Patients on a ventilator cannot cough. A balloon, the cuff, seals the breathing tube inside the windpipe, and the mucus that collects around it has to be sucked out by a nurse with a catheter, many times a day. AW Technologies, a company in Nørresundby in northern Denmark, sells a box that does something different: at the push of a button it lets the cuff go slack for a fraction of a second while the ventilator is pushing air in, so that the pressure escapes upwards like a cough and carries the secretions towards the mouth. The device is called TrachFlush.
In the spring of 2020 that idea looked tailor-made for the pandemic. The European Commission's list of winners of the March 2020 EIC Accelerator pilot cut-off names AW Technologies of Østervrå with a grant-only award for COVID-19 ICU-CARE, "a ground-breaking ICU bed-side COVID-19 trachea flushing system". CORDIS records an EU contribution of €1,196,749 towards a total cost of €1,719,017.50, for a project that ran for twelve months from 1 August 2020. It was one of 36 companies that shared close to €166 million in that round for projects against the coronavirus, according to ERRIN and The Sofia Globe, both reporting the Commission's announcement of 8 June 2020.
Company file
- Legal entity
- AW Technologies ApS, CVR 39997355 (registered as AW Technologies IVS in November 2018)
- Headquarters
- Amalienborgvej 57, Nørresundby, Denmark
- Founders
- Stephen E. Rees, Jørgen Hansen, Adam S. Hansen, Andreas M. Hejslet
- Leadership
- Adam Søholm Hansen (CEO); Jørgen Hansen (chair)
- Product
- TrachFlush cuff controller with a Flush Control artificial cough
- Staff
- 4 on average in 2025
- EIC project
- COVID-19 ICU-CARE, March 2020 cut-off, grant only, closed July 2021
- EIC Fund
- Not in the portfolio
Where AW Technologies Stands Now
The company is active and selling. Its news page lists ten distribution agreements announced between February and July 2026, covering Mexico, Germany, the Benelux countries, Greece and Cyprus, Kuwait, the United Kingdom, Italy, India, Saudi Arabia, and Australia and New Zealand. Posts shown on the LinkedIn profile of its chair, Jørgen Hansen, add later deals for Taiwan, Croatia, Chile, Guatemala and Peru, and four Southeast Asian countries, as well as launch posts by the Italian and German distributors. None of these announcements gives a sales figure. In Japan, Asahi Kasei Medical signed an exclusive distribution agreement in March 2024, according to Asahi Kasei and Business Wire, and said on 1 November 2024 that it had completed the notification and would begin sales.
The most recent regulatory step came on 13 August 2026, when the US Food and Drug Administration cleared TrachFlush under 510(k) number K261499. The FDA database gives 6 May 2026 as the date the submission was received; a third-party mirror, Innolitics, gives 10 July 2026. The two sources disagree on that date and agree on the decision.
How the Artificial Cough Works
The standard way to clear a ventilated patient's airway is endotracheal suctioning: a catheter goes down the tube and vacuums out the mucus. It is unpleasant for the patient, takes nursing time, and opens the circuit. TrachFlush does two jobs. It keeps the cuff at a set pressure breath by breath, as existing cuff controllers such as Hamilton Medical's IntelliCuff, the predicate named in its 2023 US clearance, already did. Its second function, called Flush Control on the product website, deflates the cuff during the ventilator's inspiration and reinflates it before the breath ends, so air rushes up past the cuff and pushes secretions from below and above it into the mouth. Asahi Kasei describes the same mechanism in its 2024 release.
The company's own history credits the idea to an intensive care doctor, Dr. Alberto Zanella, who tested a prototype in pigs and simulation set-ups before founding the company with four medtech entrepreneurs in November 2018. An October 2019 interview by the BioInnovation Institute names the founders as Aalborg University professor Stephen E. Rees, former Philips Healthcare manager Jørgen Hansen and two business college graduates, Adam S. Hansen and Andreas M. Hejslet. It reports that the company had joined BII's Business Acceleration Academy with funding and services worth DKK 625,000 and had received a DKK 750,000 grant from Life Science Innovation North Denmark for safety documentation.
