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Calcivis CAIS

Financiado

Cerrado

Validation of clinical performance and pre commercial development of a novel dia...

Validation of clinical performance and pre commercial development of a novel diagnostic for dental caries assessment The project will support development of the market ready version of the Calcivis Caries Activity Imaging System (currently in advanced prototype form) and validate its clinical performance against existing standards, which will en... ver más

30/06/2017

Calcivis

3M€

Presupuesto del proyecto: 3M€

Líder del proyecto

CALCIVIS LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2017-06-30

PHC-12-2014: Clinical research for the validatio... Scope:Specific challenge: Biomarkers are used in clinical practice to describe both normal and patho...

I+D

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Características del participante

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

1 Participantes

Calcivis

2.62M€ | Lider

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Duración del proyecto: 24 meses Fecha Inicio: 2015-06-02
Fecha Fin: 2017-06-30

Líder del proyecto

CALCIVIS LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 3M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto The project will support development of the market ready version of the Calcivis Caries Activity Imaging System (currently in advanced prototype form) and validate its clinical performance against existing standards, which will enable first EU launch within one year of funding and US launch within two. The Calcivis technology is a highly innovative and globally significant dental diagnostic which has the capability to enable and accelerate the ongoing paradigm shift towards preventive dentistry. Uniquely it uses a recombinant photoprotein marker and a sophisticated imaging device to detect free calcium ions at the tooth surface, to provide diagnostic and prognostic information on the development and progression of caries lesions (tooth decay). There is a significant unmet need in dentistry to differentiate early caries lesions that are actively demineralising from those that are less likely to progress to cavitation. Current state of the art is subjective visual/tactile examination which leads to active lesions being missed and inactive lesions being unnecessarily restored. Dental practice is gradually moving towards diagnosis/prevention and away from automatic ‘drill and fill’ approaches; a shift which will be further enabled by the Calcivis System. It is the only product that can directly detect ongoing demineralisation in the clinic which enables: - differentiation of active from inactive lesions - early detection of incipient active lesions - monitoring of therapeutic effectiveness i.e. ‘switching off’ of activity To date, a prototype of the Calcivis System has been used to demonstrate proof of concept in extracted teeth and is now undergoing a pilot safety and performance clinical study. The clinical prototype was granted a CE mark in December 2013. The results of this clinical study and ongoing market research are being used to support design of the commercial device and the full clinical validation programme, which is the subject of this application.

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