initial clinical Proof of Concept)
• IML ≥ 7 for Digital (Market validation)
• IML ≥ 7 for Biomarker Diagnostics (Clinical validation)

It is expected that applications include evidence that their solution works and have a measured direct impact on patient health. See https://eithealth.eu/a-framework-for-innovation-in-healthcare for further information on IML’s.

26. When should the projects start?

Costs can be claimed from the date that projects are notified that they have been selected for potential funding. However, there is a mandatory one month stand still period following the selection notification. Funding is only guaranteed once all the required contracts and agreements are signed. Any costs incurred before contracts and agreements are signed are carried out at risk. Should costs be incurred and contracts are eventually not signed, EIT Health will not be liable for any costs incurred. Project work must be completed by 31 December 2025 and there will be no extension possibility.

27. What kind of solutions can be included in the project plan?

 The Transformative Health Instrument is open for Biotech, MedTech, digital health, and Biomarker/Diagnostics solutions.

CHANGE LOG