Two US clearances, two different devices on paper
Asahi Kasei's 2024 release says TrachFlush received "FDA clearance in the United States (2023)". The FDA record for that year, K220854, cleared a "TrachCuff Cuff Controller" on 14 April 2023, intended only to "continuously measure and automatically maintain the user-set cuff pressure". The secretion-clearing claim, "simulating an artificial cough during mechanical ventilation", was added only with the August 2026 clearance, which names the 2023 device as its predicate and a Philips CoughAssist as reference device, according to the 510(k) summary.
What COVID-19 ICU-CARE Promised, and What the Record Shows
The proposal summarised on CORDIS was specific. With five leading hospitals in Denmark, Italy, the Netherlands and Spain, the project would run "a large-scale clinical study to reach TRL 8" and demonstrate in COVID-19 patients "a 90% efficient secretion removal", "a 90% reduction in ICU nurse workload" and the "elimination of any contamination between patients and staff". The company added a business plan: a market share of 5.3%, turnover of €100 million, EBITDA of €57 million and 22 additional jobs by 2025, helped by "a recently signed distribution agreement with an ICU ventilator manufacturer" that it did not name.
The final report, covering August 2020 to July 2021, lists eight activities for a multi-centre clinical trial across five European sites, from the protocol and ethics approvals to patient enrolment, data analysis and a paper, and states: "All the above activities, except the article preparation (#8 in part), have been executed on time and cost." It reports no patient numbers and no results. The CORDIS results page lists no deliverables or publications.
The published studies tell a different story. The Danish study, run at hospitals in Herning, Holstebro and Viborg, recruited its 20 patients "during the period October 19, 2021, to February 2, 2022", after the EU project had ended, according to the paper in Respiratory Care. The Amsterdam study enrolled 28 patients from August 2021 to April 2022 and says it had been designed as a multi-centre trial of 100 patients, but "delays in the start of the study because of the COVID-19 epidemic and the resulting funding issues led to a substantial decrease in inclusion of subjects, with the study conducted at a single site", according to its full text. The Dutch trial registration, which names AW Technologies among its sources of support, excluded patients with "any infection, or colonization with pathogens that require strict isolation", which would rule out COVID-19 patients in isolation. The third paper, from the Policlinico in Milan, studied 28 ICU patients and is summarised on PubMed without any mention of COVID-19. No study of TrachFlush in Spain could be found.
The Danish and Dutch papers disclose that Rees and his Aalborg University colleague Dan Stieper Karbing, both co-authors, are shareholders of AW Technologies, and the Danish paper says the company funded the research at all authors' institutions, according to PubMed and the full text. Both men sit on the company's board, according to its 2025 annual report. None of the three studies measured nurse workload in minutes or cross-contamination between patients and staff, the two other headline goals of the EU project.
- Five-hospital COVID-19 trial in four countriesNot deliveredNo COVID-19 study published; the Dutch study shrank to one site and started after the project ended.
- 90% more efficient secretion removalNot shownPublished success rates of 56% to 90%, measured in general ICU patients.
- 90% less nurse workloadNot shownNo published measurement.
- No contamination between patients and staffNot shownNo published measurement.
- Take TrachFlush to marketDeliveredCE marked in 2020, sold in Japan from 2024, distributors in more than 20 countries announced in 2026.
- €100M turnover and 22 new jobs by 2025MissedGross loss of DKK 787,090 and 4 staff in 2025.
The Money
AW Technologies files small-company accounts that do not disclose revenue, only gross profit. They show a business that made small net profits during the grant years, DKK 445,321 in 2020 and DKK 577,837 in 2021, and has lost money since 2023, according to the annual reports filed with the Danish Business Authority. Gross profit peaked at DKK 2.67 million in 2024 and turned into a gross loss of DKK 787,090 in 2025. The net loss for 2025 was DKK 3.54 million, after DKK 2.74 million in 2024.
