Feedback Regulatory News (FDBK)

13 April 2015

Feedback plc

("Feedback", the "Company" or the "Group")

Collaboration with the Oxford Stone Group, University of Oxford & Oxford University Hospital NHS Trust, Oxford, UK

Feedback plc (AIM: FDBK), the medical imaging software company, is pleased to announce that it has signed a research agreement with the Oxford Stone Group at the University of Oxford & Oxford University Hospital NHS Trust ("Oxford") in Oxford, UK to investigate the potential clinical application of Feedback's TexRAD texture analysis software on CT image data of patients with kidney stones.

The research collaboration will be led by Mr Ben Turney (Bernard Senior Clinical Researcher in Urology at the University of Oxford and Honorary Consultant Urological Surgeon) and Mr Daniel Stevens (Academic Clinical Fellow in Urology at the University of Oxford). As part of the Oxford Stone Group, Mr Turney is developing an international reputation for innovative and original research into the causes and treatment of urological stone disease.

The field of kidney stone management includes all forms of detection diagnosis and treatment of stones. In the UK, an estimated 85,000 patients attend hospital with kidney stones each year. Treatment options include Shock Wave Lithotripsy (an ultrasound based shock wave technique to break up the stones after which the tiny pieces of stone pass out of the body in the urine) or endoscopic surgery to fragment the stones using lasers. Around 40,000 treatments for kidney stones are performed in the UK each year. Stones commonly affect people between the ages of 20 and 60 and consequently the combined direct costs of treatment and indirect costs in terms of days off work are very considerable.

The majority of stone patients undergo CT scans as part of their diagnostic evaluation. TexRad based CT texture analysis of the stones in these scans might improve several aspects of stone management:

1) Diagnostic accuracy

Often there are other features on scans that can be confused with kidney stones (mimics such as phleboliths, calcification in arteries and calcified nodes). Image analysis might increase the diagnostic confidence and prevent unnecessary costly investigation and treatments.

2) Prediction of response to different treatments

Some stones respond well to shock wave lithotripsy while others are resistant. Image analysis might allow accurate triaging of patients to the correct treatment first time. This would have clear cost benefits to clinical services.

3) Determination of stone composition

Image analysis might allow correlation with stone composition. This would be important in advising the patient about prevention strategies

Potentially, these benefits could be extracted from images that are routinely acquired for patients with kidney stones.

Identifying which patients will benefit from lithotripsy would help to streamline treatment pathways and better allow clinicians to advise patients in choosing the right option for them. Similarly, using a non-invasive tool to better evaluate the composition of the stone facilitates personalised advice.

Initially Mr Turney and his team will be undertaking a pilot study of 100 patients with kidney stones on KUB CT, with four key objectives:

• TexRAD analysis of the stone on CT to look for any variation in stone characteristics. What is the heterogeneity between different stones and within individual stones?

• Evaluate the relationship between the TexRad score and clinical outcome from shock wave lithotripsy in an independent cohort of patients.

• Correlate TexRad parameters and stone composition determined by the gold standard FTIR analysis.

• Characterise the TexRad differences between stones and other mimics.

Feedback plc is focused on establishing the use of TexRAD in clinical practice. To achieve this, Feedback plc has established a strong customer base and research collaborations with key opinion leaders at world class imaging research centres and hospitals around the world. The research collaboration with the University of Oxford & Oxford University Hospital NHS Trust is another such example.

Mr Ben Turney, a leading authority on stone disease in the UK, commented:

"The prevalence of kidney stone disease is increasing globally. There is an important need to continue to develop and improve technology that will support personalised care in the management of patients with kidney stones. Feedback's TexRAD software offers the potential for important advances in this field. TexRAD captures key heterogeneity information, which will be crucial in understanding stone characteristics in a non-invasive and cost-effective manner from routinely acquired diagnostic CT images. This will potentially assist in more accurate patient risk-stratification and treatment decision choices."

Dr. Balaji Ganeshan, Chief Scientist & New Business Officer, TexRAD Ltd & CCI (both part of Feedback plc) commented:

"Mr Turney is a leading stone expert in the UK and we are delighted that he will be leading the research team working with our TexRAD software. The Oxford Stone Group as part of the University of Oxford and Oxford University Hospital NHS Trust is a leading research centre in the United Kingdom and we are delighted to be working with them and enhancing our TexRAD research collaborator base with the addition of another key site and opinion leader in the region."

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Notes to editors:

TexRAD (is a novel sophisticated imaging risk stratification research tool that analyses the textures in existing radiological scans. This research software application analyses textures, detecting and measuring tumour heterogeneity (complexity) from these images, revealing more information from medical images than it is currently possible to see with the naked eye. Research to date has shown that TexRAD could potentially assist the clinician (as an 'Imaging-Biomarker') in confident decision-making: assessing the prognosis, disease-severity (e.g. risk of metastases) and response evaluation of patients with cancer. Currently TexRAD research has shown great potential in many different oncological sites, including, colorectal, breast, lung, prostate, oesophageal, head & neck, lymphoma, liver and renal cancers and could potentially be employed as a heterogeneity assessing tool in the era of 'Precision and Personalized Medicine'.TexRAD is manufactured under licence by the ISO 13485 certified company Cambridge Computed Imaging Ltd, a subsidiary of Feedback plc. More information is available on www.fbk.com and www.texrad.com.