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SzeleSTIM: 7 Years After Its EIC Accelerator Vagus Nerve Grant

October 7, 20262,227 words12 min

The company that the European Commission listed as SZELESTIM in June 2019 now trades as AURIMOD GmbH, named after the project the EU paid for. It was one of four Austrian winners of the 5 June 2019 cut-off of the EIC SME Instrument Phase 2, according to the Commission's list of selected companies, which names it as the only beneficiary of the AuriMod project. The Horizon 2020 grant, €2,196,747 towards a €3,138,211.25 project, was meant to take a wearable stimulator for the vagus nerve in the ear through a European clinical trial to a CE mark and reimbursement, according to CORDIS. Vienna's Trending Topics reported the €2.2 million award in December 2019.

Seven years after the cut-off, the company is active and selling a product, but not the one the grant was written around. Its CE-marked device, VIVO, delivers fixed stimulation that the patient's subjective feedback guides. The self-adjusting AuriMod system, which reads the body's signals and changes the therapy automatically, still appears on the company's development pipeline.

€2.2MEU grant, EIC SME Instrument Phase 2, June 2019
39 monthsProject duration, October 2019 to December 2022
43Patients in the project's randomised pilot trial
0Published results from that trial

Company file

Legal entity
AURIMOD GmbH, FN 442018b, Vienna commercial court
Former name
SzeleSTIM GmbH, renamed December 2021 per North Data
Registered
5 November 2015
Headquarters
Modecenterstraße 22, 1030 Vienna, Austria
Founders
Jozsef Constantin Széles (Medical University of Vienna), Eugenijus Kaniusas and Stefan Kampusch (TU Wien)
Managing directors
Stefan Kampusch; Manuel Leal Garcia since February 2026
Share capital
€2,280,000, 13 shareholders
Products
VIVO ear stimulator (class IIa, CE marked); VIVO Pal pain diary app
EIC projects
AuriMod Phase 1 (2018, €50,000); AuriMod Phase 2 (June 2019 cut-off, grant only)
Staff
Not public

Where the Company Stands Now

AURIMOD GmbH is registered and active. The Austrian company register shows annual accounts filed in July 2023, October 2024, August 2025 and July 2026, capital changes in March 2024 and October 2025, new shareholders entered in October 2025 and April 2026, and a second managing director, Manuel Leal Garcia, who represents the company since 25 February 2026, according to its official publication page. No insolvency proceedings appear there. North Data gives the same register number and shows the company was called SzeleSTIM GmbH until a name change on 3 December 2021. The accounts themselves are only available for a fee from the Firmenbuch and were not reviewed for this article, so revenue, losses and staff numbers could not be verified.

The company is still selling and still testing. Its news room lists ten medical congresses in Austria, Germany and Thailand between October and November 2026 where it is presenting VIVO. In June 2026 it registered a new randomised pilot study, SENECA, which is to test a smaller "VIVO 2nd GEN" device as an add-on to four weeks of multimodal pain therapy in 44 patients at Klinikum Klagenfurt, with AIT Austrian Institute of Technology as a collaborator. Recruitment had not started when the record was last updated in August 2026.

The Technology: Needles in the Ear, Not Pills

A branch of the vagus nerve reaches the skin of the outer ear. VIVO, the company's product, uses three small needle electrodes that a doctor places in the auricle, connected to a battery-powered stimulator stuck behind the ear on the neck. The device stays on for about seven days at a time, and a treatment cycle lasts six to eight weeks, alternating ears, according to the product page, which lists chronic back pain, chronic neck pain, migraine and acute post-operative pain as indications. "The vagus nerve plays a key role in the processing of pain," chief executive Stefan Kampusch told the EU's Horizon magazine in January 2024.

The idea is older than the company. Jozsef Constantin Széles, a Vienna surgeon, applied for a first patent in 1989; a first device, P-STIM, appeared in 2003 and a second, AuriSTIM, was used at the pain clinic of Vienna General Hospital from around 2006, according to Innovation Origins. The AuriMod generation was to add what earlier devices lacked: sensors at the ear that measure physiological signals such as heart rate variability and adjust stimulation automatically, so that patients are neither over- nor under-stimulated, as TU Wien described it in 2018, when it said the market launch was planned for 2019.

The alternatives are painkillers, which the CORDIS report says can cause side effects and addiction, and implanted neurostimulators, which require surgery. External ear stimulation sits between the two. One point in the EU record does not match the product: CORDIS describes the system as "non-invasive", while VIVO works through needles in the skin, which the company itself calls "minimally invasive".

"We believe our device will offer chronic-pain patients a new line of therapy, hopefully one that will be more effective than the drugs available today."

Stefan Kampusch, chief executive, to Horizon magazine, January 2024

What the EIC Project Promised, and What CORDIS Shows

The project's objective on CORDIS was "to demonstrate the safety, efficacy and usability of AuriMod", together with a therapy management system, "in order to eventually achieve CE marking and reimbursement in target countries". It ran from 1 October 2019 to 31 December 2022. It followed a €50,000 Phase 1 feasibility study in early 2018, also called AuriMod, which looked at the same device for peripheral arterial disease rather than pain.

