Nick Talamantes 0:16
I'm here at LSI Europe in Barcelona with Cécile Dupont of BrightHeart. Thank you so much for joining me in the studio. Thanks for having me. Why don't you tell me a little bit about what you're doing at BrightHeart?
Cécile Dupont 0:26
Yeah, so at BrightHeart, we are developing a new solution, an AI based solution to improve the detection of congenital heart defects during pregnancies but isn't interested in exams?
Nick Talamantes 0:38
What is your technology adding to fetal ultrasound today that is so challenging? What's the problem that your technology is addressing?
Cécile Dupont 0:46
So our technology is addressing a major clinical need. So today, seven out of 10, babies with congenital heart defects are not detected during the prenatal period. So during the pregnancy, and that has a major impact on the mortality of these babies, you have to understand that about 40% of newborn deaths are actually, you know, happen in, in babies with with congenital heart defects. So it's a major issue. And the reason for that is that during the prenatal period, the only way to catch CHD is through prenatal ultrasound exams. So these are exams, which are typically performed during the second trimester of the pregnancy, by clinicians who are not cardiologists who have limited knowledge in in, in fetal cardiologist and do their OBGYN or MFM's. And so the screening exam consists in evaluating the entire body of the of the baby, and including the fetal heart. And when it comes to the fetal heart, the heart during that the second trimester of the pregnancy measure is less than one centimeter, so it's really tiny, it moves, you know, the baby moves in the mother. So the complex the the exam in itself is very complex. And then there is you have to understand that US clinicians are can be, you know, receive a different level of training, and which induces a huge level of variability. And the third reason for for this exam being, you know, very complex is that there is no specific classification when it comes to describing, or when it comes to looking for specific morphological abnormalities, which makes the exam even more complex. So the IDB behind bright heart is really to make us clinicians, cardiology experts, when it comes to to catching CHD.
Nick Talamantes 2:53
So with CHD, I understand that there are various severity of it. And it's my understanding that around 31% of children born with a severe CHD go on to unfortunately lose their lives. Is that something that can be prevented with early detection with technology like yours?
Cécile Dupont 3:10
Yeah, absolutely. And this is exactly what we're tackling. So the prenatal detection is really key in reducing the mortality rate of these babies with CHD. The simple reason is that when the decision is detected during the prenatal period, the sedan the mother is referred to pediatric cardiologist will plan together with a, you know, a team of surgeons and neonatologist, they would plan to delivery at specific, you know, maternities, your level three. And so that's the baby the newborn can be taken care of during the first minute of its life. And that's really key. Because otherwise, if the baby comes home, without knowing that he has a CHD, the risk of mortality is really high, or the risk of boxia is really high with a strong impact in terms of neurological development. So really the the earliest we can do earlier, we can detect the CHD during the pregnancy to better for the baby and for his family of course.
Nick Talamantes 4:15
You guys have raised a seed round already. Right? Where are you guys at in terms of fundraising right now?
Cécile Dupont 4:23
So we've raised a seed round less than a year ago, which enabled to to assemble an amazing team of machine learning experts, AI expert data scientist, and we are supported as well with clinicians, leading pediatric radiologists in Europe and in the US. And with that, we've been able to develop a pre commercial version of our device of our AI platform. We've also engaged in discussions with regulatory authorities, especially in the US to understand What it takes to bring that technology to the market and get an initial 510K approval, we've initiated the clinical validation of our pre commercial version, we've secured IP as well in Europe and in the US. And so we are now at a stage where we will be ready to submit her first 510K by early next year, and then engaging to in the development of the new commercial version of our platform. And with the implementation of pilot centers, in your opinion us in parallel. So to support that, we'll be raising it. And now we'll be raising a Series A of 9 million euros to support the development of the commercial platform and prepare for the commercial launch in 2025.
Nick Talamantes 5:50
So we're at LSI Europe right now, which is a great networking opportunity, bringing together innovators such as yourselves, the investors and the strategics. Are you having conversations that are looking like they're going to move forward with that Series A round, you know, those initial early discussions that are going to lead to productive commitments?
Cécile Dupont 6:08
Yeah, I mean, hopefully, it's LSI, it's an amazing opportunity to to meet investor from, you know, Europe, US, it's a great opportunity to to pitch our solution. It's, it's, you know, there is it's a huge market that we're addressing, we're talking about, you know, 4 million interest on exams in the US per year, same number in in Europe, about 10 million in China. So it's really a huge market that we are addressing in an AI ultrasound market, that it's booming, booming as we as we speak. So clearly there is a strong interest not only from investor from VCs, but also from corporates who see that, you know, there is a clear clinical needs in that specific indication. And, and, you know, huge market opportunity as well.
Nick Talamantes 7:01
You know, there are a lot of companies, I would say now that are developing AI Image Analysis solutions. Have you talked to any of your peers in the industry? Have they been able to provide you with any guidance or understanding of how to approach different challenges to bring a product like this to market?
