CALCIVIS has raised £3.15 million to Fund PMA Approval of the CALCIVIS® Imaging System ahead of a Planned US Launch in 2019.
Proceeds will also be used to drive sales and optimise the commercial model for this novel imaging system in the UK.
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, has announced it 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 FDA’s Pre-Market Approval (PMA) review process for the CALCIVIS® Imaging System in the United States (US), the world’s largest dentistry market. The filing of the PMA application to the FDA was made in October 2017. The Company plans the launch of the CALCIVIS imaging system in the US in 2019, subject to the PMA being approved.
The PMA submission contained positive data from the pivotal clinical study, which evaluated the CALCIVIS imaging system in the assessment of active dental demineralisation. 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”.
The proceeds will also be used to drive the commercialisation of the imaging system in the UK. The CALCIVIS imaging system was launched in the UK in March this year and there has been a high level of interest following its introduction. CALCIVIS also intends to further optimize the commercial model for the system to maximise its uptake and use by the UK dental community.
The CALCIVIS imaging system is a sophisticated medical device and consumable combination designed to transform the assessment and management of demineralisation associated with dental caries and erosion. The CALCIVIS imaging system, for the first time, allows the real-time visualisation of calcium ions released from demineralising 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.
Adam Christie, CEO of CALCIVIS, said: “We are delighted by the continuing commitment of our existing investors in this financing round. This new investment positions us to gain PMA approval for our CALCIVIS Imaging System in the US ahead of a launch planned for the second half of 2019. We also plan to use the funds to drive sales and optimize the commercial model for the system in the UK where it has received a positive reception from both dentists and patients since its first launch earlier this year.”
Dr Sarah Hardy, Chief Investment Officer at Archangels, said: “This funding round will enable CALCIVIS to generate significant shareholder value by gaining FDA approval for its unique CALCIVIS Imaging System paving the way for the product US launch in 2019. We believe the system will bring significant benefits both to patients and dental practitioners by catalysing the adoption of preventive dentistry. We are proud to contribute to the growth of such an innovative company.”
Dr Zishan Haroon, Chairman and General Partner of Julz, said: “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 revolutionise 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. We are delighted to support such an innovative company providing dentists and patients with next-generation dentistry care.”
Kerry Sharp, Head of Scottish Investment Bank, said: “We’re pleased to be co-investing with Archangels and Julz Co to help CALCIVIS gain FDA approval and launch the product in the US. We’ve assisted the company on its growth journey and it’s now showing promising commercial development with the launch of its imaging system in the UK earlier this year a significant event for preventive dentistry. We look forward to working alongside CALCIVIS to help it continue to achieve its potential, both in Scotland and internationally.”