Onera Health: Six Years After Its EIC Accelerator Grant

A full sleep study, polysomnography, has long meant a night in a sleep lab with sensors attached to the face, scalp, chest and limbs. Onera, a 2017 spin-off of the imec research institute in Eindhoven, set out to replace those sensors with stick-on patches a patient applies at home, as IO+ and Global Venturing described it. In March 2020 the European Commission picked its SOMNIO project in the EIC Accelerator pilot and awarded it a grant of €2,499,999, according to CORDIS. Six years later the patches are cleared by the US Food and Drug Administration, the company has a second hardware generation and an automatic scoring software cleared as well, and it raised a €30 million Series C in 2024.

The Commission's list of selected companies names Onera of Eindhoven, with SOMNIO as a grant-only award, in the section for "20 March 2020 cut-off date selected COVID19-related projects". No other company is listed for the project, and CORDIS names ONERA BV as its only beneficiary. The pitch to that round leaned on the pandemic: the objective on CORDIS says the technology "is valuable for remote respiratory monitoring to reduce burden on the healthcare system following the COVID-19 pandemic."

Where Onera Stands Now

Onera is operating and still filing new products. The FDA cleared its SleepMap software, which automatically scores sleep stages and breathing events from a sleep study, on 8 March 2026, according to the FDA 510(k) database. In July 2026 its home polysomnography system, Onera hPSG, won a Red Dot product design award, the company's third, according to a company release carried by Business Wire, which says Onera has commercial operations in the United States and Europe. Its website runs separate portals for EU and US customers.

The operating company Onera B.V. is listed as active at Torenallee 42-54 in Eindhoven by OpenCorporates and Liza, and North Data shows balance sheets filed for every year from 2022 to 2025, the latest published on 22 May 2026, with no insolvency notice. The investor money sits above it: the holding company Onera Technologies B.V. is registered at the same address for "holding activities", and its name is in the copyright line of the company website.

The Technology: Four Patches Instead of a Lab

The CORDIS objective sets Onera against two alternatives: the overnight lab study and consumer devices such as "smart watches or mattress sensors that provide limited and inaccurate information about sleep quality". The FDA found the first Onera system substantially equivalent to an in-lab polysomnography system marketed by Natus Medical, according to the company's release. When the FDA first cleared it in April 2022, the patient placed four wireless sensors on the forehead, upper chest, abdomen and lower leg, measuring EEG, EOG, EMG and ECG along with oxygen saturation, respiratory effort and flow, activity, body position and sound, according to the American Academy of Sleep Medicine. The sensors are shipped to the patient, returned after the night, and the data is processed in Onera's cloud into a report for the clinician, TechCrunch reported.

Descriptions of the hardware differ over time. In July 2021 Silicon Canals described the CE-marked first product as a system "that uses two patches"; the 2022 FDA clearance and later reports describe four sensors. Whether this reflects a change in the product or a difference in counting could not be verified.

The main evidence for its accuracy is a multicentre study published in the Journal of Clinical Sleep Medicine with 206 participants at seven clinical sites in Germany and a core laboratory at Johns Hopkins University, run by an independent contract research organisation, according to the company's January 2025 release on DutchNews and a report in Respiratory Therapy. Both say the home system performed comparably to in-lab polysomnography for sleep staging and breathing events. Neither gives the agreement statistics, and the paper itself could not be opened for this article.

What SOMNIO Promised, and What the Record Shows

SOMNIO ran from 1 November 2020 to 30 April 2023 under a grant agreement signed on 7 July 2020, with a total cost of €3,788,320.25, according to CORDIS. The objective promised a clinical-grade wearable of adhesive patches, a "new service model that replaces overnight in-lab studies", and use for remote respiratory monitoring after the pandemic.

The final periodic report, covering February 2022 to April 2023, says the Onera STS "is cleared for market access for both the European market as well as for the US market", that the company launched its "Onera PSG-as-a-Service" in 2022 in the EU and US, and that it had set up "its first customers and commercial pilots" in both regions. The FDA record confirms the first US clearance, K210593, decided on 6 April 2022 for Onera B.V., with a second clearance for the same device, K223573, on 18 August 2023. The CE mark had been obtained by July 2021, according to Silicon Canals, and the company website states CE marking of the Onera STS I under the old Medical Device Directive 93/42/EEC. The report names no customers, and no number of patients or studies is public.

1. Clinical-grade patch wearableDeliveredCE marked by July 2021; FDA cleared April 2022.
2. Clinical validationDelivered206-participant multicentre study, published 2025.
3. Sleep diagnostics as a service, EU and USPartlyLaunched 2022; customers and volumes not disclosed.
4. Remote respiratory monitoring after COVID-19Not achievedNo such product or deployment announced by the company or anyone else.
5. On timeDeliveredEnded 30 April 2023 as scheduled; project closed on CORDIS.

The core of the project, a home polysomnography device cleared on both sides of the Atlantic and sold as a service, was delivered within the grant period. The use that got SOMNIO into the Commission's COVID-19 section, remote respiratory monitoring, has not appeared in any company release or product listing found for this article, which is why the award is rated partly delivered.

What Came After the Grant

The next product generation followed. The Series C announcement in January 2024 said clearance procedures for a next-generation system were "pending in Europe and the United States", according to Gimv. The FDA cleared the Onera STS 2 on 3 July 2025 (K243220) and SleepMap in March 2026. A European certificate for the second generation, or a certificate under the newer Medical Device Regulation, could not be verified from public sources.

The Money

Onera's private funding grew with each round. A Series A of €8.3 million in April 2019 was led by Jazz Pharmaceuticals and imec.xpand, according to IO+ and Global Venturing. A €10.5 million Series B followed in July 2021, led by Innovation Industries with Invest-NL, bringing the total to €24 million, according to Silicon Canals and Global Venturing. In January 2024 EQT Life Sciences and Gimv co-led a €30 million Series C, which TechCrunch said took the total raised to €55 million. IO+ placed the company's headquarters in Silicon Valley in 2019, with research in Eindhoven; by 2021 Silicon Canals reported it had moved its headquarters to Eindhoven. The chief executive changed too: co-founder Raphael Michel was CEO in 2019, and Ruben de Francisco, then chief technology officer, was interim CEO in 2021 and founder and CEO by 2024.

The filed accounts of the operating company, as summarised by Liza from the Chamber of Commerce data, show staff rising from 36 FTE in 2022 to 39 in 2023 and 45 in 2024, then 43 in 2025. Equity was negative at €-3,099,858 at the end of 2022, €-485,047 in 2023 and €-73,540 in 2024, and turned positive at €755,993 in 2025. These are the accounts of Onera B.V. only, not of the holding that raised the equity rounds; the holding's figures sit behind a paywall on North Data. No revenue figure is public, and the staff and equity numbers could not be cross-checked against a second source.

Why Europe Should Care

Moving diagnostics from hospitals into homes is part of what the EU's European Health Data Space regulation, in force since 26 March 2025, is meant to support, including telemedicine and a single market for digital health services. Onera builds on more than ten years of its team's work at imec, according to CORDIS, and its backers include the Dutch state investor Invest-NL and the Brabant development agency BOM, according to Global Venturing. Its European sales so far cover the Benelux and DACH regions, according to TechCrunch and Gimv. Its newest products, the STS 2 and SleepMap, were cleared in the United States, while a European certificate for them could not be found.

The Verdict

Onera has not been asked for comment for this article. It is based on public records and published statements, linked throughout.