Primary Performance End Point Met in First Study of Calcivis® Caries Activity Imaging System
Calcivis, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, today announces headline results from the first clinical study of its Calcivis® Caries Activity Imaging System.
The study met its primary performance endpoint relating to the System's ability to identify early active caries lesions and an excellent safety profile was observed. The study was conducted in 42 patients by four general dental practitioners based in three practices in Scotland. Full results will be published in due course.
The Calcivis Caries Activity Imaging System is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries and other dental conditions. 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. The Calcivis Caries Activity Imaging System has been granted a CE Mark.
The results of this first clinical study will be used to inform the further development of the Calcivis system.
Charles Ormond, Principle Investigator, said: "It is very gratifying to see the positive results of this first clinical study of this new technology in Scotland. The images produced have the potential to provide real insights into the ongoing demineralisation disease process."
Adam Christie, CEO of Calcivis, said: "Meeting the primary performance endpoint in our first clinical study is a very promising step in the development of the Calcivis System. The System has the potential to provide dentists with an entirely new type of information and to see it work successfully in a clinical setting is extremely encouraging. We are now making good progress with the further development of the device in preparation for commercialisation."
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 enabling caries lesion activity assessment at a single patient visit and providing insight into other conditions including acid erosion.
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.