Public Funding for Sarissa Biomedical Limited

To develop the capability to design, build and operate flexible, automated manufacturing technology for the volume production of In Vitro Diagnostic (IVD) Devices to address a global first to market opportunity.

Stroke affects 150,000 in the UK each year. It is the 3rd largest contributor towards premature death and the single biggest cause of acquired adult disability. The NHS currently spends £4.4bn on treating stroke patients with a further £5bn lost from the economy because one third of survivors need frequent assistance for personal care. Stroke is caused by blockage (ischaemic; 85%) or bleeding (haemorrhagic; 15%) within the brain’s blood supply. Ischemic stroke is a treatable neuro-emergency, patient outcome is directly related to the speed at which clot busting drugs (thrombolytics) are administered or the clot is directly extracted (intra-arterial thrombecotmy). Both of these are time-critical treatments & patients are more likely to avoid significant disability if treated as soon as possible. More than 80% of stroke patients arrive in hospital by emergency ambulance. Minimising the time to intervention (scene to needle time) requires paramedics to very rapidly identify a potential stroke and transport them directly to the nearest Hyper Acute Stroke Unit (HASU) where dedicated stroke experts and brain imaging facilities are available. Time is critical, every minute delay in thrombolysis results in ~2 days lost healthy life. Stroke is a complex condition requiring clinical experts to make the final diagnosis after brain imaging. 40% of patients where paramedics suspect stroke have a “stroke mimic” which can look identical during initial assessment by the Face Arm Speech Test (FAST). Directing these patients to HASU for administration of stroke treatments is wasteful on resources and potentially hazardous due to treatment side effects. Likewise, paramedics typically do not identify 25% of genuine stroke patients, leading to delays in treatment. Unlike heart attacks (where ECGs can be used to check patients) there is no affordable rapid means of diagnosis stroke and it would be significant benefits for stroke and stroke mimic patients, and healthcare resources if a simple, portable test was available to paramedics. The NHS is working with Sarissa Biomedical to develop a simple Point of Care (PoC) blood test to help identify stroke victim. It relies on measuring blood purine levels as these are an extremely effective indicator of acute ischemia including stroke and are released from the earliest moments of pathology. Putting this technology in the hands of paramedics will enable them to more accurately stratify stroke victims and ensure they entry the correct clinical pathway more rapidly thereby shortening the ‘scene to needle’ time and improving the chance of a good outcome. Avoiding mislabelling of stroke mimic patients will free up existing resources within the HASUs resulting in a more effective and efficient uses of expensive NHS resources. This project proposes to adapt technology already developed for A&E use so that it can be carried and applied by paramedics at the point of initial patient assessment. To achieve this we will need to work with the Hospitals, the Ambulance services to understanding their needs to make sure the equipment is suitable for their environment. We will and draw on the expertise Oxford AHSN, the Ambulance service and HASUs to determine how the equipment would be used and integrated operationally and the health economic case to prove the value for money business case. The project will then plan a clinical trial within NHS ambulance services.

Sarissa Biomedical develops & sells microelectronic (enzymatic) biosensors. Its devices are highly sensitive, selective & able to measure analytes in biological tissues & fluids such as unprocessed whole blood making them ideal for point of care diagnostics (PoC). Sarissa has identified a number of diseases where biomarkers have been proposed but the technology to accurately measure them outside a pathlab does not exist. Sarissa’s solution potentially provides a very low cost bedside/ PoC solution as an alternative to existing slow, capital intensive and high-skilled pathlab operation. The Company is currently working with a number of hospitals & Universities on clinical trials to validate biomarkers and using Sarissa’s technology to directly measure these biomarkers in whole blood. Target diseases include stroke, sepsis and foetal hypoxia. Whilst highly effective therapies exist for these diseases, the critical factor for a positive outcome is early intervention. Unfortunately current diagnostics for these conditions are slow, expensive and requiring specialist clinicians. As a result patients regularly have poor outcomes. Sarissa’s technology has the potential to transform the treatment of these conditions. The successful adoption of any new medical technology requires a clear understanding of the clinical pathway, regulatory conditions, health economics and budgetary factors of the various healthcare provider. This Proof of Market study is aimed at researching these issues to provide an understanding of the market opportunity and, in particular, where within the existing clinical pathway adoption is most likely to occur and the regulatory issues that will need to be addressed. The study will be critical in developing a business and investment plan to drive future growth of the company.