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A Diagnostic Medical Device Determining the Risk of Preterm Birth

Project description

New diagnostics to determine premature birth risk

Preterm birth (before 37 weeks of pregnancy) is a leading cause of infant mortality. Survivors often have life-long issues – breathing problems, cerebral palsy or intellectual disabilities. This translates into yearly healthcare costs of EUR 20 billion in Europe and EUR 23 billion in USA. Pregnolia is a novel diagnostic device that can determine the risk of premature birth using cervical tissue stiffness. It is safe, user friendly and twice more efficient in predicting risk than current standard ultrasound technology. According to preliminary estimation, at least 80 % of women at risk of preterm birth could get timely diagnosis and treatment with the introduction of new technology. The EU-funded Pregnolia project is supporting an upgrade of the device prototype for a viable commercial model.

Objective

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. 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.
Pregnolia is a unique diagnostic device to determine the risk of PTB based on the measurements of cervical tissue stiffness. Our patented device has twice the sensitivity of the current “gold standard” (ultrasounds), it is simple, safe, and easy to use and to integrate into routine gynaecological consultations. With our solution, the majority of women, 80% out of 100% at risk, can be treated to prevent premature birth.
This phase 2 project has been defined to upgrade Pregnolia’s prototype based on our Feasibility Study outcomes, which will allow us to fulfil our 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. Pregnolia will achieve net revenues of ~€74 M, net profits of ~€30 M and, considering the investment of €8.8M a ROI of ~7 euro per euro invested at year 5. Thanks to Pregnolia, we estimate a potential reduction of PTBs costs by 42% (up to ~€8.4 billion in EU, €9.66bn in USA). Furthermore, our Pregnolia device will impact on the reduction of children’s health complications and child deaths.

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Programme(s)

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Topic(s)

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Funding Scheme

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SME - SME instrument

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Call for proposal

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(opens in new window) H2020-EIC-SMEInst-2018-2020

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Coordinator

PREGNOLIA AG
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 283 913,75
Address
WIESENSTRASSE 33
8952 Schlieren
Switzerland

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 834 162,50
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