Periodic Reporting for period 1 - iTRUST (iTRUST: In-time TReatment of acUte ischaemic STroke)
Reporting period: 2017-02-01 to 2017-07-31
The iTrust solution by COMBAT Stroke enables any hospital to instantaneously provide state-of-the-art management of emergency patients with AIS. iTrust is a clinical decision support system utilizing advanced medical imaging and clinical data from thousands of patients together with new technology to identify complex risk profiles in large unstructured data using dedicated deep learning technologies developed at COMBAT Stroke.
Today only 7% of patients with AIS are treated with clot-busting drugs and it is estimated, that even for ideal candidates up to 40% are not treated. The iTrust solution not only reduces time to treatment and guides the optimal medical intervention, but also promotes treatment in general through automated management. Moreover, most AIS patients arrive too late at the hospital to be considered candidates for therapy under today’s guidelines (4.5 hours). The iTrust solution has the potential to extend the treatment window by objectively assessing each patient’s individual potential for favourable outcome even with late treatment. iTrust can therefore substantially increase the number of patients receiving active therapy.
Combat Stroke forecasts to achieve cumulated revenues of over €41M and EBITDA of €30M within five years after market rollout. The feasibility study represents a key step towards the implementation of our overall innovation project, the primary goal of which is to validate the solution in patient cohorts, obtain CE-marking and finalize EU and US market strategy and business model. The project will also involve technology refinements in ease-of-use, such as user experience (UX) design, software/user interface. Through a methodical market survey, the demand for iTrust was clearly validated. Our study has shown that the above ambition is realistic if a focused route-to-market strategy is followed.
Roughly, the main results from the action are:
• Non-contrast Computed Tomography (CT) is the most used imaging technique in the acute setting of suspected stroke with respondents making use of the method in 86% of all AIS cases. Combat Stroke must focus attention in CT in the short-term to reach a wider market penetration with the iTrust software.
• Magnetic Resonance Imaging (MRI) is not frequently used in the acute setting of stroke with respondents accusing an average frequency of use (in % of cases) of 34% for diffusion weighted and 23% for perfusion weighted.
• Nearly 94% of respondents believe that the iTrust solution will reduce patients’ complications (further infarction) by accelerating the decision on the most appropriate treatment.
• There is a consensus surpassing 87% of respondents that the iTrust solution will increase confidence in the treatment decision taken by the attending physician.
• Importantly, most (75%) respondents believe that iTrust solution will open for thrombolytic treatment decision in hospitals without stroke specialists.
• The acknowledged most valuable (scored at 4.5 out of 5) proposition from the iTrust solution to KOLs is “a software that is easy to use, with minimal interaction”. Therefore, in this project we will pay close attention to improve the usability and ease of use of the software before market launch.
• Equally valuable (4.3/5) is the capacity of the iTrust solution in using CT images as input information, reinforcing the strategic importance of enabling CT-based workflows for iTrust.
• The survey conformed the unique selling points for the iTrust:
o A software that shows the location and extent of tissue predicted to infarct as a function of different treatment strategies; with nearly 70% of respondents recognizing the feature as real innovation.
o A software that uses both epidemiological and clinical markers as the underpinnings of a predictive algorithm; with over 70% of respondents acknowledging the disruptiveness of the feature.
The acknowledged more appropriate commercialization strategy for the iTrust software should be via a yearly subscription fee; whose preference was stressed by over 85% of respondents.
The results of the analysis overall confirm the suppositions set forth in the SME phase 1 application, namely that:
1. The classification for the iTrust product in the EU is CE class I.
2. The classification for the iTrust product in the US is FDA class IIa, under the product code LLZ.
In the hospital setting, iTrust’s predictions will assist the physician in choosing the individually most advantageous intervention and ensure the patient receives the state-of-the-art treatment. It is estimated that up to 7 million EUR could be saved per year per each additional 2% of patients treated timely with the state-of-the-art. On top of those socio-economic benefits, iTrust provides an attractive business case with sound and realistic economic benefits for a start-up company such as Combat Stroke that strives to reach sustainable revenue through organic growth. In addition, the solution can be the propeller for a range of additional, positive societal benefits such as job creation – with an expected 24 additional employees at Combat Stroke five years after market launch.
The commercialization of the iTrust solution will have the following socio-economic impact | New job positions at Combat Stroke):
2020 – € 750,000 | 2
2021 – € 2,250,000 | 5
2022 – € 6,500,000 | 10
2023 – € 11,750,000 | 16
2024 – € 20,000,000 | 24