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Delivering ECMO-BIOMARKER – a ground-breaking ICT-enabled ECMO Biomarker system providing clinicians with bedside decision support for better care and reduced costs of severe ICU patients

Periodic Reporting for period 2 - ECMO-BIOMARKER (Delivering ECMO-BIOMARKER – a ground-breaking ICT-enabled ECMO Biomarker system providing clinicians with bedside decision support for better care and reduced costs of severe ICU patients)

Reporting period: 2020-04-01 to 2021-09-30

One out of ten ICU respiratory patients are characterised as being “severe”, with a lung function of less than 20% due to acute respiratory failure. This group are often referred to ECMO (Extra Corporal Membrane Oxygenation) treatment, in which the patient’s blood is oxygenized by an external machine, costing European healthcare centres €26Bn+ annually. The problem is, due to the rudimentary tools that ICU doctors use to diagnose these patients, 20% of all ECMO patients should not have been treated with ECMO and instead could have stayed in conventional intensive ventilation care.

Industry partner Mermaid Care aims to solve this problem with ECMO-BIOMARKER – the world’s first biomarker-based companion diagnostic tool for severe lung injury patients. ECMO-BIOMARKER will potentially reduce ECMO referrals by 10-20%, slashing costs for the average European ECMO centre by an estimated €23-48M annually. Based on clinically predictive biomarker measurements, ECMO-BIOMARKER uses novel algorithms and physiological model to deliver accurate diagnosis recommendations for each patient, bedside and in less than 2 minutes. This ICT-approach changes workflow and empowers low-skilled ICU doctors to perform ECMO diagnosis.

In the proposed action, ECMO-BIOMARKER value proposition (reduction in ECMO patients) will be clinically documented together with 4 world-leading partners in the field of ICU management and ECMO treatment: 3 clinical research partners – Imperial College London with the clinical site Royal Brompton Hospital (UK), Medical University of Vienna (AT) and Centre Hospitalier Universitaire de Clermont-Ferrand (FR) – and research partner Aalborg University (DK). After the project, ECMO-BIOMARKER is launched on the EU market, allowing European hospitals to cut ICU costs and improve patient quality of care. This project will allow Mermaid Care to reach sales of €160M in 2025 and hire 30 new employees. The innovation is based on +16 years of research and 10 patents.
Our overall objective is to validate the expected 20% reduction of ECMO patients using the ECMO-BIOMARKER companion diagnostic tool. The ECMO-BIOMARKER project seeks to prepare and execute a multi-centre clinical trial (MCCT) with 100 patients.
In a partnership between
• Mermaid Care (DK),
• Aalborg University (DK),
• Imperial College London with the clinical
o Royal Brompton Hospital (UK),
o Medical University of Vienna (AT) and
o Centre Hospitalier Universitaire de Clermont-Ferrand (FR),

we have established a powerful consortium of partners with extensive knowledge and experience in ICU management and ECMO treatment.

In order to execute the ECMO-BIOMARKER project succesfully, several activities are required. Those are:
- Prepare overall project management plan
- Prepare Quality Management plan
- Prepare dissemination plan
- Prepare Data management plan
- Draft a study protocol
- Obtain Ethical Approval for all sites
- Manufacture and install ECMO BIOMARKER systems at all sites and perform training for all staff members including verification of usability
- Initiate study and monitor enrollment, consenting, eCRF fill out etc, and then enroll first patient
- Mid-way interim results UK, FR and Austria
- Final patient enrolled UK, FR and Austria
- Article for journal delivered
- Mermaid Care Business plan updated

Some of the above activities have been executed for this reporting period, and today we have:
- Plans for
o The project management
o The Quality management
o The Dissemination of the results
o The Data management
- A study protocol which has Ethical approval for all sites
- Manufactured and installed ECMO BIOMARKERs at all sites and trained > 85% of all staff members for all sites (target was >75%) and with a usability score of 7.6 across all sites (target was >7, out of 9)
- And finally, our first patient on all sites have been enrolled in the study

So our ECMO-BIOMARKER project is on time and on cost, and we have achieved our deliverables and milestones for this RP1 period as planned.

Covid-19 comments:
In the end of the reporting period, RP1, we have started to face the Covid-19 challenges.
From march 2020, all our consortium partners have been impacted with the Covid-19 pandemic, and we are closely monitoring if the pandemic will have an impact on the execution of this ECMO-BIOMARKER project. In our first reporting period, RP1, it did not, but depending on the various countries lock-downs, and re-prioritization of clinical efforts, it may well have an impact.
If this occurs, it has been agreed between the consortium partners, that the coordinator will approach the Commission and ask for guidance.
For this reporting period, limited data of the expected outcome has been generated, despite the fact that we are enrolling patients, however, we have not yet enough data to be able to claim any LOS reduction. It is simply to soon/early in the project

However, when the ECMO-BIOMARKER project is completed, and we have proof of the LOS reduction, then using a simulation case that shows that when the ECMO-BIOMARKER System cuts ECMO patients by 20%, this will save one ECMO centre ~€48M/year compared to current clinical practice. This is a massive cuts in spending and will have a huge impact on cost of care across Europe.
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