Perfuze Since the EIC Accelerator: An FDA-Cleared Stroke Catheter

When a clot blocks an artery in the brain, the best chance of a good recovery is to get the whole clot out at the first attempt. In 2019 doctors managed that in about 31% of patients, according to Perfuze's report to the European Commission. Perfuze, a Galway start-up founded the year before, said its Millipede catheter could do it "in up to 90% of cases" in its own tests. On the European Commission's list of winners of the 3 April 2019 cut-off of the EIC SME Instrument Phase 2, the Horizon 2020 forerunner of the EIC Accelerator, Perfuze Limited is the only company named for its project. The grant was €2,484,012 towards a total cost of €4,473,543.75, according to CORDIS.

Seven years on, the catheter has a CE mark, five announced US Food and Drug Administration (FDA) clearances across its product family, and a pivotal trial of 180 patients. In March 2026 the FDA cleared the Millipede88 for removing clots on its own, without other devices, according to NeuroNews International and Endovascular Today. What the record does not yet show is a business: sales are in a "limited market release" in the US, and no revenue has been published.

Where Perfuze Stands Now

Perfuze is active. The Irish company register shows its status as "Normal", with accounts for the year to 30 September 2025 filed on 6 March 2026, according to Solocheck. It is registered as a small company, so the filed accounts do not have to include a profit and loss account, and no revenue, result or headcount from them could be found in free sources.

The company is selling in the US in a limited release to selected comprehensive stroke centres, with "broader commercialisation to follow", it said when the Millipede88 was cleared. In September 2026 it published a bench study in Clinical Neuroradiology comparing its super-bore catheter with cyclic aspiration through a standard 6Fr catheter, according to NeuroNews International. In that model the Millipede88 reached an 88% first-pass effect in middle cerebral artery occlusions, against 71% for conventional aspiration and 62% for cyclic aspiration. It is a bench model, not a patient study, and its first author, Ameer Hassan, was also a principal investigator of Perfuze's pivotal trial.

The Technology: A Wider Mouth at the Clot

Mechanical thrombectomy pulls a clot out of a brain artery through a catheter threaded up from the groin or wrist. Doctors either trap the clot in a stent retriever or suck it into an aspiration catheter. The wider the catheter's opening, the more suction reaches the clot, but wide catheters are stiff and hard to steer through the bends of the arteries at the base of the skull.

Perfuze's answer is a 0.088-inch catheter, at the large end of what is used in the brain, built with what the company calls a corrugated wall instead of the usual coiled or braided construction. The company says the corrugation keeps the inner lumen round in tight bends, where conventional catheters "can ovalise", so the full suction reaches the clot face. At the time of the CE mark it claimed up to 50% more tip surface area than existing devices, according to NeuroNews International. Its first peer-reviewed paper, a bench and cadaver study published in 2020 in the Journal of NeuroInterventional Surgery, was written by Perfuze staff with Raul Nogueira of the University of Pittsburgh, who later led the pivotal trial.

The goal is to make "direct aspiration" with one large catheter enough on its own, cutting the stent retrievers and second catheters that add cost and time. The MARRS trial was designed to test exactly that.

What the EU Grant Promised, and What CORDIS Shows

The grant agreement was signed on 31 July 2019, and the project ran for two years from 1 August 2019 to 31 July 2021, according to CORDIS. Its three stated objectives were to validate the technology in a first-in-human study, to prepare the company for EU commercialisation and scale, and to secure US regulatory approval for a large clinical trial. The proposal also promised "52 jobs by 2024" and "over €17m in turnover".

The final report, published on CORDIS, says Perfuze ran three cadaver studies on seven specimens, built an in-house cleanroom that let it keep manufacturing through the Covid-19 pandemic, and doubled its headcount from 7 to 14. It says the FDA granted the Millipede Breakthrough Device Designation in August 2019, which Silicon Republic also reported. The deliverables CORDIS lists include CE mark certification, ISO 13485 certification, a patent for the corrugated design and ethics approval for the first-in-human study. The report says the company had "received approval to proceed to treat our first patient". Other sources show the first patients were treated before the project ended: Perfuze had a CE mark in February 2021 and had treated its first five stroke patients at Beaumont Hospital in Dublin, according to NeuroNews International and Silicon Republic.

