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

Summary
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.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/831055
Start date: 01-01-2019
End date: 30-06-2021
Total budget - Public funding: 3 822 508,00 Euro - 2 675 756,00 Euro
Cordis data

Original description

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.

Status

CLOSED

Call topic

EIC-FTI-2018-2020

Update Date

26-10-2022
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Horizon 2020
H2020-EU.2. INDUSTRIAL LEADERSHIP
H2020-EU.2.1. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
H2020-EU.2.1.0. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Cross-cutting calls
H2020-EIC-FTI-2018-2020
EIC-FTI-2018-2020