iThera Medical reports initiation of fifth clinical site in ongoing study for the non-invasive assessment of inflammatory bowel disease

June 21, 2022

Munich, DE – Medical device company iThera Medical announces that the fifth site in Germany has been initiated for the ongoing clinical study in the EU-funded Horizon 2020 project EUPHORIA. The project aims to further develop the company’s proprietary optoacoustic imaging technology and demonstrate its clinical value in the assessment of inflammatory bowel disease (IBD).

IBD is a chronic condition marked by recurring phases of inflammation and remission of the gastrointestinal tract. For many patients, adequate treatment can help to effectively manage the symptoms of the disease and help improve their quality of life. However, therapy failure occurs in 30-50 percent of patients, making it necessary to closely monitor inflammatory activity of the bowel throughout treatment management.

The current gold standard method to examine the bowel wall in IBD diagnosis and monitoring is endoscopy — an inherently invasive procedure that requires bowel preparation and sedation. Not only does endoscopy pose a significant burden for patients, but it also carries an additional risk of complications. A non-invasive alternative method of assessment could allow for more frequent monitoring, improve clinical understanding of disease status, and lead to better-informed decisions regarding choice of therapy.

Multispectral Optoacoustic Tomography (MSOT) is a new diagnostic imaging method based on the conversion of light energy into sound waves – also known as the photoacoustic effect. This technique combines pulsed laser excitation of tissue with ultrasound detection to allow non-invasive assessment of inflammation in the bowel wall. Through previous pilot studies, MSOT has already demonstrated its clinical value in IBD, where the technology may offer an effective alternative to endoscopy to monitor disease status.

The €2.3 million Horizon 2020 research project EUPHORIA (Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities) led by iThera Medical aims to assess the ability of MSOT to measure disease activity in patients with IBD. Clinical validation of the diagnostic performance of the MSOT Acuity Echo investigational device is underway in a multicenter international study, with the I.R.C.C.S. San Raffaele Hospital (HSR) in Milan now added as the latest initiated site and the second site in Italy.

The initiation of new study sites will allow for faster patient recruitment to acquire data necessary for the clinical validation of the MSOT technology in the application of disease monitoring in IBD. Furthermore, iThera Medical will use the feedback from the various patient and investigator groups to guide the ongoing development of the MSOT technology to best benefit doctors and their patients.

Dr. Mariangela Allocca – a leading physician at HSR’s department of Gastroenterology and Gastrointestinal Endoscopy as well as EUPHORIA’s principal investigator at the Milan study site – comments on the site’s participation in EUPHORIA: “We are very excited about the initiation of HSR, and we hope to strongly contribute to the ongoing clinical validation for the use of MSOT technology in the non-invasive assessment of IBD.”

EUPHORIA marks a key step towards establishing MSOT as a competitor in the broader medical imaging market and offering a better way to monitor IBD.

For more information on the EUPHORIA project, visit: www.euphoria2020.eu

 

 

About iThera Medical
Since its incorporation in 2010, iThera Medical develops and markets optoacoustic imaging systems for preclinical and clinical research. More recently, the company has started translating its technology for routine diagnostic clinical use across various types of diseases, including cancer, inflammatory, fibrotic, and cardiovascular diseases. Optoacoustic imaging utilizes the photoacoustic effect – the conversion of light energy into acoustic signals – to visualize and quantify optical contrast in deep tissue, at high spatial and temporal resolution. For details, see: www.ithera-medical.com

 

The EUPHORIA Project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 830965. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.

 

For further information, please contact:

Christian Wiest
Phone: +49 (0)89 700 7449-21
Email: christian.wiest@ithera-medical.com

 

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