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A Diagnostic Medical Device Determining the Risk of Preterm Birth

Periodic Reporting for period 1 - Pregnolia (A Diagnostic Medical Device Determining the Risk of Preterm Birth)

Reporting period: 2019-09-01 to 2020-08-31

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 the 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 phase 2 project has been defined to develop Pregnolia’s new probe, generation 1, ensuring a reliable, scalable, high-quality device, with significant manufacturing cost reduction in comparison with the current generation 0, and to prepare its successful market launch. The generation 1 device will allow us to fulfill the 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. The technical activities are focused on the development and validation of generation 1 probe, based on the design specifications defined in our feasibility study. The commercial activities focus on disseminating and promoting Pregnolia; on preparing documentation and establishing necessary contacts for reimbursement and certifications; and on building a strong distributor network (when deemed necessary).
In relation to WP1(Technology maturation and final prototyping), we have selected the new thermoplastic material for the body of the probe, redesigned some parts for the injection molding manufacturability, generated rapid prototypes for technical evaluation and usability tests, and generally improved the design based on experience with the generation 0 and the usability tests. Furthermore, a new design of the generation 1 probe package has been created.
Concerning the supply chain consolidation and internal growth (WP3), we have performed activities related to the upstream supply chain and we have obtained quotes for process development and industrialization, assessed and selected the final manufacturer, planned process development and industrialization, ensured close communication with the selected manufacturer to guarantee efficient design for manufacturing and transferability of the completed design. The remaining activities of WP2 will start in February 2021.
As per WP4 (Commercial readiness), we have initiated consultation with national reimbursement agencies in Switzerland (two major health insurance companies) and we are analysing the focus markets. On the regulatory side, we are continuously in contact without notified body (NB) in order to perform the annual surveillance audit and plan the certification audit for the generation 1 device, and Finally, we are in contact with consultants and experts for defining aa strategy to get FDA approval.
Regarding WP5 (Communication, dissemination & exploitation), we have designed and produced new flyers for users and pregnant women, we have created a direct mailing to 1000 doctors, we have re-designed rollups for congresses and events, we have conducted an in vitro study to demonstrate the superiority of the Pregnolia device compared to digital palpation and we have created a video abstract to disseminate the results of the study, we have created a testimonial video with our first customer, we have improved our webpage and created a specific section for the project. Furthermore, we have visited approximately 30 doctor practices/hospitals and met the Swiss key opinion leaders.
PTBs 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 €23bn in USA. Thanks to Pregnolia, we can estimate a potential reduction of PTBs costs by 42% (up to ~€8.4 billion in EU, €9.66bn in USA). Furthermore, Pregnolia device will impact on the reduction of children’s health complications and child deaths.
Pregnolia will not also make an essential contribution to healthcare in the EU for the benefit of European citizens, it will also contribute to the European medical devices industry, which is currently providing €110 billion in sales and 675,000 jobs in Europe. The EU is a net exporter in this sector.
During the first year of the project, and during the COVID-19 pandemic, we have successfully closed our series A financial round, and we have raised more than 4 million CHF.
Until the end of the project, we expect to have our generation 1 probe ready for certification and we expect to have almost terminated our phase 1 commercialization strategy, which includes promotion of the measurement device based on the generation 0 probe and sales to early adopters. However, the launch of the new generation device depends on the completion and supporting data of the SoftCervix clinical trial. The recruitment rate of the trial has been affected by the COVID-19 pandemic and the completion of the trial during the duration of this project is now considered not achievable. This means that upon completion of the project, we will have to await the completion of the SoftCervix trial to obtain product certification and subsequent market launch.
The phase 1 of the commercialization strategy will be followed by phase 2: sales to mainstream customers with a diagnostic device. We also expect to have initiated contacts with FDA for the approval in the US market during the timeline of this project.
Pregnolia continues to be the sole company developing a non-ultrasound-based biomechanical approach to determine the risk of premature birth. The state of the art continues to present ultrasound-based solutions, however, these are up to now mostly non-commercial techniques.