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Accelerating market introduction of the first real-time diagnistic and monitoring device for upper gastrointestinal bleeding (UGIB)

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Improving the lives of millions with upper gastrointestinal bleeding

Around 2 million people in Europe and the United States suffer from potentially life-threatening, upper gastrointestinal bleeding. Current systems of diagnosis are cumbersome and costly, so a new approach is needed.

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Diagnosis of upper gastrointestinal bleeding (UGIB) is only conclusive through endoscopy, which means that endoscopic resources are used every time there is a suspicion of a bleed. Along with being invasive and, at around EUR 2 433 each time, costly, all too often endoscopy and consequent hospital admission are unnecessary. Along with all these drawbacks, endoscopy can only provide a snapshot of the patient’s condition at a given point in time – it is unable to provide prolonged monitoring. By using an ingestible capsule that communicates with an external receiver, the EU-supported PillSense project, developed by a consortium headed up by EnteraSense, has created a real-time detection system that can monitor high-risk patients, without the need for endoscopy. “We have submitted our technology for approval in Europe and in the United States. We are currently engaged with the Food and Drug Administration (FDA) in America and our expectation is that we will gain regulatory approval in the new year. This will put us in a strong position to commercialise the device in the United States. “In parallel we are working towards approval in Europe, but this is taking longer than it would have previously, due to the implementation of the new Medical Devices Regulation,” explains project coordinator Donal Devery.

Disruptive technology at work

As Devery explains, the form factor is very similar to existing capsules used in gastrointestinal diagnosis today. But PillSense doesn’t involve a camera, it is based on optical sensing technology. “We use the optical signature of blood to determine the presence of a bleed, its presence in the gut, and to differentiate that from any other liquids that may be present there.” This is enabled with, what Devery proudly says is: “a very elegant algorithm,” implemented in firmware in the capsule. The capsule, which acts as a sensor, gathers and transmits the data through the body to a handheld receiver unit. This displays the information on a screen, allowing doctors to make the best decision for their patient.

Accelerating care through timely monitoring

A variety of testing was carried out. “Initially, in vitro testing was performed in clinically equivalent models to determine how well the device performed. Once this was completed, the in vivo testing in a preclinical setting validated the performance and made the device ready for first human trials,” adds Devery. The team has conducted two sets of human trials, initially using the device in healthy volunteers to determine they could ingest it, that the device would detect blood, and that it would pass normally through the human gastrointestinal system. “We completed this at the Institute for Clinical and Experimental Medicine (IKEM) in Czechia under the control of Pharmnet. To detect blood, we had the volunteers swallow a mixture simulating blood and I’m happy to say the trial was very successful.” A patient study was also conducted in three hospitals in Czechia, at IKEM, Olomouc and Ostrava. “We enrolled 30 patients in the study and again the results were excellent. As expected, we were able to detect patients that have, or had bleeds, enabling the physicians to accelerate their care,” says Devery. EnteraSense has scaled up manufacturing and can supply the next 2 years of sales projections. “We are very excited to be starting on our commercial journey now. The project has positioned us perfectly to get the product to market and make a difference to patients.”

Keywords

PillSense, upper gastrointestinal bleeding, UGIB, endoscopy, EnteraSense, capsule, optical sensing technology

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