Periodic Reporting for period 2 - PRESSURO (A life-changing PREssure Sensor System for UROdynamics to solve global urinary storage and voiding problems)
Okres sprawozdawczy: 2023-09-01 do 2024-10-31
Urinary dysfunction affects around 900 million people globally with an estimated cost of 1.4 trillion euros. This problem grows with the aging population and increasing incidents of diabetes and obesity. 80% of patients can be cured or treated with the correct diagnosis.
Urologists have reported an urgent need for better solutions in this field. Deciding upon the right treatment - medication, assistive devices, rehabilitation, and/or surgery, can be challenging. Untreated, life-threatening situations caused by high pressures may occur. Problems associated with shame, social isolation, depression, and withdrawal from workforce can also arise from urinary dysfunction.
Bladder pressure measurement constitutes the most important part of the current standard for evaluating bladder function. The current method is a mere snapshot based on the artificial filling of the bladder and results only provide limited understanding of the patient's true bladder function. For bladder obstructions as well as urinary incontinence, physicians want the ability to continuously measure to monitor bladder pressure under normal physiological conditions and during normal daily routines.
InVivo Bionics is in the forefront of the field of micro and nanotechnology solutions for direct monitoring of organ pressure. PRESSURO is a solution for long-term monitoring of bladder pressure. This innovation improves physicians’ ability to set the right diagnosis and to decide upon the best treatment.
Urologists have reported an urgent need for better solutions in this field. Deciding upon the right treatment - medication, assistive devices, rehabilitation, and/or surgery, can be challenging. Untreated, life-threatening situations caused by high pressures may occur. Problems associated with shame, social isolation, depression, and withdrawal from workforce can also arise from urinary dysfunction.
Bladder pressure measurement constitutes the most important part of the current standard for evaluating bladder function. The current method is a mere snapshot based on the artificial filling of the bladder and results only provide limited understanding of the patient's true bladder function. For bladder obstructions as well as urinary incontinence, physicians want the ability to continuously measure to monitor bladder pressure under normal physiological conditions and during normal daily routines.
InVivo Bionics is in the forefront of the field of micro and nanotechnology solutions for direct monitoring of organ pressure. PRESSURO is a solution for long-term monitoring of bladder pressure. This innovation improves physicians’ ability to set the right diagnosis and to decide upon the best treatment.
Over the PRESSURO project, significant strides were made in the technical and scientific domains, culminating in the successful development and validation of a market-ready medical device system. These achievements represent a cohesive effort to meet regulatory requirements, refine technological capabilities, and ensure scalability for clinical and commercial success.
The development and design freeze of the hardware and software solutions were key milestones. The PRESSURO Sensor Probe and Sensor Data Logger were meticulously engineered, encompassing all components required for functionality, safety, and regulatory compliance. Each unit underwent rigorous performance, safety, and EMC trials, both as standalone products and as integrated components, ensuring seamless operation within the complete PRESSURO system.
Concurrently, the software solution was finalized with robust data pipelines enabling automated data exchange, storage, and processing through its services. Security features, including identity access management and disaster recovery strategies, were implemented to safeguard clinical data. APIs were developed to ensure ease of interpretation for clinicians, while PRESSURO-UX, a real-time monitoring tool, is on track for release in 2025.
The verification and validation process was pivotal in ensuring PRESSURO’s compliance with safety, efficacy, and quality standards. Biocompatibility testing for the PRESSURO Sensor Probes was rigorously conducted in accordance with standards, FDA and MDR regulations. Preliminary evaluations were supported by external experts, with final chemical characterization and toxicity reports been prepared by independent third-party laboratories. Electrical safety and electromagnetic compatibility (EMC) were successfully verified in compliance with world-wide standards, confirming PRESSURO’s readiness for both clinical and home-use environments. Sterilization protocols were validated ensuring safety and reliability for patients and doctors alike.
Design transfer and preparation for production marked another major accomplishment. A risk-based approach guided the selection of suppliers and subcontractors, with quality agreements established for critical components. Production processes were validated through prototype manufacturing for clinical and verification trials. In-house assembly lines were documented and validated, enabling efficient production scaling. The manufacturing capacity was demonstrated with the assembly of numerous PRESSURO kits.
