Osypka: The EIC Accelerator AFib Device That Still Awaits Its Data

Up to 70% of patients develop atrial fibrillation in the days after heart surgery, and it makes a stroke three times more likely, according to a CORDIS results article on the project discussed here. Doctors usually respond with beta blockers, anti-arrhythmic drugs or an external shock of about 200 to 250 joules. Osypka, a medical device maker in Rheinfelden near the Swiss border, built a hand-held alternative: DefiPace, an external device that paces both upper chambers of the heart through thin temporary wires and, when fibrillation starts, delivers a shock of up to 10 joules directly to the atria.

The European Commission's list of companies selected in the 9 October 2019 cut-off of the Horizon 2020 EIC Accelerator pilot names OSYPKA AG of Rheinfelden as the only beneficiary of DefiPace-System, with grant-only funding. The grant agreement, signed on 4 May 2020, provided an EU contribution of €1,969,950.50 towards a total cost of €2,814,215 for a project that ran from 1 June 2020 to 30 November 2023, according to CORDIS. The project's title promised the "market introduction" of the system. Three years after it closed, the device is on the market, but the evidence that would show how well it works in everyday care is not yet public.

What Osypka Is Doing Now

Osypka has been acquired and has a new legal form. In April 2025 the Munich investment holding Armira bought into the company in what the announcements call a "strategic partnership"; the deal closed on 9 April 2025, according to Armira's adviser William Blair, and Osypka and its shareholders were advised by the law firm Heuking. None of the announcements discloses the size of the stake or the price. Osypka's own company history says Armira's support is meant to expand its global presence and production capacity, and that Nicola Osypka, daughter of the founder and chief executive since 2008, moved from the management to the advisory board.

The commercial register shows the rest of the change, according to North Data: Nicola Osypka left the management board in May 2025, the company converted from an AG into OSYPKA GmbH with registered capital of €512,000 in October 2025, and in April 2026 a profit transfer and domination agreement with a holding company was entered, a structure usually used when a parent controls a subsidiary. North Data abbreviates the holding company's name, and whether it belongs to Armira could not be verified. The same record shows new managing directors in 2026, trademark entries in July and September 2026, and patent publications in 2025 and 2026. The company's careers page gives 375 staff in Germany, Czechia and the USA and lists open positions; an ISO 13485 certificate issued to OSYPKA GmbH for 2026 to 2029 is posted on its website.

DefiPace is a small part of a broader business. Osypka sells valvuloplasty balloon catheters, electrophysiology catheters and temporary pacing wires under its own name, and develops and manufactures active implants, mainly neurostimulators, for other medical device companies, according to its product pages and the Heuking release. Its history page says a neurostimulator it co-developed and manufactures received FDA clearance in the United States in 2023. Revenue and profit figures for recent years are not freely available: North Data holds filed accounts only to 2021, behind a paywall, so the company's financial development since the award could not be verified.

The Technology: Pacing and Shocking Both Atria

After open-heart surgery, surgeons routinely stitch temporary pacing wires onto the heart, which leave the chest through the skin and connect to an external pacemaker for a few days. Standard systems pace only the right atrium and right ventricle, because the left side of the heart sits at the back of the chest and is hard to reach. Osypka's TMA wires, "slightly thicker than a strand of hair", have a mechanism that lets surgeons attach them to the left atrium as well, Nicola Osypka told CORDIS. The DefiPace device then paces both atria at once to keep a steady rhythm, and, if fibrillation still sets in, delivers a shock of up to 10 joules through the atrial wires, which the project summary says needs no anaesthesia.

The alternatives are drugs with side effects and high-energy external cardioversion, usually under sedation. Osypka's product page describes DefiPace as an external three-chamber pacemaker with bi-atrial stimulation, overdrive pacing to prevent atrial flutter and fibrillation, and epicardial, interatrial low-energy cardioversion. The idea is not new, as Osypka herself says; what was missing was a commercial device and wires. The company has filed patents on an external pacemaker and cardioverter, listed by North Data from 2016 onwards.

