Inside Sensocure's EIC Accelerator Project on Ischemia Sensors

When blood stops reaching a piece of tissue, carbon dioxide builds up in it before the damage becomes permanent. Sensocure, a company in Skoppum near Horten in southern Norway, makes a sensor thinner than a millimetre that is placed in the tissue and reports that rise in real time. In March 2020 the European Commission picked the company in the EIC Accelerator pilot with blended finance, grant plus equity, according to its list of selected companies. The grant, €1,958,512.50 towards a €2,797,875 project, was to pay for the last steps to market: clinical trials, a CE mark and scaled-up production, according to CORDIS.

Six years on, the sensor, IscAlert, is CE-marked and on sale in Norway. The EU medical device database EUDAMED lists four Sensocure devices as class IIa and "on the market". What the record does not show yet is a business: the company's operating income was NOK 2.1 million in 2025, against a net loss of NOK 14.9 million, according to its accounts in the Norwegian accounts register.

Where Sensocure Stands Now

Sensocure is an active company. The Brønnøysund Register Centre lists it as a private limited company with 23 employees, not bankrupt and not in liquidation, with its 2025 accounts filed. Its share capital has been raised three times since September 2024, from NOK 192,125 to NOK 283,637 in August 2026, and the shareholders gave the board authority in June 2026 to raise it by up to NOK 120,000 more, according to the register's public announcements. How much money those share issues brought in is not public.

On 5 February 2026 the company held a national launch of IscAlert in Oslo. Its news page reprints a MedWatch report that the product "can now be bought by Norwegian hospitals" (translated) after it received CE marking in mid-2025, and that Norway is the first market. In 2026 the company presented IscAlert at ISICEM 2026, at SCAPLAS 2026 in Oslo and at the congress of the Scandinavian Society for Surgery of the Hand, and hired a key account manager with more than 20 years in pharmaceutical sales, according to its news archive. No hospital customer, order or price has been made public.

The Technology: Reading CO2 Inside the Tissue

Ischemia means that tissue gets too little blood. It is the mechanism behind a failed skin flap after breast reconstruction, a reattached finger that dies, compartment syndrome in a crushed leg, or organs starved during shock. Clinicians today mostly judge it from the outside, by colour, temperature, pulse or a Doppler signal, or from blood tests that reflect the whole body rather than one flap or muscle.

IscAlert measures the partial pressure of carbon dioxide (pCO2) in the tissue around the sensor tip, plus its temperature. When blood flow falls, CO2 from the cells is no longer carried away and the local pCO2 rises early, while the injury can still be reversed, the company says on its product page. The sensor is single-use, placed through an introducer and meant for use of up to 14 days, according to the company's website. The idea goes back to the research of Tor Inge Tønnessen, an anaesthesiologist at Oslo University Hospital and the company's founder, who co-authored a paper on a biomedical pCO2 sensor in 2004 and tested CO2 sensors in a porcine pancreas model as recently as 2022.

The concept is older than the company. The US Food and Drug Administration cleared an "IscAlert Sensor System" in November 2007 for an earlier Norwegian firm, Alertis Medical AS, under 510(k) number K071165, which is also the only IscAlert entry in the FDA's 510(k) data. How that clearance relates to Sensocure, which was founded in 2011, could not be verified; Sensocure itself says it is still "preparing to submit a 510(k) application" for today's product.

What the EIC Project Promised, and What CORDIS Shows

The IscAlert project was signed on 15 October 2020 and ran from 1 January 2021 to 31 October 2023. The EIC list names Sensocure as the only beneficiary. It was Sensocure's second EU grant: in 2015 a €50,000 SME Instrument Phase 1 grant paid for a feasibility study, CLINISC, which planned clinical testing with Oslo University Hospital and "up to five" other European hospitals.

The objective on CORDIS is specific: finish clinical trials, gain a Class II CE mark for Europe, scale up production, then seek €3.5 million of EIC equity and FDA approval. It also forecast that by 2027 the company would employ 113 more people, sell 38,000 sensors a year and have earned €59.92 million in cumulative revenue. The final periodic report, covering November 2022 to October 2023, gives a mixed account. The first clinical study, at Oslo University Hospital, started in September 2021 after delays from Covid-19 and was completed in June 2022 with 50 patients, showing "that IscAlert is a safe and reliable monitor of ischemia", the company wrote. The trial registry entry NCT04879875 gives 50 enrolled patients and a completion date of 24 July 2022, a month later than CORDIS.

