A simple, reliable and safe diagnostic device for preterm birth prevention

Project Information

Pregnolia

Grant agreement ID: 835715

DOI

10.3030/835715

Project closed

EC signature date 28 November 2018

Start date 1 December 2018

End date 31 March 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

PREGNOLIA AG
Switzerland

Periodic Reporting for period 1 - Pregnolia (A simple, reliable and safe diagnostic device for preterm birth prevention)

Reporting period: 2018-12-01 to 2019-03-31

Summary of the context and overall objectives of the project

Premature birth (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 a unique diagnostic device to determine the risk of PTB based on the measurements of cervical tissue stiffness. The objective of the project was to assess its technical, commercial and financial viability.

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 feasibility study has shown positive results, proving than Pregnolia is:
- Technologically feasible: It is possible to improve the design of the current prototype to achieve a manufacturing cost reduction. A phase 2 project addressing the required improvements has been defined.
- Commercially feasible: Pregnolia targets the attractive PTB diagnosis market niche within gynaecological devices. Pregnolia’s business plan has been developed to ensure a successful market entry by Q1 2022.
- Economically feasible: The financial requirements for Pregnolia commercialisation have been estimated and sales forecast updated.

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)

The Pregnolia device consists on a reusable control unit with a disposable single-use probe. Pregnolia is clearly ahead of state of the art solutions due to its higher specificity, sensitivity and accuracy and its easy application, furthermore it enables immediate preventive action for preterm birth management. It has the potential to be a truly disruptive technology within PTB screening which can contribute to decrease PTB rates significantly reducing the associated health problems and increasing survival rates, bringing a potential reduction of PTBs costs by 42% (~€8.4 bn in EU, €9.66bn in USA).

Pregnolia device and major benefits