InVera Medical and the EIC Accelerator: A Vein Device Cleared

InVera Medical, founded in Galway in 2018 as Venari Medical, set out to close diseased leg veins without burning them. Chronic venous disease affects up to 60% of adults over 50 and can end in venous leg ulcers, according to its EIC project. The company's idea was to injure the vein wall mechanically so that the body's own healing response seals the vein.

The European Innovation Council granted €2,497,614 towards EnVena, a €3.6 million project from October 2022 to September 2024 whose title promised to cure venous leg ulcers. The final report lists a clinical study under way, a design freeze and a quality certification. In February and April 2026 the company announced EU and US clearance for its InVera Infusion Device, a catheter that disrupts the vein wall "for enhanced infusion of sclerosant", according to its FDA announcement.

Where InVera Stands Now

On 13 February 2026 the company announced the CE Mark for its InVera Infusion Device, and on 7 April 2026 FDA 510(k) clearance. Chief executive Stephen Cox said the two approvals enable "our limited market release in select US and European centers this year". No sales, launch sites or new funding round have been announced since.

The Technology: Scratching the Vein Wall

The cleared catheter carries a helical coil that "mechanically prepares the vein wall by disrupting the inner media layer", to enhance the delivery of a sclerotherapy agent. The procedure needs one injection of local anaesthetic and can be done in a doctor's office. The EIC report instead describes the clinical study as "Exclusively Mechanical Venous Ablation Gen 2", EMVA2; the press releases do not say whether a device without the drug was pursued.

On 21 April 2026 the company reported 12-month results from a single-centre pilot at Semmelweis University in Budapest: 10 patients with chronic venous disease graded C2 to C4, nine with the treated vein closed, and no serious adverse events. It said it is preparing larger comparative studies.

What the EIC Project Promised, and What CORDIS Shows

EnVena promised "the world's first device to mimic the body's natural healing response" for venous leg ulcer patients. By its end in September 2024 the report lists patients enrolled in the EMVA2 study from Q2 2023 with a second site recruiting, ISO 13485 certification from the British Standards Institution and a design freeze of the commercial product. It gives no clinical results, and no results in ulcer patients have been published since: the published pilot enrolled patients graded C2 to C4.

1. Commercial designDeliveredDesign freeze, 2024.
2. Quality systemDeliveredISO 13485 from BSI.
3. Market approvalAchievedCE and FDA, 2026.
4. Curing venous leg ulcersNo dataNo ulcer results published.

The Money

InVera does not publish accounts or revenue figures, and we found no announced equity round since the EIC award. In December 2022 it was named lead of a €4.6 million consortium under Ireland's Disruptive Technologies Innovation Fund, with the University of Galway, Atlantic Technological University and Innovative Catheter Solutions, to develop a vessel wall intervention for venous leg ulcers.

What Cannot Be Checked

Why Europe Should Care

An Irish company funded by the EIC and the Irish state took a vein catheter to CE Mark and FDA clearance within 18 months of the project's end. The EU's grant was for ulcer patients; the evidence published so far comes from ten patients graded C2 to C4, and the release reports no ulcer patients.

The Verdict

InVera Medical and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.