During the first phase of EUPHORIA, we focused on optimising existing MSOT technology for application in IBD. Improvements to the technology have now been completed and implemented in the new MSOT Acuity Echo. We have succeeded in delivering improved image quality by developing a new transducer array (addressing image artefacts and enhanced bandwidth). We have also implemented software adaptations (including transfer of ultrasound and optoacoustic reconstruction algorithms to a fast, parallel computing platform and adapting the system software). We have devised a new industrialisation process for future manufacture of the transducer, which we will continue to optimise as we plan for commercialisation.
The enhanced MSOT Acuity Echo is now being used in the EUPHORIA clinical study for assessment of inflammation status in patients with IBD. The study is a multi-centre diagnostic accuracy study to establish the performance of the MSOT Acuity Echo in distinguishing remission from active disease using endoscopy as a reference test. The ongoing study will be conducted at a minimum of five sites across Germany and Italy and will include approximately 540 patients in total between two cohorts (270 Crohn’s Disease (CD) and 270 Ulcerative Colitis (UC) patients).
Despite the challenges and delays experienced as a result of COVID-19, the first patient in the study attended the site at Erlangen, Germany on 08 February 2021. As of 30 June 2022, 4 sites have been opened since the project began (with a further site expected to open soon) and there were 105 analysable patients in the study - 48 were patients with UC and 57 were patients with CD. While it has not been possible to complete the study during the lifetime of the project, due to COVID-19 delays, plans have been made to continue the study after project end.
CE mark was awarded to the MSOT Acuity Echo in May 2021. This is a significant milestone for the project and allows for initial sales of the system as a medical device (for use in general imaging). When the results of the EUPHORIA study are available, we will seek an updated CE mark, with imaging for IBD as a specified intended purpose.
iThera Medical have updated their business plan for exploitation of the MSOT Acuity Echo, and we have undertaken extensive research into reimbursement across different countries and markets. We are also developing a business case for use of MSOT in monitoring IBD, so we can demonstrate to hospitals and healthcare payors that MSOT is an effective, reimbursable, validated clinical procedure. Engagement with insurance companies, health agencies, patient organisations and other stakeholders will intensify once the study is complete and results can be analysed.
We have shared news about the project through several different channels, including our website, (
https://euphoria2020.eu/(se abrirá en una nueva ventana)) our social media accounts (e.g.
https://twitter.com/EUPHORIAH2020(se abrirá en una nueva ventana)) press releases, project materials (e.g. the project video: link), and presentations. The team intend to present on the study at key conferences and publish in peer-reviewed journals as soon as results are available.
We have already seen significant interest in the MSOT Acuity Echo, including first systems sales.
