James Carpenter, SurePulse Medical - Wireless Heart Rate Monitor | LSI Europe '22

Transcription

James Carpenter  0:00  

Good afternoon, everyone. It's great to be here I'm I'm James Carpenter. And our mission at SurePulse is to improve the life chances for premature and sick babies. And that's because one in 10 Babies need some form of stabilization or resuscitation immediately after delivery. So this might be because they're born premature, or have congenital defects, or had some trauma during the actual delivery process, such as the umbilical cord being wrapped around the baby's neck. That adds up to around 77,000 in the UK funeral 80,000 in the USA. Now to that there'll be a range of outcomes. But at the more severe end, those babies that are starved of oxygen during the resuscitation process or delivery process, which adds up to around 10,000 a year in the USA 1700 a year in the UK. And within that group, there's a number of what what have been identified as avoidable deaths. These are ones where mismanagement of the resuscitation could have actually prevented the death from taking place. So when a baby is born, on the left is an extract of the neonatal resuscitation guidelines. These are really the first few steps that are designed to take place within the first 60 seconds. So obviously, once the baby is born, the aim is to delay the clamping of the cord because that allows vital blood flow and oxygen to get to the baby to dry and wrap to stimulate the baby to keep them warm. And then immediately to make an assessment of the tone, and the breathing and the heart rate. Now, it's been shown through studies and meta analysis of adherence to this program that up to 55%, of resuscitations, and that's in the USA, do not adhere to the basic steps of the neonatal resuscitation program. This is for a variety of reasons, but one of the main ones is around the actual monitoring technology that is available to clinicians and healthcare providers at birth. So pulse oximeters, which are ubiquitous in hospitals now can be very slow to pick up a reading, I've got some data coming up showing that one pulse oximeter took six minutes to pick up a heart rate after birth, ECG electrodes don't stick very well to freshly born skin, they fall off and go go skin stripping. And so clinicians fall back on the stethoscope. And that's been shown to have one in three assessment errors. And so when things go wrong for these for these babies, they can go badly wrong, resulting in brain damage and more adverse morbidities and mortality. So our vision of SurePulse is to give clinicians and healthcare providers the tools they need to write optimal newborn care. And our product strategy ranges from giving the basics of a vital sign monitoring the heart rate, which is essential for Infinity resuscitation in our VS cap through a multiparameter system for extremely premature babies. And to build on that platform of sensing and data gathering with a data and analytics platform that provides intelligent analysis of the resuscitation data and information for skills improvement and personalized training. We now have a suite of six patents underlying the technology and form factor the product of which four are granted. And our freedom to operate search has not identified any conflicts with our competitors. So the VS Cap is a wireless heart rate monitor that's specifically designed for you straight after birth. So lots of existing monitors are kind of really adult devices that are repurposed for neonatal care. This is an optical sensor integrated into a bonnet, it's put on a bonnet put on every baby to keep their head warm, that communicates wirelessly with the display, which is mounted on the resuscitation table. This now has C approval and FDA clearance. Here's just an example of some of the data that the device gives in comparison to a pulse oximeter. So the the time trace on the left starts at birth. You see the pulse oximeter in orange takes six and a half minutes to pick up a pulse rate. And at that time, the pulse rate is actually incorrect. And it's hard to the actual rate, whereas the short pulse picks up within 35 seconds. Now when every second counts, this is absolutely absolutely critical to give clinicians what they need to to be able to manage the resuscitation appropriately. And current technologies just don't do what they need to. Whereas SurePulse because of the location of the sensor and the optimization for birth, we can pick up the heart rate when it's needed. We're really excited about the next phase of our of our products, which is a multiparameter patch. Again, this is specifically designed for you straight after birth. So it consists of a multiparameter sensor that is actually attaches to the wet newborn skin using a polyethylene wrap that sticks using surface tension and the properties of the vernix and other liquids on the skin. It measures oxygen saturation, pulse rate, ECG and temperature. It uses video recording for the purposes of audit and training and also interfaces with with respiratory function monitors. So this is a complete resuscitate Patient package for extremely premature infants. And, again, is designed to give clinicians everything they need to manage these babies in the best way possible. So with RDS cat, we now have five pilots across the UK, and one in the USA. We're now seeking to sign a US distribution partnership with our patch products. We're at clinical trial prototype stage standard clinical trials within a month or so, and aiming for FDA submission in the middle of next year. We're targeting a large and growing market rates of prematurity are increasing is about $7.7 billion spent on neonatal care across the the UK EU and USA, around 25% of that is spent on monitoring. But just working from the bottom up. We operate a razor razor blade model with the caps and patches being single patient use and these are priced from 40 to $100. The actual Capitol displays are priced from 5000 to $15,000. dollars for the multiparameter system. And with a license fee for the the audits and training package. It's around the target market of around $800 million per year with a beachhead of $46 million dollars BIA which represent the highest risk births. In terms of competition, there are a number of players now looking at operating in the neonatal field. Laerdal is the only one that's actually looking at the problem of resuscitation and they're offering only does ECG heart rate. Other players such as Siebel and vitals are looking at the intensive care environment. But their offerings firstly aren't indicated for use in the neonatal, the neonatal period, and also to have the complete range of vital sign parameters. So we're the only company looking at giving clinicians everything that they need in a specific package that will work for babies in those crucial moments after birth. So I founded the company along with Don Sharkiv clinical director and bio skill. Our research director, Barry previously founded Monica healthcare, which is a fetal monitoring company that was sold to GE a few years ago. I've now raised six and a half million pounds of investments in grants to support SurePulse to where we are today. We've recently brought on Bill Allen as our as our chairman. We've also amassed a clinical advisory board here in the UK. We're looking at adding to that in the USA, but it's a multidisciplinary board including obstetrics, neonatology and midwifery because it's so important to have the voice of everyone on the team in the resuscitation, where all the roles obviously, really, really matter. We've just been awarded on top of the 2 million pounds of grants we've been awarded already, we've just been awarded another 2 million pounds of grants to fund development of the patch and regulatory clearances. And that builds on Cornerstone investors via the University of Nottingham and simpatico. We're now raising 2 million pounds to expand the commercial rollout of the VS Cap in the USA with our distribution partner and to sport match funding with our trials. And that is designed to take us through regulatory approvals for the patch and into the commercial phase. Their neonatal indication is a highly underserved market. Pediatrics is ripe for investment. There's a significant unmet need. We have got a track record we've been operating for seven years got regulatory clearances, and we've got substantial non dilutive funding to match this investment. We've already got a proven track record within the team, taking devices monitoring devices through to for acquisition by med tech strategics. And that is our planned course for short balls. So I'm James Carpenter. Thank you very, very much for listening. And have a good afternoon.