Calcivis, a medical devices company focused on the management of tooth decay and enabling preventive dentistry, has closed a £3.15m equity funding round from existing investors Archangel Investors, Julz and the Scottish Investment Bank.
Image: Calcivis has raised £3.15m to fund PMA approval of imaging system. Photo: courtesy of CALCIVIS.
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 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.”
CALCIVIS is an innovative medical devices company focused on revolutionising the management of dental caries or ‘tooth decay’. CALCIVIS brings together novel biotechnology approaches and world-class device development expertise and is at the forefront of applying biotechnology to dentistry.
Source: Company Press Release