Periodic Reporting for period 2 - HYDRUSTENT (Hydrogel Biodegradable Ureteral Stent)
Période du rapport: 2024-12-01 au 2025-11-30
Hydrustent: A Biodegradable Ureteral Stent Revolution
Challenges with Traditional Stents
Ureteral stents are crucial for kidney and ureteral stone management but present significant drawbacks:
•Stent-Related Symptoms (SRS) – ~80% of patients suffer from pain, hematuria, or discomfort due to stent rigidity.
•Forgotten Stents & Complications – Non-biodegradable stents require removal (€900/patient in the EU). 13% are forgotten, leading to severe encrustation, urinary obstruction, kidney failure, and costly surgical removal.
•Biofilms, UTIs & Encrustation – Biofilm formation begins immediately, increasing UTI risk (80-96% of patients within 30 days). 50%+ of stents encrust within 6-12 weeks, complicating removal.
Despite advancements, no stent material has effectively prevented infections or encrustation.
Hydrustent: A Game-Changing Solution
Hydrustent is a biodegradable, hydrogel-based ureteral stent that dissolves after 10 days, eliminating complications associated with traditional stents.
Key Advantages:
✔ No Removal Needed – Avoids secondary procedures, cutting treatment costs by ~60%.
✔ Soft & Flexible – 94% water composition mimics natural tissue, enhancing comfort and reducing SRS symptoms.
✔ Prevents Infections & Encrustation – Reduces biofilm formation, UTIs, and mineral buildup, lowering complications.
✔ Eco-Friendly & Cost-Effective – Reduces medical waste by 50%, promoting sustainability.
Designed for 94% of patients needing stents for ≤10 days, Hydrustent degrades naturally via urine flow, preventing forgotten stents and the need for additional interventions.
Transforming Urology: Hydrustent eliminates stent removal procedures, reduces complications, and lowers healthcare costs, offering a safer, more effective, and sustainable alternative to traditional ureteral stents.
Challenges with Traditional Stents
Ureteral stents are crucial for kidney and ureteral stone management but present significant drawbacks:
•Stent-Related Symptoms (SRS) – ~80% of patients suffer from pain, hematuria, or discomfort due to stent rigidity.
•Forgotten Stents & Complications – Non-biodegradable stents require removal (€900/patient in the EU). 13% are forgotten, leading to severe encrustation, urinary obstruction, kidney failure, and costly surgical removal.
•Biofilms, UTIs & Encrustation – Biofilm formation begins immediately, increasing UTI risk (80-96% of patients within 30 days). 50%+ of stents encrust within 6-12 weeks, complicating removal.
Despite advancements, no stent material has effectively prevented infections or encrustation.
Hydrustent: A Game-Changing Solution
Hydrustent is a biodegradable, hydrogel-based ureteral stent that dissolves after 10 days, eliminating complications associated with traditional stents.
Key Advantages:
✔ No Removal Needed – Avoids secondary procedures, cutting treatment costs by ~60%.
✔ Soft & Flexible – 94% water composition mimics natural tissue, enhancing comfort and reducing SRS symptoms.
✔ Prevents Infections & Encrustation – Reduces biofilm formation, UTIs, and mineral buildup, lowering complications.
✔ Eco-Friendly & Cost-Effective – Reduces medical waste by 50%, promoting sustainability.
Designed for 94% of patients needing stents for ≤10 days, Hydrustent degrades naturally via urine flow, preventing forgotten stents and the need for additional interventions.
Transforming Urology: Hydrustent eliminates stent removal procedures, reduces complications, and lowers healthcare costs, offering a safer, more effective, and sustainable alternative to traditional ureteral stents.
WP1: Throughout the project, strong management and quality control ensured effective execution of all technical and scientific tasks. A dedicated project manager coordinated planning, monitoring, and alignment with objectives, supported by professional software for task structuring, progress tracking, risk control, and collaboration. A project handbook ensured consistent procedures. Quality management involved GAP analysis and regular coordination meetings, ensuring compliance with standards for manufacturing validation, pre clinical testing, and clinical investigation preparation. Continuous IP monitoring secured freedom to operate and protected Hydrustent’s technology.
