Public Funding for Morgan Innovation & Technology Ltd

Over 10% of pregnant women experience high blood pressure (hypertension) and related conditions such as pre-eclampsia (PE). Untreated PE is the second biggest cause of maternal deaths - 63,000 annually worldwide, but despite this, there is no way of accurately predicting who may develop PE. This causes anxiety for expectant mothers and puts them and their baby at risk. The NHS incurs avoidable costs from monitoring pregnant women who are wrongly assigned as having a high-risk pregnancy, emergency interventions on women with undiagnosed PE and paying compensation when mothers or babies suffer due to undiagnosed hypertensive disorders. This project builds upon research that has shown that measuring the concentration of a chemical called uric acid in saliva (SUA) can predict which expectant mother will develop hypertension. Over the last ten years, Morgan Innovation and Technology (MIAT) have used a mixture of grant funding and own revenues to: \*Develop chemistry so that SUA causes a measurable colour change on a test paper, proportional to its concentration \*Develop a saliva sampling device that is easier to use than a typical pregnancy test \*Develop technology to relate colour change to SUA concentration \*Relate SUA concentration to how likely it is that a pregnant woman will develop hypertensive disorders We call this novel technology Salurate. Currently patients defined as high risk from hypertension attend extra clinics for regular blood pressure and urinary protein measurement. Yet this monitoring is not effective at identifying women who may be at imminent risk of developing complications such as PE. Salurate can identify these women more accurately, with a non-invasive test that women can use at home. By identifying women more accurately, and earlier, women who really need it can get the targeted treatment they require. Our aims in this project are: 1.Maximise performance and minimise environmental impact of sampling device 2.Conclude associated software development 3.Carry out a clinical study on 4,000 participants to validate the data-learning algorithm from a representative UK population 4.Produce a technical file compilation for regulatory approval (UKCA marking) We plan a pilot launch for Salurate within six months of finishing the project. Ultimately, we aim to save the NHS £22m per year and improve patient outcomes by reducing inconvenient clinic attendances and identifying the women who need further interventions more accurately.

Around 300,000 women start experiencing hot flushes every year in the UK. They are uncomfortable, embarrassing and above all inconvenient, striking any time - day and night. Choosing a solution can be confusing and difficult. Those days could soon be gone. Enter Grace (product name), the world's first automated tracking and cooling bracelet, ready to detect and fend off your flushes 24 hours a day. Grace aims to detect a hot flush before you know you're going to have one. At that point, a cooling patch is activated on your wrist, aiming to reverse the effects of a flush. With full automation, Grace can also be worn while you're asleep to combat your night sweats. The aim of the project is to demonstrate technical and commercial feasibility of Grace. This will be achieved by creating prototypes and recruiting highly symptomatic women to validate performance. Our consortium brings together leading experts in the development, manufacture and commercialisation of medical products. Furthermore, Loughborough University, highly-rated in national university league tables and ranked No.1 in the world in the QS World University Rankings by Subject for three years in a row, is a project partner to validate the performance of Grace. Successful project delivery will enable our vision to change global perceptions of stigmatised health conditions, paving the way for health-tech designed to be seen.

"We aim to create an innovative device for use in vitreoretinal surgery (operations to treat sight-threatening eye disorders involving the retina, macula, and vitreous fluid). The opportunity is that the mixing and introduction of a gas/air mix during vitreoretinal surgery using current devices is imprecise, subject to human error, and its critical parameters cannot be measured or recorded for audit and risk control. Current practice relies on manual gas/air mixing operations and is subject to human error in terms of accuracy and homogeneity of the % mix, and inaccuracy and instability of pressure when the gas mix is introduced into the eye during the operation. Inaccuracy and inhomogeneity of the gas mix, and inaccuracy and instability of pressure, are potentially dangerous, and may lead to surgical failure or complication, and consequent sight loss. Mistral - our innovative system - will overcome the limitations inherent in current techniques through the use of calibrated, precise, and reliable gas mixing and delivery; it will also support recording of all clinically-relevant parameters, ensuring traceability. The successful outcome of the project will mean safer operations that are quicker and less expensive, and better surgical outcomes."

