Public Funding for Surepulse Medical Limited

One in ten babies need assistance with their breathing at birth i.e. 77,000/year (UK), 14 million/year worldwide. The reasons for this include being born too early or with unexpected birthing problems. Babies receiving optimal treatment quickly and efficiently will generally go on to lead normal lives, however, those where this is not the case are at risk of long-term problems including brain damage. Healthcare professionals have several ways in which they can help sick newborn babies, but they also need ways of assessing when to start these treatments and how well they are working. They do this by measuring the baby's heart-rate (HR), oxygen levels and making sure their temperature is stable during this critical time. Currently, the stethoscope is the usual method for checking HR, but the baby's heartbeat can be weak and therefore in such a stressful environment it is known that errors occur. Pulse oximeters, instruments used to measure oxygen levels, can be awkward to apply and take as long as 5-10 minutes to provide accurate information. Temperature is not routinely monitored and this can mean babies get cold affecting recovery and even increase the risk of dying. Once stable after birth, there are considerable long-term benefits of skin-to-skin contact between parents and baby. However, there are barriers because they need to be monitored and warm, but many wires from different devices makes this challenging. We have started to address these limitations by designing a unique soft cap containing a small and safe, wireless optical sensor that measures newborn HR whilst keeping the newborn warm. This monitor is already approved for use in UK, Europe and America. We now wish to give healthcare professionals, caring for the most vulnerable high-risk babies another advanced device with extended features including ECG, oxygen levels and temperature. It will also make it easier and more natural for parents to have the essential delivery room skin-to-skin care knowing their baby is safely monitored. This new multi-function device, complementing our advanced cap, will be a safe and gentle, **chest mounted, wearable,** multi-sensor, wireless **patch** aimed at improving a baby's long-term outcome. The benefits of this patch include improved information for healthcare professionals when they need it, a better parental skin-to-skin experience post birth, and improved patient safety. We estimate after five years that this technology will benefit the lives of ~439,000 babies and their parents/year.

"Amazingly, 10% of babies need assistance with their breathing at birth ~14M/year worldwide. Reasons for this include being born too early or partial umbilical cord strangulation. Those who receive the necessary aid quickly/efficiently will generally go on to lead normal lives, however those for which this is not the case are at risk of harm including damage to their brain or blindness for example. Doctors have several ways they can help but need a way of assessing how well their treatment is working. They do this by measuring the heart rate (HR) and Oxygen Saturation (SpO2), the amount of oxygen in the baby's blood. HR becomes much lower than it should be if the baby is poorly. An increase in HR means that treatment is working. However, unfortunately there is no good way of measuring HR reliably straight after birth. A stethoscope is the common method, but the baby's heart beat can be weak making the heart's sounds difficult to hear and errors can occur in calculating the HR. SurePulse was set up to solve this dilemma. The HR monitor that we have developed uses a small and safe optical sensor mounted in a soft cap placed on the baby's head. This sensor detects small pulsatile changes in blood supply to the forehead to calculate a HR. The SurePulse monitor has been successfully tested at the Nottingham University Hospitals. The second important indicator for a newborn baby at birth is the amount of oxygen in the blood. This is measured in a totally safe manner by shining two LED colours at the skin (red and Infrared) and measuring the amount of each colour that returns. The ratio of the light power from these two colours indicates the amount of oxygen in the blood. We also have a patent that that allows us to detect the signature in these colours and we will be using this. Overall this means that we will be exploring another hugely important factor so that we can provide paediatricians with an ability to measure the SpO2 in even the smallest of babies where the signals are weak. This proposed Innovate UK project has a highly experienced team of engineers, clinicians, scientists, parents and the general public to ensure a successful outcome which will benefit newborns in the years to come."

"Around 10% of babies need assistance with their breathing at birth -- equivalent to 14M every year globally. Reasons for this include being born too early or something untoward happening during birth such as strangulation by the umbilical cord. Those who receive the necessary aid quickly and efficiently will generally go on to lead normal lives, however those for which this is not the case are at risk of harm including damage to their brain or blindness for example. Doctors have several ways they can help the baby but need a way of assessing how well their treatment is working. They do this by measuring the heart rate (HR) which becomes much lower than it should be if the baby is having problems. An increase in heart rate means that the treatment is effective. However, unfortunately there is no good way of measuring the heart rate reliably and conveniently straight after birth. Currently, a stethoscope is the common method, but the baby's heart beat can be weak making the heart's sounds difficult to hear whilst in such a stressful environment it is known that errors in calculating the heart rate commonly occur. SurePulse was set up to solve this dilemma. The heart rate monitor that we have developed uses a small and safe optical sensor mounted in a soft cap placed on the baby's head. This sensor detects small pulsatile changes in blood supply to the forehead to calculate a heart rate. The SurePulse monitor has been successfully tested at the Nottingham University Hospitals on premature babies as a pre-cursor for selling devices around Europe and USA. SurePulse aims to become the company known to provide specialised neonatal intensive care and resuscitation monitoring. This proposed Innovate UK project has a highly experienced team of engineers, clinicians, scientists, human factors experts, the parents themselves and general public to ensure a successful outcome which will benefit newborns in the years to come. The gains in terms of societal benefits, personal fulfilment and financial, that include costs of stay in intensive care, life-long support and litigation, make this an extremely cost-effective solution to a well-known problem. We now aim to engage with a wider NHS audience throughout the United Kingdom, outside of Nottingham University Hospitals, via the funding provided by this Innovate UK award."

Approximately 10% of newborns require some form of resuscitation at birth, for example because the baby doesn’t begin breathing after delivery. If babies are not resuscitated effectively they can suffer a range of poor outcomes, for example cerebral palsy due to low oxygen levels. Effective resuscitation is guided by changes in heart rate (HR). Current methods of assessing HR (via a stethoscope) are prone to error, interrupt resuscitation or only give HR after too long (1-2 mins). SurePulse is a platform technology for monitoring HR whose effectiveness has already been studied on 210 babies. The objectives, for this joint clinical, design and engineering team, are to integrate the SurePulse optical sensor into a single use newborn hat and undertake clinical studies on newborn babies. The hat will enable clinicians to resuscitate ‘hands-free’, reduce delays and errors, and so improve resuscitation outcomes, giving newborn babies the best start to life.