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

Informazioni relative al progetto

Pregnolia

ID dell’accordo di sovvenzione: 835715

DOI

10.3030/835715

Progetto chiuso

Data della firma CE 28 Novembre 2018

Data di avvio 1 Dicembre 2018

Data di completamento 31 Marzo 2019

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

PREGNOLIA AG
Switzerland

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

Periodo di rendicontazione: 2018-12-01 al 2019-03-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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