Haptic technology, or haptics, is a feedback technology, which mimics the sense of touch by applying stimuli, such as compression, friction & vibration forces to the user. In gaming & in "sensory rehabilitation" for individuals with disability, the ability for a user to 'feel' a virtual environment as well as ‘see’ it would be a significant advance on what is currently available & will open up numerous opportunities. MIAT, in conjunction with Southampton University, is developing a haptics (multi sensory) system for the hand that will provide the user with a sense of touch, which when combined with position sensing technology, will allow the user to 'see' that motion or action. This technology has significant commercial potential as a gaming product, particularly as virtual reality gaming is becoming more popular, but will also be transferable to pioneering rehabilitation technology for sensory re-education in medicine, e.g. stroke recovery.

There is currently a clinical study being undertaken in 6 hospitals of up to 1000 women for Salurate a predictive device which tests for the condition known as pre-eclampsia which can occur during pregnancy. The clinical study is to confirm the results of a Pilot Study carried out at one of the hospitals and is partly funded by a TSB Grant. The grant also covers the completion of the design, potential manufacture and determination of whether the best route to market is through distribution or licencing of the device. It was thought probable that the latter would ensure quicker penetration of the market but that a foreign licensee was most likely. Working with the NHS on the study has identified a further alternative route to market that of offering a unique telehealth testing service and the Company wishes to investigate its feasibility in parallel with the current work.

Intra-arterial catheters are used to introduce fluids, such as drugs, into or take blood samples from patients. The catheter itself is a small plastic tube with connectors. The plastic tube is inserted into the artery and the connectors lie on the outside of the patients’ body making introducing fluids or taking samples straightforward and painless. Intra-arterial catheterisation procedures have become very common in modern medical practice and are of great benefit to patients for a number of reasons, especially when operating in critical areas such as the brain and the heart. However they are not without risk. One potential problem is that blood clots can form at the end of the plastic tube within the artery and these can cause minor and major clinical incidents. To prevent the clot formation saline is dripped through the catheter either manually or through an electronic infusion pump. There are however a number of documented deficiencies with the latter which means that the potential for clot formation is not eliminated. This study is to quantify the rates of blood clot formation incidents, and other associated problems and to explore the possibility of designing and developing a new system, to be manufactured in the UK, that would connect with current infusion pumps to eliminate the deficiencies.

Pre-ecampsia (PE) is a syndrome that is a major cause of morbidity and mortality in mothers and babies. Current indicators have limited reliability, an apparently-well woman throughout pregnancy may suddenly develop PE symptoms close to term, with potentially catastrophic consequences. There have been many studies, in 2008 Khan et al reviewed over 1700 research problems which were seeking a reliable test for PTE and none were judged to be effective. The need for such a test is not questioned. A Pilot Study carried out by a clinician in Hampshire showed a causal link between the uric acid levels in the saliva of pregnant women and gestational problems such as preeclampsia and small babies. The test which is simple, non invasive and inexpensive, appears to be much more accurate than traditional PE indicators and in particular appears to have greater efficacy in predicting gestational problems from week 20 onwards than other tests. With regard to pregnancy the UK has an unacceptable annual record, with over 4000 still births, 2500 neo natal deaths and over 80 maternal deaths per annum, indicating an urgent need for early identification of those pregnancies that may be at risk, to allow preventative measures to be taken. The study gave, on average, indications of problems as early as 24 weeks, some 6 weeks earlier than other tests. The study used a prototype testing system on 135 pregnant women; a multi centre study with up to 1000 subjects is now proposed to confirm the efficacy of the test to provide an evidence based solution to a problem that causes much distress to many families and adds considerable cost to maternity services across the world. It is only with evidence from a multi centre study that there will be adoption of the test in the UK and overseas.