The Food and Drug Administration (FDA) has accepted a pre-market approval (PMA) application from CALCIVIS for its imaging system for substantive review. The imaging system uses a unique, proprietary bioluminescence combined with a specialized imaging device to accurately detect and visualize active demineralization, enabling dentists to better discuss evidence-based and personalized treatment with their patients.
CALVICIS filed its PMA application on October 2, 2017. Since then, the FDA has conducted its initial administrative and limited scientific review and determined that the submission is complete. Subject to a successful outcome of the overall review process, the company plans to launch its CALCIVIS imaging system in the United States in 2019.
The system uses a photoprotein, or a dental biologic that produces light when it reacts with the free calcium ions released on actively demineralizing tooth surfaces. This reaction creates a short, low-level flash of light that is undetectable by the naked eye and is only possible in the presence of free calcium. Since bound calcium in sound enamel does not generate the light signal, the system delivers a predictable result with low or no false positives.
The CALCIVIS imaging device is designed exclusively to image the tooth surface after delivering a metered dose of the photoprotein. Initiated by a one-touch computer controlled process, a specialized sensor integrated into the device immediately detects the luminescence that results from the photoprotein dose. In less than a second, the system’s software presents a chairside demineralization hot-spot image map to clinicians, enabling better dialogue with patients.
The application included positive data from the PMA clinical study, which evaluated the system in the assessment of active demineralization of tooth surfaces in patients aged 6 years and older. It assessed the safety and performance of the imaging system as measured by the correlation between the luminescent images it produced and a clinical assessment of active demineralization associated with caries lesions. Also, the study assessed the usefulness of the system’s images as a communication tool between the patient and dentist
“The level of correlation between the images and clinical assessment gives us great confidence in the ability of the system to assess active demineralization. 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,” said study principal investigator Neil Shanks. “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.”
The results also showed a highly significant level of agreement between the original dentist doing the clinical assessment and the independent dentist’s assessment using the system for teeth with active lesions and healthy teeth, according to CALCIVIS. Plus, the results of the user and patient questionnaires showed high levels of usability and acceptance of the CALVIVIS system with patients reporting the procedure to be “quick and painless.”
“The in-depth market research that we have conducted with the dental community in the United States 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,” said Adam Christie, CALCIVIS CEO. “Images that will help to establish a new standard or preventive care in dentistry, which will benefit both dentists and their patients.”
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