After winning Pitch@Med-Tech Innovation Expo, James Carpenter, CEO of SurePulse, gave us his reaction, and told us a little bit more about his company.
First, congratulations on winning Pitch@Med-Tech Innovation – without sounding too cliched, how did it feel?
It was great - it's always gratifying and a huge honour to win an award. I felt proud for the whole team who are working away behind the scenes so hard and have had to face some real challenges over the past couple of years. Also, I was delighted that the judges picked up on what is the essence of our vision at SurePulse, the importance of innovation from the very first moments of a baby’s life when every second counts. That sort of feedback really energises me and makes me want to get back to work to continue trying to make a difference!
Give us a broad overview of SurePulse, where did the idea behind the company come from?
SurePulse was born out of a collaboration between the Faculties of Engineering and Medicine at the University of Nottingham. The technology was originally being developed for monitoring the heart rate of miners working underground, and one off the Nottingham neonatologists happened to see it in a presentation and said that such a wireless approach might be very useful for the Delivery Room. Our vision to improve vital signs monitoring for newborn babies was established and then followed several years of technology and product development and clinical trials. SurePulse was spun-out of the University in 2014.
You outlined in your presentation, about the potential errors in correctly identifying and recording vital signs in newborns, tell us more about how your product range addresses those challenges?
Existing vital sign monitoring solutions do not meet clinicians' satisfaction in the Delivery Room. They are often not accurate enough or quick enough in providing a reliable heart rate, and this means that newborn babies can be over-treated (if the assessed heart rate is lower than the actual heart rate) or under-treated (if the assessed heart rate is higher than the actual heart rate). Either can result in clinical interventions that are inappropriate and can result in the baby needing to stay in hospital for longer than necessary or, sometimes even harm to the baby.
This is for a variety of reasons. Pulse oximeters are positioned on the wrist or ankle where perfusion (blood flow) is compromised, and so take a while for a heart rate to be shown; ECG is the 'gold standard' for heart rate monitoring in newborn babies and usually performs well (when available), however electrodes are fiddly to apply to wet vernix-covered skin, and can cause delays if they fall off, and occasionally in preterm babies with fragile skin there can cause skin damage; the stethoscope is the fall-back in most situations in hospitals across the UK and heart rate assessment using the stethoscope has been shown to be fairly unreliable in the resuscitation of newborn babies as it relies on mental calculations in a highly stressful environment.
SurePulse’s patented optical sensor is integrated into a soft cap which can be rapidly applied to the baby’s head at birth (preterm babies will usually have a wooly cap put on anyway to keep them warm). This positions the sensor on the forehead where blood perfusion is maintained, even during physiological compromise. These advantages enable SurePulse to provide a fast and accurate heart-rate signal wirelessly, giving clinicians and healthcare providers the right information at the right time, when every second counts.
How does your product cater for babies of different sizes? Particularly with a premature birth who would be smaller than a baby born at full term.
The caps come in five sizes and will fit babies from about 24 weeks gestational age (full-term is 37 weeks) to 42 weeks gestational age. Feedback from parents, midwives and nurses is fantastic about the Caps - the design means that they are easy to put on, very comfortable for the baby and keep them warm (this is something that was validated in one of the clinical trials). Also, there is less waste potential for the NHS - the materials that we use for the SurePulse Cap means that we have reduced the size range to 5. Many other medical hats for newborns have 12 or more different sizes.
Give our readers an idea of your presence in the medical setting in the UK.
As well as on-going clinical trial work at the Nottingham University Hospitals NHS Trust, we are now conducting a large-scale beta trial at Manchester University Hospitals NHS Foundation Trust, one of the largest trusts in the UK. We are also anticipating expanding this to two more NHS hospitals in the next month.
Tell us about the future. What else is coming down the track in terms of products, the business itself?
We’ve just received our FDA 510(k) clearance for the US market which is really exciting. The US is the world's largest healthcare market and has a huge population and 3.8 million births every year (it's about 750,000 in the UK). We are currently meeting with potential importers, distributors, and sales channel providers as well as neonatologists in the US to establish our first clinical sites. With CE and FDA approval under our belt we have major commercial opportunities in Europe and the US to realise over the next few years and alongside that, we are developing future vital signs monitoring solutions and clinical trials are due to start next year.