The CE marking was not finished. "We have experienced long lead times at the Notified Body," the report says; the formal application had been submitted and the first audit was expected in the first quarter of 2024. The other clinical studies were also still running at project end. The report dates the start of the finger replantation study to January 2023, while the registry entry NCT05297266 gives 15 November 2022; both list it with Oslo University Hospital. The study on reconstruction flaps, NCT05487820, began on 13 October 2023 and is planned to finish in October 2027. The compartment syndrome study, which the report said would start in January 2024, is listed as "not yet recruiting" with a start date of October 2025 under NCT06079255.

1. First clinical studyDelivered50 patients, finished mid-2022, per CORDIS and ClinicalTrials.gov.
2. Complete the clinical trial programmePartialReplantation and flap studies still active; compartment syndrome study not yet recruiting.
3. Class II CE markLateClass IIa CE mark announced 3 June 2025, 19 months after the project ended.
4. Scaled-up productionPartialCORDIS reports "scalable production capacity is demonstrated"; no sales volumes are public.
5. Published clinical resultsNot foundNo paper on the 50-patient study in PubMed, four years after it ended.
6. FDA clearance for the USNot achievedNo Sensocure 510(k); the company is "preparing to submit".
7. 38,000 sensors a year, 113 new jobs by 2027Not achievedNOK 2.1M operating income in 2025; 23 employees in 2026.

The core technical goal was met: the sensor was taken through a clinical study and onto the market. The CE mark came late, which the company blames on the notified body, and the commercial forecasts in the proposal have not come close.

What Sensocure Has Achieved Since the Award

The CE marking is the main result. Sensocure announced on 3 June 2025 that IscAlert complied with the EU Medical Device Regulation (MDR) 2017/745, in a press release. EUDAMED confirms four class IIa devices registered by Sensocure, among them the IscAlert CU and the IscAlert Introducer, all with the status "on the market". The company registered in EUDAMED as a manufacturer in December 2022.

The EIC equity came late. The final CORDIS report said the EIC Fund had approved "up to €3.5million" for Sensocure. On 9 January 2025 the company announced that the EIC Fund had invested NOK 12 million in a NOK 24 million round, in a press release that quotes Svetoslava Georgieva, chair of the EIC Fund board. The EIC lists Sensocure in its EIC Fund portfolio, without an amount or date. Whether the EIC Fund invested more than NOK 12 million in total could not be verified. The other investors in the round were not named.

Smaller grants continued. In June 2024 the Regional Research Fund for Vestfold and Telemark granted NOK 500,000 for a "membrane concept for a planar PCO2 sensor", according to the fund, a project the company links to a second product for patients with lung disease, CriticAlert. A study at the Hospital of Vestfold on measuring the body's CO2 level with the sensor, NCT06367686, enrolled 21 participants and was completed in March 2026. Its results are not published.

The Money

The company's accounts show a business that is still almost entirely funded by its owners and lenders. Operating income was NOK 3.14 million in 2023, NOK 1.99 million in 2024 and NOK 2.13 million in 2025; the register records identical sales of NOK 1,887,504 for both 2023 and 2024. Net losses were NOK 20.4 million, NOK 13.4 million and NOK 14.9 million, a total of NOK 48.8 million in three years.

Equity doubled from NOK 11.6 million at the end of 2023 to NOK 23.4 million a year later, and stood at NOK 23.9 million at the end of 2025. Debt grew faster. Total liabilities rose from NOK 57.1 million to NOK 77.8 million in 2025, of which NOK 51.1 million is due within a year. Most of the NOK 101.7 million balance sheet, NOK 86.8 million, is fixed assets; the public extract does not say what they are. Cash was NOK 9.3 million at the end of 2025, against an operating loss of NOK 14.6 million that year.

Why Europe Should Care

Sensocure's story is a case study in what the EU's medical device rules cost a small company. Sensocure had filed its CE application with a notified body by October 2023, according to its CORDIS report, was still waiting a year later, according to the Gjengangeren interview, and announced the certificate in June 2025. On 16 December 2025 the Commission proposed a targeted revision of the MDR, citing CE mark delays and products leaving the market, with fee cuts for small manufacturers and maximum timelines for notified body assessments, as summarised by Morgan Lewis and RAPS. The proposal still needs the Parliament and the Council.

The clinical case is also European. All of Sensocure's trials run at Norwegian public hospitals, and its first market is the Norwegian health service. If continuous tissue monitoring proves that it saves flaps, limbs and intensive-care days, it is a European-made answer to a problem every hospital has. That proof, in published trial data, is not yet public.

The Verdict

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