Calcivis Starts Clinical Study To Support FDA Filing In H2 2017
EDINBURGH, Scotland, January 9, 2017 /PRNewswire/ --
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces that it has begun recruitment into a clinical study of approximately 100 patients assessing the performance of a commercial version of its CE marked CALCIVIS® imaging system across four general dental practices in Scotland. The study is the next step required to support the planned US Premarket Approval (PMA) submission later this year. The FDA has been consulted on the study design and statistical approach as part of the regulatory pre-submission process.
The study's primary endpoints are to assess the safety and performance of the commercial CALCIVIS imaging system as measured by the correlation 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 active phase of the study should be complete by mid-2017.
This post approval study follows the successful completion of a UK pilot clinical study of the prototype device in 42 patients in 2015. A controlled launch in the UK is on track for the second half of 2017.
Adam Christie, CEO of CALCIVIS, said: "The start of this study is a key corporate milestone for CALCIVIS as the data we will generate will be a major component of our PMA filing to the FDA later this year. Gaining approval for our CALCIVIS imaging system in the US is critical for us to maximise the commercial potential of this novel technology which we believe can transform the management of dental caries."
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 about their caries management programme and allow the development of a tailored, rational, evidence-based treatment in line with dental best practice. Ends-
Contacts:
Adam Christie, CEO Tel: +44 (0)7795 600571
E-mail: info@calcivis.com
David Dible, Katja Stout, Citigate Dewe Rogerson Tel: +44 (0) 207 638 9571
E-mail: calcivis@citigatedr.co.uk
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 operations began in 2012. The Company is based in Edinburgh, Scotland and has been funded by Archangel Investors Limited and the Scottish Investment Bank, the investment arm of Scottish Enterprise. http://www.calcivis.com
SOURCE CALCIVIS