Calcivis, a medical devices company focused on revolutionising the management of tooth decay, today announces that its Calcivis® Caries Activity Imaging System has been granted a CE Mark in Europe. A CE Mark is required before a medical device can be marketed in the EU and a number of other countries and signifies that the manufacturer meets the requirements of European legislation.
The Calcivis® Caries Activity Imaging System is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries (tooth decay). It involves a unique, proprietary bioluminescence approach combined with a specialised imaging device which allows accurate detection and visualisation of demineralisation by imaging free calcium ions at the tooth surface; a caries lesion which is actively demineralising is more likely to progress and lead to cavitation.
Adam Christie, CEO of Calcivis, said: “The granting of a CE Mark is a landmark for Calcivis. Our system will, for the first time, allow the real-time detection and visualisation of calcium ions released by demineralising caries lesions in routine dental practice. This has the potential to allow for tailored, rational, evidence-based treatment in line with dental best practice.
“We believe there will be significant demand for our technology and are now working towards full commercialisation.”
Professor Nigel Pitts, King’s College London Dental Institute, who has collaborated on the development of the Calcivis approach, said: “Dental caries is a significant clinical and public health problem and there are important differences in the treatment requirements for active and inactive caries lesions, with consequent marked differences in costs and outcomes for the patient, dentist and third-party payer. The ability to assess the activity of dental caries at a single patient visit has the potential to radically change the management of tooth decay, one of the most common diseases in the world and one which can have a significant impact on patients’ lives.”
The Calcivis® Caries Activity Imaging System is an in-clinic device which combines a sensitive intraoral camera and application technology to deliver a precise amount of disclosing solution, containing a photoprotein, onto the tooth surface.
The photoprotein binds calcium ions and emits a blue light signal proportional to the amount of calcium present. This exquisitely sensitive chemiluminescent system produces a demineralisation map of the tooth. The resulting images provide a focus for discussion with patients about their caries management programme and the development of a tailored, rational, evidence-based treatment in line with dental best practice.
Calcivis, a medical devices company focused on revolutionising the management of tooth decay, today announces that its Calcivis® Caries Activity Imaging System has been granted a CE Mark in Europe. A CE Mark is required before ...