Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities

Project Information

EUPHORIA

Grant agreement ID: 830965

DOI

10.3030/830965

Project closed

EC signature date 14 December 2018

Start date 1 January 2019

End date 30 June 2022

Funded under

• Horizon 2020 Framework Programme

Total cost

€ 3 406 968,72

EU contribution

€ 2 314 315,13

Coordinated by

ITHERA MEDICAL GMBH
Germany

Periodic Reporting for period 7 - EUPHORIA (Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities)

Reporting period: 2022-01-01 to 2022-06-30

Summary of the context and overall objectives of the project

Inflammatory bowel diseases (IBD), such as Crohn’s disease (CD) and ulcerative colitis (UC), are chronic conditions that affect more than 2.5 million people in Europe, posing a significant burden to patients and health care systems. The total economic burden of IBD (including unemployment, sick leave, and work disability costs) is estimated at €4.5-5.6 billion each year in Europe alone. There are treatments that can reduce disease symptoms and prevent severe complications, but a better way is needed to monitor IBD and assess inflammation during treatment. Endoscopy is currently the best established method for diagnosis and monitoring, but it is an invasive, expensive procedure that can cause complications and cannot be used frequently. A non-invasive alternative is needed to improve patient care and yield healthcare savings.

The EUPHORIA project aims to establish Multispectral Optoacoustic Tomography (MSOT) as a widespread routine clinical tool for non-invasive monitoring of IBD. MSOT is based on the photoacoustic effect – the emission of acoustic signals following light absorption. The enhanced MSOT Acuity Echo (developed in EUPHORIA) combines optoacoustic and ultrasound tomography. We believe this combined approach will allow for the effective assessment of IBD in a non-invasive manner.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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/) our social media accounts (e.g. https://twitter.com/EUPHORIAH2020) 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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

We believe that the MSOT Acuity Echo will provide a non-invasive, patient-friendly, cost-efficient way to monitor IBD. The technology has particular value in IBD, owing to its ability to differentiate between many types of soft tissue and fluid within the body, which may enable more accurate assessment and more sensitive monitoring of IBD than alternative technologies.

The MSOT Acuity Echo delivered in EUPHORIA has the potential to greatly benefit patients and health care systems. Our aim is that:

• Patients benefit from reduced risk of complications and improved quality of life, with better and more convenient diagnosis, monitoring, and care management.
• Physicians and hospitals benefit from an easy, efficient way to monitor IBD, with reduced risk, that is suitable for office-based use and frequent follow-up.
• Payors and healthcare systems benefit from saving costs (reducing the number of costly endoscopies, avoiding complications, and stopping ineffective treatments earlier, etc.), enabling more efficient use of clinical expertise and facilities, and improving patient outcomes.

The work undertaken during the project on improving the MSOT technology, carrying out the EUPHORIA study, achieving CE mark, assessing reimbursement opportunities, and developing an updated business plan, have laid the foundations needed for us to deliver on EUPHORIA’s key objectives in the future.

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