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.
