Calcivis expects Pre-Market Approval (PMA) of its imaging system from US FDA, which will provide access to the world’s largest dentistry market
Calcivis, a Scottish medical devices company that focuses on the management of tooth decay and enabling preventive dentistry, has closed a £4.5m equity funding round led by Edinburgh-based angel investment syndicate, Archangels, and supported by the Scottish Investment Bank.
The company will use the proceeds to support its development as it expects Pre-Market Approval (PMA) of the Calcivis Imaging System from the US Food and Drug Administration (FDA), which will provide access to the world’s largest dentistry market.
The company plans to launch the imaging system in the US in 2020.
Calcivis submitted the PMA based on data from a clinical study, which evaluated the Calcivis Imaging System in the assessment of active dental demineralisation.
Results showed an agreement between the clinical assessment of the original dentist and the independent dentist’s assessment using the 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 also showed usability and acceptance of the imaging system.
Calcivis Imaging System is a combination of medical device and consumable
The imaging system is a combination of medical device and consumable that helps dental practitioners offer evidence-based preventive treatment for dental caries (tooth decay) patients.
The imaging system provides visual evidence of demineralisation at an earlier stage than was previously possible, allowing dentists to differentiate between active and non-active lesions on tooth surfaces.
Dentists will also be able to monitor the condition of tooth enamel accurately and effectively over time.
Calcivis CEO Adam Christie said: “We are delighted by the continuing commitment of our existing investors in this financing. This new investment allows us to continue to execute our strategy as we anticipate PMA approval for our CALCIVIS Imaging System later this year from FDA.
“We remain very confident in the potential of this new approach to preventive dentistry in the US, when it is launched in the world’s largest dentistry market in 2020.
“This optimism has been reinforced by our experience in the UK, where the CALCIVIS Imaging System has been shown to provide reliable, visualisation of demineralisation enabling bespoke, evidence-based preventive treatment for dental caries patients.”
Based in Edinburgh, Calcivis began operations in 2012 and has raised equity and grant funding totalling more than £14m since its inception.
The company has received funding from the European Union’s Horizon 2020 research and innovation programme and Innovate UK’s Biomedical Catalyst.