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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.

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

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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