Imaging Device and Photoprotein

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, presented new clinical and experimental data for the CALCIVIS imaging system at the 63rd Congress of the European Organisation for Caries Research (ORCA) in Athens, Greece on 6-9 July 2016.

CALCIVIS presented the results of a clinical study to evaluate the safety and performance of its advanced prototype CALCIVIS imaging system, the first of its kind to allow direct, real-time detection of active demineralisation by combining a special intraoral camera/applicator and a photoprotein that is applied to the teeth and produces light in the presence of free calcium ions. In this pilot study the System was used to compare tooth surfaces with and without visible caries lesions in 42 subjects (16-25 year olds). There were no adverse events relating to the use of the photoprotein and the primary performance endpoint was achieved, relating to the level of agreement between dentist assessment and the CALCIVIS images. A second poster presentation focuses on an evaluation of the CALCIVIS imaging system in an ex vivo assessment of caries activity and demineralisation following exposure to acid challenge. This study demonstrated the capability of the CALCIVIS imaging system to detect and image active mineralisation in association with caries lesions and acid erosion.

Adam Christie, CEO of CALCIVIS, said: “We are pleased to present these promising results of our prototype system at ORCA this year. The clinical results in particular provided valuable feedback for the development of the second generation, commercial, CALCIVIS imaging system. Plans for a controlled launch in the UK market early next year are well underway. We are confident that the CALCIVIS imaging system will support the ongoing shift towards preventive dentistry.

Following the successful completion of the UK pilot clinical study, 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, and PMA submission to FDA, in the first half of 2017.

The CALCIVIS imaging system is an in-clinic device which combines a sensitive intraoral camera and application technology to deliver a precise amount of CALCIVIS photoprotein, onto the tooth surface. CALCIVIS 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 patient 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 allows the development of a tailored, rational, evidence-based treatment in line with dental best practice.