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In-time TReatment of acUte ischaemic STroke

Periodic Reporting for period 1 - iTrust (In-time TReatment of acUte ischaemic STroke)

Reporting period: 2019-05-01 to 2020-04-30

The iTrust project targets acute ischemic stroke (AIS), which is a disease where one or more brain arteries are suddenly occluded, leading to brain ischemia and associated neuronal death and loss of neurological function. AIS affects more than 15 million people each year of these cases 5 million die, while another 5 million become permanently disabled. While a devastating disease for patients and relatives, another aspect is the socio-economic burden for the society. According to the European Cardiovascular Disease Statistics (European Heart Network, 2017), the total cost of AIS surpasses €45 billion in EU alone, of which >€20 billion is caused by direct health care costs. An additional €11.1 billion is calculated for the value of informal care. The severity of the disease, in conjunction with its high incidence rate emphasizes the importance for the society to target this particular disease.
One great challenge in AIS contexts is the hyper-critical nature of the disease. In 2006, Jeffrey L. Saver reported that close to 2 million brain cells die each minute an artery is occluded. Hence, the most important aspect of AIS management is identification of patients eligible for timely intervention either pharmaceutically or mechanically, which defines the overarching objective of the iTrust solution.
Today the complex and time-critical therapeutic decision on AIS relies on the availability of expert stroke radiologists. However, many hospitals lack the facilities to support the standards of comprehensive stroke care, which result in only about 30% of AIS patients receiving specialized stroke unit care across Europe according to Mikulik et al (2017). Standardization of diagnosis and care across clinical levels of expertise, e.g. specialized stroke clinic to peripheral intensive care units is therefore of utmost importance. Standardization of image analysis relevant for AIS cases according to the American Heart Association (AHA) is a key element in the iTrust project, supporting AIS workflow in radiological settings from non-contrast CT scans to advanced multi-modality MRI scans.
The work performed during the project falls into several categories, including (i) market intelligence, (ii) product development, (iii) regulatory work, and (iv) administrative and dissemination tasks. The latter is considered a natural element in all projects of this character and will not be reported on here, as it is not project specific. Regarding (i), it has been very informative to attract a broader market reach. During an extensive combination of customer interviews, surveys, and meetings at conferences and clinical institutions, it has been made clear that there is a great need for the iTrust solution. Especially, the requirement for a uniform solution capable of supporting the entire workflow has been made very clear during the extensive market contact, which has spawned the specification of scope to include the early diagnostic procedures and across-site integration models. These updates to the scope fall well within two challenges noted in the project application, namely: ‘Ensure the product’s best possible support for AIS clinical workflow’ and ‘Mature the solution for the evolving radiological field’.
On the product development side, quite a bit has been achieved including all necessary steps to handle data I/O, processing of data, and AI algorithms to support the disease specific region of interest finding. In addition, the AI technologies have been streamlined and expanded upon, which ensures fast and efficient development with compliance to regulatory requirements naturally fulfilled. In addition, initial updates to the end-user facing parts of the product has been received from a subcontractor based on feedback from clinicians sourced during the market research and UX activities.
Regulatory wise, the internal quality management system (QMS) was audited by a notified body and received ISO13485 certification. In addition, an initial release of Cercare Medical software was used to attain MDD (medical device directive) certification. Hence, the European part of the regulatory compliance is progressing fully according to the planned activities.
After the initial 12 months of the iTrust project, the results have exceeded expectations. The clinical feedback on the market research has been impressive and the scientific and commercial interest in Cercare Medical technologies and solutions no less so. In conjunction with the ahead of time attained ISO13485 and MDD certification, commercial installation and in-clinic testing of the software is possible and several installations are in progress and more are planned for implementation as soon as the COVID-19 situation in Europe makes this possible. In addition, several research licenses are currently being sold in the US, which provides for additional feedback from this important market. The main part of the iTrust solution, namely the assessment of tissue outcome based on information available in the acute stage, has experienced a bit of delay for various reasons including the COVID-19 pandemic and concerns regarding GDPR. However, the flexible AI framework implemented as part of the action effectively mitigates any risk associated this delay. In short, the impact expected from the action is maintained and due to the early adoption of the technologies and possibility for direct market approach already at this stage, even higher confidence in the success of the project is attained.
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