Premature birth (PTB, 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. PTB represents about 75% of all neonatal deaths and 60% of all infant deaths. 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. Nevertheless, to date, there are no reliable diagnostic methods to prevent PTB, consequently women are sent home with a false sense of security while being at risk of having a spontaneous and uncontrolled preterm delivery, and clinicians are left without power to intervene preventively.
Pregnolia is developing a unique diagnostic device to determine the risk of PTB based on the measurements of cervical tissue stiffness. The device is composed of a reusable control unit with a disposable single-use probe. The major benefits of the device are that it allows a quantitative, objective and accurate measurement of the cervical stiffness; it is easy to integrate into routine pregnancy consultation; its application is simple, painless and fast; and it will enable a faster preventive intervention with increased sensitivity to detect PTB risk.
The aim of the CervixCare project is to further develop our current product in order to improve its profitability, to clinically validate it and to turn it into a medical device for expanded clinical and commercially favorable use. The innovation associate (IA) is involved in the design validation and clinical validation of the device to fulfil the regulatory requirements for the diagnostic certification. As such, we have recruited a specialist in characterization of soft tissues through experiments and simulations. The IA is capable of developing the experimental assays and methods to characterize device performance, aid development and data gathering for regulatory submissions. Such assays are required to ensure performance quality of the product. He is part of the R&D team of Pregnolia AG.