What the EIC Project Promised, and What CORDIS Shows

The proposal summary on CORDIS was ambitious. It called DefiPace "the only system in history and today" that allows physicians to prevent and terminate postoperative atrial fibrillation in all patients, put the market at €1.5 billion, promised savings of "at least €1,000 per day/patient" and said the system "will lead to significant increase of sales and employees", adding: "We will revolutionize the pacemaker market a second time in our history". The closing periodic report, covering June 2021 to November 2023, lists four main results: clinical testing of the device and electrodes, "CE marking of the complete system", completion of a single-centre clinical study "in submission for publication", and recruitment of 10 centres for a large international multi-site trial. Nicola Osypka told CORDIS that the device was already advanced when the project began, but the wires were "at an early prototype stage".

1. CE mark for the complete systemDeliveredReported in the CORDIS final report; DefiPace is listed on Osypka's product pages. No public notified-body record names the device.
2. Single-centre clinical studyDeliveredPublished April 2022: 29 patients, 4 with atrial fibrillation, 2 converted by low-energy shocks.
3. Large international multi-site trialStill runningTen hospitals listed; still recruiting, primary completion now estimated for September 2027.
4. Significant increase of sales and employeesNot shownNo DefiPace sales, customer or staff figures published.

The published study is small. In Reviews in Cardiovascular Medicine in April 2022, surgeons at Artemed Klinikum München Süd reported 29 patients treated with the system in 2016 and 2020. Four developed postoperative atrial fibrillation; two were converted with shocks of 3.5 and 4.5 joules, one converted on its own and one remained in fibrillation. The authors reported no device-related adverse events and called the efficacy results preliminary. The paper names a German federal research ministry grant, not the EIC, as Osypka's funding for the work, and two of the authors are listed as medical consultants for Osypka.

The Registry That Has Not Reported

The larger study is The DefiPace Study, a prospective observational registry sponsored by the Institut für Pharmakologie und Präventive Medizin with Osypka AG as collaborator. It was registered in March 2021, began on 28 March 2023 and lists ten sites: the Medical University of Vienna and university or major hospitals in Erlangen, Nuremberg, Würzburg, Oldenburg, Dresden, Freiburg, Hannover, Jena and Ulm. That matches the ten centres in the CORDIS report. The record, last updated on 30 July 2026, still shows it as recruiting, with primary completion estimated for 30 September 2027 and study completion for 31 December 2027. The registry started two years after it was registered and almost three years into the EIC project, and its first results are now due close to four years after the project ended. The trial listing site Decentrialz gives the same picture: 450 participants needed at 10 sites, still recruiting.

The design matters for what the registry can prove. It is not a randomised trial. Phase A documents standard care in about 150 patients; phase B follows about 300 patients who receive the special atrial wires, of whom about 100 are expected to need DefiPace treatment. It will describe how the device performs in practice, but without a control arm it cannot show on its own that DefiPace reduces strokes, hospital stays or deaths compared with drugs.

What Osypka Has Achieved Since the Award

The EIC grant was the largest of Osypka's five Horizon 2020 projects listed on CORDIS, and the only one in which it was the sole beneficiary. In the others, Osypka was a partner in consortia on accelerometer-based assessment of heart function (SAMBAfun), pilot lines for smart catheters and implants (POSITION-II), microfabricated medical devices (Moore4Medical) and photonics packaging (APPLAUSE). North Data also lists several German federal research grants since 2019, including €578,014 from September 2024 for a double-balloon catheter to prevent arrhythmias.

Beyond DefiPace, the visible milestones are company-wide: MDR CE marking for a class III cardiac pacing electrode in August 2022, reported by Cardiac Rhythm News, which did not name the electrode, the 2023 FDA clearance of a co-developed neurostimulator, and the Armira deal. Osypka is not in the EIC Fund portfolio, which listed 320 companies when checked for this article; the award was grant only, so none was expected. How many DefiPace systems have been sold, and to which hospitals outside the registry, is not public.

Why Europe Should Care

Cardiovascular disease causes one in three deaths in the EU and affects 62 million people. On 16 December 2025 the Commission adopted the Safe Hearts Plan, its first plan dedicated to cardiovascular health, which aims to cut premature cardiovascular deaths by 25% by 2035 and asks every member state to have a national plan by 2027, as reported by DAIC and the European Society of Cardiology. Stroke after surgery is exactly the kind of avoidable complication that plan targets. Osypka is also a European maker of cardiac electrodes and active implants, with its own clean rooms in Rheinfelden and production in Czechia, and it develops and manufactures neurostimulators for other companies, a capability that keeps part of the implant supply chain in Europe.

The Verdict

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