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CALCIVIS Completes £4.5 million Fund Raising Ahead of Anticipated PMA Approval in US

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has closed the final part of a £4.5 million equity funding round led by Edinburgh based business angel investment syndicate, Archangels, and supported by the Scottish Investment Bank.

The proceeds will be used to support the Company’s development as it anticipates Pre-Market Approval (PMA) of the CALCIVIS® Imaging System from FDA in the US, providing access to the world’s largest dentistry market. The Company plans the launch of the CALCIVIS imaging system in the US in 2020, subject to the PMA being approved.

The PMA submission is based around 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 clinical assessment of the original dentist 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).

In addition, the results of the User and Patient Questionnaires from the study showed high levels of usability and acceptance of the CALCIVIS system, with patients reporting the procedure to be “quick and painless”.

The CALCIVIS imaging system is a sophisticated medical device and consumable combination that helps dental practitioners offer bespoke, evidence-based preventive treatment for dental caries patients. This new approach will dramatically change care planning and intervention for patients, leading to better preservation of their original teeth and improved oral hygiene.

The CALCIVIS imaging system provides reliable, visual evidence of demineralisation at an earlier stage than was previously possible. It means dentists can differentiate between active and non-active lesions on tooth surfaces, allowing them to monitor the condition of tooth enamel accurately and effectively over time. This is a significant improvement on the visual inspection and X-ray images that dentists have relied on for decades as the main detection and diagnostic aids for caries.

Adam Christie, CEO of CALCIVIS, 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.”

Dr Sarah Hardy, Chief Investment Officer at Archangels, said: “Our investment in CALCIVIS is driven by our belief that the CALCIVIS Imaging System will prove to be a catalyst for the wide-spread adoption of preventive dentistry, bringing significant benefits both to patients and dental practitioners. We are confident that PMA approval of this system will add shareholder value and we look forward to Adam and the CALCIVIS team achieving this major breakthrough, which would not only be game-changing for dentistry but an amazing achievement for the company.”

Kerry Sharp, Director of Scottish Investment Bank, Scottish Enterprise said: “We are pleased to provide further support to CALCIVIS as it progresses towards PMA approval for the CALCIVIS Imaging System, in advance of the US launch of this novel product in 2020. We have been an enthusiastic supporter of CALCIVIS for many years and we remain excited about its potential to transform dental practice globally, resulting in improved dental health for individuals, families and communities.”