Proceeds will be used to file a PMA with FDA and to launch the imaging system in the UK
Edinburgh, Scotland -- October 4, 2017 -- CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has secured new equity funding. Existing investors, Archangel Investors and the Scottish Investment Bank participated in the round alongside Julz, a US-based healthcare fund.
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 will, for the first time, allow 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 enable the development of a preventive treatment plan in line with dental best practice. The CALCIVIS imaging system has gained a CE Mark in Europe and will be launched in the UK later this year.
The new investment will support the next key commercialisation steps:
UK launch of the CALCIVIS imaging system to dental practices, the product's first commercial launch.
Pre-Market Authorisation (PMA) filing with the FDA before the end of 2017 in anticipation of early 2019 launch in the US.
CALCIVIS will host an event at the British Dental Industry Association 'Showcase' in Birmingham, UK, October 19th - 21st, 2017. The CALCIVIS imaging system will be presented at the exhibition and through a series of short lectures, one on each day of the event.
Adam Christie, CEO of CALCIVIS, said: "This new investment will enable the Company to progress the unique CALCIVIS imaging system towards commercialisation in the UK and the US. Our completely novel approach to dental imaging allows the live visualisation of active tooth demineralisation and will help to establish a new standard of preventive care in dentistry. Clinicians will be able to provide a clear justification to their patients for the preventive dental care plan that they propose to undertake, ensuring better compliance and allowing them to build a stronger relationship with their patients."
Dr. Zishan Haroon, Chairman and General Partner of Julz, said: "The new and distinct method used by CALCIVIS of envisioning free calcium allows early detection of demineralization. This ability dramatically changes care planning and appropriate intervention for patients leading to preservation of their original teeth and better oral hygiene. We are delighted to participate in the growth and scaling of such an innovative company providing real solutions to the dental field."
Dr Sarah Hardy, Chief Investment Officer at Archangels, said: "With a number of key value-generating milestones including clinical data, a PMA filing and the launch of the CALCIVIS imaging system in the UK expected in the coming months, we are delighted to continue to support the company as it reaches the market adoption phase in its development. We are confident that the CALCIVIS imaging system will make a real impact on the management of caries and erosion and will herald a new era of preventive dentistry in both the US and Europe."
Kerry Sharpe, Director of Scottish Investment Bank, said: "This funding round will enable CALCIVIS to demonstrate the commercial potential of their dental imaging system, taking the company to its next stage of development. It will also further contribute to Scotland's Life Sciences cluster - one of the most accessible, well-connected and collaborative in Europe."
CALCIVIS is an innovative medical devices company focused on revolutionising the management of dental demineralisation associated with caries and erosion. CALCIVIS brings together novel biotechnology approaches and world-class device development expertise and is at the forefront of applying biotechnology to dentistry.
The technology utilises a unique, proprietary bioluminescence approach combined with a specialised imaging device which allows visualisation of active, ongoing demineralisation. The resulting images provide a focus for discussion with patients and enable the development of a preventive treatment plan in line with dental best practice.
CALCIVIS began operations in 2012 and is based in Edinburgh, Scotland. The Company has been funded by Archangel Investors Limited and the Scottish Investment Bank, the investment arm of Scottish Enterprise. The Company has raised equity and grant funding totalling over £9m since its inception.
CALCIVIS has received funding from the European Union's Horizon 2020 Research and Innovation programme and Innovate UK's Biomedical Catalyst.