Untreated caries (tooth decay) in permanent teeth was found to be the most prevalent condition evaluated in the entire 2010 Global Burden of Disease Study (Murray et al, The Lancet 380), affecting 35% of the global population. In the EU, while there has been significant progress in recent decades in the prevention of caries in children, ‘the bad news is that having damaged, missing or filled teeth is still the norm rather than the exception in Europe’ (The State of Oral Health in Europe, Patel et al, 2012). The same report identified that the cost of traditional curative dental care to the EU 27 countries ‘is close to €79 billion, and if the trends continue, this figure could be as high as €93 billion in 2020’. Improvement of oral health and containment of the associated costs requires a shift away from the curative ‘drill and fill’ paradigm, which locks patients into a cycle of recurrent tooth restoration and progressive age-related loss of tooth structure, and towards preventive dentistry. While this requires changes in health care practice, it also needs the introduction of enabling new technologies.
Calcivis is developing a globally competitive, disruptive technology that addresses a major unmet need in general dentistry. Fundamental to the effective management of caries is 1) the ability to detect caries early (before cavitation when the disease process can still be reversed) and 2) to identify which lesions are active i.e. likely to progress, and those which are inactive and therefore unlikely to progress. Until now, the assessment of caries activity has relied primarily on subjective visual and tactile inspection, which leads to active caries lesions going untreated, and the unnecessary treatment of inactive lesions.
The Calcivis Imaging System will, for the first time, allow the real-time detection and visualisation of calcium ions released by active demineralising caries lesions, in routine patient dental examinations. Early detection and assessment of caries activity with the Calcivis System will allow for tailored, rational, evidence-based treatment in line with dental best practice. It will accelerate the ongoing development of preventive dentistry and the move away from the ‘drill and fill’ paradigm.
This overall objective of the project was to get the Company to the point where the Calcivis System is clinically validated in preparation for launch, thereby accelerating commercialisation and enabling the company to raise the substantial funding and form the industry partnerships required to realise the full global potential of the technology.
The broad objectives of the project are as follows:
1. Validate the clinical performance of the Calcivis System through two clinical studies
2. Scale up manufacturing in preparation for EU launch
3. Create and submit a regulatory filing to FDA to enable US market access
