NEOS Surgery's EIC Accelerator Disc Implant: Still Not CE Marked

After surgery for a slipped lumbar disc, the hole the surgeon leaves in the disc wall stays open, and some patients herniate again through it. NEOS Surgery, a medical device maker based near Barcelona, has spent more than a decade on an implant that plugs that hole. The European Union has paid for it twice. In the EIC Accelerator pilot's October 2020 cut-off the company won €1,934,572.50 for DISC care, a project to run the clinical trial, complete the product range and win CE marking under the EU Medical Device Regulation "to prepare the market launch of the product in 2023", according to CORDIS. Five years earlier, an EU SME Instrument grant of €1,905,575 for the same barrier, then called ACE, had set the goal of "launching its first Spinal Product, an Annulus Closure Device in 2018".

Neither launch happened. The DISC care project did finish a 30-patient safety and performance trial, its final report says. But in February 2026 the company was still describing itself as "advancing toward CE marking", with a second clinical study under way, according to its own news release. That study's estimated completion date is June 2028, according to ClinicalTrials.gov.

What NEOS Surgery Is Doing Now

NEOS Surgery is active. The Spanish commercial register lists the company as "activa", with capital increases registered in May 2026 and a transfer of its registered seat from the Tecnalia building in San Sebastián to Cerdanyola del Vallès, near Barcelona, registered on 20 May 2026, according to Empresia, which reprints BORME entries. InfoNIF shows the same seat change and a share capital of €147,120. In September 2026 the company announced it would exhibit its STERN FIX sternal fixation system at the EACTS cardiothoracic surgery meeting in Barcelona, on its news page.

Its revenue comes from products that have nothing to do with the spine. Cranial LOOP, a bone flap clamp the company calls the first made of PEEK, and Cranial COVER, a burr hole cover, are its long-standing lines; STERN FIX, a carbon fibre sternal fixation system for heart surgery, is the newest. The US Food and Drug Administration cleared STERN FIX through the 510(k) route on 19 January 2022, according to the FDA database, and the company's product page says it is CE marked. Its certifications page lists an EN ISO 13485:2016 quality system and MDSAP certification.

The disc implant has not been dropped. The company's R&D page calls DISC care "the cornerstone of NEOS' Strategic Plan". On 23 February 2026 Prof. Claudius Thomé performed the first DISC care procedure at the hospital in Innsbruck as part of the clinical study, and the company said patient recruitment was "nearing completion", according to its release. The study's registry entry, last updated in January 2026, lists seven hospitals, all in Spain, an estimated 30 participants and a two-year follow-up, according to ClinicalTrials.gov; Innsbruck is not among them.

The Technology: A Permanent Plug for the Disc Wall

A lumbar disc has a gel-like core inside a ring of collagen fibres. When the ring tears, the core bulges out and presses on nerves. The standard operation, a discectomy, removes the herniated material through the tear but leaves the hole open. One year after surgery an average of 10% of patients are operated on again because of re-herniation, the ACE project report says. Surgeons can lower that risk by removing more of the core, but that compromises the disc and can cause chronic back pain, the DISC care objective notes.

DISC care is an expandable barrier fixed to the vertebra that closes the defect, combining implant design, medical textiles and advanced manufacturing, according to NEOS. The company's project summary on CORDIS says the market had only one other such device, making DISC care "the second worldwide", without naming the first. One device of this type is the US company Intrinsic Therapeutics' Barricaid, a woven polyester barrier anchored with a titanium bone anchor, which the FDA approved on 8 February 2019 to reduce re-herniation and re-operation after discectomy at a single level between L4 and S1, according to the FDA approval record. The approval came after an FDA advisory panel voted 5 to 8 that its benefits outweighed its risks, ORTHOWORLD reported. No head-to-head data between DISC care and Barricaid are public.

