Periodic Reporting for period 1 - TISSUE (Tissue In Stroke Stratification Using e-ASPECTSTW)
Reporting period: 2014-10-01 to 2015-03-31
The aim of the TISSUE (Tissue In Stroke Stratification Using e-ASPECTSTW) feasibility study was to compose a phase II project and design a prospective clinical trial to validate the ASPECTS method and its automated version, the medical device software e-ASPECTSTW, as a biomarker on brain non contract CT (NCCT) scans to identify patients with a stroke symptoms at awakening (wake-up strokes) who are eligible for thrombolysis. These patients are 15% of ischaemic stroke patients and are currently untreated.
During the feasibility study six activity streams were carried out: (1) Detailed analysis of clinical needs/benefits based on a literature review and a survey with a structured questionnaire, (2) development of a health economics model, (3) e-ASPECTSTW technical specifications, (4) design of the protocol study and operational structure for phase 2 study, (5) risk analysis which included the identification of risks and mitigation actions related to the study, the technology and the commercialisation issues, and (6) a full business plan with market and competition analysis, positioning, marketing and market entry strategy and financial projections.
The result of the feasibility study is that the TISSUE trial will be a drug trial (with the thrombolytic drug rt-PA), as the medical device e-ASPECTSTW will be an augmented version of e-ASPECTS which is already CE marked. The trial will only include patients with symptoms of stroke on awakening (wake-up patients). The planned participating sites will be in UK, Greece and Poland. The protocol for this study has been designed in detail and the operational resource allocation has been arranged between Brainomix, George Clinical and FGK Clinical Research GmbH. In addition, a steering committee of stroke experts has been formed with a view towards the implementation of the study. 30 hospitals in UK, Greece and Poland have expressed interest to participate in the TISSUE study. The total cost of the phase II project will be 4,995,226 Euros and will last 3.5 years.
The result of the feasibility study is that the TISSUE trial will be a drug trial (with the thrombolytic drug rt-PA), as the medical device e-ASPECTSTW will be an augmented version of e-ASPECTS which is already CE marked. The trial will only include patients with symptoms of stroke on awakening (wake-up patients). The planned participating sites will be in UK, Greece and Poland. The protocol for this study has been designed in detail and the operational resource allocation has been arranged between Brainomix, George Clinical and FGK Clinical Research GmbH. In addition, a steering committee of stroke experts has been formed with a view towards the implementation of the study. 30 hospitals in UK, Greece and Poland have expressed interest to participate in the TISSUE study. The total cost of the phase II project will be 4,995,226 Euros and will last 3.5 years.
The business analysis for the route to market has demonstrated that - based on existing market entry mechanisms, networks and know-how - e-ASPECTSTW offers a very attractive business opportunity, since it will be the only clinically validated system on NCCT for the selection of wake-up stroke patients for thrombolytic treatment. This will increase Brainomix addressable market and will satisfy and unmet clinical need as wake-up stroke patients are currently untreated. Health economic analysis demonstrated that e-ASPECTSTW will be cost effective for the healthcare system and cost reducing for the hospital. Approximately 150,000 wake-up stroke patients in Europe could benefit from e-ASPECTSTW. Treatment rates will be improved, increasing the percentage of eligible patients receiving thrombolysis. Worldwide, 1,500,000 stroke patients could improve their care. This will result in a significant ROI for Brainomix while establishing the company as a market leader in diagnostic imaging for acute stroke treatment.