Why TADA Medical's EIC Accelerator IV Connector Ships at a Loss

When a patient rolls over, stands up or catches an infusion line on a bed rail, the tug often ends at the weakest point: the catheter in the vein. TADA Medical, a Stockholm company that now trades as Interlinked AB, built a connector meant to give way first. ReLink sits in the IV line and separates under excess force, and both halves seal so that neither blood nor drug spills. In the EIC Accelerator pilot's March 2020 cut-off the European Commission selected "TADA Medical AB" of Stockholm for the project, grant only, according to the Commission's list of selected companies, which names no other beneficiary for ReLink.

The grant was €1,740,030 towards a €2,485,758.75 project that ran from 1 September 2020 to 30 April 2023, according to CORDIS. The goal was to take ReLink "from its current prototype phase to a market ready product", with a frozen design, clinical evidence, an ISO certificate, a CE mark and an application for FDA approval. Six years on, the connector carries a CE mark and is selling. The company is also still losing more than SEK 12 million a year, and at the end of 2025 its liabilities exceeded its assets.

Where the Company Stands Now

The company is active and has changed its name. The Swedish register entry, as shown by Ratsit, lists Interlinked AB as an active limited company with Katarina Hedbeck as chief executive and records the current name as registered on 25 March 2024. North Data attributes both of the company's Horizon 2020 grants to the same organisation number, and the EIC Fund's list of invested companies carries it as "Interlinked (TADA Medical)". The old website address, tadamedical.com, now leads to interlinked.care, which lists four products, ReLink IV, ReLink Drain, LinkUS IV and LinkUS Drain, and trade fairs through November 2026.

The sources disagree on when the company began. A 2021 company release says TADA Medical was founded in 2016 by a team from the EU-funded Clinical Innovation Fellowship programme. Ratsit says the legal entity was formed on 7 June 2011 and registered on 18 July 2011, while Hitta gives a registration date of 28 February 2012. No public filing explains how the older company became TADA Medical.

Commercially, 2025 was the turning point. In November the company announced its first major international distribution agreement, a multi-year contract with a guaranteed minimum revenue of €3 million; it did not name the distributor or the markets. A week later it said ReLink, "the company's CE-MDR approved medical device platform", had been approved as a dual-use solution for civilian and military care and had "recurring sales and clinical use across hospitals in several European countries". In January 2026 it reported distributor agreements in Europe, the Middle East and North America with binding minimum volumes. None of the three releases names a customer, a distributor or a sales figure.

The Technology: A Weak Link on Purpose

Intravenous lines are usually secured by making the connection stronger, with tape, dressings and securement devices. ReLink takes the opposite approach. The connector is designed to "separate when there is excessive force on the IV line", so the line breaks at the connector instead of pulling the catheter out of the vein, and its self-sealing valves are meant to stop fluid leaking and protect staff from "contaminated blood or hazardous drugs", chief executive Katarina Hedbeck told CORDIS. The company's website calls it "the only breakaway connector designed to function without opening the system".

The size of the problem rests on the company's own figures, which vary. The 2020 project summary says "up to 36%" of IV treatments are interrupted by an accidental pull, at an annual cost of €28.3 billion; the final report three years later says "around 10% of all IV lines" are accidentally ripped out, according to the CORDIS report. Neither figure is sourced on CORDIS.

ReLink is not the only breakaway connector. In the United States, Lineus Medical's SafeBreak Vascular received a De Novo grant from the FDA on 27 May 2021, which created the device category "intravenous catheter force-activated separation device", and the FDA database lists three further clearances for it in 2022 and 2023. That is the market TADA Medical promised to enter.

What the EIC Project Promised, and What CORDIS Shows

The project ended on schedule on 30 April 2023. Its final report says ReLink moved from TRL 6 to TRL 8, that the quality management system was certified to ISO 13485:2016, that "the ReLink device is commercially ready, including CE mark", that production was validated for low volumes and that the patent was extended to "more than ten more countries". It also records a win in the booster category at the World Innovation Summit for Health. A November 2021 release had already said the first-generation product, ReLink Care, had received a CE mark, and the Lille accelerator Eurasanté reported in June 2021 that ReLink development was complete and CE certified. The certificates themselves, their class and the notified body are not public.

"Commercially ready" did not mean on sale. The reports of the company's second EU project, SAFE-Infusion, say that as late as 2024 the partners had "engaged established Notified Bodies to assess the technical documentation and approve the technologies for clinical use in due course", according to CORDIS. A CORDIS article from February 2025 says hospitals in Europe "can already place orders for ReLink®, with the first deliveries expected in the summer of 2025". The company's first release calling ReLink "CE-MDR approved" came in November 2025.

