A Diagnostic Medical Device Determining the Risk of Preterm Birth

Project Information

Pregnolia

Grant agreement ID: 873553

DOI

10.3030/873553

Project closed

EC signature date 23 July 2019

Start date 1 September 2019

End date 30 June 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 834 162,50

EU contribution

€ 1 283 913,75

Coordinated by

PREGNOLIA AG
Switzerland

Periodic Reporting for period 3 - Pregnolia (A Diagnostic Medical Device Determining the Risk of Preterm Birth)

Reporting period: 2022-01-01 to 2022-06-30

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 goal of this phase 2 project is to develop Pregnolia’s new probe, generation 1, ensuring a reliable, scalable, high-quality device, with significantly 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 fulfil 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).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

WP1 has been concluded and all activities have been performed. In particular, we have selected the new thermoplastic material for the body of the probe, redesigned some parts for the injection molding manufacturability, created an entirely new packaging concept, the design of the generation 1 probe has been finalized and finally we have performed production runs for the 0-series .
WP2 (Technical validation) is ongoing. The generation 1 probes from the production runs are undergoing all the verification and validation activities, in particular sterilization validation, technical functional validation, transport validation, stability validation and packaging validation.
Concerning WP3, we have performed activities related to the upstream supply chain and having identified potential suppliers for process development and industrialization, assessed, and selected the final manufacturer. Furthermore, during the second reporting period, we have analyzed our sales and distributor networks, we have started a collaboration with a distributor in Switzerland and enlarged our internal sales team. We have identified focus regions in Germany for our pilot launch and started several activities in the identified regions.
As per WP4, we have successfully established reimbursement path with two major health insurance companies in Switzerland, and started an “Ambassador” program in Switzerland involving current customers. Furthermore, we have started new collaborations for clinical studies with several KOLs in Europe. The cost and price structure of our devices have been revised and we have identified three possible price structure. Moreover, we are constantly ensuring certifications and regulatory compliance. In addition, we have also analyzed the possible path to obtain FDA approval with the aid of several FDA consultants
Regarding WP5, we have designed and produced new flyers, 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 and our image video, we have improved our webpage and created a specific section for the project. We have attended congresses in person and with a booth, in those cases, we have also demonstrated the device to participants.

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)

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.
Furthermore, during the second reporting period, we have started several collaborations with investigators interested in conducting clinical investigations with our device. This shows the interest in the device and the promise of this biomarker, as a risk signal derived from a fundamentally different mechanistic behavior, increasing its potential for diagnostic complementarity in a complex problem as preterm birth diagnostic. Furthermore, some of them have shown interest not only in the application of the device to identify women at risk of preterm birth, but also in its application to identify women who will benefit from induction of labor, opening up the possibility of using the Pregnolia System for another very important clinical application where the standard of care is poor.
Until the end of the project, we expect to have our generation 1 probe ready for certification under MDR. Moreover, with the completion of the recruitment for the SoftCervix trial, the clinical data will most likely be available in summer Q3 2022. The data will be pivotal in the adoption of the generation 1 device as they will give clear guidance on how to clinically interpret the device results.
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.