System designed to catalyse a paradigm shift towards the preventive management of caries
Edinburgh, Scotland – Calcivis, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, showcased for the first time a prototype of its Calcivis® Caries Activity Imaging System device at the 151st Meeting of the Chicago Dental Society, held in Chicago, USA.
The Calcivis® Caries Activity Imaging System is the first device to allow dentists to see active demineralisation, a key step to them practising the preventive management of caries. The Calcivis system is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries and other dental conditions.
Adam Christie, CEO of Calcivis, said: “I am pleased to be able to showcase Calcivis’ lead product to dental professionals at the Meeting of the Chicago Dental Society. It is the first system that allows direct, real-time detection or imaging of active ongoing demineralisation. We are confident that these unique capabilities will catalyse a paradigm shift towards the preventive management of caries. We are excited about our plans for a controlled launch of the product in the UK market early next year and its US commercialisation by the end of 2017.”
Following the successful completion of the UK pilot study in 2015, Calcivis is on track to conduct two larger studies in 2016, including one to support the PreMarket Authorisation (PMA) filing to FDA and another in an orthodontic setting. These studies are expected to support a controlled launch of the product in the UK in early 2017 and in the US market later that year.
The Calcivis® Caries Activity Imaging System is an in-clinic device, which combines a sensitive intraoral camera and application technology to deliver a precise amount of disclosing solution, containing a photoprotein, onto the tooth surface. The photoprotein binds calcium ions and emits a blue light signal proportional to the amount of calcium present. This exquisitely sensitive chemiluminescent system produces a ‘demineralisation’ map of the tooth, enabling caries lesion activity assessment at a single visit and providing insight into other conditions including acid erosion.
The resulting images provide a focus for discussion with patients about their caries management programme and allow the development of a tailored, rational, evidence-based treatment in line with dental best practice.