Approximately 135 M babies are born yearly worldwide, of which 14.94 M are born at pre-term. Only in Europe 5.1 M babies are born annually, of which >0.38 M are born at pre-term. Babies born before 37 weeks are premature and can have short- and long-term medical problems or die in 7% of the cases. Thus, European health cost are estimated in €50,000 per premature baby, this is, ~€20 billion per year. However, there are no fully reliable methods to diagnose the risk of preterm birth (PTB) to date and only 40% of women at risk are detected. Ultrasounds, biomarkers blood and fetal/placenta protein analysis are the main alternatives, but none of them solve the current problem. Thus, the remaining 60% women at risk cannot be benefited from preventing preterm birth therapies. These women will most likely have a spontaneous and uncontrolled preterm birth, which is extremely dangerous for baby and mother, leading to long-term health baby problems.
In response, we have developed Pregnolia device to determine the risk of preterm birth. Our patented device is the first one in the market based on the determination of cervical tissue stiffness, which has twice the sensitivity to the ultrasounds “gold standard”. The device is formed by a reusable control unit with a disposable single-use probe. It is simple, safe, easy to use and integrated into routine gyneacological consultations. With our solution, the majority of women, 80% out of 100% at risk, can be treated to prevent premature birth. Thus, Pregnolia diagnosis will enable gynecologists to take key decisions about preterm birth management (bed rest and hormone medication) and pregnant women will be able to adapt their lifestyle.
Our device will enable a reduction of PTBs costs of 42%, which could represent savings up to 8.4 € billion for the EU healthcare system. Furthermore, after 4-year sales, it will give net revenues of ~€99 M, net profits of ~€56 M and considering the investment of €8M, a ROI of ~7 euro per € invested.
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