CALCIVIS Announces FDA Filing of the Pre-market Approval (PMA) Application

1. CALCIVIS Announces FDA Filing of the Pre-market Approval (PMA) Application for Its Unique CALCIVIS Imaging System CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces that the FDA has accepted its CALCIVIS imaging system Pre- Market Approval (PMA) Application for substantive review. The filing of the PMA application to the FDA was made on 2 October 2017. Since then the FDA has conducted its initial administrative and limited scientific review and determined the submission to be complete. Subject to a successful outcome of the overall review process, the Company plans to launch its CALCIVIS imaging system in the USA in 2019. The submission contains positive data from the pivotal PMA clinical study, which evaluated the CALCIVIS imaging system in the assessment of active dental demineralisation. The pivotal 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. Results showed a highly significant level of agreement between the original dentist doing the clinical assessment and the independent dentist’s assessment 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 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”. Adam Christie, CEO of CALCIVIS, said: “The FDA acceptance of our PMA application is a major achievement for CALCIVIS. Gaining approval in the US is a key step in our strategy to maximize the commercial potential of the CALCIVIS imaging system. The in-depth market research that we have conducted with the dental community in the US gives us great confidence that there is a clear and significant market opportunity for the CALCIVIS imaging system, which allows the live visualization of active tooth demineralization. Images that will help to establish a new standard of preventive care in dentistry, which will benefit both dentists and their patients.” 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 active 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. About CALCIVIS: CALCIVIS is an innovative medical devices company focused on revolutionizing the management of dental caries or ‘tooth decay’. For more information, please visit: http://calcivis.com/