Neurescue's EIC Accelerator Catheter Got Its CE Mark in 2025

Most people whose heart stops cannot be helped by a defibrillator. Shocks only work on certain heart rhythms; in about 81% of cardiac arrests the rhythm is non-shockable, and only 4% of those patients survive, according to Neurescue. The Copenhagen company has built a catheter that, during CPR, inflates a soft balloon in the descending aorta. With the lower body cut off, the blood that chest compressions push around goes to the heart and brain instead.

The EIC Accelerator selected the project, PULSE, at its October 2024 cut-off for a grant of €2,499,999, according to CORDIS. In September 2025, three months into the project, the device received a CE mark for non-shockable cardiac arrest. It is the second time the EU has funded the same device: a 2018 SME Instrument project promised a commercial roll-out by 2021. The new target is 2027.

A balloon in the aorta during CPR

Blocking the aorta with a balloon is also a way to stop severe bleeding, and that is the use the device is cleared for in the United States. For cardiac arrest, Neurescue built it for speed outside the operating room: a catheter and a handheld control unit that inflate and deflate the balloon automatically, with a sensor in the catheter giving position feedback, so that no X-ray imaging is needed. The device is meant to bridge patients to a heart-lung machine, a heart pump or a coronary intervention, according to DAIC's report on the CE mark.

The PULSE summary claims the device can extend the resuscitation window from 20 to 30 minutes to about 60 minutes and could raise survival by up to 40%. Those are the company's projections; no published trial has shown a survival effect.

The 2018 project and its 2021 promise

The EU first funded the device under Horizon 2020. The SME Instrument phase 2 project CAtALySt received €1,632,251.25 from August 2018 to January 2023 to collect data for FDA clearance and the CE mark and to treat 20 cardiac arrest patients in Germany and the United States. It projected that the device would be "ready for commercial roll-out by 2021".

The FDA cleared the device through the 510(k) route in 2021, but for temporary occlusion of large vessels, including emergency control of bleeding, not for cardiac arrest, according to the company's June 2021 announcement. The cardiac arrest trials followed. ARISE-EU enrolled 10 patients at the Charité in Berlin and the University Hospital Heidelberg between August 2022 and November 2023; ARISE enrolled 6 patients at Long Beach Medical Center in California between December 2022 and September 2024. Both are listed as completed, and neither has posted results.

CE mark in the first months of PULSE

On 9 September 2025 Neurescue announced that TÜV SÜD had granted the CE mark for the treatment of non-shockable cardiac arrest after an expedited review of about six months under the Medical Device Regulation, as DAIC reported. In trials, every physician who tried the procedure succeeded, with a mean procedure time of about five minutes, the company said. "For the first time, we now have a device for the vast majority of cardiac arrest patients who present as non-shockable," said founder and CEO Habib Frost.

The first PULSE periodic report, covering June 2025 to January 2026, lists finalised clinical protocols, manufactured sensor catheters and technology readiness level 7. It reports a 20% rate of return of spontaneous circulation and a 20% rhythm conversion rate in the feasibility study, and describes the ARISE trial as ongoing with 84 patients enrolled. That figure does not match the ARISE record on ClinicalTrials.gov, which lists the study as completed with 6 patients; the report does not say which study the 84 patients belong to.

1. CE markDeliveredTÜV SÜD, September 2025, for non-shockable cardiac arrest.
2. Clinical validationUnder way84 patients reported in period 1; no registered trial of that size or published outcome found.
3. Adoption by emergency services and hospitalsNot yetNo customer or sales announced; no revenue in the accounts.
4. Commercial roll-out by 2027Too earlyThe project runs to May 2027.

Losses growing faster than the funding

Neurescue raised a Series A of DKK 50 million, about €6.7 million, led by London-based West Hill Capital, as MedTech Innovator reported; West Hill announced a £5.5 million investment in January 2024.

The accounts filed with the Danish Business Authority show why it was needed. Equity was negative at the end of 2022 and 2023, at minus DKK 14.4 million in 2023, before the round lifted it to DKK 26.9 million at the end of 2024, according to estatistik.dk. The net loss rose from DKK 7.4 million in 2021 to DKK 12.9 million in 2024 and DKK 15.6 million in 2025, and equity fell to DKK 11.3 million at the end of 2025. The accounts report no revenue.

At the 2025 rate of loss, the remaining equity would cover less than a year. The EIC grant runs alongside, but no new equity round has been announced since 2024.

A European answer to a common cause of death

Cardiac arrest causes 45% of the world's 17.9 million cardiovascular deaths a year, the PULSE report says, and a device that helps the large majority of patients a defibrillator cannot help would matter for every emergency service. The report puts the potential at more than 300,000 lives a year worldwide, a projection rather than a result. For now the CE mark gives European patients access first: in the United States the device is not cleared for cardiac arrest.