MiWEndo's Polyp Detector: What the EIC Accelerator Paid For

14 October 20262,206 words12 min

Colonoscopy is the reference test for colorectal cancer, and it still misses polyps. MiWEndo Solutions, a Barcelona spin-off of two universities and the Hospital Clínic, builds a ring that slides onto the tip of an ordinary colonoscope and reads the tissue with microwaves instead of light. When it senses a polyp, it sounds an alarm. In the EIC Accelerator pilot's March 2020 cut-off, the European Commission selected the company with blended finance, according to the Commission's list of selected companies, where MiWEndo Solutions is the only beneficiary named for the project.

The grant agreement, signed on 21 September 2020, gave the company an EU contribution of €1,453,930.63 towards a total cost of €2,077,043.75, from 1 October 2020 to 31 December 2023, according to CORDIS. The project summary was unambiguous: "By the end of the project, the device will have obtained the CE mark and FDA approval." The ring was built and has been tested in people. Neither approval has been announced.

€1.45MEU grant for the MiWEndo project
15Patients in the first-in-human study, 2022
86.9%Sensitivity for polyps in that study
No CE markPromised for 2023, still not announced in October 2026

Company file

Legal entity
MiWEndo Solutions SL, CIF B67508168, Barcelona commercial register
Founded
2019, deed of incorporation dated 29 October 2019
Origin
Spin-off of Universitat Pompeu Fabra, Universitat Politècnica de Catalunya, IDIBAPS-Hospital Clínic and ICREA
Headquarters
Avinguda de Roma 109, Barcelona, since July 2026
Leadership
Tomás Escuin (CEO); Marta Guardiola (co-founder, CTO, board chair); Glòria Fernández-Esparrach (medical director)
Staff
12 in 2024 per Informa; 1 to 9 per Infoempresa
Share capital
€6,541.56
EIC project
MiWEndo, CORDIS 960251, EIC Accelerator pilot, March 2020 cut-off, blended finance

Where MiWEndo Solutions Stands Now

The company is active and still in clinical testing. In July 2026 the commercial register published the move of its registered office from Avinguda Pau Casals to Avinguda de Roma 109 in Barcelona, according to the BORME entries reproduced by Empresia; Infoempresa lists the company as active with its last BORME notice on 10 July 2026. Annual accounts up to the 2024 financial year have been filed, Empresia shows. On 24 June 2026 MiWEndo announced that it had started "the second and final stage" of its pivotal clinical trial, according to MedTech Innovator, an accelerator that lists it in its cohort news. The trial, MiWEndo II, was still recruiting when its record was last updated on 8 October 2026, with 50 patients planned at Hospital Clínic and primary completion estimated for 29 November 2026, according to ClinicalTrials.gov.

The company's focus is widening. In September 2025 it won €1.2 million from Spain's Ministry of Science, Innovation and Universities, in a call for public-private collaboration projects, to develop a single-use device that characterises lesions during the procedure, with the technology centre LEITAT leading mechanical design and additive manufacturing, according to Hospital Clínic and Biotech Spain. Both describe a shift "from focusing exclusively on polyp detection" to telling doctors in real time whether a lesion needs to be removed. The same announcement said the first product, the colonoscope add-on, was expected to obtain CE marking "by the end of the first quarter of 2026". No CE mark had been announced by the company, the hospital or the accelerator by 14 October 2026.

The record

Each public launch date has slipped to a later one

The company first aimed for a mid-2023 launch, then a 2024 launch, then a CE mark by the end of March 2026. By October 2026 its pivotal trial was still recruiting.

  1. Sep 2019Company foundedSpin-off of UPF, UPC, Hospital Clínic and ICREA; mid-2023 launch targeted
  2. Mar 2020EIC Accelerator pilot cut-offMiWEndo selectedblended finance
  3. Oct 2020EU project starts€1.45M grant, CE mark and FDA approval promised by the end
  4. Dec 2020Board of directors formedCapital raised from €3,000 to €5,606
  5. Oct 2022First-in-human study15 patients at Hospital Clínic, NCT05477836
  6. Aug 2023Pivotal study startsMiWEndo II, 50 patients planned, NCT05988645
  7. Dec 2023EU project endsNo CE mark; launch moved to 2024deadline missed
  8. Jul 2024Co-founder leaves boardIgnasi Belda's posts revoked
  9. Mar 2025Pilot results publishedCancers, sensitivity 86.9%
  10. Sep 2025€1.2M Spanish grantSingle-use device for lesion characterisation; CE mark expected by Q1 2026
  11. Jun 2026Final pivotal stageSecond stage of pivotal trial announced
  12. Oct 2026Still recruitingPrimary completion estimated 29 November 2026no CE mark

Clínic Barcelona, CORDIS, BORME via Empresia, ClinicalTrials.gov, MedTech Innovator.