WP2: Significant progress was achieved in establishing a scalable and validated manufacturing process for Hydrustent. A new ISO Class 7 cleanroom was implemented at Hydrumedical’s facilities and fully validated to support clinical-grade production. All manufacturing stations involved in Hydrustent production were installed, qualified, and validated, with SOPs and records defined to support reproducibility, traceability, and regulatory compliance. The injection process was optimised through improved control of mixing, injection, drying, and post processing, significantly increasing robustness, consistency, and scalability, and preparing the line for future industrial scale up without compromising quality or performance.
WP3: Following successful pilot production, a GLP compliant in vivo pre clinical study assessed Hydrustent’s safety and performance. Results showed a favourable safety profile, effective function, complete homogeneous degradation without obstructive fragments, preserved urine pH and renal function, and no irritation or urothelial pathology at 72 hours, 4 weeks, or 13 weeks. Renal function remained normal across all groups, with no significant safety or efficacy differences versus the RocaJJ® Soft stent. Hydrustent was confirmed suitable for clinical investigation. In parallel, the regulatory team prepared a Design and Development File consolidating technical, pre clinical, and risk management data to support EU MDR conformity and CE certification.
WP4: A detailed clinical study protocol covering design, methodology, endpoints, and safety procedures was submitted to INFARMED and CEIC, obtaining full regulatory and ethical approval. The clinical investigation has been authorised and initiated, with contractual, data protection, and operational agreements established with participating hospitals. Site initiation was completed and patient recruitment is ongoing. Six patients have been enrolled, four under active follow up. Interim data show good device performance and a favourable safety profile, with no device related serious adverse events. In parallel, a Clinical Evaluation Plan was prepared to define the methodology for the Clinical Evaluation Report supporting regulatory approval.
WP5: Significant progress was achieved toward Hydrustent’s regulatory approval. An agreement with Notified Body PCBC supports CE certification of this Class III device, and regulatory preparation aligned the technical file, quality system, and clinical evidence with EU MDR. Work also advanced in Brazil through collaboration with Sobel for future ANVISA submission, coordinated with broader FDA related strategy. Market oriented technical and scientific activities assessed clinical needs, regulatory contexts, and reimbursement pathways, refining the value proposition, clinical evidence strategy, and product positioning for adoption.
Although clinical approval delays prevented completion of all milestones, the planned technical objectives were achieved, establishing a solid basis for final clinical validation and CE certification.
WP2: Significant progress was achieved in establishing a scalable and validated manufacturing process for Hydrustent. A new ISO Class 7 cleanroom was implemented at Hydrumedical’s facilities and fully validated to support clinical-grade production. All manufacturing stations involved in Hydrustent production were installed, qualified, and validated, with SOPs and records defined to support reproducibility, traceability, and regulatory compliance. The injection process was optimised through improved control of mixing, injection, drying, and post processing, significantly increasing robustness, consistency, and scalability, and preparing the line for future industrial scale up without compromising quality or performance.
WP3: Following successful pilot production, a GLP compliant in vivo pre clinical study assessed Hydrustent’s safety and performance. Results showed a favourable safety profile, effective function, complete homogeneous degradation without obstructive fragments, preserved urine pH and renal function, and no irritation or urothelial pathology at 72 hours, 4 weeks, or 13 weeks. Renal function remained normal across all groups, with no significant safety or efficacy differences versus the RocaJJ® Soft stent. Hydrustent was confirmed suitable for clinical investigation. In parallel, the regulatory team prepared a Design and Development File consolidating technical, pre clinical, and risk management data to support EU MDR conformity and CE certification.
