Video Transcription
Rubén Molina 00:02
Rui, good morning everyone. This is Rubén Molina. I'm the CEO of INNITIUS. My background is civil engineering, but this company was part of my PhD, and I co-founded this company with Dr. Molina. Here, I have to make a disclaimer: we are not related, we are not married, we are not family. That's a common sort of name in the south of Spain. Dr. Molina is a visionary OB-GYN who recognized a few years ago a major clinical problem: the inability to predict accurately the birth timing. For the last 30 years, nothing has changed. They keep doing the same tests: digital examination, transvaginal ultrasound, and biomarkers. The three of them share the same problems. They are not reproducible between different users, and also they have poor accuracy. And you might think, now, OK, if nothing has changed over the last 30 years, the problem isn't that big. OK, I'm going to tell you something: the problem is huge. They're using those old-fashioned techniques for diagnosing problems like threatened preterm labor, which is the leading hospitalization cause during pregnancy, preterm labor before 32 weeks of pregnancy, which is the leading cause of infant mortality around the world, and induction of labor, which is the leading fetal distress source during pregnancy. More than 6 million pregnant women every year in the United States and Europe suffer one of those three problems, with almost 3 million of them being incorrectly diagnosed. Incorrect diagnoses mean unnecessary hospitalizations, treatments with corticosteroids and antibiotics, or missed opportunities to prevent preterm labor or reduce the timing of induction of labor. This represents a $1.6 billion market coming from a clinical need that is seeking innovation, and the solution was always there, but not easily achieved.
Check this circle: the cervix is the key barrier that must soften and shorten to allow vaginal delivery. We have developed a system for measuring an intravaginal probe for measuring how soft the cervical tissue of the pregnant woman is. We do it with civil engineering precision. We have created a new type of wave called torsional waves, and it allows us to quantify what we provide to the doctor. It is not imaging; it's a number. We are not ultrasound; we are a new type of wave, reliable, but we discovered that cervical consistency gets influenced by the clinical profile of the patient, and that's how our problem was born. It's a three-part problem. The first one is the hardware for measuring the cervical tissue stiffness or softness. The second one is an artificial intelligence model which combines the output of the hardware with the clinical profile of the patient. And third, a software where the doctor receives the actionable diagnostic. We don't provide the number; we provide a diagnostic for each pathology. The device is patented twice in Europe, Canada, Australia, and the USA. FTO positive. FTO analysis has already been done, and we improve ultrasound and biomarkers in accuracy, reproducibility, and reliability. We published an article in Nature about comparing ourselves versus ultrasound. We published another paper in the American Journal of Obstetrics and Gynecology, comparing ourselves versus ultrasound again and for the biomarkers, the reliability. We have completed a 10 clinical site study with more than 350 patients comparing ourselves versus the current standard of care, the biomarkers, and we have already improved sensitivity and specificity on them.
Check also this picture from here: building our AI model, cervical consistency emerged as the top variable related to the prediction of birth timing, more than any other of the 200 variables that we analyzed in our clinical research. The product development is done; the clinical research you have seen the results. We already are an ISO 13485 certified company. We are already in conversations with the FDA. So now is the moment to move forward with the product development. We are going to prepare one hardware, and we can target three different indications. We will sell in 2025 the probe for measuring the cervical tissue stiffness as a Research Use Only medical device. We will launch our research program. The first indication, threatened preterm labor assessment, will go under a 20-site clinical trial in Germany, the Netherlands, and Spain in 2025. FDA approval is expected, and we have already negotiated with the FDA through a BLA study for the second indication. This is key; I need to tell you because a physician from the UK, Prof. Ki Pros Nicolaitis, the creator of the Down Syndrome test and preeclampsia test, is going to pay himself through the Federal Medicine Foundation for a 7,000 patient clinical trial for our second indication. We are already working on the third indication, induction of labor, where we are going to start the clinical research by 2026. We have a team of 18 full-time employees so far, led by Francesca Molina and myself, but also guided by great advisors in clinical research, product development, and business strategy.
Please check the key opinion leaders that are already committed to our development. We have Prof. Nicolas. We also have Prof. Fran Leuven, the professor who is the president of the International OB-GYN Association, and also other physicians around the world. But also check the investors that have already committed their capital to our company. The business model is: they can buy once the hardware and they can use it for every single software indication. The diagnostic indications are going to be commercialized as software as a service. The pricing for each indication will be tailored based on the market and based on the reimbursement scenario in each key market that we're going to target. The pricing, distribution, marketing, and market access strategy has been set up using more than 400 face-to-face interviews and an external reimbursement study that we have performed in the key market. We will start commercializing the diagnostic indications by 2027, with a break-even point by the last quarter of 2028, with nearly 30 million euros of revenue by 2031. As you can see here, we are pivoting from a hardware company at the very beginning, where 90% of the revenues are coming from the hardware, to a software as a service company, as we set up our software as a service business model. We have already raised to date 7 million euros, four of them coming from equity. And now we are seeking 6 million euros in a Series A round; we already have most of it committed. I will talk about that now. But with that money, we can start selling the Research Use Only device in Europe and the USA, gather more than 80% of the data from the two first indications, start with the third indication clinical research, and also keep moving forward with the FDA pathway, including the breakthrough designation application for that.
As I was saying, we already have committed 1.5 million euros from the current investors, 4 million euros from an external VC, and now we are looking for a ticket of 5.5 million euros to complete this 6 million round. But also we are open to talk about a larger round, including the financial needs that we have by 2026. The total ticket we are looking for here is between half a million to 4 million euros. Talking about the exit, we can be really easily integrated with ultrasound manufacturers, but also with women's health diagnostic companies. We already have conversations with them. We can be another probe of the ultrasound, but also we can complement the product pipeline that companies like Ology, Chia Jim, or Lobri have with the same clinical target. We already have two letters of interest from one of each company here, and we also have the support from key opinion leaders like Prof. Nicolas and Prof. Leuven. We have the strategy set up, we have the right team, we have the right technology, and now it's time for you to join us in revolutionizing women's health. Thank you. Applause.
