A Diagnostic Medical Device Determining the Risk of Preterm Birth

ended

Premature birth (birth before 37 weeks of pregnancy) is a global, yet unsolved, problem. With a global amount of 14.94 M babies born prematurely, PTB is the leading cause of neonatal and infant mortality globally, and those who survive often have breathing problems, cerebral palsy, intellectual disabilities and other lifelong problems. On top of the associated suffering and societal long-term consequences, PTB is associated with more than €50,000 in healthcare costs per premature baby, which translates into total yearly costs for the healthcare system of €20 billion in Europe, and €23 billion in USA. Pregnolia is a unique diagnostic device to determine the risk of PTB based on the measurements of cervical tissue stiffness. Our patented device has twice the sensitivity of the current “gold standard” (ultrasounds), it is simple, safe, and easy to use and to integrate into routine gynaecological consultations. With our solution, the majority of women, 80% out of 100% at risk, can be treated to prevent premature birth. This phase 2 project has been defined to upgrade Pregnolia’s prototype based on our Feasibility Study outcomes, which will allow us to fulfil our clinical and commercial goals by delivering an innovative and cost-effective diagnostic device for addressing the unmet need of PTB, while sustaining a viable commercial model. Pregnolia will achieve net revenues of ~€74 M, net profits of ~€30 M and, considering the investment of €8.8M, a ROI of ~7 euro per euro invested at year 5. Thanks to Pregnolia, we estimate a potential reduction of PTBs costs by 42% (up to ~€8.4 billion in EU, €9.66bn in USA). Furthermore, our Pregnolia device will impact on the reduction of children’s health complications and child deaths.