Mode Sensors: An EIC Accelerator Story of a Hydration Patch

Hospitals and nursing homes still track how much fluid a patient takes in and passes out largely by hand, on fluid balance charts that nurses fill in during busy shifts. Mode Sensors, a Trondheim company founded in 2016, set out to replace the chart with a disposable patch worn on the back that measures the body's electrical resistance and turns it into a continuous reading of fluid status. In the European Innovation Council's last Horizon 2020 round, the EIC Accelerator pilot cut-off of 7 October 2020, the company was selected for ReBalans with blended finance, a grant plus equity, according to the Commission's list of selected companies. Mode Sensors is the only beneficiary listed for the project.

The grant was €2,497,250 towards a total cost of €3,567,500, for a project that ran from 1 March 2021 to 29 February 2024, according to CORDIS. The proposal promised a product that would be "cheaper and more efficient" than current methods and accumulated revenues of €107 million in the five years after the project. The patch now exists and is cleared in the United States. The revenue does not.

Where Mode Sensors Stands Now

Mode Sensors is an operating company. The Norwegian register shows no bankruptcy or liquidation, nine employees and a board chaired by co-founder Martin Engebretsen, according to the Central Coordinating Register for Legal Entities. Its register announcements record a move to new offices at Sluppenvegen 6 in January 2026, a share capital increase from NOK 56,441 to NOK 62,006 in February 2026, and approved 2025 accounts in July 2026. The amount raised in the share issue is not public in the register.

On 16 October 2025 the US Food and Drug Administration cleared the Re:Balans patch through the 510(k) route, according to the FDA database. The company's website now calls the device "FDA cleared" and available to American healthcare providers, lists two product lines, Re:Balans Care and Re:Balans Insight, and invites visitors to request early access to Insight. It names no customer and mentions no European approval. In January and February 2026 the company was due to pilot the patch with Vesthimmerland Municipality in Denmark, testing whether hydration data could help prevent falls, infections and hospital admissions among older people, under the Interreg North Sea ACE pilot programme. No results from that pilot have been published.

The Technology: Reading Fluid Through Resistance

Water conducts electricity, so the more fluid there is in the tissue under a sensor, the lower its electrical impedance. Re:Balans is an adhesive patch with four electrodes, placed on the upper back, that sends a small current at several frequencies and calculates base impedance and the resistance of the fluid outside and inside the cells, according to the 510(k) summary. It records for up to seven days and sends data over Bluetooth to an iPad app. The CORDIS results article adds an accelerometer and thermistors to filter out movement and temperature.

Bioimpedance itself is not new. The FDA cleared Re:Balans as "substantially equivalent" to an older device, the IMED-Z Fluid Status Monitor, which measures impedance at the same place on the back, through a cable, for up to 24 hours. Mode Sensors' differences are the wireless link, the multiple frequencies, the lower current and the seven-day wear time. The clearance is also narrower than the project's language. CORDIS describes a "medical grade" sensor with "better accuracy than the best-practice method"; the FDA summary calls Re:Balans "an assessment tool" that "is not intended to be a medical diagnostic device", gives no real-time alarms, and must be read in the context of all clinical data. The clinical evidence in the summary comes from two studies outside the United States: healthy volunteers dehydrated with a diuretic, and dialysis patients monitored for about three weeks.

What ReBalans Promised, and What CORDIS Shows

The final periodic report lists solid engineering work: a new sensor patch with better wear, water resistance and measurement accuracy, production testers for high-volume manufacturing, an improved on-device hydration algorithm, a prototype gateway and interface for integrators, a clinical validation report from a study in nursing home residents, the full set of safety tests, an ISO 13485 quality system and completed technical files for both FDA 510(k) clearance and CE marking. It also reports "three commercial co-development agreements with multinational commercial partners in med-tech, military, welfare technology markets", none of them named. The CORDIS results article quotes Engebretsen saying the aim was to launch in Europe and the United States in 2025, after a pilot in elderly care rehabilitation units planned for late 2024.

The project ended on schedule, but the regulatory milestones came later or not at all. The FDA received the 510(k) on 3 December 2024, nine months after the project closed, and cleared it ten months later. No CE mark under the EU's medical device rules has been announced by the company or reported by anyone else, so the patch cannot yet be sold as a medical device in the European market the grant came from.

1. Improved wearable patch and algorithmDeliveredReported in the final report; described in the FDA summary.
2. Clinical validationPartlyNursing home study report finalised; two non-US studies in the FDA file; no peer-reviewed paper found.
3. ISO 13485 quality systemDeliveredImplemented and audited, per CORDIS.
4. US clearanceDelivered lateFDA K243727, October 2025, 20 months after the project ended.
5. CE markingNot achievedTechnical file written in 2024; no CE mark announced.
6. Launch in Europe and the US in 2025Not achievedNo named customer; early access only for Re:Balans Insight.
7. €107M revenue in five yearsOff trackSales revenue of NOK 633,010 in 2025, the second post-project year.

What Mode Sensors Has Achieved Since the Award

The clearest result is the FDA clearance. The second is a working product that municipalities have tested. As early as August 2019, a year before the EIC award, founder Gøran van den Burgt told Teknisk Ukeblad that the company had 15 people, that the municipalities of Trondheim, Oslo and Åfjord were customers, and that two pilot studies had matched established methods. The register now shows nine employees. The two figures come from different sources and are not strictly comparable, but neither points to growth.

Mode Sensors has also taken part in a second EU project. It is one of eight participants in NEMECYS, a Horizon Europe project on cybersecurity for connected medical devices that ran from January 2023 to December 2025, with a net EU contribution to Mode Sensors of €243,750. No other EU project of the company appears on CORDIS. Its leadership has changed hands and changed back: van den Burgt was registered as managing director in March 2021, Henrik Lund in June 2021, and van den Burgt again in February 2023, according to the register announcements.

The Money

The free accounts from the Register of Company Accounts cover 2023 to 2025. Mode Sensors lost NOK 12.6 million in 2023 and NOK 13.2 million in 2024, with wage costs of about NOK 11 million each year. In 2025 it reported a profit of NOK 3.0 million, on total operating income of NOK 11.3 million and wage costs of NOK 2.0 million, while fixed assets rose from NOK 2.4 million to NOK 12.0 million. The free register data does not explain the shift, and the full annual report was not available for this article. What it does show is that sales revenue, the money customers paid, has never passed NOK 1 million in these three years. Cash fell from NOK 18.4 million to NOK 2.1 million during 2025, and equity stood at NOK 10.2 million at year end.

Why Europe Should Care

ReBalans pitched itself to the EIC as an answer to ageing populations, multimorbidity and healthcare worker shortages. The Commission says health system capacity "strongly depends on the availability of a workforce with the right skills and flexibility" and calls for reforms of "critical health workforce issues", according to its health workforce page. A patch that takes over a manual nursing task in elderly care fits that agenda directly.

The irony is regulatory. A Norwegian device funded by the EU to help European nursing homes reached the American market first, and its makers have not announced an approval for the European one. Why the CE mark has not followed is not public.

The Verdict

Mode Sensors has not been asked for comment for this article. It is based entirely on public records, regulatory filings and EU project data, linked throughout.