CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay, announces the first commercial launch of its unique CALCIVIS imaging system in the United Kingdom (UK).
The CALCIVIS imaging system is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries and erosion. It involves a unique photoprotein that reacts directly with the calcium ions released from the tooth surface in the early stages of demineralisation. The photoprotein creates a vivid bioluminescence that is captured by the imaging device, providing visual evidence of early signs of decay. The resulting images provide dentists with unique visual information to discuss with their patients in support of their treatment plan.
CALCIVIS has generated positive data from a pivotal clinical study that compared the CALCIVIS imaging system with the current best standard of care in the assessment of active dental demineralisation. Results from the study showed a highly significant level of agreement between the original dentist conducting the clinical assessment and the assessment of an independent dentist using the CALCIVIS imaging system. For teeth with active lesions there was 90.7% agreement (p<0.0001) and for sound (healthy) teeth there was 97.8% agreement (p<0.0001).
User and patient questionnaires conducted as part of the clinical study showed that dentists found the product easy to use and that there was good acceptance of the CALCIVIS imaging system amongst patients who reported the procedure to be “quick and painless.”
Adam Christie, CEO of CALCIVIS, said: “The first commercial launch of the CALCIVIS imaging system is a transformational event for preventive dentistry. We are confident that the availability of this unique system which enables the real-time detection and visualisation of demineralisation, an early sign of caries and erosion, will speed up the adoption of preventive dentistry in the UK. For the first-time, dentists will be able to see active tooth demineralisation as it is happening, enabling them to develop a preventive treatment programme that will benefit both dentists and their patients.”
He added: “Our confidence in the potential of the CALCIVIS imaging system has been reinforced by the very positive feedback we have seen from both dentists and patients during the product’s beta launch phase. We introduced the product to dental professionals in October last year at the Dental Showcase exhibition in Birmingham and have now created our own UK commercial organisation to ensure that we can communicate the clear benefits that the CALCIVIS imaging system provides directly to the dental community. We believe its introduction will trigger the greater adoption of preventive dentistry, a more cost-effective approach to dental health that benefits both dentists and their patients.”
CALCIVIS plans to launch its unique imaging system in the United States, the world’s largest dentistry market. The Company filed a PMA application with FDA in October 2017. The Company anticipates launching the CALCIVIS imaging system in the US in 2019, subject to the successful review of its PMA by FDA.
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