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.
