Periodic Reporting for period 1 - HYDRUSTENT (Hydrogel Biodegradable Ureteral Stent)
Reporting period: 2023-12-01 to 2024-11-30
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
A project manager was assigned to this project to ensure the project is managed effectively and efficiently with a strong focus on achieving project’s goals and providing results that meed the stakeholders expectations.
A project management software was aquired (Atlassian - Jira) to guide the tasks of each WP and each team member can contribute and add relevant content while a project handbook is being prepared.
The quality team has raised a GAP analysis and weekly meetings are scheduled to ensure that the project is completed on schedule, on budget and with the necessary quality standards, while addressing unforeseen issues that may arise and acting immediately to meet the project’s outcomes.
IPR monitoring is also conducted by intellectual property specialists from Patentree, ensuring that the product’s potential benefits are achieved, that its commercial viability is preserved and that it is safeguarded from improper usage or distribution.
WP2
A new ISO 7 cleanroom was created at Hydrumedical new facilities to ensure an effective optimization of the manufacturing process. The cleanroom was validated and is now ready to accomodate the Hydrustent production. All stations involved in the production of Hydrustent were validated, defined the procedures and records to support the manufacturing process for the product testing and clinical validation.
A new injection method is being optimized in order to ensure that the production process is strong, dependable, and scalable without compromising quality or consistency as the demand for the biodegradable ureteral stents increases.
WP3
After stents’ production an in-vivo trial in animal model under GLP certification was conducted at CCMIJU to test the stents' effectiveness and any possible negative effects. The outcomes of these studies were very satisfying. HYDRUSTENT proved to be safe, with good degradation rate and no alteration of the urine pH or renal function. It is non-irritant and causes no modifications in the urothelium at 72h, 4 weeks, or 13 weeks. Hydrustent degraded completely without obstructing fragments in the first 72h. The renal function was normal and no significant differences in safety and efficacy were registered. It demonstrated normal renal function across all study groups and showed no significant differences in safety and efficacy compared to the RocaJJ® Soft stent.
To ensure Hydrustent complies with the standards and certifications needed for commercialization, a dedicated regulatory team has worked in this WP, preparing a design and development file to submit to the Notified Body who will evaluate that the stents can be authorized for use, after all necessary pre-clinical research was done to ensure its safety and effectiveness.
WP4
Clinical trial is one of the main objectives of this project. Its success demonstrates clinical safety in the documentation required for CE-Marking. Our team has prepared a clinical study protocol that outlines the study design and methodology of the clinical trial which was submitted to national authorities and ethical comission for approval.
After submission of clinical study protocol to the national authority INFARMED and national ethical comission (CEIC), we sucessfully passed the first step of the process approval for both entities in october 2024 and, since then, a more deep technical analysis is ongoing in order to get clearance to start the recruitment. 2 hospitals, already signed the final agreement and are ready to start at any time and other hospitals are willing to join the trial if necessary to boost the recruitment process.
Clinical Evaluation Report (CER) comprises the conclusions of a clinical evaluation of a medical device. The CER contains the analyzed clinical data that was collected during the clinical investigation of a device.
WP5
CE certification of a medical device class III as Hydrustent is a rigorous process and requires conformity assessment by a Notified Body as, on the other hand, ANVISA clearance requires a local entity responsible for regulatory compliance. As we prepare for both certifications we signed an agreement with PCBC (polish Notified Body) and ongoing negotiations are in place with a regulatory company in Brasil (Sobel) to be our local representative, with whom we are working for other devices as they can also be our local agent for FDA approval.
During this task our sales team is focused on gathering insights from different territories, understanding each regulatory landscapes, market needs, reimbursement pathways and distribution channels. Along with our regulatory team, we are seeking information to understand how hospitals, insurers and healthcare providers are reimbursed. Targeting our key customers is also crucial, so we are building a close contact with most relevant segments to develop a unique value proposition and meet their clinical needs.
A project manager was assigned to this project to ensure the project is managed effectively and efficiently with a strong focus on achieving project’s goals and providing results that meed the stakeholders expectations.
A project management software was aquired (Atlassian - Jira) to guide the tasks of each WP and each team member can contribute and add relevant content while a project handbook is being prepared.
The quality team has raised a GAP analysis and weekly meetings are scheduled to ensure that the project is completed on schedule, on budget and with the necessary quality standards, while addressing unforeseen issues that may arise and acting immediately to meet the project’s outcomes.
IPR monitoring is also conducted by intellectual property specialists from Patentree, ensuring that the product’s potential benefits are achieved, that its commercial viability is preserved and that it is safeguarded from improper usage or distribution.
WP2
A new ISO 7 cleanroom was created at Hydrumedical new facilities to ensure an effective optimization of the manufacturing process. The cleanroom was validated and is now ready to accomodate the Hydrustent production. All stations involved in the production of Hydrustent were validated, defined the procedures and records to support the manufacturing process for the product testing and clinical validation.
A new injection method is being optimized in order to ensure that the production process is strong, dependable, and scalable without compromising quality or consistency as the demand for the biodegradable ureteral stents increases.
WP3
After stents’ production an in-vivo trial in animal model under GLP certification was conducted at CCMIJU to test the stents' effectiveness and any possible negative effects. The outcomes of these studies were very satisfying. HYDRUSTENT proved to be safe, with good degradation rate and no alteration of the urine pH or renal function. It is non-irritant and causes no modifications in the urothelium at 72h, 4 weeks, or 13 weeks. Hydrustent degraded completely without obstructing fragments in the first 72h. The renal function was normal and no significant differences in safety and efficacy were registered. It demonstrated normal renal function across all study groups and showed no significant differences in safety and efficacy compared to the RocaJJ® Soft stent.
To ensure Hydrustent complies with the standards and certifications needed for commercialization, a dedicated regulatory team has worked in this WP, preparing a design and development file to submit to the Notified Body who will evaluate that the stents can be authorized for use, after all necessary pre-clinical research was done to ensure its safety and effectiveness.
WP4
Clinical trial is one of the main objectives of this project. Its success demonstrates clinical safety in the documentation required for CE-Marking. Our team has prepared a clinical study protocol that outlines the study design and methodology of the clinical trial which was submitted to national authorities and ethical comission for approval.
After submission of clinical study protocol to the national authority INFARMED and national ethical comission (CEIC), we sucessfully passed the first step of the process approval for both entities in october 2024 and, since then, a more deep technical analysis is ongoing in order to get clearance to start the recruitment. 2 hospitals, already signed the final agreement and are ready to start at any time and other hospitals are willing to join the trial if necessary to boost the recruitment process.
Clinical Evaluation Report (CER) comprises the conclusions of a clinical evaluation of a medical device. The CER contains the analyzed clinical data that was collected during the clinical investigation of a device.
WP5
CE certification of a medical device class III as Hydrustent is a rigorous process and requires conformity assessment by a Notified Body as, on the other hand, ANVISA clearance requires a local entity responsible for regulatory compliance. As we prepare for both certifications we signed an agreement with PCBC (polish Notified Body) and ongoing negotiations are in place with a regulatory company in Brasil (Sobel) to be our local representative, with whom we are working for other devices as they can also be our local agent for FDA approval.
During this task our sales team is focused on gathering insights from different territories, understanding each regulatory landscapes, market needs, reimbursement pathways and distribution channels. Along with our regulatory team, we are seeking information to understand how hospitals, insurers and healthcare providers are reimbursed. Targeting our key customers is also crucial, so we are building a close contact with most relevant segments to develop a unique value proposition and meet their clinical needs.
Work is ongoing, no results beyond the state of the art are registered at this time.