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Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities

Periodic Reporting for period 5 - EUPHORIA (Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities)

Reporting period: 2021-01-01 to 2021-06-30

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 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. This combined approach allows for the effective assessment of IBD in a non-invasive manner.
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:
(i) developing a new transducer array (addressing image artefacts and enhanced bandwidth) and
(ii) implementing software adaptations (including transfer of ultrasound and optoacoustic reconstruction algorithms to a fast, parallel computing platform and adapting the system software).

The enhanced MSOT Acuity Echo is now being used in the EUPHORIA study for assessment of inflammation status in patients with IBD. The study is a multi-center diagnostic accuracy study to establish the performance of MSOT in distinguishing remission from active disease using endoscopy as a reference test. The study will be conducted at 4 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).

All ethics and regulatory approvals for the study are now in place. Despite the challenges and delays experienced as a result of COVID-19, enrolment of patients has started at site 01 University Hospital Erlangen, where 88 patients have been recruited to date. The other study sites are expected to open in August and September 2021.

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.

As we enter the final phase of the project, 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. An updated strategy for exploitation and commercialisation has been produced.

We continue to share news about the project across 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 publish peer reviewed papers as soon as the results of the EUPHORIA study are available.

We have already seen significant interest in the MSOT Acuity Echo, including first systems sales.

In the final phase of the project we will continue our work on the EUPHORIA study. 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 in the period ahead.
The MSOT Acuity Echo provides a non-invasive, patient-friendly, cost-efficient way to monitor IBD. It has particular value in IBD, because of its ability to differentiate between many types of soft tissue and fluid within the body - this enables more accurate assessment and more sensitive monitoring of IBD than other technologies.

The MSOT technology developed during EUPHORIA promises to greatly benefit patients and health care systems:
• Patients will benefit by reduced risk of complications and improved quality of life, with better and more convenient diagnosis, monitoring and care management.
• Physicians and hospitals will benefit from an easy, efficient way to monitor IBD, suitable for office-based use and for frequent follow-up.
• Payors and healthcare systems will 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 so far in the project on improvements to the MSOT technology, establishment of 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.
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