Dr. James Carpenter, SurePulse Medical - Vital Signs Monitoring for Newborns |LSI USA '24

James Carpenter  0:04  
I'm the CEO of SurePulse Medical. We're a company and neonatal care, targeting 1% improved survival rate and a 6% reduction in neonatal disability. In the last 12 months, we've been validating our technology in adults, that's an oxygen desaturation trial. We've also won a grant of one and a half million dollars than ours to transform and take that platform and apply it into new areas in neonatal care such as kangaroo care. We believe that this platform will enable us to scale into lots of different areas, as well as the delivery room, nasal care and home care as well. And the investment that we are raising at the moment will allow us to go for FDA clearance for our first patch device to sign a distribution contract, and to submit CFD for a kangaroo care device as well. So what is the challenge that we're addressing, it's around the problem of newborn resuscitation around one in 10. Babies need some form of resuscitation at delivery, that's around 380,000 in the USA per year. And the failure to maintain newborns within set parameters increases the risk of death, or significant morbidity, including brain injury. And because it's, you know, babies are born, not breathing. And clinicians have to ascertain the status that they'd be very, very quickly. existing devices such as pulse oximeter as ECG electrodes, can take a long time to pick up a signal and be asked because they're really not designed for the specific needs of newborn babies premature infants at delivery. And it's been shown as a 55% error rate in adherence to the basic steps of the neonatal resuscitation program. And these delays and errors, you know, when every second counts when a baby is not not getting enough oxygen, that can that can really sort of add up to catastrophic outcomes, such as cerebral palsy, and even death. So our mission is to put babies and their families at the heart of our monitoring solutions, delivering better outcomes for the natal journey from birth to home and beyond. So our solution is the short pulse near patch. This is a wireless vital sign monitoring system designed for you straight after birth. It's a multi parameter system that measures SPO, to pulse rates, ECG heart rate, skin temperature, and also supports integration with respiratory function monitors, and video recording. And it's designed to provide wireless, reliable monitoring of nasal vital signs to support optimal adherence to guidelines. And there's a significant benefits for the for the infants that that that would use this patch. It's firstly improve survival and reduction hospital length of stay. Because it's specifically designed around the needs of the newborn. It's not a repurposed adult device, it can be applied quickly and easily. But beyond the initial steps of resuscitation, it can also improve parental bonding, and breastfeeding and birthday cuddles. But the main value proposition is arrived improved heart rate assessment, respiratory management, that optimizes the treatment of infants at birth. And that eventually leads to a 1% improve survival rate and a 6% reduction in disability. And we have 280,000 infants a year in the US needing trip treatment that adds up to a huge amounts of money, it's been estimated that the the lifetime cost of caring for infant with cerebral palsy is around $1 million. But the liability can add up to 10s of million dollars. So there's a significant opportunity for saving. We've collected a lot of market validation of our technology across the US and Europe and around the world. We've validated the need, not just amongst clinicians, but amongst our distribution partners. And also we've leveraged significant grant funds in excess of two and a half million dollars in the US in in the UK. In terms of the market size, that we're addressing this as a growing market, there's increased rates of prematurity. There's also increased awareness that interventions that we make in the near to a period have a huge impact on both on the quality of life for newborn babies. And so it's increased focus on investing in quality of care, you know, imagine that an infant is is receives brain damage at birth as a huge impact on their entire life 80 or 90 years perhaps. And so, you know, it's really important to, to focus investments on those early years. But we're targeting a market that's projected to grow to 30 and a half billion dollars by 2030 of rich around a billion dollars is in neonatal monitoring devices, specifically terms our roadmap where we're launching with our core features around ECG and temperature and data connectivity this year, adding an SPO to after our pivotal trial in the UK. They're starting in a couple of months time, and then integrating other other parameters and outside partners into our system. Terms of the business model, the end user price for the system is around $15,000, which is commensurate with other monitoring systems in use at delivery. But it's a razor razor blade model, where the single use patch retails around $125 to end users. And we validated this pricing with neonatologists in the USA, short pulse itself, partners with distributors and key territories in the USA, we have several distribution partners that we're talking to across Europe and the Middle East as well. And our main customers are knee and the taller jests. But obviously we understand that the neonatal nurses are also key key allies as well. This adds up to a strong revenue growth opportunity. Here's just an illustration of the numbers across across the USA. So selling both main systems and single use patches into the into hospital systems over five years, leads to revenues over $100 million. In terms of competition. There's only really one other company which has learned or which are targeting devices specifically for resuscitation, they have their near BT device, which is a kind of a simple ECG monitor they really developed for use in the developing world. And it is wireless and designed for the delivery, but it doesn't have the range of vital signs that are needed to support optimal care. So what is it about short pulses that kind of clearly differentiates us from our competitors? Well, there's no adhesive in the patch. So one of the key issues around premature infants is the the skin damage that's existing technologies can sometimes can sometimes bring takes advantage of central positioning, so pulse oximeter that are used at the moment and positioned on the limbs, and that can lead to poor poor signal uptake. It's wireless, so supports increased practice of delayed cord clamping, single patient use, and it's all in one and it's all underpinned by novel reflection mode pulse oximetry technology, which is proprietary to short pulse. The investment strengthens the commercial team. We already have nine employees and a strong board. We're looking to bring on a Chief Commercial Officer into the business with this new investment. Alongside myself. Bill Allen is our chairman who's got a different experience in in med tech and exits under his belt. We also work closely with the University of knots impressive Barry Hayes Gil and Don Sharkey. And Barry himself has previously founded company Monica healthcare it was sold to GE in fetal monitoring. As I said, we've raised significant grant money to leverage the technology that we've developed and apply it to other areas of of neonatal care. Our kangaroo kangaroo care product is only now a few months behind obvious patch product uses the same underlying technology and an integration platform. So our strategic timeline is to go for FDA 510 K clearance later on this year. And commercial launch in the USA. We've now got $1.8 million committed out of our $2.6 million raise. So I'd be delighted to talk to you, if that's of interest to you. But thanks very much for your for your time and your attention. I'm James    Carpenter Thank you