The final periodic report, covering October 2021 to December 2022, lists real progress. The wearable can now record stimulation settings and physiological data continuously; a smartphone app and a therapy management platform were built; VIVO, described as "our first product for personalized auricular vagus nerve stimulation based on subjective feedback of the patient", was CE marked; a manufacturing line was set up with contract manufacturers and commercial production of VIVO was ramped up. The platform, built with AIT on its telehealth system, was published in 2022. But at the project's close the report still describes the central goal in the future tense: "We aim to demonstrate safety and performance of our AuriMod system in the ongoing clinical trial, and obtain the clinical evidence needed for CE marking."

That trial is registered as NCT04753528: a randomised pilot study of the AuriMod CT01 device in intractable chronic low back pain, sponsored by Aurimod GmbH with Klinikum Klagenfurt and Hôpital de La Tour in Geneva. It enrolled 43 patients between 13 April 2021 and 25 October 2022 and is marked completed, but no results have been posted to the registry, and no paper reporting it appears among Stefan Kampusch's publications indexed by PubMed. The CORDIS report calls it "multicentre, multinational"; the registry lists two sites in two countries.

  1. Optimised wearable that records stimulation and body signalsDeliveredReported in the CORDIS final report.
  2. Therapy management system and appDeliveredPlatform published in 2022; VIVO Pal app in the app stores.
  3. Industrial-scale productionDeliveredManufacturing line with contract manufacturers, for VIVO.
  4. European multicentre clinical validationPartly43-patient pilot at two sites completed in 2022; results never published.
  5. CE mark for the AuriMod systemNot achievedOnly VIVO is CE marked; the integrated system is still listed as pipeline.
  6. Reimbursement in target countriesNo evidenceNo reimbursement decision has been announced.

On that record the award is partly delivered. The grant produced a certified product, a production line and the software platform, which is more than many grant-only projects of 2019 can show. The device that the project was named after, and the clinical evidence for it, are still missing almost four years after the project ended.

What the Company Has Achieved Since the Award

VIVO is on the market. The first generation is sold mainly to private clinics in Austria, Germany and Switzerland, Horizon magazine reported in January 2024, which also cited an evaluation of 148 users in which the stimulation halved chronic low back pain in around 60% of them within six weeks. The magazine does not describe it as a controlled trial, and no comparison group is mentioned. The company's pain trade show circuit, with congresses in Linz, Göppingen, Mannheim, Graz, Berlin, Salzburg, Kassel and Vienna in autumn 2026, points to the same German-speaking market.

The research output continues, largely with clinical partners and with company staff as co-authors. A 2024 meta-analysis in Pain and Therapy on ear vagus nerve stimulation for chronic and acute pain counts Kampusch among its authors. In March 2026 a retrospective analysis of 24 chronic pain patients treated in Klagenfurt and Geneva reported that blood pressure fell in the 11 with hypertension; four of its nine authors are declared AURIMOD employees, and the authors call for sham-controlled trials to confirm the effect.

The Money

No funding round has been announced in the press, and the company does not appear in the EIC Fund's list of invested companies, which was checked across all 16 pages for this article; the 2019 award was grant only. The company register tells a quieter story of repeated capital increases. Registered share capital rose from €35,000 at founding to €465,000 in February 2021, €1.5 million in July 2022, €1.85 million in March 2024 and €2.28 million now, according to North Data. The register lists 13 shareholders, including four entered on 30 January 2021, among them Stefan Kampusch, AVADOS GmbH since July 2022, seven shareholders entered on 9 October 2025, among them ILUM Tec GmbH, Lisentis GmbH and Convergence Partners AG, and one entered on 3 April 2026, recorded as Prof. Dr. h.c. Roland Berger.

Nominal share capital says nothing about the price paid for the shares, so the amounts raised are not public. North Data also lists two COVID-19 state aid awards, of €198,148 and €400,000, which could not be confirmed in a second source.

Why Europe Should Care

Chronic pain affects one adult in five, the CORDIS summary says, and costs Europe about €441 billion a year in healthcare and lost productivity. Pain is still fighting for a place in EU health policy: the Societal Impact of Pain platform, led by the European Pain Federation, used a European Parliament event in October 2025 to call for pain to be built into the EU's policy on non-communicable diseases. A drug-free therapy built and produced in Austria fits that agenda and the EU's interest in a home-grown medical device industry, but small medtech firms also face the cost of clinical evidence under the EU's device rules, which is where AuriMod has stalled.

What the company said

A self-adjusting, biofeedback-controlled pain therapy, validated in a European multicentre trial, CE marked and reimbursed; market launch first planned for 2019.

What the record shows

A CE-marked fixed-pattern device sold to private clinics, a 43-patient pilot trial without published results, and a new pilot of a second-generation VIVO set for 2026 to 2027.

The Verdict

A product, but not the promised one

The grant left SzeleSTIM, now AURIMOD, with a certified ear stimulator, a production line, a software platform and a business that is still attracting shareholders. It did not deliver what it was named for: the self-adjusting AuriMod system has no CE mark, and no results of the trial meant to prove it could be found. Until those results appear, the clinical case for the technology rests mostly on retrospective data.

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

Industry

HealthMedical devices

Focus
  • Neurology devices
Technologies
  • Neuromodulation
Keywords
  • Vagus nerve stimulation
  • Chronic pain
  • Auricular stimulation
  • Opioid alternatives

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EIC AcceleratorBeneficiary Deep Dive#SzeleSTIM#AURIMOD#AuriMod#VIVO#vagus nerve stimulation#chronic pain#medical devices#Austria
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