Calcivis CAIS
Validation of clinical performance and pre-commercial development of a novel diagnostic for dental caries assessment
Total Cost €
0EC-Contrib. €
0Partnership
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0Calcivis 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.
Project "Calcivis CAIS" data sheet
The following table provides information about the project.
| Coordinator |
CALCIVIS LIMITED
Organization address contact info |
| 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.
| # | ||||
|---|---|---|---|---|
| 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
| 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.