James Carpenter Presents SurePulse at LSI USA ‘23

Transcription

Well, good afternoon I'm James Carpenter, the CEO of SurePulse Medical. I'm delighted to be over here from the UK. And at SurePulse, our aim is to improve the life chances for premature and sick babies. Were focused initially on the problem of newborn resuscitation. Infants need resuscitation at delivery for a variety of reasons, including prematurity, congenital defects and trauma during the labor and delivery process. This means that you're not breathing, I need help to establish stability outside of the womb, and healthcare providers follow the steps of the neonatal resuscitation program. This involves making an assessment of heart rate and other vital signs within the first 60 seconds after birth. However, existing monitoring tools, such as pulse oximetry, and ECG do not work well delaying crucial information, as they were not designed for the unique needs of newborn babies and providers at this critical time. And this leads to delays and errors up to 55% error rate in adherence to the basic steps of the neonatal resuscitation program. And this can lead to prolonged oxygen starvation, cerebral palsy and avoidable deaths. And over in the UK, these traumatic cases are gaining national and political attention with providers saying in some instances, they just didn't know what the vital signs of the infant were. So with one in 10, babies needing resuscitation and delivery, this adds up to around 380,000 babies a year in the USA, of which 10,000 will develop cerebral palsy and around two and a half 1000 Die avoidably in the neonatal period. And the lifetime costs of caring for somebody with cerebral palsy are around $1 million per person. And that's before litigation costs were can cost in excess of $20 million. So this means in the US alone, there's $10 billion dollars of extra health care costs are introduced through poor management of labor delivery in the neonatal period as well as increase hospital system risk and provide a risk. So there are significant drivers for improving resuscitation Practice and Technology. So our vision at  is to give clinicians and healthcare providers the tools they need to write optimal newborn care. So introducing the SurePulse vs patch. This is a wireless multiparameter monitoring system specifically designed for use straight after birth. Its patented application method uses polythene wrap to hold the wet vernix cover newborns hold sensors against the wet vernix covered newborn skin. And it measures the vital signs required for newborn care in the first few minutes and hours after birth, alongside wireless respiratory function monitoring and video integration for post practice review. The patch itself is single use and communicates with a SurePulse bedside monitor. The advantages are speed of placement and acquisition tailored to target that first minute after birth. And the provision of immediate feedback on the status of the baby allows healthcare providers to make critical care decisions earlier and more accurately in an environment where every second counts. The VAs patch is now at clinical trial stage and we've just been awarded a 1 million pound grant to further develop the system. Now we've confirmed the demand for such a device the wireless functionality isn't a gimmick. It helps declutter the busy resuscitation area and is essential for supporting delayed umbilical cord clamping to ensure ongoing maternal oxygen delivery after birth. The demand for multi parameter monitoring in neonatal resuscitation ranks alongside kangaroo or skin skin care. And this application also sits within our product pipeline for the technology. We've conducted market research on the proposed pricing. The single use patch fits into codes for existing premature or high risk deliveries. And the multiparameter monitor is commensurate with the pricing of existing systems with software license fees, which range according to the size of the hospital. It is around $150 million market scan for 2.1 billion worldwide. Now, whilst whilst neonatal and pediatric indications are often labeled as being smaller, a sizable opportunity does exist alongside the societal opportunity to make an impact on someone's whole life from the very beginning. The business model is built on installing base units in delivery rooms and obstetric operating rooms and supplying single use patches working with leading neonatal distributors per territory. SurePulse supports by seeding early sales and expanding the clinical evidence base working with key opinion leaders We have an established supply chain with Far East and UK based contract manufacturers. And we already have relationships with existing neonatal resuscitation guideline authors, who we join with in seeing and realizing the future of neonatal care. Regulatory clearances in the US, UK and EU establish revenue growth and achievable market penetration yields attractive revenue projections based on the razor razor blade business model and software license. Now, there are a number of companies working on neonatal monitoring Laerdal have currently the only company specifically designing devices for the delivery room. But they're offering is purely ECG heart rate, and has so far been targeted at developing world markets. Existing pulse oximeters are placed on the limbs, and so they're slow to pick up vital signs as blood pressure and flow to the periphery is poor, particularly in compromised infants. The other new entrants to the market are hampered by a lack of centrally placed oxygen saturation monitoring, which is a key requirement as perfusion is maintained to the core of the infant. So facilitating earlier detection of oxygen saturation. So SurePulse unlocks this threat reflection mode sensor that can be placed on the forehead or sternum and take advantage of that of that core blood flow. outlets have now announced that they're working towards FDA clearance for their sock monitoring device. But again, this is placed peripherally, which aligns with the problems with existing devices. So therefore ShopHouse is the only company with a full vital sign set in a package that's specifically designed for you straight after birth. Now that's reflectance oxygen saturation capability, put SurePulse in a very strong position to target the NICU with ergonomic kangaroo or skin to skin care monitoring. And we've just won a 1.4 million pound grant to develop such a system. We know the markets there from our research and our position SurePulse as a company supporting care of high risk births from delivery through home. And the wealth of information collected and database during neonatal resuscitation provides the foundation for a data strategy to support personalized provider training, benchmark against international standards and intelligent analysis of data. We have a well established team with 10 employees and an experienced board including several members with multiple medtech exits in the fetal monitoring space. We plan to use the investment to strengthen the commercial team with particularly us focus introducing product management alongside Chief Commercial Officer role. The various patch hardware has now developed and we have regulatory clearance in the UK to commence clinical trials and adults before moving to neonatal trials later this year. And the regulatory strategy is to fight and K class to predicated on existing pulse oximeter as an EKG monitors for accuracy. But with enhanced usability and speed of acquisition at birth. We know the areas that the FDA have focused on with the neonatal devices in the past and are aiming for submission next year. So we're now raising $3 million to build towards the US market entry and regulatory clearances where we have clear track record. We've got $1.2 million committed and we'll be delighted to talk to anyone who could help fill the rounds to co invest in a strong proposition in the highly underserved neonatal markets. We believe we represent a compelling strategic acquisition either by traditional global med tech, but potentially also an analytics play through the strength of the novel resuscitation database. So we're SurePulse, we're committed to improving the life chances for premature and sick babies. Thank you very much for your attention.