Cécile Dupont Presents BrightHeart at LSI Europe '23

Transcription

Cécile Dupont  0:05  
So my name is Cécile, and fortunate and happy mother of three healthy young kids. But, you know, I could have been one of these parents of babies who, who are born with a severe congenital heart defect. And that's the case for seven out of 10 babies with congenital heart defects. And this is a major, major issue. Why? Because CHD accounts for free percent of deaths in newborns with birth birth defects. And this is here, this is in Europe, this is in the US. This is where clinicians are trained to detect CHD. And prenatal detection is really key in saving us baby and impacting their the mortality and enter morbidity by implementing the delivery of the mother in the right setting, but also by implementing the right therapeutic management during the first minute of life of these babies. And this is not an isolated problem. Every single pregnancy has a risk of CHD misdetection. And let me tell you why. First, because 80% of CHDs happen in low risk pregnancy, so everybody's at risk. And the second is that prenatal ultrasound exam, which is the exam that's universally recommended during the second trimester of the pregnancy, only catches 3% of CHD. It says it's the only exam that's available during the pregnancy to catch these defects. And it's not good enough. So here is a typical example of what a clinician so typically an OBGYN, and NMFM has to evaluate during a nutrition screening exam. So this is a fetal heart. Is it normal? Well, here the answer is no. It's a very complex exam, even for people who are trained and for experienced experience, and who've been doing that for many years. So here is the current CHD detection and management pathway during the pregnancy. The first step consists of the prenatal screening ultrasound that's performed for any pregnancy in the world by an OBGYN or an MSM. It consists in detecting early signs of CHD, or morphological abnormality so that the patient can be appropriately referred to a pediatric cardiologist who will not only confirm the diagnosis, but also refine the diagnosis and make sure that the delivery takes place in the right setting, and that the delivery takes place with an appropriate team in place that the baby can be managed from the very first minute of life. What happens if the first step is missed? Well, there is no detection, there is no referral, the delivery does not happen in the right setting. And there is no therapeutic management for the baby during the first minute of life, which is really dramatic. And that's the case for 70% of the babies with CHD. So your next question is going to be why CHD ultrasound screening performed so poorly? Well, the first reason is that the prenatal ultrasound exam is performed by a wide range of clinicians who are not pediatric cardiologists, it can be an OBGYN, and NMSM, a midwife, a radiologist, or even a general practitioners, they all receive a training, but with a different level of expertise and high variability. The second is that the there is classification, there are standard classification to describe the normal morphology of the fetal heart. But there is no standard classification to detail what an abnormal fetal heart looks like. And the third reason is that during the pregnancy during the second trimester of the pregnancy, the fetal heart measures less than a centimeter and keeps moving, which has another another layer of complexity to the exam. So really catching CHD during the prenatal period is the absolutely is absolutely key in reducing newborn deaths. And this is possible only by making clinicians who are performing this exam cardiology experts and this is what we are doing at BrightHeart. So how are we doing that? Our BrightHearts AI platform is a SaaS solution that makes every clinician a fit all cardiology experts. Our solution catches, abnormalities, morphological abnormalities, on ultrasound sign exams and flag them for the clinician so that it knows exactly where to look at what to focus on, and so that you can immediately refer the patient to a pediatric cardiologist. So it's really meant to be a second pair of high another, another opinion during the exam for the clinician who is not a cardiologist. Our solution is really streamline and adapted so that it fits really the diagnosis and interpretation workflow of the interpreting physician. The images are typically recorded by a stenographer who does the exam, our software is connected to the PACs, so that the videos are analyzed in less than a few minutes, and annotated and send back with experts Evola notation to the interpreting physicians while he's preparing these reports, so that he knows exactly where on which examined needs to focus, and immediately whether the patient needs or not to be to be referred to a pediatric cardiologist. So here is Dr. Sory Gavril. She's a fetal medicine doctor based in the US and this is what she says, people are so afraid to look at the hearts and to get you. And this is a fact, people, clinicians are really afraid of getting sued because of a miss detection. And there is no question for her that there would be a valid value to BrightHeart. And even for someone like her who's been doing this kind of exam for more than 30 years, sometimes detection of CHD is very clear, very simple. And sometimes it's just really challenging. So we are addressing a really large markets. The prenatal screening ultrasound exam is recommended for any pregnancy in the world. And that presents almost 20 million exams per year if we just look at the US, Europe and China. And this is happening in an ultrasound AI market that is just booming. So we've started initiated the project 11 months ago based on an idea of coming from two pediatric cardiologists here in Europe, and we've consolidated consolidated an amazing team of data scientists and machine learning experts who have been involved in the success of AI medical companies, and were supported with leaders in the field of pediatric cardiologists. We've made great progress in developing our first solution, our pre commercial version of our device. We've secured initial IP, both in Europe and in the US. We've secured a unique access to an interested into database of ultrasound exam more than 3000 fetal heart ultrasound exam. And we've engaged on discussions with regulatory authorities from the get go so that we know exactly what it takes to bring the device to the markets. We are about to submit our first 510K early next year. And we still have major milestone ahead of us including the development of the commercial version of the of the device development or initiation of pilot sites, both in Europe and in the US and we prepare for commercial launch in 2025. So to support this, we are raising a 9 million euro series A so please don't hesitate to, to come if you'd like to be part of the journey. Thank you