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

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.

Field of science

  • /medical and health sciences/clinical medicine/odontology
  • /social sciences/economics and business/business and management/commerce
  • /natural sciences/chemical sciences/inorganic chemistry/inorganic compounds

Call for proposal

H2020-SMEINST-2-2014
See other projects for this call

Funding Scheme

SME-2 - SME instrument phase 2

Coordinator

CALCIVIS LIMITED
Address
9 Edinburgh Bioquarter, Little France
EH16 4UX Edinburgh
United Kingdom
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 2 615 000