The Technology: Reading Tissue With Microwaves

A colonoscope sees what its camera sees. Polyps hidden behind folds, flat lesions and small polyps can be missed, and the CORDIS objective says 22% of polyps go undetected "due to visual limitations of the colonoscope camera" and that 8% of colorectal cancers are diagnosed after a negative colonoscopy. MiWEndo does not try to improve the picture. Its ring carries antennas that send microwave signals into the bowel wall and measure how the tissue responds. Healthy mucosa, polyps and cancer differ in their dielectric properties, and the company's algorithms use that difference to flag lesions all around the ring, covering 360 degrees rather than the camera's forward view, according to CORDIS, which cites the company's European patent EP3195786A1.

The difference from the established method is the contrast mechanism: a standard colonoscopy depends on what the endoscopist sees on screen, while MiWEndo adds a signal that does not depend on the image. In the published study, the device is a disposable ring on a standard high-definition colonoscope, scanning at 5 frames per second, according to the paper in Cancers.

What the First Patients Showed

The first-in-human study ran at Hospital Clínic from 18 October to 25 November 2022 and enrolled 15 patients, according to its ClinicalTrials.gov record. The results, published in March 2025 in Cancers, report that the colonoscope reached the caecum in all 15 patients and that no immediate or delayed adverse events were recorded, although the authors count 16 minor incidents in 14 patients, 11 of them superficial mucosal abrasions. The detection figures come from 23 polyps in 6 patients: sensitivity of 86.9%, specificity of 72%, a positive predictive value of 58.8% and a negative predictive value of 92.3%, rising to 97.3% for adenomas alone. Most false alarms were caused by water or debris; small hyperplastic polyps were the main misses.

The first clinical data

The ring caught most polyps but raised many false alarms

Results for 23 polyps in 6 of the 15 patients. Fewer than six in ten alarms were real polyps (positive predictive value 58.8%); most false positives came from water or debris.

Ortiz et al., Cancers 17(7):1073, March 2025.

The authors list the limits themselves: a small sample, no randomisation, deep sedation and only experienced endoscopists. Two of them, Marta Guardiola and Glòria Fernández-Esparrach, are shareholders of MiWEndo Solutions, the paper discloses, and the study acknowledges funding from Horizon 2020 grant 960251. The authors describe microwave colonoscopy as a possible complement to colonoscopy, not a replacement.

The evidence base

Fifteen patients so far, fifty planned for the pivotal study

The first-in-human study is complete. The pivotal study, started in August 2023, was still recruiting in October 2026.

ClinicalTrials.gov, NCT05477836 (actual enrolment) and NCT05988645 (estimated enrolment).

What the EIC Project Promised, and What CORDIS Shows

The proposal summarised on CORDIS set out a financial need of €3.8 million from 2020 to 2023, up to "product launch", with the EU grant covering 70% of the project budget. At the end, MiWEndo was to reach technology readiness level 8, complete clinical validation in a trial, and obtain the CE mark and FDA approval "prior to product launch in early markets". When the company was founded, it had aimed to launch in mid-2023 in Europe, the United States and Japan, according to Hospital Clínic.

The final periodic report, covering October 2021 to December 2023, says the accessory prototype was "designed, manufactured, and verified", that a clinical trial assessed it, and that the regulatory milestones included "ISO 13485 implementation, CE mark progress, Phase I trial completion, and FDA DeNovo pathway approval". "Plans are underway for device introduction in 2024," it adds. CE mark progress is not a CE mark, and the report does not say the FDA granted a De Novo authorisation; the phrase reads as agreement on the regulatory route. The FDA's public openFDA 510(k) data return no entry for MiWEndo. No device introduction in 2024 was announced.

