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

Project description

Sensor technology for detection and monitoring of upper gastrointestinal bleeding

Upper gastrointestinal bleeding (UGIB) is a life-threatening emergency resulting in 2 million hospitalisations each year in Europe and the United States. The Irish company EnteraSense is developing an innovative sensor technology to detect and monitor UGIB. A capsule containing the sensor is ingested in the same way as existing capsules in the market today. The optical-based sensor acquires data from the environment during its transit along the gastrointestinal tract. The data are processed to determine the presence of blood and to send a signal to an external monitor. This technology will significantly enhance the diagnostic capabilities of gastrointestinal physicians. The current EU-funded PillSense project aims to optimise the product design, develop a commercial manufacturing process, and gain clinical approval through two stages of in-human clinical trials.

Objective

Upper gastrointestinal bleeding (UGIB) is a potentially life-threatening condition that affects approx. 2 million people annually in Europe and in the United States. Current UGIB diagnosis comprises a long and slow set of laboratory tests and culminates ultimately with an endoscopy which is the only conclusive mean for UGIB diagnosis. This results in an over usage of endoscopic resources every time there is a suspicion of a bleed. Clinical data shows that up to 60% of the time endoscopy and consequent hospital admission is not necessary. In addition, endoscopy is invasive, expensive (approx. €2433) and cannot deliver prolonged monitoring. Multi-disciplinary consortium led by EnteraSense are developing a disruptive technology ‘PillSense’ which enables real-time detection of UGIB and subsequent monitoring of high risk patients without the need of endoscopy. The product includes an ingestible capsule and an external receiver. The capsule contains an optical based sensor to detect bleeding in the upper gastrointestinal tract. EnteraSense development team has already proven the core technology through lab-testing and in-vivo clinical studies. During this FTI project, the consortium aims to optimise PillSense product design, gain regulatory approvals, develop a commercial scale manufacturing process and gain clinical approval through two stages in-human clinical trials. Successful development and commercialisation will enable consortium to generate revenues of €59million and a gross profit of €29million over five years- post commercialisation.

Coordinator

ENTERASENSE LIMITED
Net EU contribution
€ 1 366 734,75
Address
PENN ENGINEERING MERVUE BUSINESS AND TECHNOLOGY PA
H91D3T0 Galway
Ireland

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ireland Northern and Western West
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 1 952 478,21

Participants (5)