What the EIC Grant Promised, and What the Record Shows

The European Commission's list of companies selected in the 7 October 2020 EIC Accelerator cut-off names NEOS, of Donostia San Sebastián, with DISC care as a grant-only project; no other beneficiary is listed for it. The grant agreement was signed on 22 January 2021 for a project from 1 January 2021 to 30 April 2023, with a total cost of €2,763,675, according to CORDIS. In its announcement of December 2020, NEOS said it aimed to finish the trial in five Spanish university hospitals during 2021, then enter the regulatory phase in Europe and the United States and start marketing the product in 2023. Tecnalia, a shareholder, still describes the hernia blocking device as having "initial sales expected in 2022" on its portfolio page.

The trial ran longer than planned. The first study, sponsored by NEOS, started on 23 October 2019 and reached its primary completion on 26 June 2023, two months after the EU project ended, with 30 patients enrolled; its primary outcome is symptomatic recurrent herniation at 24 months, and no results have been posted on ClinicalTrials.gov. The CORDIS report says the trial proved the device's "safety and performance" but gives no figures, and no peer-reviewed publication of its results could be found. The report is silent on the other two goals, the complete product range and CE marking.

1. Clinical trialDelivered30 patients, completed June 2023 (NCT04188236); no results posted.
2. Complete product rangeNot reportedNot reported on CORDIS or by the company.
3. CE marking under the MDRNot achievedCompany still "advancing toward CE marking" in February 2026.
4. Market launch in 2023Not achievedNot on the company's product list; second study runs to 2028.

An Older Promise

DISC care is the second EU-funded attempt to bring the same barrier to market. ACE, an SME Instrument Phase 2 project from 1 October 2015 to 30 September 2018, described "a barrier to re-herniation which is expandable, is securely fixed to the vertebra" in words NEOS still uses on its R&D page today, and said sales would "more than triple NEOS' turnover between 2018 and 2022", according to CORDIS. Its final report, covering the year to September 2018, said the device was "finishing preclinical phase" and moved the expected sales boost to "between 2020 and 2023", according to the ACE reporting page. The design came out of a Eurostars project supported by Spain's CDTI and won a Eureka Innovation Award, the company's spine page says.

Beyond the two single-company grants, CORDIS lists NEOS as a partner in three collaborative projects: OPTOGENERAPY (2017 to 2020, €206,985 for NEOS), PMSMatTrain (2019 to 2024, €501,809.76) and WISE (2024 to 2026, €321,750).

The Money Since the Award

NEOS has raised money mostly from public and industrial backers. In July 2020 it completed a €5 million operation combining €2 million of capital, a commercial agreement with its distribution partner Jiadel Medical, and a €1 million loan, with Avançsa, the Catalan government's investment vehicle, joining as a shareholder, according to the company and Capital Riesgo, which put 2019 revenue at €1.5 million with sales in 12 countries. In October 2025 the Catalan government approved a further €1 million from Avançsa, half by converting an earlier participative loan into equity and half in new capital, according to Capital Riesgo; the company confirmed the renewed support without amounts on its website.

The register shows a steady run of small capital increases and a new board member: on 17 July 2025 Nanjing Sunlike Medical Co. Ltd was appointed director in place of MT Global Grup SL, according to Empresia and InfoNIF. The size of its stake is not public. No venture capital round and no EIC Fund investment could be found: NEOS does not appear among the 319 organisations on the EIC Fund portfolio list, consistent with a grant-only award.

Why It Matters for Europe

NEOS pitched DISC care as the first hernia blocking device from a European company. The comparable device found for this article, Barricaid, comes from a US company and has had FDA approval since 2019. The EU's medical device rules set a high evidence bar for spinal implants, and NEOS, with 18 staff by one register count, is trying to clear it with a second clinical study after the first ended in 2023. The Catalan government has kept investing, and the EU has paid €3.84 million towards the implant across two grants. The return on that public money now depends on whether the second study produces data strong enough for a notified body.

The Verdict

NEOS Surgery and the EIC were not asked for comment for this article. It is based on public records and published statements, linked throughout.