  1. Accessory prototype built and verifiedDeliveredReported in the CORDIS report and used on patients in the 2022 study.
  2. Clinical validation in a trialPartly15-patient feasibility study completed; the 50-patient pivotal study was still recruiting in October 2026.
  3. CE mark by the end of 2023Not achievedNot announced; in September 2025 still expected by the end of March 2026.
  4. FDA approval by the end of 2023Not achievedNo FDA authorisation announced or listed in openFDA.
  5. Product launch in early marketsNot achievedLaunch planned for 2024; no sale or launch announced.

The project budget

The EU paid 70% of a €2.08M project

The EU contribution covered €1.45M of the total cost. The rest came from the company.

CORDIS, project 960251. Values in € millions.

The Money and the Company

MiWEndo Solutions was incorporated by public deed on 29 October 2019 with €3,000 of share capital, according to the BORME record on Empresia, which gives 18 September 2019 as the start of activity; a Hospital Clínic article of 20 September 2019 says it was constituted the day before. Two capital increases followed: to €5,606 in December 2020, when a board was formed that included the investment company Asiria Inversiones SA, and to €6,541.56 in February 2023. The register shows nominal amounts only, so the money raised in each round is not public. In November 2023 the company obtained the status of an emerging company under Spain's start-up law (Ley 28/2022) for seven years. Ignasi Belda, chief executive when the company was founded, left the board in July 2024, when Marta Guardiola was appointed managing director (consejera delegada), the BORME entries show.

The financial picture is thin and partly contradictory. Empresia says annual turnover is below €500,000, Infoempresa says below €2 million, and Empresite, drawing on Informa D&B data, puts it below €300,000. Empresite reports 12 employees in 2024 and a 20% fall in staff; Infoempresa gives a range of 1 to 9. CB Insights puts total funding at $8.6 million across 15 rounds but does not show the amounts, and its named backers are accelerators (MedTech Innovator, BIND and Emprende inHealth) rather than venture funds. That total could not be verified. No private equity round has been announced by the company.

The EIC equity

The award was listed as blended finance, which means a grant plus an equity investment by the EIC Fund. CORDIS records only the €1.45 million grant, and MiWEndo Solutions does not appear among the 326 organisations on the EIC Fund's list of invested companies (pages checked on 14 October 2026). There is no public evidence that the equity part was ever invested.

CORDIS lists no other EU research project for the company. Its own news page records awards and grants from 2021 and 2022, including EIT Health and CaixaImpulse support shown on its website, but it has not been updated with the trial or funding news of 2025 and 2026.

Why Europe Should Care

Colorectal screening is EU policy. The Council recommendation on cancer screening adopted on 9 December 2022 recommends faecal immunochemical testing "before referring individuals between 50 and 74 years old to follow-up colonoscopy", and aims to offer screening to 90% of eligible citizens by 2025, as part of Europe's Beating Cancer Plan, according to the European Commission and the European Parliament's legislative train. Every positive test in such a programme ends in a colonoscopy, so a device that reduces missed polyps would act on the most expensive and decisive step of the chain.

What the company said

A device at TRL8, clinically validated, with CE mark and FDA approval by the end of 2023 and a launch in early markets.

What the record shows

A working prototype, a 15-patient feasibility study published in 2025 and a pivotal trial still recruiting in October 2026. No CE mark, FDA authorisation or launch announced.

The Verdict

Built, tested, not yet approved

The EIC money paid for real engineering: a microwave sensing ring that works on a standard colonoscope and found most polyps in its first patients, with too many false alarms still to fix. It did not buy what the project promised at its end date. Nearly three years after the grant closed, no CE mark, FDA authorisation or launch has been announced for the device, and every public launch date has moved back by a year or more. The company has kept going on public grants and small capital increases and has kept its clinical programme alive, and the pivotal results due around the end of 2026 will decide whether the delay was the normal pace of medical devices or a sign of a harder problem.

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

Industry

HealthMedical devices

Focus
  • Gastrointestinal devices
Technologies
  • Electromagnetic sensing
Keywords
  • Colonoscopy
  • Colorectal cancer
  • Polyp detection
  • Endoscopy accessories