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Eliminating Uncertainty in Coronary Artery Disease

Periodic Reporting for period 2 - EU-CAD (Eliminating Uncertainty in Coronary Artery Disease)

Reporting period: 2021-08-01 to 2022-07-31

The EU-CAD project aims to solve the clinical need of improving diagnostics in Coronary Artery Disease, where 40% of all patients receive false or inconclusive diagnoses.

With the EIC grant, MedTrace can finalize its product development and seek the necessary regulatory approvals in the EU. The overall project milestones are:
1) recoding of the analytical software aQuant incl testing and validation
2) CE-marking as medical device

A total of four work packages consisting of 22 sub-work-packages have been defined to obtain these two overall milestones

This way, MedTrace can help millions of heart patients get the right diagnoses and save significant costs for healthcare systems

With the EIC equity component, MedTrace should improve its position to attract additional investors to expand the business from Europe to the US
Starting the EU-CAD project proved to be more challenging than anticipated. The first big milestone to hit is the recoding of the aQuant software, and the demand specification took four month longer than planned. Subsequently we discovered that we needed to recruit two new internal resources alone to manage this work package.

However, the solid work done on demand specification helped accelerating work package delivery once it was kicked-off. Today, we are approx. 2 months behind plan.

The overall project delivery is however not delayed as we have been able to tap into an already ongoing clinical study for our own validation testing. Besides, we have fortunately secured one of the limited seats for CE-marking at the Dutch notified body BSI, other projects have experienced wait times of 2-3 years for this.

The EU-CAD project is more relevant than ever. Demographic development increases coronary artery disease (CAD) and the cost pressure on hospitals post-Covid-19 is higher than ever before. A solution to improve diagnostics in CAD while improving efficiency and reduce costs is mitigating this pressure significantly.

There are no changes to the end products of the project deliverables, but we have had to realign the budget composition to reflect the much higher amount of internal work necessary to secure progress of the EU-CAD project in line with the overall project objectives.

WP 1 - Project Management and Dissemination
-Financial reporting, IPR management and risk register now up and running
-Thor Brønsvig has been added to the MedTrace team as Head of Controlling and Business Support applying continuous dedication to controlling the EU-CAD project
-There is a solid structure around the project now

WP 2 - Code and Infrastructure Development
-Dedicated project manger and project coordinator (2*100%)
-Code development closely monitored
-Have had first big adjustment
-Most likely challenges ahead
-Little behind schedule but more the 50% done
-First test validations of code - good results
-Clinicians eager to participate in technical validation

WP 3 - Clinical study EU
-A more relevant study (Dan-NICAD3) emerged after projects start. It was decided to collaborate with Aarhus University Hospital instead of acquiring the PACIFIC trail data from Amsterdam UMC
-All hardware systems produced at A/S Kurt Hansen
-1st installation of hardware system went really well (Uppsala, SE, see images)
-Installations delayed due to Covid-19 travel bans
-Kits has been more challenging then expected due to redesign and technical errors. Final delivery have been made.
-Notified body engaged; BSI (major achievement)

WP 4 - Market Access EU
-Most of the seven sub-work packages in WP4 have been delayed due to Covid-19’s travel bans
-Scope is not going to change, but a lighter approach necessary
-Virtual dialogue have been more positive than expected
-Mock-up produced as planned, just not used at conferences yet due to Covid-19
Three topics come to mind speaking of progress beyond the state of the art, expected results.

#1 - the "pre-approval" of MedTrace technology/solution in form the exemption permits for clinical use granted by the Danish Medicines Agency -
#2 - Using the exemption permits mentioned in #1, the impressive clinical performance of Aarhus University Hospital having scanned 1,000 cardiac patients in the period Dec 7, 2020 to Aug 10, 2021.
#3 - Despite the obvious bottleneck situation of notified bodies, that MedTrace has been able to attract a seat with the Dutch notified body, BSI in competition with larger corporate entreprises.

The performance mentioned under #2 is under academic scrutiny to document the socio-economic implications and wider societal implications of the EU-CAD project. It is too early to disclose preliminary data at this point in time, but with no adverse events and the strong performance in mind, there are basis for keeping expectations high.

For further details, please refer to the PowerPoint presentation uploaded in the Communications Centre for verbal presentation at the Status Meeting on Aug 26th.
Inside MedTrace's P3 system, the production chamber
MedTrace's P3 system (Point-of-Care chemistry system) next to a PET scanner
MedTrace's aQuant User Interface (polar maps of the heart)