CALCIVIS announces that it has begun recruitment into a clinical study of approximately 100 patients assessing the performance of a commercial version of its CE marked CALCIVIS imaging system across four general dental practices in Scotland.
The study is the next step required to support the planned US Premarket Approval (PMA) submission later this year.
The FDA has been consulted on the study design and statistical approach as part of the regulatory pre-submission process.
The study's primary endpoints are to assess the safety and performance of the commercial CALCIVIS imaging system as measured by the correlation between the luminescent images and clinical assessment of caries lesion activity.
The secondary endpoint is to assess the usefulness of CALCIVIS images as a communication tool between patient and dentist. The active phase of the study should be complete by mid-2017.
This post approval study follows the successful completion of a UK pilot clinical study of the prototype device in 42 patients in 2015. A controlled launch in the UK is on track for the second half of 2017.
Adam Christie, CEO of CALCIVIS, said: "The start of this study is a key corporate milestone for CALCIVIS as the data we will generate will be a major component of our PMA filing to the FDA later this year.
Gaining approval for our CALCIVIS imaging system in the US is critical for us to maximise the commercial potential of this novel technology which we believe can transform the management of dental caries."
The CALCIVIS 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.
The resulting images provide a focus for discussion with patients about their caries management programme and allow the development of a tailored, rational, evidence-based treatment in line with dental best practice.