Versono Medical and the EIC Accelerator: Crossing Blocked Arteries

Versono Medical, founded in Galway in 2018, has developed FastWire, now called the ProSonic System: a flexible guidewire that carries ultrasonic energy to its tip to cross hardened, completely blocked arteries in the legs of patients with critical limb-threatening ischaemia, the most severe form of peripheral artery disease. It was selected in the EIC Accelerator's January 2023 cut-off and received an EU grant of €2.48 million for FASTWIRE, a €3.54 million project that ran from March 2023 to March 2025, according to CORDIS. The goal was a crossing system "to prevent amputation".

The project is closed. Its final report points to the FREEFLOW pilot study, whose results were presented in September 2023, and says that "a further study, the FREEFLOW pivotal study is merited", according to the CORDIS reporting page. The pilot enrolled 8 patients; the US pivotal study, which began in November 2024, plans 65, according to ClinicalTrials.gov. The company states that its technology "is not approved/cleared for sale or commercial use in any market", according to its website.

Where Versono Stands Now

In June 2026 Versono said the US multi-centre FREEFLOW pivotal study "is now nearing completion" across five clinical sites, and that it plans a first-in-human pilot of the device in coronary arteries "early next year", according to its news page. The registry estimates primary completion for November 2026. In February 2026 the ProSonic System won the Dragons' Den innovation prize at the CX Symposium in London. When enrolment began in November 2024, the company said it expected to complete the study "over the coming months".

The Technology: Ultrasound at the Tip of a Wire

Doctors treating blocked leg arteries first have to push a guidewire through the blockage; if they cannot, patients may face open surgery or amputation. Versono's wire follows the curves of the artery and vibrates at its tip to break through calcified lesions, including in small vessels below the knee. In the pilot, lesions from 60 to 500 mm long were crossed and no adverse events were reported, the company says; two-thirds of the pilot patients had already had an amputation on the other leg.

What the EIC Award Promised, and What the Record Shows

The award promised a crossing system ready to transform treatment and avoid amputations. The EIC project period covered the pilot results and the start of the pivotal study, but ended before that study finished. The company had said in 2022 it would qualify the device for its first indication in 2023, and in 2023 that the pivotal study would come in 2024 "before bringing the product to market". In late 2026 the product is still investigational.

1. Pilot studyDelivered8 patients, no adverse events reported.
2. Pivotal studyUnder wayStarted November 2024.
3. Market approvalNot yetNot cleared anywhere.
4. Published resultsUnverifiedNone on registry.

The Money

Versono raised €6.7 million in May 2022 from existing investors including DHKN and BVP and the state investors Western Development Commission and Enterprise Ireland, according to the company. A consortium it leads won a €7 million Irish Disruptive Technologies Innovation Fund grant in 2022 for a separate coronary project, according to Silicon Republic. Versono's revenue and losses could not be checked from free sources.

What Cannot Be Checked

Why Europe Should Care

The final report cites 2.3 million people with peripheral artery disease in Germany alone and a rise in minor amputations. The EIC funded an Irish device aimed at that problem, but its pivotal trial is running in the United States, where the company plans to seek approval.

The Verdict

Versono 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.