CALCIVIS Completes Patient Recruitment of PMA Clinical Study Evaluating its Unique CALCIVIS® Imaging System
EDINBURGH, Scotland, June 5, 2017 /PRNewswire/ --
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces that it has completed patient recruitment into its PMA clinical study assessing the safety and performance of a commercial version the CALCIVIS® imaging system for visualising active demineralisation on tooth surfaces. The study involved 111 patients across four general dental practices in Scotland. Edinburgh based dentist, Neil Shanks, is the study's principal investigator.
The primary endpoints of the study are to assess the safety and performance of the commercial CALCIVIS imaging system as measured by the agreement between the luminescent images and clinical assessment of caries lesion activity. The secondary endpoint is to assess the usefulness of CALCIVIS images as a communication tool between patient and dentist.
The study data will be used to support the planned US Premarket Approval (PMA) for the CALCIVIS® imaging system in the second half of 2017. The FDA has been consulted on the study design and statistical approach as part of the regulatory pre-submission process. The first data read-out from the study is expected next month.
Neil Shanks, principal investigator of the study, said: "I am pleased that we have completed this important clinical study with the CALCIVIS imaging system. This unique medical device, which allows the live visualisation of active tooth demineralisation, will help to establish a new standard of preventive care in dentistry by allowing dentists for the first time to identify active caries and erosion. It will also provide a clear explanation and justification of preventive management approaches to patients, helping to ensure their compliance."
Adam Christie, CEO of CALCIVIS, said: "The completion of the active phase of this study is a key corporate milestone for CALCIVIS as the resulting data will be a major component of our PMA filing to the FDA later this year. Gaining US approval is critical for us to maximise the commercial potential of the CALCIVIS imaging system which we believe will transform the management of enamel demineralisation associated with caries and erosion and support the wider adoption of preventive dentistry."
The CALCIVIS imaging system is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries and other dental conditions. It involves a unique, proprietary bioluminescence approach combined with a specialised imaging device which allows accurate detection and visualisation of demineralisation. The resulting images provide a focus for discussion with patients and enable the development of a tailored, rational, evidence-based treatment in line with dental best practice. The CALCIVIS imaging system has gained a CE Mark in Europe and will be launched in the UK later this year.
About CALCIVIS
CALCIVIS is an innovative medical devices company focused on revolutionising the management of dental caries or 'tooth decay'. CALCIVIS brings together novel biotechnology approaches and world-class device development expertise and is at the forefront of applying biotechnology to dentistry.
The CALCIVIS imaging system will, for the first time, allow the real-time detection and visualisation of calcium ions released by demineralising caries lesions in routine dental practice.
CALCIVIS began operations in 2012 and is based in Edinburgh, Scotland. The Company has been funded by Archangel Investors Limited and the Scottish Investment Bank, the investment arm of Scottish Enterprise. The Company has raised equity and grant funding totalling close to £8m since its inception.
CALCIVIS has received funding from the European Union's Horizon 2020 Research and Innovation programme and Innovate UK's Biomedical Catalyst.
Contacts:
CALCIVIS
Adam Christie, CEO
Tel: +44-(0)-7795-600571
E-mail: info@calcivis.com
Media relations
Citigate Dewe Rogerson
David Dible, Marine Perrier
Tel: +44-(0)-207-638-9571
E-mail: calcivis@citigatedr.co.uk
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