Cercare Medical's EIC Accelerator Stroke Software, Seven Years On

In an acute ischaemic stroke, a clot cuts off blood to part of the brain, and every minute of delay kills brain cells. The decision on whether to dissolve the clot with drugs or pull it out with a catheter depends on reading brain scans, and most hospitals have no specialist stroke radiologist on call. Cercare Medical, a 2013 spin-out from Aarhus University, set out to put that expertise into software. In the European Innovation Council's January 2019 round of the SME Instrument Phase 2, the forerunner of today's EIC Accelerator, it won a grant for iTrust, a decision-support tool meant to predict, from a patient's scans and clinical data, how much brain tissue each treatment option would save.

The EU paid €1,831,375 towards a €2,616,250 project that ran from 1 May 2019 to 31 October 2021, according to CORDIS. The company appears as "CERCARE MEDICAL APS" of Aarhus, with iTrust as its project, in the European Commission's list of SME Instrument Phase 2 winners; no other company is listed for the project, and CORDIS names Cercare as its sole beneficiary. Seven years after the cut-off, the software is sold in Europe, the US and Asia and has five clearances from the US Food and Drug Administration. The company behind it has never reported a profit since the grant, and its 2025 accounts carry a going-concern warning from its auditor.

Where Cercare Medical Stands Now

Cercare Medical is operating and launching products. On 27 May 2026 it and Siemens Healthineers announced a global collaboration that pairs Cercare's software with Siemens' Syngo DynaCT Multiphase protocol, so that brain perfusion can be measured on the angiography system in the room where clots are removed, without moving the patient to a CT or MRI scanner. The next day the company announced FDA clearance K253831 for that cone-beam CT perfusion product, supported by a study at Bern University Hospital in which 13 neuroradiologists rated perfusion maps from stroke patients. NeuroNews International and Endovascular Today reported both announcements.

The same accounts that record that progress show a company running on investor money. Cercare lost DKK 56,743,481 in 2025 and ended the year with negative equity of DKK 11,269,508, according to its annual report filed with the Danish Business Authority on 29 June 2026. Its auditor, PwC, drew attention to "a material uncertainty that may cast significant doubt on the Company's ability to continue as a going concern". Management wrote that money received in early 2026 would fund the company "until January 2027" and that further investment was expected over the summer of 2026. The register shows share capital rising from DKK 1,000,918 to DKK 1,307,253 on 1 April 2026 and to DKK 1,454,815 on 28 May 2026, according to North Data. How much cash those increases brought in, and whether they include the conversion of the DKK 22.4 million the company owed its owners and management at the end of 2025, is not public.

The Technology: Measuring Oxygen, Not Only Blood Flow

Perfusion imaging tracks a pulse of contrast agent through the brain to show where blood flow has dropped. Doctors use the maps to separate tissue that is already dead, the core, from tissue that is starving but can still be saved, and to decide whether a patient is worth treating late. The established method, a mathematical technique called singular value decomposition, was first applied to perfusion imaging in a 1996 paper by Leif Østergaard of Aarhus University, who now sits on Cercare's scientific board, according to the company's history.

Cercare's software instead fits a physiological "Vascular Model" of the capillaries. Besides the usual maps of blood flow, blood volume, mean transit time and Tmax, it reports what the company calls metabolic biomarkers: oxygen extraction fraction, the cerebral metabolic rate of oxygen and capillary transit time heterogeneity, a measure of how unevenly blood passes through the smallest vessels. The company says this shows how well tissue is supplied with oxygen, not just with blood. Added modules detect intracerebral haemorrhage and large-vessel occlusions with machine learning. The software runs on the hospital's own servers and works with scanners from any vendor, according to the company's product pages.

What iTrust Promised, and What CORDIS Shows

The iTrust objective on CORDIS describes a decision-support tool using convolutional neural networks to "predict the outcome of treatment strategies" in stroke, shown as "high-resolution images of probable brain tissue outcomes in function of each treatment available". It was to be sold for an annual licence fee, distributed at first through "strategic partnerships (formal agreements already signed)" with the major CT and MRI vendors, and to generate "an accumulated turnover exceeding EUR 41 million" in the five years after the project.

The final periodic report, covering May 2020 to October 2021, says the project produced five software modules: Cercare Medical Neurosuite, Capillary Function, Virtual Expert, intracerebral haemorrhage detection and large-vessel occlusion detection. The company's quality system was certified to ISO 13485, an early release received a CE certificate under the old Medical Device Directive, and "FDA clearance was obtained for the base technology". The FDA database confirms clearance K202793 for Cercare Medical Neurosuite on 17 May 2021, five months before the project ended. The report also says COVID-19 "hampered implementation of the action", that clinical testing was held back and that the focus shifted to "market needs and regulatory processes". CORDIS gives 31 October 2021 as the end date, 30 months after the start.

