Hydrumedical and the EIC Accelerator: A Stent That Dissolves
Hydrumedical, a company in Guimarães, Portugal, has developed Hydrustent, a ureteral stent made of a hydrogel that is 94% water, placed after kidney stone treatment to keep urine flowing and designed to dissolve in the urine within seven to ten days, so no second procedure is needed to remove it. It was selected in the EIC Accelerator's March 2023 cut-off with blended finance and received an EU grant of €1.52 million for a €2.23 million project that ran from December 2023 to November 2025, according to CORDIS. The objective claimed the stent could cut treatment costs by up to 60%.
The final report says Hydrumedical built and validated an ISO Class 7 cleanroom for clinical-grade production, and that a GLP animal study found a favourable safety profile with complete degradation and no obstructive fragments, performing like a conventional soft stent, according to the CORDIS reporting page. The human study was approved and started, but "six patients have been enrolled", and the report concedes that "clinical approval delays prevented completion of all milestones". The study, which plans 134 patients at four Portuguese hospitals, began in September 2025 and is due for primary completion at the end of 2026, according to ClinicalTrials.gov.
Company file
- Legal entity
- Hydrumedical, S.A., Guimarães
- Device
- Hydrustent, class III biodegradable stent
- Notified body
- PCBC, for CE certification
- Study sites
- Aveiro, Guimarães, Lisbon, Viana do Castelo
- Other products
- Sports medicine devices, Precision MR meniscus repair
- Brazil partner
- Sobel, for ANVISA filing
- EIC funding
- Blended finance
Where Hydrumedical Stands Now
The Hydrustent study was still recruiting at its last registry update in April 2026. Hydrumedical has an agreement with the notified body PCBC for CE certification of the device, which is class III, the highest risk category, and is working with Sobel on a future filing in Brazil, the report says. Its website presents a wider medical device business, with sports medicine and orthobiologic products and a urology section. Revenue, staff numbers and whether the EIC Fund invested are not public.
The record
From lab hydrogel to a first clinical study
Hydrumedical built a cleanroom, passed a GLP animal study and started its first human study during the EIC project. Delays in clinical approval meant not all milestones were met.
- Mar 2023EIC Accelerator cut-offHYDRUSTENTblended finance
- Dec 2023Project starts€1.52M EU grant
- 2024-2025ISO Class 7 cleanroomClinical-grade production validated
- 2025GLP animal studySafe, fully degraded, no obstruction
- Sep 2025Clinical study starts134 patients planned, 4 Portuguese sites
- Nov 2025Project ends6 patients enrolled
- Dec 2026Primary completion, estimatedCE certification then possible
CORDIS and ClinicalTrials.gov.
"Although clinical approval delays prevented completion of all milestones, the planned technical objectives were achieved."
Hydrumedical, final report to the EICThe Technology: A Soft Stent That Washes Away
Conventional ureteral stents are stiff plastic tubes. The company says about 80% of patients report pain or blood in the urine, more than half of stents encrust within six to twelve weeks, and 13% are forgotten, which can lead to kidney damage. Removal costs about €900 per patient in the EU. Hydrustent is soft and lubricated, which the company says limits bacterial adhesion, and it is meant for the 94% of patients who need a stent for ten days or less.
The problem
Complications with conventional ureteral stents
Hydrumedical says about 80% of patients suffer stent-related symptoms, 13% of stents are forgotten and more than half encrust within 6 to 12 weeks. These are the company's figures.
Hydrumedical, final report (CORDIS). Values in %.
What the EIC Award Promised, and What the Record Shows
The award aimed to validate manufacturing, complete preclinical testing and run a clinical investigation towards CE marking. Manufacturing and animal testing were done. The clinical investigation started in the final quarter of the project and had enrolled a small fraction of its patients. Interim data showed no device-related serious adverse events, the report says.
- Clinical-grade productionDeliveredCleanroom validated.
- GLP animal studyDeliveredFavourable safety.
- Clinical investigationStarted6 of 134 enrolled.
- CE certificationNot yetNeeds clinical data.
The Money
The EU paid 68% of the project. No private funding round has been announced. The clinical study must finish before a CE application can be completed, which means more spending before any Hydrustent revenue.
The clinical study
Patients planned and enrolled in the Hydrustent study
By the end of the EIC project six of the 134 planned patients had been enrolled.
ClinicalTrials.gov NCT06719089 and CORDIS final report. Patients.
The project budget
Who paid for the €2.23M project
The EU covered 68% of the HYDRUSTENT project's cost.
CORDIS, project 190169028. Values in € millions.
What Cannot Be Checked
Questions for the EIC
How many patients the study has enrolled since November 2025, whether the EIC Fund invested, when a CE application will be filed, and Hydrumedical's finances are not public.
Why Europe Should Care
Conventional stents placed after kidney stone treatment must later be removed, at about €900 a patient in the EU, the company says. A stent that dissolves would save procedures, costs and complications. Hydrumedical has taken its hydrogel to a clinical study; the evidence the EU needs to approve it is still being collected.
What the award promised
Validated production, preclinical testing and a clinical study towards CE marking.
What the record shows
A cleanroom, a positive animal study and a human study with six patients at project end.
The Verdict
Groundwork done, trial late
Hydrumedical says the planned technical objectives were achieved, though delays prevented completion of all milestones. The clinical study started late and slowly, so the stent is not yet available to patients.
Hydrumedical and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Industry
HealthMedical devices
- Focus
- Urology devices
- Technologies
- Hydrogels
- Biomaterials
- Keywords
- Ureteral stents
- Kidney stones
- Biodegradable implants
- Stent removal