CALCIVIS announces positive results from PMA clinical study evaluating its unique imaging system
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces positive results from its pivotal Premarket Approval (PMA) clinical study evaluating its unique CALCIVIS imaging system in the assessment of active dental demineralisation. The successful study provides the clinical data needed for the Company’s US PMA submission to the FDA due before the end of this year.
The PMA study’s primary endpoints were to assess the safety and performance of the CALCIVIS imaging system as measured by the correlation between the luminescent images produced by the system and a clinical assessment of active demineralisation associated with caries lesions. The secondary endpoint was to assess the usefulness of CALCIVIS images as a communication tool between patient and dentist. The FDA was consulted on the study design and statistical approach as part of the regulatory pre-submission process.
Results showed a highly significant level of agreement between the original dentist doing the clinical assessment and the independent dentist using the CALCIVIS imaging system for teeth with active lesions (90.7%; p<0.0001) and sound (healthy) teeth (97.8%; p<0.0001).
The study recruited 110 patients. No adverse events related to either the device or photoprotein were reported. The results of the User and Patient Questionnaires showed high levels of usability and acceptance of the CALCIVIS system with patients reporting the procedure to be “quick and painless”.
Neil Shanks, Principal Investigator, said: “I am very pleased that the study has proved to be such a resounding success. The level of correlation between the images and clinical assessment gives us great confidence in the ability of the system to assess active demineralisation.
“In practice this will mean that we can identify active decay early, before cavities form, and use preventive products such as sealants or fluoride varnish, to prevent progress of the lesion. Perhaps most importantly, we can use the images to show patients where there is a problem and to demonstrate the effectiveness of the preventive treatment plan.”
Adam Christie (above) CEO of CALCIVIS, said: “The positive data from this pivotal study confirms the ability of the CALCIVIS imaging system to clearly identify teeth with active lesions paving the way for preventive dentistry.
“Successfully completing this study is a key milestone for CALCIVIS as the data will form a major component of our PMA filing to the FDA. Gaining US approval will allow CALCIVIS to maximise the commercial potential of its unique imaging system, the first to allow the live visualisation of active tooth demineralisation.”
“We believe this unique technology will accelerate the development of a new standard of preventive care in dentistry.”
The PMA study was a prospective, multi-site, non-randomised, post-approval study to investigate the use of the commercial version of the CALCIVIS imaging system in the assessment of active demineralisation of surfaces of teeth in patients aged ≥6 years (NCT02780856). At Visit 1, photographs were taken with a standard intra-oral camera and patients were then imaged with the CALCIVIS imaging system. Patients returned at 7–14 days after Visit 1 for an oral examination. An independent dentist reviewed all images.
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.