1. Stroke decision-support softwareDeliveredFive modules reported on CORDIS; sold today as Neurosuite.
2. European and US regulatory approvalDeliveredCE marking under the MDD during the project, now under the MDR; FDA K202793 in May 2021.
3. Distribution through scanner vendorsDeliveredSiemens syngo.via OpenApps from 2018, global Siemens Healthineers collaboration in May 2026.
4. Predicted tissue outcome for each treatment optionNot achievedNo product or clearance that predicts outcomes per treatment has been announced; the cleared tools segment and map perfusion.
5. €41M accumulated turnover by 2026Not verifiableRevenue is not disclosed; the accounts report a gross loss every year from 2020 to 2025.

The project delivered what an SME grant can most fairly be judged on: certified software that reached hospitals. The most ambitious promise, a tool that shows the probable result of each treatment before it is chosen, has not been announced as a product, and Cercare's commercial story today rests on its perfusion biomarkers rather than on treatment prediction. iTrust was not the company's first EU money. It had already received €50,000 for a 2017 SME Instrument Phase 1 feasibility study of the same name and €114,405 to hire an innovation associate for TreatStroke, a 2017 project on predicting bleeding after stroke treatment. CORDIS also lists Cercare as a partner organisation in FutureMIND, a doctoral network on AI in neuro-oncology coordinated by Heidelberg University that is due to start in January 2027.

What Cercare Medical Has Achieved Since the Award

The regulatory record is the strongest part of it. The FDA's database lists five 510(k) clearances for the company: Neurosuite in May 2021 and July 2023, Capillary Function with Virtual Expert in December 2024, the version for MRI, CT and cone-beam CT in May 2026, and a brain-tumour segmentation module, Oncology Virtual Expert, on 22 June 2026. The company's own about page still says CT clearance is "pending", which the May 2026 clearance has overtaken.

The partner list has grown alongside. In December 2025 Aidoc announced that Cercare's MR perfusion algorithm would be integrated into its aiOS platform for US hospitals, according to AuntMinnie. The company's history page lists distribution deals with TeraRecon and Viz.ai in 2022, a 10-year contract with Karolinska University Hospital in 2021, Harvard Medical School as a customer in 2022, an agreement with Denmark's Central Denmark Region in 2022, and selection in a national tender for "all public hospitals in Norway" in June 2025. These customer claims come from the company and could not be checked against tender records for this article.

The money came from private investors. DLA Piper said it advised Cercare Medical ApS, before its conversion to an A/S in January 2021, on an investment of about €6.5 million, or about DKK 48.5 million, from its main shareholder Smedvig Capital, a Norwegian family office, and new investors, according to a DLA Piper notice; the accounts show equity rising from DKK 4.6 million to DKK 40.8 million in 2020. A further capital increase followed in 2023, and the 2025 annual report says a round of €7.4 million led by the UK's West Hill Capital was received "across both 2024 and early 2025". The company says existing investors Smedvig and Bagger-Sørensen took part. The Danish state also granted it DKK 1,399,678 under the Innobooster programme in February 2025, according to North Data.

The Money

Cercare does not publish revenue. Danish accounting rules let it report gross profit or loss, which nets revenue against direct and external costs, and that line has been negative every year from 2020 to 2025, counting the restated 2021 figure, reaching DKK -33.3 million in 2025. The only growth figure the company discloses is contracted annual recurring revenue, which it says rose 117% in 2025, without saying from what base. Net losses from 2019 to 2025 add up to DKK 221.9 million, using the restated 2021 figure.

The accounts also contain a correction. The 2022 annual report says a grant had been "recognised twice" in the 2021 accounts, an error of DKK 7,435,133. The 2021 net loss was restated from DKK 10.9 million to DKK 18.3 million and year-end equity from DKK 35.5 million to DKK 28.1 million. Data services that copy the original 2021 filing, such as estatistik.dk, still show the unrestated figures. The report does not name the grant.

Why Europe Should Care

Stroke is one of the largest causes of death and disability in Europe, and access to fast specialist imaging is uneven. The Action Plan for Stroke in Europe 2018 to 2030, drawn up by the European Stroke Organisation and the Stroke Alliance for Europe, aims to treat 90% or more of stroke patients in a dedicated stroke unit. On 16 December 2025 the European Commission presented its Safe Hearts Plan, the first EU plan against cardiovascular disease, which includes an incubator for AI and digital technologies in cardiovascular care. A European, vendor-neutral imaging tool that runs on hospital servers fits both aims, and the Siemens Healthineers deal puts a Danish component inside a German manufacturer's stroke offering.

The Verdict

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