Periodic Reporting for period 1 - CervixCare (Validation of Cervical Stiffness Characterization for Prenatal Care and Preterm Birth Diagnostics) Reporting period: 2020-11-30 to 2022-02-27 Summary of the context and overall objectives of the project 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. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The Associate joined Pregnolia in February 2021 and was helped by the company during the first weeks following his arrival in Switzerland.The Associate followed an extensive training on several business-related topics. He has also joined virtual and in-person company events planned for his integration in the company, working with the COVID-19 restrictions. During the project, the associate has performed the following tasks:• Designing and planning of the functional requirements verification and validation for the medical device.• Ensuring that the design of the Pregnolia System complies with these requirements.• Providing hands-on feedback from on-site testing in a clinical setting.• Scientifically and technologically characterization of the device in terms of measuring functions (e.g. intra-observer variability).• Gathering clinical evidence for regulatory submission and to ensure the performance of the product.All the innovation project’s objectives were successfully reached: the contribution of the Associate has strongly and greatly improved the quality of the technical documentation of the device which will be used for certification submission, by adding key information about the functionality, performance, and quality of the device. The impact and contribution of the Associate on the project has been of extreme relevance for Pregnolia. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Preterm births represent a huge economic burden for our society. Recent UK and American studies provide a similar estimation of overall costs per preterm birth at approximately € 50,000. These estimations translate into a total cost of €20 billion for the EU healthcare system, and €23 billion in the USA. Thanks to Pregnolia, we can estimate a potential reduction of PTB costs by 42% (up to ~€8.4 billion in EU, €9.66 billion in USA). Furthermore, the Pregnolia System will more broadly help contribute to the reduction of children’s health complications and infant deaths.Pregnolia will not only make an essential contribution to healthcare in the EU for the benefit of European citizens, it will also strengthen the European medical device industry, which is currently providing €110 billion in sales and 675,000 jobs in Europe. The EU is a net exporter in this sector.Pregnolia continues to be the sole company developing an aspiration-based device to determine the risk of premature birth. The state of the art continues to present ultrasound-based and imaging-based solutions, however, these are up to now mostly non-commercial techniques. Pregnolia System. The device is composed of a single use sterile probe and a reusable control unit.
