CALCIVIS has closed a £3.15 million equity funding round from existing investors Archangel Investors, Julz, and the Scottish Investment Bank. The proceeds will be used to support the completion of the Food and Drug Administration’s pre-market approval (PMA) review process for the CALCIVIS Imaging System in the United States. The company plans to launch the system in the United States in 2019, pending PMA approval.
The PMA submission included data from the company’s clinical study evaluating the CALCIVIS Imaging System in assessing active dental demineralization. Results showed a highly significant level of agreement between the original dentist performing the clinical assessment and the independent dentist’s assessment using the CALCIVIS Imaging System for teeth with active lesions (90.7%) and sound teeth (97.8%), according to the company. Also, user and patient questionnaires indicated high levels of usability as well as a “quick and painless” patient experience, CALCIVIS reports.
The proceeds also will be used to drive the commercialization of the imaging system in the United Kingdom. CALCIVIS launched the imaging system in the UK in March. The company additionally intends to further optimize the commercial model for the system to maximize its uptake and use by the dental community in the UK.
The CALCIVIS Imaging System is designed to transform the assessment and management of demineralization associated with dental caries and erosion, the company says. It allows for the first time, CALCIVIS reports, the real-time visualization of calcium ions released from demineralizing tooth surfaces in routine dental practice. The resulting images provide a focus for discussion with patients and enables the development of a preventive treatment plan in line with dental best practice, CALCIVIS says.
“The CALCIVIS Imaging System is a breakthrough innovation in an industry that has for long been using visual inspection and x-ray images as the main detection and diagnostic aids for caries. The CALCIVIS Imaging System is designed to revolutionize the assessment and management of dental caries by paving the way for the adoption of preventive dentistry. We believe this approach will dramatically change care planning and intervention for patients leading to preservation of their original teeth and better oral hygiene,” said Zishan Haroon, MD, PhD, chair and general partner of Julz.
Related Articles
Demineralization Detector Begins FDA Approval Process
Updated Software Improves Caries Detection Efficiency
Cavity Detector Gets FDA Clearance
