Periodic Reporting for period 2 - iTrust (In-time TReatment of acUte ischaemic STroke)
Berichtszeitraum: 2020-05-01 bis 2021-10-31
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 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 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 the 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.
During the project, Cercare Medical has successfully developed several software products based on the objectives of the project. During the last reporting period, work related to the training and validation functionalities was completed. These modules have been further refined and undergone additional regulatory considerations and clinical testing, resulting in the modules:
• Cercare Medical Neurosuite (CMN)
• Capillary Function (CF)
• Virtual Expert (VE)
• Intra-cerebral hemorrhage detection (ICH)
• Large-vessel occlusion detection (LVO)
The modules CF, VE, ICH and LVO constitutes a complete AIS product package and forms the core of the iTrust software.
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 the 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.
During the project, Cercare Medical has successfully developed several software products based on the objectives of the project. During the last reporting period, work related to the training and validation functionalities was completed. These modules have been further refined and undergone additional regulatory considerations and clinical testing, resulting in the modules:
• Cercare Medical Neurosuite (CMN)
• Capillary Function (CF)
• Virtual Expert (VE)
• Intra-cerebral hemorrhage detection (ICH)
• Large-vessel occlusion detection (LVO)
The modules CF, VE, ICH and LVO constitutes a complete AIS product package and forms the core of the iTrust software.
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. Administrative tasks will not be reported on, as they are not project specific.
Regarding (I), an extensive combination of customer interviews, surveys, and meetings at conferences and clinical institutions has been utilized to fine-tune the commercial strategy for Cercare Medical. Cercare Medical is collaborating with internationally recognized clinical sites such as the Karolinska University Hospital in Stockholm, Sweden. Cercare Perfusion was utilized to assess brain MRI from a patient with COVID-19 and it was found the patient had multiple lesions in the brain. This case demonstrates the clinical value of the iTrust software.
On the product development side (ii), 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 have been received from a subcontractor based on feedback from clinicians sourced during the market research and UX activities.
Regulatory-wise (iii), 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.
The second reporting period saw continued issues with the COVID-19 pandemic, which hampered implementation of the action. Being unable to fully execute the planned actions, focus was instead shifted to market needs and regulatory processes, where two new products were completed and regulatory cleared in Europe and FDA clearance was obtained for the base technology. Initial clinical and research sales to KOL institutions was also possible and will provide a good foundation for further sales and commercial growth.
Dissemination tasks (iv) to optimize and continually improve the Cercare Medical brand and the accessibility and exposure of the iTrust solution software included redesign of the company webpage. This rebranding process was based on user feedback. Marketing material such as brochures and presentations have similarly been redesigned and actively promoted on social media platforms such as Facebook and LinkedIn.
Due to the COVID-19 pandemic, radiology conferences switched to online format and Cercare Medical adjusted by actively participating in online events. During the last reporting period, Cercare Medical has participated in three online conferences:
o European Congress of Radiology (ECR) 2021 – online edition
o Neuroradiologie Aktuel 2021 – online edition
o the 56th annual meeting of the German Society of Neuroradiology – NeuroRad
The online activities of Cercare Medical have raised awareness of the Cercare Medical brand and products with statistics showing good engagement numbers on the company webpage and other online sites.
Regarding (I), an extensive combination of customer interviews, surveys, and meetings at conferences and clinical institutions has been utilized to fine-tune the commercial strategy for Cercare Medical. Cercare Medical is collaborating with internationally recognized clinical sites such as the Karolinska University Hospital in Stockholm, Sweden. Cercare Perfusion was utilized to assess brain MRI from a patient with COVID-19 and it was found the patient had multiple lesions in the brain. This case demonstrates the clinical value of the iTrust software.
On the product development side (ii), 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 have been received from a subcontractor based on feedback from clinicians sourced during the market research and UX activities.
Regulatory-wise (iii), 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.
The second reporting period saw continued issues with the COVID-19 pandemic, which hampered implementation of the action. Being unable to fully execute the planned actions, focus was instead shifted to market needs and regulatory processes, where two new products were completed and regulatory cleared in Europe and FDA clearance was obtained for the base technology. Initial clinical and research sales to KOL institutions was also possible and will provide a good foundation for further sales and commercial growth.
Dissemination tasks (iv) to optimize and continually improve the Cercare Medical brand and the accessibility and exposure of the iTrust solution software included redesign of the company webpage. This rebranding process was based on user feedback. Marketing material such as brochures and presentations have similarly been redesigned and actively promoted on social media platforms such as Facebook and LinkedIn.
Due to the COVID-19 pandemic, radiology conferences switched to online format and Cercare Medical adjusted by actively participating in online events. During the last reporting period, Cercare Medical has participated in three online conferences:
o European Congress of Radiology (ECR) 2021 – online edition
o Neuroradiologie Aktuel 2021 – online edition
o the 56th annual meeting of the German Society of Neuroradiology – NeuroRad
The online activities of Cercare Medical have raised awareness of the Cercare Medical brand and products with statistics showing good engagement numbers on the company webpage and other online sites.
During the last reporting period the interest in the iTrust solution has continued to gain momentum. The number of installations at clinical sites has been continually increasing and Cercare Medical has collaborated with several notable research institutions to continually increase the knowledge of the company and in turn drive the product development forward and explore new business opportunities.
Despite the hindrances to clinical testing imposed by the COVID-19 pandemic, the iTrust solution has shown the potential to beneficially impact not only patients in the AIS workflow, but has been shown to reach into areas that could not have been foreseen from project initiation and has been driving disease understanding and has the potential to alter clinical practice for long COVID-19 and other diseases.
Despite the hindrances to clinical testing imposed by the COVID-19 pandemic, the iTrust solution has shown the potential to beneficially impact not only patients in the AIS workflow, but has been shown to reach into areas that could not have been foreseen from project initiation and has been driving disease understanding and has the potential to alter clinical practice for long COVID-19 and other diseases.