This document is a primer on the? CALCiViS imaging system, a medical device developed by a company called CALCiViS in Edinburgh, Scotland.

Introduction

CALCiViS was founded in 2012 by CEO Adam Christie and CTO Bruce Vernon and is based in Edinburgh, Scotland. The company’s major traction point for the past decade has been the CALCIVIS imaging system- a CE marked class IIa medical device used in the UK and Europe. CALCiViS claims to have developed a “completely novel imaging technology that enables clinicians to visualise active decay early, when it can be stopped and potentially reversed, so that patients can be treated before a cavity develops that requires drilling and filling.” The company is focused on revolutionising the way in which dental dematerialisation is managed by providing clinicians what many believe to be the “Holy Grail” of cariology (tooth decay), real-time chair side assessment of the caries (decay) disease process. Demineralisation is defined as “the removal of minerals (mainly calcium) from any of the hard tissues: enamel, dentine, and cementum.” It begins at the surface and may progress into either cavitation (tooth decay) or erosion (tooth wear).

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CALCiViS’ History

After the company’s founding in 2012, they completed the clinical study of the CALCIVIS imaging system in 2015 and raised ￡4.5 million in new equity and grand funding for the development of the imaging system. ?Over the next year or two, the company attended various events to showcase the new product such as the 2016 Chicago Dental Society, the 2016 Organisation for Caries Research, and the MedTech Showcase 2017. On January 9 2017, the company announced that it began a new FDA clinical study to assess the safety and performance of the commercial CALCiViS imaging system as well as the usefulness of the CALCiViS images as a communication tool between patient and dentist. Shortly after, CALCiViS presented new clinical evidence regarding the photoprotein within the imaging system to an International Research Association. After presenting the system to Parliament in July 2017 as well as receiving FDA acceptance in November 2017, the company finally soft launched its unique imaging system in the United Kingdom. On September 4^th?2019, the company completed ￡4.5 million fund raising which will be used to support the company’s development as it anticipates pre-market approval of the CALCIVIS imaging system from FDA in the USA, greatly extending the company’s market.

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CALCiViS’ Goal

The foundation on which CALCiViS has been built seems to be the relatively recent concept of ‘Minimal Intervention (MI) Dentistry.’ This variation of dentistry integrates modern methods of minimalist management of enamel demineralisation. ?CALCiViS believes that MI dentistry is more practical and beneficial than the traditional surgical approach of drilling and filling, which only treats the observable clinical signs of a disease, rather than dealing with the underlying causes and processes of said disease. MI dentistry has also become more viable over the years due to increasing understanding of the caries process, improved risk assessment techniques, developments in rematerialisation techniques, adhesive materials and the increased availability of new detection/diagnostic tools. The assessment of active demineralisation associated with caries is currently a challenge; when a dentist detects an early lesion, existing approaches do not allow the probability of progression to be determined. The dentistry community has now accepted the mantra that “prevention is greater than cure” as it is now recognised that early-stage enamel can be healed and the surgical approach proposed over a century ago is no longer appropriate.

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CALCiViS’ MI Principle

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1.Locate possible demineralisation sites

2.Perform CALCIVIS imaging system ‘capture’ of located sites to aid diagnosis

3.Discuss with patient and client and recommend actions to minimise identified risk factors, preventing further dematerialisation

4.Treat using reparative mineralising materials and/or sealing techniques to aid repair of enamel structure and help protect against further damage

5.Follow up

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How does the CALCiViS Imaging System work?

The CALCIVIS Imaging System allows dentists and patients to visualise active demineralisation as it happens. The system is based on the patented CALCiViS photoprotein, which reacts directly with the soluble calcium ions released from demineralising enamel to produce light, representing the “first use of biotechnology in dentistry.” Firstly, the system captures an image using visible light. Then, the photoprotein is released and in the presence of free calcium ions, a very short, low light level flash is released. An integrated intraoral sensor built in the CALCIVIS imaging system immediately detects the flash and identifies areas of high active demineralisation based on the presence of luminescent hotspots. CALCiViS believes that using these images to explain the diagnosis to the patient as well as discuss potential treatment methods will enhance communication and provide powerful visual images to motivate and engage patients.

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Figure 2: CALCIVIS imaging system with photoprotein in green

Figure 3: Tooth after bioluminescent calcium ions are released

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Summary?

In summary, CALCiViS is a medical devices company that is focused on modernising the management of tooth decay and enabling preventive dentistry. There is no denying that this novel technology has a place in today’s dentistry industry, which can be seen in the company’s growing success over the past few years. CALCiViS’ branching out to America (full US national rollout of the system is planned to begin in 2022) will greatly increase the company’s growth as the US is the world’s largest dentistry market. In conclusion, the CALCiViS imaging system is removing the old, ineffective methods of surgical dentistry and ushering in a new era of preventive, minimal intervention dentistry.

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Bibliography:

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·?“Calcivis - Crunchbase Company Profile & Funding.”?Crunchbase,www.crunchbase.com/organization/calcivis

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·?Calcivis. “CALCIVIS Completes ￡4.5 Million Fund Raising Ahead of Anticipated PMA Approval of the CALCIVIS? Imaging System in the US.”?Cision PR Newswire: News Distribution, Targeting and Monitoring, 4 Sept. 2019,?www.prnewswire.com/news-releases/calcivis-completes-4-5-million-fund-raising-ahead-of-anticipated-pma-approval-of-the-calcivis-imaging-system-in-the-us-300910797.html

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·?“CALCiViS.”?Calcivis, 5 Mar. 2020,?www.calcivis.com