These technical and scientific advancements were complemented by extensive clinical validation activities, including trials conducted at hospitals in Norway and Germany. Together, the project’s achievements have not only realized the technical and scientific objectives but also established a strong foundation for market entry and long-term success.
The development and design freeze of the hardware and software solutions were key milestones. The PRESSURO Sensor Probe and Sensor Data Logger were meticulously engineered, encompassing all components required for functionality, safety, and regulatory compliance. Each unit underwent rigorous performance, safety, and EMC trials, both as standalone products and as integrated components, ensuring seamless operation within the complete PRESSURO system.
Concurrently, the software solution was finalized with robust data pipelines enabling automated data exchange, storage, and processing through its services. Security features, including identity access management and disaster recovery strategies, were implemented to safeguard clinical data. APIs were developed to ensure ease of interpretation for clinicians, while PRESSURO-UX, a real-time monitoring tool, is on track for release in 2025.
The verification and validation process was pivotal in ensuring PRESSURO’s compliance with safety, efficacy, and quality standards. Biocompatibility testing for the PRESSURO Sensor Probes was rigorously conducted in accordance with standards, FDA and MDR regulations. Preliminary evaluations were supported by external experts, with final chemical characterization and toxicity reports been prepared by independent third-party laboratories. Electrical safety and electromagnetic compatibility (EMC) were successfully verified in compliance with world-wide standards, confirming PRESSURO’s readiness for both clinical and home-use environments. Sterilization protocols were validated ensuring safety and reliability for patients and doctors alike.
Design transfer and preparation for production marked another major accomplishment. A risk-based approach guided the selection of suppliers and subcontractors, with quality agreements established for critical components. Production processes were validated through prototype manufacturing for clinical and verification trials. In-house assembly lines were documented and validated, enabling efficient production scaling. The manufacturing capacity was demonstrated with the assembly of numerous PRESSURO kits.
These technical and scientific advancements were complemented by extensive clinical validation activities, including trials conducted at hospitals in Norway and Germany. Together, the project’s achievements have not only realized the technical and scientific objectives but also established a strong foundation for market entry and long-term success.
The results of the PRESSURO project represent a significant milestone in advancing innovative urological solutions, with impactful outcomes extending beyond the technical and clinical domains.
Over the course of the project, InVivo Bionics has successfully developed a robust market entry strategy, leveraging extensive engagement with healthcare professionals, industry leaders, and key opinion leaders (KOLs). Strategic participation in events like ICS, MEDICA, and the NOME has not only solidified the company’s presence in the medical technology community but also provided essential feedback to refine the PRESSURO system and its positioning. These efforts have been complemented by a dynamic online presence through the company’s website and LinkedIn, ensuring stakeholders remain informed about ongoing progress. Furthermore, efforts to increase market awareness have also included the evolution of the company’s brand identity.
The granting of 11 patents across key global markets underscore the project’s emphasis on protecting intellectual property and establishing credibility.
To ensure the successful uptake of PRESSURO, additional steps are essential. Expanding market readiness efforts beyond the Nordic region to larger EU markets will require sustained collaboration with distribution partners and further alignment with regulatory requirements. Building trust within the medical community through ongoing dialogue with clinicians and KOLs remains pivotal. Continued evolution of advertising content, dissemination strategies, and trial result publications will further strengthen market positioning.
Over the course of the project, InVivo Bionics has successfully developed a robust market entry strategy, leveraging extensive engagement with healthcare professionals, industry leaders, and key opinion leaders (KOLs). Strategic participation in events like ICS, MEDICA, and the NOME has not only solidified the company’s presence in the medical technology community but also provided essential feedback to refine the PRESSURO system and its positioning. These efforts have been complemented by a dynamic online presence through the company’s website and LinkedIn, ensuring stakeholders remain informed about ongoing progress. Furthermore, efforts to increase market awareness have also included the evolution of the company’s brand identity.
The granting of 11 patents across key global markets underscore the project’s emphasis on protecting intellectual property and establishing credibility.
To ensure the successful uptake of PRESSURO, additional steps are essential. Expanding market readiness efforts beyond the Nordic region to larger EU markets will require sustained collaboration with distribution partners and further alignment with regulatory requirements. Building trust within the medical community through ongoing dialogue with clinicians and KOLs remains pivotal. Continued evolution of advertising content, dissemination strategies, and trial result publications will further strengthen market positioning.