Our market disruptive TAVIguide™ ICT solution (a Software-as-a-Service platform) will be distinctly beneficial for the global healthcare system with a positive impact on two main groups: a favourable economic impact for medical centres and physicians and an improved quality of care and experience for patients. Our ICT platform addresses an innovative digital health ICT concept and service and will help to tackle the society's challenge of growing needs for sustainable and personalized healthcare (ICT Pillar VII “ICT-enabled benefits for EU society”). It provides surgeons with a groundbreaking ICT solution thanks to beyond State-of-the-Art patient-specific 3D heart modelling and blood flow simulation for pre-operative analysis and preparation of aortic valve implantation. These unique features, not found in competitive offerings, allow to correctly assess and mitigate the complications risk, thereby reducing mortality rates across all TAVI patients from up to 25% after 1 year to <5%. Our TAVIguide™ platform offers a huge potential to device manufacturers who can use the accurate modelling and simulation features to further optimize their TAVI devices and prepare the way for patient-specific valve design. Our business concept is based on a software license revenue model plus fee per case. FDA approval and validation in a prospective patient study during Phase 2 will give us a unique selling proposition for different TAVI stakeholders. Commercialization of TAVIguide™ is planned on a global scale (EU and US). Due to the growing medical importance of the TAVI procedure and an ageing population, the target TAVI market is expected to grow from 1.4B€ (2014) to 4.7B€ (2025). We aim for a 12.6% share by 2021. An additional market entry for mitral valve disease therapy, 4x the TAVI market size, will be analysed. The elaborated business plan and verified technical and marketing feasibility for additional medical applications will prepare our solution for fast market uptake.

Improving healthcare systems mandates a shift towards personalised and preventive management of disease. Specifically, the management of cardiovascular diseases has a huge impact on European society in terms of mortality, morbidity and healthcare costs, being responsible for 1.9 million deaths in the EU annually (42% of all deaths) with a total cost of €169 billion. Advances in computational and simulation technologies now provide us with unparalleled capacity to analyse clinical data in-silico, rendering the vision of an early detection of disease through model-based diagnostic biomarkers, and the design of personalised therapies through predictive models. In-silico methodologies enable the optimization of clinical protocols, from data acquisition to device parameters and intervention choices. In-silico tools also enable the reduction of animal use in the development of novel cardiac therapies and drugs. PIC is the European ITN that will train the cohort of 15 of the future innovation leaders able to articulate and materialise the vision of a Personalised In-silico Cardiology (PIC). It will address specific challenges originated by cultural and structural barriers between sectors and disciplines, articulating a fluent dialogue and work between clinicians and engineers. Fellows will be exposed to the generation of novel academic ideas, the design of practical solutions that meet actual clinical needs, the translation into industrial products, and the compliance with safety and regulation requirements. This will be achieved by pooling the expertise of leading experts from 4 academic, 3 industrial and 3 clinical beneficiaries. A highly inter-disciplinary program will be delivered in 4 research work packages, with companies leading two of them. New talent and innovation will be produced through the training in the disciplines of computational cardiac modelling, medical imaging & sensing, and clinical devices & instrumentation.

While transcatheter procedures for heart structural diseases present strong advantages over open-heart surgeries, their adoption remains low. Indeed, the difficulties to predict the optimal size and positioning of the heart implant cause high rate of complication. FEops has developed HEARTguide, a cloud-based pre-operative planning tool that will enhance the use of the transcatheter procedures. HEARTguide simulates virtually the interactions between the implant and the real patient anatomy. HEARTguide predictive power was shown in a retrospective clinical trial on 80 patient cases. HEARTguide is CE marked for two indications. The next generation of HEARTguide will be artificial intelligence-powered and the analysis will be automated. The enhanced platform will be clinically validated through four clinical trials including 700+ patients and limited access releases with selected physicians. The data base contains 1000+ patient data that surpasses all over tools marketed. Agreements have been established with several worldwide implant manufacturer leaders to run feasibility studies and clinical trials. The commercial launch of HEARTguide is planned for 2024 and intends to be clinically validated for four different applications. HEARTguide will be marketed in EU, US, China and Japan following market approvals by the respective competent authorities. Our business model is to include HEARTguide in the implant package sold by implant manufacturers to hospitals. According to our estimations, the company will grow to 125 employees by 2024 while generating a positive EBITDA of €10M.

MUltiSectoral Integrative approaches to CArdiac care – MUSICARE - is proposed by a team of universities, companies and hospitals from 4 EU countries (Italy, United Kingdom, The Netherlands, Belgium). The main scope of MUSICACARE is to structure a new trans-sectoral and multidisciplinary network capable of developing research and technology with no barriers between academia, industries and clinicians in the cardiac arena, and of shaping young researchers with a novel and truly multidisciplinary mindset, capable of developing clinical- and business-oriented technology including tools for the advancement of base knowledge. MUSICARE activity will impact on the field of cardiac surgery in three ways: i) from a scientific standpoint, new knowledge will be gained regarding the response of tissues to their surgical reshaping, to the implantation of devices and to drugs; ii) from a technological standpoint, new technologies will be developed to improve the design and generation of new clinical solutions, the clinical training, and image-based diagnosis and prognosis; iii) from an educational standpoint, a new paradigm of PhD track will be implemented, which will combine academic research in the field of biomedical engineering with industrial research activities and with on-the-field activity within clinical infrastructures. This novel PhD track will be accessed by 15 Early Stage Researchers (ESRs) recruited in the project by universities (7) and companies (8).

Market trends show advanced usage of safety-critical systems with novel services based on smart data analytics. Customers require continuous updates to applications and services and seek lower cost (Bill-of-Material, BoM) and easy to install solutions (maintenance) for safety-critical cyber-physical systems (CPS). To respond to these trends, TRANSACT will leverage edge and cloud technologies and establish business partner eco-systems to enhance safety-critical systems in regulated environments. TRANSACT will transform local safety critical CPS into distributed safety-critical CPS solutions with a heterogeneous architecture composed of components along a device-edge-cloud continuum. The distributed solutions incorporating data and cloud services will simplify the CPS devices, reducing their software footprint, and consequently their BoM and Lower of Cost or Market. Business-wise, system manufacturers thus transform to solution providers. To that end TRANSACT will research distributed reference architectures for safety-critical CPS that rely on edge and cloud computing. These architectures shall enable seamless mixing of on-device, edge and cloud services while assuring flexible yet safe and secure deployment of new applications, and independent releasing of edge and cloud-based components vs. on-device. Moreover, safety, performance, cybersecurity and privacy of data will be kept on the same level as on-device only safety-critical CPS architectures. By also integrating AI services into distributed CPS, TRANSACT will enable fast development of innovative value-based services and business models leading to faster market introduction in the various multi-billion euro markets addressed by TRANSACT. Encouraged by ARTEMIS' 2019 publication on embedded intelligence, TRANSACT will be a crucial enabler for Europe to shift towards a solution-oriented market "so as to still matter in the Embedded & Cyber-Physical Systems field of tomorrow’s world."