The clinical evidence did arrive, and it is mixed. A randomised trial at Uppsala University Hospital, registered as NCT05814887 with ReLink as the intervention and completed on 1 March 2024, was published in The Journal of Vascular Access in November 2025, according to PubMed Central. Among 146 stroke and orthopaedic patients, ReLink did not significantly reduce the total rate of mechanical complications (42% against 46% per protocol, p = 0.56), but dislodgements fell from 12% to 3.4% (p = 0.04), a 73% reduction, with no device-related adverse events. The paper says the study was funded by the EIC Accelerator grant, and its first author, Christopher Blacker, declares that he owns shares in Interlinked AB and is the company's co-founder and co-inventor of the device; Ratsit lists him on the company's board. A second, larger trial sponsored by the company in Barcelona and Coimbra, planned for 548 patients, is still shown as recruiting on ClinicalTrials.gov, with an estimated completion date of March 2025 that has passed and no results posted.

The FDA application has not surfaced. In May 2023 the company said a new loan would help it advance "clinical trials beyond Europe, starting in the USA and submitting to the FDA", according to its release. The FDA's database of 510(k) and De Novo decisions has no entry for Interlinked or Tada. The FDA's establishment listing shows Interlinked AB with one product, LinkUS Drain, listed on 3 April 2024 under the class I code for irrigation catheters, and the January 2026 release says only that LinkUS Drain is "FDA registered". A listing is not an approval, and the IV connector, the product the EIC funded, has no FDA authorisation on record.

1. Frozen design and productionDeliveredLow-volume production validated, per the final report.
2. ISO 13485 certificateDeliveredReported in 2021 and 2023; certificate not published.
3. CE markDeliveredClaimed in 2021 and 2023; "CE-MDR approved" from November 2025.
4. Clinical evidenceDeliveredRandomised trial of 146 patients published in November 2025: fewer dislodgements, no drop in total complications.
5. FDA applicationNot deliveredNo 510(k) or De Novo for the IV connector in the FDA database.
6. Market launchLateFirst deliveries expected summer 2025, two years after the project ended.

What It Has Achieved Since the Award

The award brought more EU money. In June 2021 Eurasanté reported that TADA Medical and partners had won €5.8 million in grants from the EIC Accelerator, the EIC Fast Track to Innovation programme and Eurostars-2 within a year. The Fast Track project, SAFE-Infusion, ran from 1 April 2021 to 30 September 2024 with a €3,998,661.62 budget; the company coordinated it and received €1,046,509.45, and its partners included Tessen Solutions of Cork and the Sant Joan de Déu research foundation in Barcelona, according to CORDIS. It paired ReLink with AirVault, an air-removal device whose maker, Gasgon Medical, is quoted in the February 2025 CORDIS article. North Data also lists Swedish state aid of SEK 4,950,378 in August 2025 under the ordinance on aid for research, development and innovation; the granting body is not named there and could not be verified elsewhere.

The EIC Fund followed the grant. In November 2021 the company said the fund had approved €1.5 million, a €700,000 convertible loan followed by €800,000 of equity when the loan matured. In January 2023 Tada Group AB said it had closed a bridge round of more than SEK 10 million from angel and institutional investors, arranged with the adviser Apollonian, and planned a Series A "in the next year". In May 2023 it announced a SEK 9 million convertible loan from the EIC Fund. Whether that loan is the first tranche approved in 2021 or a separate one, and whether the €800,000 of equity was ever paid in, is not public. No Series A has been announced. Andreas Dahlén, whom the January 2023 release names as Apollonian's chief executive, now sits on the company's board, according to Ratsit and Hitta.

The Money

The accounts show a company that has spent several years building for a launch that only arrived in 2025. Its net loss grew from SEK 0.8 million in 2021 to SEK 13.7 million in 2024, according to Ratsit, and was SEK 12.87 million in 2025, according to Hitta. Turnover in 2025 was SEK 3.58 million. Equity fell from SEK 6.58 million at the end of 2023 to SEK 2.56 million a year later and to minus SEK 4.28 million at the end of 2025, against short-term liabilities of SEK 25.73 million.

The two register summaries disagree on earlier turnover. Hitta lists SEK 6.73 million for 2023, while Ratsit lists zero for the same year and a profit margin of minus 28,151.6%, which implies sales of only a few tens of thousands of kronor. The summaries do not show how much of the reported turnover is grant or other income, and the annual reports themselves were not opened for this article.

Why Europe Should Care

The spill-proof design ties ReLink to a change in EU workplace law. Directive (EU) 2022/431 brought hazardous medicinal products, such as many cancer drugs, into the EU rules on carcinogens, mutagens and reprotoxic substances; more than 12.7 million health and veterinary workers in the EU are potentially exposed to such drugs, according to Social Europe, and member states had until 5 April 2024 to transpose the directive, according to BD, a manufacturer of IV equipment. A connector that closes when it breaks speaks directly to that duty. The company has also begun to pitch ReLink for military field hospitals and medical preparedness, according to its November 2025 release. The US market, where a rival breakaway device has held FDA authorisation since 2021, is the gap.

The Verdict

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