Obiettivo 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 activityTo 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. Campo scientifico engineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsoptical sensorsmedical and health sciencesclinical medicineodontologynatural scienceschemical sciencesinorganic chemistryalkaline earth metalsnatural sciencesbiological sciencesbiochemistrybiomoleculesproteins Programma(i) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Argomento(i) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Invito a presentare proposte H2020-SMEInst-2014-2015 Vedi altri progetti per questo bando Bando secondario H2020-SMEINST-2-2014 Meccanismo di finanziamento SME-2 - SME instrument phase 2 Coordinatore CALCIVIS LIMITED Contribution nette de l'UE € 2 615 000,00 Indirizzo 9 Edinburgh BioQuarter, Little France EH16 4UX Edinburgh Regno Unito Mostra sulla mappa PMI L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione. Sì Regione Scotland Eastern Scotland Edinburgh Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 2 975 531,25
