This announcement contains inside information as stipulated under the Market Abuse Regulation (EU) No 596/2014 (MAR).
Feedback plc
("Feedback" or the "Company")
First CE marked release of TexRAD® technology
Feedback plc (AIM: FDBK), the specialist medical imaging technology company, announces the first CE marked release of TexRAD®; the Company's patented quantitative image texture analysis technology for diagnostic radiological scans.
TexRAD® has the potential to assist clinicians in diagnosis, prognosis and treatment of patients with cancer and is currently installed in over 40 of the world's leading research institutions across Europe, North America, Asia and Australasia. Feedback's subsidiary company, Cambridge Computed Imaging Ltd, has affixed a CE mark to "TexRAD® Lung"; a "software only" Class 1 medical device providing additional information for the interpretation of computerised tomography (CT) and positron emission tomography (PET) scans of patients with lung cancer. The CE mark confirms that TexRAD® Lung meets the requirements of the Medical Device Directive (MDD - 93/42EEC) ensuring the technology satisfies the quality, safety and performance standards for medical devices in the European Union (EU).
Lung cancer has been the most common cancer in the world for several decades, estimated at 13% of all cancer diagnoses globally. It is also the most common cause of death from cancer worldwide, estimated to be responsible for nearly one in five. In the EU alone there are approximately 417,000 new cases of lung cancer every year. Radiologists are under significant pressure due to increasing patient numbers, more examinations required per patient and the need for earlier diagnosis. By analysing the texture features in CT scans, TexRAD®'s quantitative imaging capabilities provide clinicians with additional information to make better decisions in order to improve patient outcomes.
Dr Alastair Riddell, Chairman at Feedback plc, said: "TexRAD® Lung is our first TexRAD® product with a CE mark which represents a significant accomplishment. This development will expedite TexRAD®'s clinical use in the treatment of lung cancer across the EU, expand its market presence and support the Company's ongoing commercial discussions for the technology.
"We expect that the rigorous regulatory review required for the CE mark will pave the way for TexRAD®'s clinical use worldwide and we are now investigating the clinical application of TexRAD® in liver cancer and chronic obstructive pulmonary disease (COPD). By arming clinicians with disease-specific tools, we believe this technology has the potential to transform radiological decision making."
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Notes to editors
About Feedback plc
Feedback plc is a specialist medical imaging technology company. It develops software and systems that provide innovative techniques and improved workflows for practitioners involved in medical research and treating patients. TexRAD®, the Company's patented quantitative image texture analysis technology, has the potential to assist clinicians in diagnosis, prognosis and treatment of patients with cancer and is currently installed in over 40 of the world's leading research institutions across Europe, North America, Asia and Australasia. The Cadran platform provides a suite of medical imaging tools for decision support. The Cadran range includes the picture archiving communication system (PACS) to provide decision support for scan analysis, diagnostic workstations which provide secure remote access to view scans on demand, and products to securely share and transport patient data. Visit www.fbk.com.
About CE marking
CE marking (and compliance with the directive) is legally required before placing a device on the market in the EU. 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 Directive and contains extensive documentation on the use, design, risk assessment, testing, clinical evaluation and manufacture of the device.
For further information, please contact:
Feedback plc Dr Alastair Riddell, Chairman Lara Mott, Investor Relations |
Tel: 01954 718072 [email protected] |
Allenby Capital Limited (Nominated Adviser and Joint Broker) David Worlidge / James Thomas |
Tel: 020 3328 5656 |
Northland Capital Partners Ltd (Joint Broker) Patrick Claridge / David Hignell / John Howes |
Tel: 020 3861 6625 |
Peterhouse Corporate Finance Ltd (Joint Broker) Lucy Williams / Duncan Vasey |
Tel: 020 7469 0936 |
