Feedback (FDBK) – Progress with CE mark and trading update

Feedback plc (AIM: FDBK), the medical imaging software company, is pleased to update shareholders on obtaining the CE Mark for TexRAD. The Group had previously announced its expectation of obtaining the CE mark for TexRAD Lung by a target date of end May 2017.  In the course of development and review in compliance with ISO 13485:2016, enhancements have been identified which will improve the performance of this version of TexRAD and which will assist in the progression of future versions to wider clinical usage. The introduction of these modifications will result in a delay of several weeks before the CE Mark for TexRAD Lung is obtained. This is not expected to have any effect on the commercial negotiations which are underway or on future sales of TexRAD.

The CE mark will allow the sale of TexRAD Lung in the EU and certain other markets as a medical device that provides analysis of PET/CT images of lung cancer for clinical use. As previously announced, Feedback’s subsidiary company, Cambridge Computed Imaging Ltd, has signed a Letter of Intent with a leading global medical imaging company which would make TexRAD Lung available for purchase on its diagnostic imaging solutions platform. The schedule for release on this platform remains unaffected.

CCI continues to pursue its ongoing discussions with other leading imaging companies to broaden the range of potential routes to market for clinical versions of TexRAD. The funds raised from the recent placing have enabled the Company to initiate recruitment for business development and customer relations positions as well as scaling up the software development collaboration with Future Processing.

Note on CE Marking

CE marking is a claim by a medical device manufacturer that a product meets the essential requirements of relevant Medical Device Directives, which outline the safety and performance requirements for medical devices in the EU.  CE marking (and compliance with the directives) is legally required before placing a device on the market in the EU.  CCI has obtained certification to ISO 13485, the International Standard relating to quality management systems for organisations involved in the manufacture of medical devices.  An appropriate quality management system and the preparation of a technical file are requirements for CE marking.  The CE technical file is a comprehensive description of the device intended to demonstrate compliance with the Medical Device Directives and contains extensive documentation on the use, design, risk assessment, testing, clinical evaluation and manufacture of the device.

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