WP4: A detailed clinical study protocol covering design, methodology, endpoints, and safety procedures was submitted to INFARMED and CEIC, obtaining full regulatory and ethical approval. The clinical investigation has been authorised and initiated, with contractual, data protection, and operational agreements established with participating hospitals. Site initiation was completed and patient recruitment is ongoing. Six patients have been enrolled, four under active follow up. Interim data show good device performance and a favourable safety profile, with no device related serious adverse events. In parallel, a Clinical Evaluation Plan was prepared to define the methodology for the Clinical Evaluation Report supporting regulatory approval.
WP5: Significant progress was achieved toward Hydrustent’s regulatory approval. An agreement with Notified Body PCBC supports CE certification of this Class III device, and regulatory preparation aligned the technical file, quality system, and clinical evidence with EU MDR. Work also advanced in Brazil through collaboration with Sobel for future ANVISA submission, coordinated with broader FDA related strategy. Market oriented technical and scientific activities assessed clinical needs, regulatory contexts, and reimbursement pathways, refining the value proposition, clinical evidence strategy, and product positioning for adoption.
Although clinical approval delays prevented completion of all milestones, the planned technical objectives were achieved, establishing a solid basis for final clinical validation and CE certification.
HYDRUSTENT overcomes major limitations of conventional non‑degradable stents, which require removal surgery and cause 60–80% symptoms, 7–20% infections, rising encrustation, 10–15% re‑interventions, and up to 13% forgotten stents leading to severe complications.
It is the first fully biodegradable hydrogel ureteral stent, made from natural-origin polymers (~94% water), maintaining drainage function and degrading predictably via homogeneous erosion.
Pre‑clinical GLP studies showed full degradation in 72h, no obstructive fragments, preserved renal function, stable pH, and no urothelial damage.
A validated, scalable ISO Class 7 manufacturing process enables clinical‑grade and future commercial production.
First‑in‑human clinical investigation is ongoing, with interim data showing good performance, no device‑related serious adverse events, no unexpected complications, and no migrations.
Eliminating removal procedures (EUR 800–1,500) may reduce treatment costs by 50–60% and save high‑volume hospitals EUR 1–3M/year.
The project validated a hydrogel biodegradable platform applicable to other stents, especially biliary stents that currently require replacement every 3–4 months.
IP also enables drug‑eluting versions for antibiotics, anti‑inflammatories, or oncology drugs, addressing unmet needs in urology and hepatobiliary care.
Next steps include completing the clinical study, finalising the CER, obtaining CE MDR and international approvals, generating real‑world evidence, scaling production, and extending the platform.
HYDRUSTENT delivers a clinically and industrially validated biodegradable stent that avoids removal surgery, reduces complications, enables predictable degradation, and supports expansion into biliary and drug‑eluting devices.
It is the first fully biodegradable hydrogel ureteral stent, made from natural-origin polymers (~94% water), maintaining drainage function and degrading predictably via homogeneous erosion.
Pre‑clinical GLP studies showed full degradation in 72h, no obstructive fragments, preserved renal function, stable pH, and no urothelial damage.
A validated, scalable ISO Class 7 manufacturing process enables clinical‑grade and future commercial production.
First‑in‑human clinical investigation is ongoing, with interim data showing good performance, no device‑related serious adverse events, no unexpected complications, and no migrations.
Eliminating removal procedures (EUR 800–1,500) may reduce treatment costs by 50–60% and save high‑volume hospitals EUR 1–3M/year.
The project validated a hydrogel biodegradable platform applicable to other stents, especially biliary stents that currently require replacement every 3–4 months.
IP also enables drug‑eluting versions for antibiotics, anti‑inflammatories, or oncology drugs, addressing unmet needs in urology and hepatobiliary care.
Next steps include completing the clinical study, finalising the CER, obtaining CE MDR and international approvals, generating real‑world evidence, scaling production, and extending the platform.
HYDRUSTENT delivers a clinically and industrially validated biodegradable stent that avoids removal surgery, reduces complications, enables predictable degradation, and supports expansion into biliary and drug‑eluting devices.