Cécile Dupont 7:17
Yeah, I think one of the one of the key challenges first, you know, from a regulatory standpoint, making sure that we have a good understanding of what it takes to to bring that technology to the market, having a greater understanding of how we clinically validate the performance of this device. So, you know, it's both through discussions with, you know, peers, developing the same kind of approaches on other indications, but also, through engaging really early with, with regulatory authorities that we that we've done from the get go. And then I think one of the key challenge for us is, you know, understanding the go to market strategy and understanding how to bring that technology to, you know, high number of clinicians in in the coming months. And that's, you know, I think a problematic that's all digital companies developing AI solution for clinical user facing today. So understanding the right channel, what's the most aptitude for example, the US practice versus the European practice, which is pretty different. So yeah, actively actively working on on that topic?
Nick Talamantes 8:25
Are you guys working then very closely with clinical advisors to sort of develop the way the technology is implemented within the practice?
Cécile Dupont 8:34
Yeah, yeah, absolutely. And that's a that's a great question. So here, the, the entire matter of the technology we're developing is to bring the expertise of a pediatric cardiologist to non cardiology experts, to OBGYN to MFM, to midwives, or radiologists, who can perform this ultrasound exam. And so, you know, it's it's a matter of transferring the pediatric pediatric cardiology knowledge from these experts to non experts. So we are working with pediatric cardiologist from the very beginning so to establish, you know, the approach of the platform, understanding what makes sense to detect what's you know, make less sense. So, we are working for that with our two co founders who are Pediatric Cardiologist based in France, working from the the nuclear hospital as well as to have a huge private practice in in France. And we are also supported by a pediatric cardiologist out of Stanford in the US Dr. Irina Mehta. So, you know, we took that into account from from the very beginning. Now when it comes to developing a solution that fits the workflow and the clinical practice of OBGYN or MFM we are also working with with us clinicians. So in booths geographies in Europe and in the US making sure that we have a good understanding of, you know, how they work, and that we're developing something that's adapted to their practice. And for that we are implementing pilot centers with our pre commercial version, making sure that we have a perfect alignment of, you know, our features with their needs.
Nick Talamantes 10:23
Speaking of product adaptability, is this going to be a device agnostic solution then for ultrasounds?
Cécile Dupont 10:29
Yeah, absolutely. So the our approach is to develop a SAS, you know, solution. So that's adapted to not only any practice, but also agnostic to an interesting mission. That's, you know, a must have when you want to address a large market, and it's also adapted to, to, you know, especially to the US practice where which is different from from the European practice when it comes to performing the exam. In for example, in Europe, the gynecologist is the one performing the ultrasound, but also interpreting in real time, the the videos in the US, the sonographer does the technical exam and requires or records, the videos, and then the interpreting physician who is the typically the OBGYN or GMFM, does the interpretation fees are flying after the exam has been recorded. So this is how, you know having a sense approach is really relevant and kind of streamlines the interpretation and reporting workflow for the clinician.
Nick Talamantes 11:40
How accurate is the solution, then is this something you only need to use when one ultrasound exam with a patient, you identify it and you're, you're confident then that you can go on and recommend this, this mother and her infant child go on and have that treatment that they're going to need?
Cécile Dupont 11:58
No, so really, I think it's important to understand the workflow and return standard of care to detect CHD. So really, the first step of this workflow is the detection step. So that's done by the OBGYN during the second trimester of the pregnancy, through the screening ultrasound exam, the objective of this exam is to catch early sign of CHD. It's to really detect red flags, you know, of potential abnormalities, it's not a matter of, you know, seeing the mother, you have this kind of CHD. That's the role of the pediatric cardiologist. So really, the first step is, is there to catch early sign of CHD. And then if there is any suspicion of congenital heart malformation, then the clinician or the OBGYN would refer the mother to a pediatric cardiologist who would confirm the presence of a CHD would refine the diagnosis, there is a spectrum of CHD is really wide. And if that's confirmed, then, you know, there is an entire team of clinicians who was put together to define what's the therapeutic pathway for for that baby, and what needs to be implemented. So really, the first step of detection is the bottleneck in the current workflow. And you know, if you miss that step, then you miss the contribution by the Pediatric Cardiologist, you miss the deterministic pathway, and this is what's currently happening for seven out of 10 babies with CHF.
Nick Talamantes 13:34
You are at LSI Europe last year, as an investor, correct or was sofinnova. Now you're back as an innovator with your new company. Is there any advice that you would give to the starting entrepreneur about the value that coming to an event like this can bring to a team?
Cécile Dupont 13:53
Yeah, I think it's, it's really important to to expose yourself early on to you know, the venture world making sure that you have a good understanding of what VCs are expecting and looking for, and making sure that you craft your development plan accordingly and that you have the appropriate milestones, you know, setup and that your your financial plan matches that plan as well. So, you know, engaging on discussions with with potential investors from from the get go is, is creating a lot of value for the company. Same for corporates.
Nick Talamantes 14:32
Cecile. It sounds like you guys have a bright future ahead at Bright heart. I look forward to following your company and I wish you all the success. Thank you