Pregnolia and the EIC Accelerator: Preterm Test Still in Trials

An estimated 13.4 million babies were born before 37 weeks of pregnancy in 2020, and complications of preterm birth are the leading cause of death among children under five, according to the World Health Organization. Current methods of predicting when labour will really start are inaccurate, Pregnolia argues in its latest EU project description, so some women miss treatment and others are hospitalised without need. Pregnolia, a spin-off of ETH Zurich based in Schlieren near Zurich, measures one of the warning signs directly: how soft the cervix has become.

The European Union has backed the company four times. In the April 2019 round of the EIC SME Instrument Phase 2, the forerunner of the EIC Accelerator, it awarded Pregnolia €1,283,913.75 to turn its prototype into a cheaper, commercial device. In the 1 October 2025 cut-off of the Horizon Europe EIC Accelerator it selected the company again, this time for blended finance, to pay for the clinical trial that is supposed to prove the device can predict preterm birth. Between the two awards lies the central fact of this story: Pregnolia has sold a CE-marked device since 2020, but it is approved as a measuring instrument, not as a test that tells a woman her risk.

What Pregnolia Does Today

Pregnolia is an active company. Its entry in the Swiss commercial register shows a capital increase to CHF 420,489 on 28 January 2026 and a new capital band adopted on 20 July 2026, and North Data lists it as active at Wiesenstrasse 33 in Schlieren. No accounts are available from the register or North Data, so its revenue, losses and headcount could not be verified. Its website names six team members and a four-person board.

The company sells the Pregnolia System to gynaecologists and maternity clinics. Five Swiss health insurers reimburse the examination under supplementary plans: Sanitas from May 2021, CSS from January 2022, Helsana from September 2022, and Atupri and KPT from September 2024, according to the company's news page. Sanitas, the first, also invested in the company, its press release said, and noted that the examination is not a mandatory benefit under Swiss basic health insurance and that the studies needed for inclusion were still under way.

Every page of the company website carries the same qualification: the Pregnolia System "supports the diagnostic, but does not predict the risk of a premature birth". In March 2026 Swiss public broadcaster SRF reported that further tests are needed before the device may be used for diagnosis in routine care.

The Technology: Suction Instead of a Finger

Clinicians judge the cervix by touch, as in the Bishop score used before induction of labour, and by measuring its length with transvaginal ultrasound, which Pregnolia's 2019 project objective calls the current "gold standard". Both methods appear as comparators in the studies of Pregnolia's device cited below. Pregnolia's probe is placed on the cervix and applies a gentle vacuum; the control unit records the pressure needed to draw the tissue a fixed distance into the probe tip. A softer cervix needs less suction. Researchers in Naples describe the device in exactly these terms in a 2026 study, calling the result a Cervical Stiffness Index measured in millibar.

Badir developed the method during her doctorate at ETH Zurich and the University Hospital Zurich. A 2020 paper she co-wrote with company staff, listed on the company's studies page, found the device more reliable than palpation on silicone models of the cervix. That was a bench test. Whether a soft cervix measured this way predicts an early birth in real patients is the question the company has spent the years since trying to answer.

What the 2019 Project Promised, and What CORDIS Shows

The European Commission's list of winners of the 3 April 2019 cut-off names Pregnolia AG of Zurich as the only company in its project, "A Diagnostic Medical Device Determining the Risk of Preterm Birth". It followed a €50,000 Phase 1 feasibility study from December 2018 to March 2019. The phase 2 grant agreement was signed on 23 July 2019 and the project ran from 1 September 2019 to 30 June 2022, with a total cost of €1,834,162.50, according to CORDIS.

The objective was ambitious. It claimed the patented device had "twice the sensitivity" of ultrasound, that with it "80% out of 100% at risk" could be treated, and that Pregnolia would reach net revenues of about €74 million and net profits of about €30 million by year five. The concrete work was narrower: develop a "generation 1" probe that is much cheaper to make than the existing "generation 0", validate it and prepare the market launch.

The final periodic report, covering January to June 2022, is candid. The new probe was designed, a manufacturer chosen and a first production series made, but sterilisation, transport, stability and packaging validation were "ongoing" at the close. The company expected the probe to be ready for certification under the EU Medical Device Regulation by the end of the project, and clinical data from the SoftCervix trial "in summer Q3 2022". It had started working with a Swiss distributor, identified focus regions in Germany for a pilot launch, sent a mailing to 1,000 doctors and secured reimbursement from two Swiss insurers.

1. Generation 1 probe designed and producedDeliveredDesign finalised and a 0-series produced, per the CORDIS report.
2. Probe validation completedPartialStill ongoing when the project closed in June 2022.
3. Ready for MDR certification by June 2022LateTÜV SÜD first issued its MDR certificate on 21 December 2023.
4. Reimbursement by Swiss insurersDeliveredTwo insurers by 2022, five by September 2024.
5. SoftCervix clinical data by Q3 2022LateThe Swiss and Belgian multicentre study was published in December 2025.
6. Pilot launch in GermanyNot achievedNo German launch or customer announced.
7. A device that diagnoses preterm birth riskNot achievedThe company says the system does not predict the risk.
8. About €74M revenue by year fiveNot achievedNo revenue figure has been published.

