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Calcivis CAIS

Validation of clinical performance and pre-commercial development of a novel diagnostic for dental caries assessment

Total Cost €

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EC-Contrib. €

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Partnership

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 Calcivis CAIS project word cloud

Explore the words cloud of the Calcivis CAIS project. It provides you a very rough idea of what is the project "Calcivis CAIS" about.

prognostic    validate    progress    device    commercial    safety    free    ions    detect    subjective    validation    examination    progression    proof    uniquely    market    differentiate    tooth    extracted    actively    lesions    demineralisation    cavitation    restored    diagnosis    undergoing    granted    paradigm    therapeutic    2013    mark    clinic    drill    uses    monitoring    demineralising    recombinant    marker    teeth    automatic    enabled    switching    capability    ready    effectiveness    sophisticated    imaging    form    inactive    globally    preventive    gradually    ongoing    first    unmet    standards    unnecessarily    dentistry    launch    pilot    fill    december    caries    dental    accelerate    prevention    missed    performance    decay    calcium    prototype    subject    full    visual    shift    calcivis    incipient    photoprotein    moving    innovative    clinical    detection    diagnostic    away    ce    tactile    date    active    version    differentiation    leads    surface    off   

Project "Calcivis CAIS" data sheet

The following table provides information about the project.

Coordinator
CALCIVIS LIMITED 

Organization address
address: 9 Edinburgh BioQuarter, Little France
city: Edinburgh
postcode: EH16 4UX
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Project website http://www.calcivis.com
 Total cost 2˙975˙531 €
 EC max contribution 2˙615˙000 € (88%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SMEINST-2-2014
 Funding Scheme SME-2
 Starting year 2015
 Duration (year-month-day) from 2015-07-01   to  2017-06-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CALCIVIS LIMITED UK (Edinburgh) coordinator 2˙615˙000.00

Map

 Project objective

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.

 Deliverables

List of deliverables.
Receipt acknowledged by FDA Documents, reports 2019-07-24 15:31:51
Ethics and NHS R+D approval letter received Documents, reports 2019-07-24 15:31:51
Clinical study 1 report (interim) completed and approved Documents, reports 2019-07-24 15:31:51

Take a look to the deliverables list in detail:  detailed list of Calcivis CAIS deliverables.

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The information about "CALCIVIS CAIS" are provided by the European Opendata Portal: CORDIS opendata.

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