Most of the company's assets are its own development work: DKK 19.25 million of capitalised development costs, completed in 2024 and written off over 12 years, stood at DKK 16.04 million at the end of 2025. Against total assets of DKK 18.23 million, short-term debt reached DKK 15.84 million, including DKK 791,251 owed to banks and DKK 2.52 million of prepayments from customers. Cash was zero. The registered share capital rose in steps from DKK 10,000 at registration to DKK 67,239, its level since the end of 2023, according to the accounts and North Data; no investment round has been announced publicly.
"The company has lost its entire share capital and is thus covered by section 119 of the Companies Act."
AW Technologies, management review in the 2025 annual report, approved 16 June 2026 (translated)The same report calls the 2025 result "satisfactory", says management expects the capital to be re-established through normal operations in the coming years, and states that the company has sufficient financial resources for at least 12 months from the balance sheet date. The first note to the accounts is headed "Uncertainty about going concern". The accounts were reviewed by Grant Thornton under an extended review, not a full audit. The board consists of Jørgen Hansen as chair, Claus Lindholt, Stephen Edward Rees and Dan Stieper Karbing, with Adam Søholm Hansen as chief executive since January 2022.
AW Technologies is not among the companies listed on the EIC Fund portfolio, which was checked on all 17 pages, and its award was grant only. CORDIS shows no other EU project for the company. It also appears unrelated to Covid-19 Telemedicine ApS, the next Danish row on the same Commission list: that company, now Levvel Health ApS of Hørsholm, has a different project, address and set of directors, according to North Data.
Why Europe Should Care
Pneumonia caught in intensive care is a European problem beyond any pandemic. In 2022, 9.8% of patients who stayed in an ICU for more than two days had at least one infection acquired there, 6% had pneumonia, and 83% of pneumonia episodes were associated with intubation, according to the European Centre for Disease Prevention and Control. A device that reduces suctioning and keeps the breathing circuit closed addresses both patient safety and nursing workload. In 2020 the EIC bet that a small Danish company could prove that during the pandemic, at speed. The product survived; the pandemic-specific evidence did not appear.
What the company said
A five-hospital COVID-19 trial would show 90% better secretion removal, 90% less nurse work and no contamination, leading to €100 million in turnover by 2025.
What the record shows
Three small studies in general ICU patients, two of them started after the project ended; a product on sale with new distributors; four staff and negative equity at the end of 2025.
The Verdict
A product, not the proof
AW Technologies took TrachFlush to market and, six years after its EU grant, won a US clearance for the artificial cough itself, which is more than many pandemic-era grantees managed. What the EIC paid for, a multi-country trial in COVID-19 patients with 90% targets, never appeared in print, and the final report's claim that the trial ran "on time and cost" sits badly with the study dates. The company now has to turn its new distributors into revenue before its negative equity becomes a constraint.
AW Technologies has not been asked for comment for this article. It is based entirely on public records, company statements, published studies and EU project data, linked throughout.
Sources
- CORDIS, COVID-19 ICU-CARE fact sheet, periodic report and results page
- European Commission, EIC Accelerator pilot selected companies, March and May 2020 cut-offs
- ERRIN, 8 June 2020 and The Sofia Globe, 8 June 2020
- Danish Business Authority, AW Technologies filings and 2025 annual report
- North Data, AW Technologies ApS and Levvel Health ApS (formerly Covid-19 Telemedicine ApS)
- US FDA, 510(k) K261499, its summary and K220854; Innolitics, K261499
- Asahi Kasei, 28 March 2024, Business Wire, April 2024 and Asahi Kasei Medical, 1 November 2024
- AW Technologies, news, company history and TrachFlush product website
- Jørgen Hansen, LinkedIn activity
- BioInnovation Institute, "Meet the start-ups: AW Technologies", 25 October 2019 (archived)
- Nielsen et al., Respiratory Care 2023, Sinnige et al., Respiratory Care 2024 and Vivona et al., Respiratory Care 2025
- Overview of Medical Research in the Netherlands, trial NL-OMON51050
- European Innovation Council, EIC Fund invested companies
- ECDC, healthcare-associated infections acquired in ICUs, data for 2022