Several items need context. The device was on the market before the grant ended: Sanitas said it gained its CE certificate in 2019, while the notified-body certificates the company publishes, for the control unit and the probe, are dated April and May 2020. The 2023 MDR certificate covers class I obstetric measuring devices, the regulatory class of an instrument, not of a risk test. The company has not said publicly whether the probe it sells today is the generation 1 design the EU paid for. And the SoftCervix data arrived three years late: the SoftCervix registration lists 1,002 participants in Switzerland and Belgium, completion in December 2022 and David Scheiner of the University of Zurich as sponsor, and Scheiner is the corresponding author of the multicentre paper by Hösli and colleagues in the American Journal of Obstetrics & Gynecology MFM, published online on 5 December 2025, which Pregnolia's news page describes as its Swiss and Belgian study. Badir is a co-author.

The Evidence So Far

The first independent clinical results appeared in late 2025. A team at Amsterdam UMC published the STIPP cohort study as a short research letter in the American Journal of Obstetrics and Gynecology, online on 3 November 2025. The University of Naples Federico II measured 100 women with threatened preterm labour between April 2022 and August 2024, according to its paper in the European Journal of Obstetrics & Gynecology and Reproductive Biology. For delivery within 14 days of the measurement, the stiffness index reached an area under the curve of 0.979, against 0.744 for cervical length. Only five women delivered within 14 days, and the authors write that the findings "require confirmation in larger, independent cohorts".

Not every study is positive. In a Liverpool feasibility study of 100 women before induction of labour, published in BJOG in 2026, the measurement was feasible and less uncomfortable than a manual exam, but neither it nor the standard Bishop score predicted vaginal delivery well; the Pregnolia result had an area under the curve of 0.466, no better than chance.

The Money

Pregnolia has been financed in small rounds. It raised CHF 3.25 million in seed money led by investiere.ch, with Zürcher Kantonalbank and CADFEM, reported by startupticker.ch in February 2018. A Series A of CHF 4.2 million followed in June 2020, according to Venturelab; the CORDIS report puts it at "more than 4 million CHF". In November 2023 the company raised CHF 2.2 million to fund clinical studies and an FDA roadmap, as its press release and Femtech Insider reported, without naming investors.

In March 2026 Badir said the EIC award "enabled the successful completion of the third financing round amounting to CHF 3.4 million", in a company press release; Venturelab reported the same figure but described it as "bringing the total raised to CHF 3.4 million". Neither reading fits the record: the seed round, Series A and 2023 round alone add up to CHF 9.65 million, and SRF put the total that has flowed into the company at CHF 15 million. The register shows the matching capital increases, the largest in May 2020.

The EIC Fund's list of invested companies, checked across all its pages on 14 October 2026, does not include Pregnolia. The equity part of the 2025 blended finance award has therefore either not been invested or not been published. Pregnolia's own announcement speaks only of an "EIC Accelerator Grant".

The 2025 Award: Paying for the Proof

The Commission's list of companies selected at the 1 October 2025 cut-off names Pregnolia AG and its project Pregnolia Dx, with blended finance recommended. It was one of 61 companies chosen from 121 interviewed, the EIC announced on 17 February 2026. CORDIS records grant agreement 101298109, signed on 1 June 2026, with an EU contribution of €2,195,550 and a run from 1 July 2026 to 31 December 2028; no total cost is listed.

The project describes the Pregnolia Diagnostic System as cervical stiffness measurements combined with a "risk prediction algorithm", and promises a "pivotal clinical trial" starting with women in threatened preterm labour. That is a direct admission that the diagnostic promised in 2019 does not yet exist. The first studies are visible: Pregnolia registered a 100-woman study in Czechia in September 2026, not yet recruiting, and its news page says hospitals in the UK Preterm Clinical Network are preparing to use the device in a sub-study meant to update the QUiPP risk tool. It is too early to judge the project.

Why Europe Should Care

The second award was possible because Switzerland is again part of the EU's research programme. The agreement signed on 10 November 2025 associates it to Horizon Europe retroactively from 1 January 2025, according to Euresearch, the Swiss network for EU research funding. CORDIS lists Pregnolia's Horizon Europe grant with the company as sole coordinator. Pregnolia's own EU report frames its case as part of the European medical device industry, which it says provides €110 billion in sales and 675,000 jobs, and its device is certified under the EU Medical Device Regulation. The EIC's announcement of the round highlighted another women's health project, Oxolife's fertility tablet, and said 28% of the selected companies have women in key leadership roles; Pregnolia is one of them, run by its founder.

The Verdict

Pregnolia has not been asked for comment for this article. It is based entirely on public records, company statements, published studies and EU project data, linked throughout.