CALCIVIS five years and counting

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The 13th August 2017 marks the five-year anniversary of CALCIVIS innovative caries visualisation technology

The 13th August 2012, is a milestone in the history of CALCIVIS. On this date, Adam Christie (above left) and Bruce Vernon (above right) co-founded the company to pursue the novel idea of visualising enamel demineralisation using biomarkers. With Dr James Browning as chair and Emma Christie managing financial matters and equity funding of £1.2 million from science-focused investment firm Archangels and Scottish Investment Bank, CALCIVIS became one of Edinburgh BioQuarter’s first residents.

The company’s operations grew quickly with Marjory Willins establishing its clinical research facility in early 2013. An advanced prototype system focusing on capturing active caries images was developed by year end, gaining CE marking in December 2013 with the appointment of LRQA as the notified body.

The company subsequently received ISO13485 accreditation and began preparation for post-approval clinical studies, meeting the US Food & Drug Administration first in January 2014 to agree on a US regulatory path. In 2015, CALCIVIS was awarded a grant of 2.6 million euros from the European Commission’s Horizon 2020 programme for research and innovation. The grant, along with an additional £2.6 million funding from Archangels, contributed to impressive growth in its operations, including the development of a commercial device, the hiring of a dedicated scientific/laboratory team and increased clinical, regulatory and supply chain capabilities.

Following a pilot clinical study in 2014/15, initiation of larger scale clinical studies began with the availability of a commercial version of the CALCIVIS imaging system in late 2015. The commercial supply chain for the photoprotein and associated consumables was also established over this period. Pre-launch preparations began in 2016 following the appointment of Robert Teague as marketing and sales director.

A UK beta test was initiated in the second quarter of 2017 across 20 practices and CALCIVIS participated in two major UK dental shows. The summer has brought more major gains, with the FDA Premarket Authorisation (PMA) due for submission in Q3, with a decision on approval set for 2018.

In five short but significant years, CALCIVIS has set a firm course to launch its revolutionary approach towards the preventive management of active caries, and its imaging system is scheduled for release before the end of the year.