1. First-in-human validationDeliveredFive patients treated in Dublin by May 2021, inside the project period.
2. Ready for EU salesDeliveredCE mark for Millipede 088 in February 2021; in-house cleanroom manufacturing per CORDIS.
3. US approval for a large trialLateMARRS enrolled its first patient in November 2023, 28 months after the project ended; the date of the FDA trial approval is not public.
4. 52 jobs by 2024Unverified14 staff in 2021 per CORDIS; no filed headcount found; Revelio Labs estimates 33 for 2023 and 60 for 2025.
5. Over €17M turnoverNot achievedNo revenue published by the company or any third party; US sales only in limited release from 2025.

On the technical goals Perfuze did what it promised, mostly within the two years; the US trial came later than the project plan implied. The commercial targets are another matter: neither the €17 million turnover nor the 52 jobs can be checked against any published figure.

What Perfuze Has Achieved Since the Award

The grant was followed by two much larger rounds. In February 2022 Perfuze closed a €22.5 million Series A led by LSP and Seroba Life Sciences, with SV Health Investors and its seed investors Earlybird, the HBM-MedFocus Fund and Enterprise Ireland, according to NeuroNews International and EQT, which now owns LSP. In March 2025 it added €22 million from existing investors Earlybird, EQT Life Sciences, Seroba and SV Health, according to NeuroNews International and Silicon Republic. The €3 million seed round of January 2019, led by Earlybird, came three months before the EU cut-off, according to BioSpace.

The FDA clearances came one product at a time. The first, for the Millipede 088 as an access catheter that guides other devices, was announced in February 2023 with first US cases at Stony Brook and the University of Pittsburgh Medical Center, according to NeuroNews International. Later company releases date that clearance to 2022, and Silicon Republic to 2023; the FDA decision date was not checked for this article. In December 2023 Perfuze announced FDA clearance of the smaller Millipede 070 aspiration catheter and a second-generation 088 access catheter, according to NeuroNews International and Business Wire, followed by the Zipline access catheters in March 2025 and the Millipede88 for direct aspiration in March 2026.

The team grew with the money. Perfuze hired Joe Rotger, formerly of Stryker Neurovascular and Boston Scientific, as executive vice president of sales in April 2025, according to NeuroNews International. Revelio Labs, which models headcount from public profiles, estimates 33 staff in 2023 and 62 in 2026; these are estimates, not filed figures.

The Money

Announced funding adds up to €47.5 million of equity plus the €2.48 million EU grant. CB Insights puts the total raised at $76.39 million, a figure that could not be matched to announced rounds. Perfuze has not published revenue, losses or cash. The filed abridged accounts were not obtained, so this article cannot say how much of the funding has been spent or how long the money lasts. The company did not take EIC equity: the 2019 SME Instrument was a grant-only scheme, and no EIC Fund investment in Perfuze was found.

Why Europe Should Care

Stroke is the second most common cause of death and the leading cause of adult physical disability, Perfuze's EU report notes. On 16 December 2025 the European Commission presented its Safe Hearts Plan, the first EU plan for cardiovascular disease, covering prevention, screening, treatment and care. Stroke groups said it does not go far enough: the European Stroke Organisation and SAFE wrote that stroke prevention, acute care, rehabilitation and long-term support "remain fragmented and unequally available across the EU" and asked for stroke to be "explicitly integrated" across the plan, in a joint response.

A catheter designed and made in Galway, with clearances on both sides of the Atlantic, adds to Europe's own medical device base in a field where faster, simpler clot removal is part of the acute care the stroke groups want improved. But the strategic return is not yet European. The pivotal trial was run under a US FDA exemption, the sales hire and the limited market release are in the US, and the company announcements found for this article since 2022 do not report European sales figures or a European launch plan.

The Verdict

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