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MaiRa Preeclampsia Test®: Smart prevention for maternal-fetal carebroad

MaiRa · Horizon Europe grant · 2026-06-01–2028-05-31

EC contribution

€2,499,999

Total cost

€0

Beneficiaries

1
About the data

Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-EIC-2025-ACCELERATOR-02 · scheme HORIZON-EIC-ACC · topic HORIZON-EIC-2025-ACCELERATOR-02-OPEN-01. CORDIS record →

Objective

Pregnancy complications such as preeclampsia (2–5% of pregnancies in EU) remain a major unmet need in prenatal care, with current detection often occurring only after maternal organ damage, when prevention is no longer possible. The consequences include maternal and neonatal morbidity, emergency interventions, and intensive care, costing EU health systems over €436M annually. Existing screening methods such as maternal history, Doppler ultrasound, late biomarkers, are subjective, operator-dependent, or too late for effective prophylaxis.iPremom addresses this gap with MaiRa Preeclampsia Test®, the first non-invasive, first-trimester cfRNA + AI screening solution predicting early-onset preeclampsia (EOPE) up to 18 weeks before symptoms. Based on a proprietary 36-gene cfRNA signature linked to impaired uterine decidualization, the test delivers an individualized risk score through MaiRa Predict, an in-house SaMD. Validation has shown actionable performance (83% sensitivity, 90% specificity, AUC 0.88), within the preventive window where clinical management following ACOG guidelines, such as low-dose aspirin prophylaxis, is effective in preventing EOPE.Commercialization will follow a dual route: launch as a clinical service via tech-transfer to leading reference laboratories, in parallel with a decentralized kit + SaMD model for NGS-capable hospitals and private labs. This approach accelerates access, minimizes workflow disruption and supports adoption. Commercialisation starts in EU-5 in 2028, expanding to broader EU, LATAM, and the US.With CE-IVDR Class C pathway underway, robust IP, strategic partners, and validated demand, iPremom is positioned to reach TRL9 by 2028. With EIC support, MaiRa Preeclampsia Test® can prevent thousands of EOPE cases annually, reduce preterm births, save >€300M/year in healthcare costs, and establish EU leadership in AI-powered maternal-fetal diagnostics, while paving the way for pipeline extensions to other pregnacy complications.

Beneficiaries (1)

OrganisationCountryRoleEC contributionSME
IPREMOM PREGNANCY HEALTHCARE DIAGNOSTICS SL ES coordinator €2,499,999 Yes

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