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Calcivis CAIS

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

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

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 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.	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.