Periodic Reporting for period 2 - FILBERT (An innovative implantable device and management platform to prevent chronic fluid congestion)
Berichtszeitraum: 2024-08-01 bis 2025-07-31
Rughly 60M people worldwide suffer from chronic congestive heart failure. The condition manifests in systemic congestion, i.e. excess fluids that accumulate in patient’s tissue, veins and arteries. Most of the excess fluid accumulates in the tissue, including the chest and lungs (pleural edema) and limbs (peripheral edema). The former causes severe breathing difficulty and loss of patient functioning and quality of life. The standard of care is pharmaceutical, primarily a class of medications called diuretics. While effective, diuretics cause loss of kidney function and ultimately drive the disease progression. Roughly 30% of patients develop resistance to diuretics, and must seek repeat hospitalizations. Once this condition sets in, median life expectancy drops to 18 months.
There are more than 2M congestion-driven hospitalizations annually for chronic heart failure patients. At least half of patients remain congested at discharge. Roughly 25% are readmitted within 30 days, and a further 50% are admitted more than twice in six months. This condition alone is the largest healthcare cost generator in Europe and the US. Furthermore, hospitals in the US lose money on each hospitalization of patients in this category.
Health systems globally seek a solution to care for these patients on an outpatient bases, prevent re-admissions and improve care.
Paragate’s IPUD Implantable Peritoneal Ultrafiltration Device is designed to:
- Continuously remove excess fluids at a low rate from patients’ tissue and clear them to the bladder for normal urination.
- Remove isotonic fluid, i.e. remove excess sodium from patients’ body. CHF patients lose the ability to clear sodium, and it is this factor that most adversely affects the disease’s progression.
- Enable personalized outpatient therapy via remote adjustment of the implant’s operation b the physician, as required and based on monitoring data provided by the IPUD.
- Improve patients’ symptoms and quality of life.
- Greatly reduce repeat hospitalizations due to fluid overload in CHF patients, thus saving billions of dollars/euro in unnecessary healthcare costs.
There are more than 2M congestion-driven hospitalizations annually for chronic heart failure patients. At least half of patients remain congested at discharge. Roughly 25% are readmitted within 30 days, and a further 50% are admitted more than twice in six months. This condition alone is the largest healthcare cost generator in Europe and the US. Furthermore, hospitals in the US lose money on each hospitalization of patients in this category.
Health systems globally seek a solution to care for these patients on an outpatient bases, prevent re-admissions and improve care.
Paragate’s IPUD Implantable Peritoneal Ultrafiltration Device is designed to:
- Continuously remove excess fluids at a low rate from patients’ tissue and clear them to the bladder for normal urination.
- Remove isotonic fluid, i.e. remove excess sodium from patients’ body. CHF patients lose the ability to clear sodium, and it is this factor that most adversely affects the disease’s progression.
- Enable personalized outpatient therapy via remote adjustment of the implant’s operation b the physician, as required and based on monitoring data provided by the IPUD.
- Improve patients’ symptoms and quality of life.
- Greatly reduce repeat hospitalizations due to fluid overload in CHF patients, thus saving billions of dollars/euro in unnecessary healthcare costs.
In the course of the project implementation, we performed the following activities:
Under WP2, the Company carried out targeted dissemination activities addressing key communities: clinical, industry and investor ones. Communication and dissemination to these and other communities centered around participation in key events such as D-HF, PCR Innovator Day, ICI, HFSA ASM and LSI conferences. Additionally, SAB members are active in presenting FILBERT in relevant events.
These were supported by selective content creation and social media efforts.
Under WP3, Paragate:
- Designed and developed a membrane-encased absorption chamber using voluntarily obtained biological fluids from human patients (adhering to all relevant regulations), so as to absorb fluids and salt from patient's tissue, but not proteins.
- Validated the design of the aforementioned chamber in-vitro and in-vivo
- Put a well documented and validated standards-compliant manufacturing process in place.
- Defined the Gen2 device high-level design and delivery mechanisms and implantation procedures
- Delivered functional specs of the fully implantable pump unit, its design specification and performance, the hydraulic head design description and durability performance testing. Gen-2 pump design is now ready to proceed to the next testing phase for subsequent design freeze.
- Defined a percutaneous bladder catheter and implantation procedure, which are now ready for in-vivo V&V and subsequent clinical trial.
- Produced the Gen 1.5 system to support an 8-patient clinical trial
Under WP4, the company:
- Validated the Gen1.5 IPUD and its implantation procedure in-viitro and in-vivo.
- Implemented successful simulation and pre-clinical testing.
- Confirmed that the device meets its design specifications and is safe and effective for its intended use before clinical deployment, thanks to the engineering V&V tests.
- Launched the CLEAR-HF clinical trial as a pilot study with the Gen1.5 FILBERT system
- Obtained all the necessary ethics and regulatory approvals for the incoming trials
- Activated 4 trial sites in Europe
Under WP2, the Company carried out targeted dissemination activities addressing key communities: clinical, industry and investor ones. Communication and dissemination to these and other communities centered around participation in key events such as D-HF, PCR Innovator Day, ICI, HFSA ASM and LSI conferences. Additionally, SAB members are active in presenting FILBERT in relevant events.
These were supported by selective content creation and social media efforts.
Under WP3, Paragate:
- Designed and developed a membrane-encased absorption chamber using voluntarily obtained biological fluids from human patients (adhering to all relevant regulations), so as to absorb fluids and salt from patient's tissue, but not proteins.
- Validated the design of the aforementioned chamber in-vitro and in-vivo
- Put a well documented and validated standards-compliant manufacturing process in place.
- Defined the Gen2 device high-level design and delivery mechanisms and implantation procedures
- Delivered functional specs of the fully implantable pump unit, its design specification and performance, the hydraulic head design description and durability performance testing. Gen-2 pump design is now ready to proceed to the next testing phase for subsequent design freeze.
- Defined a percutaneous bladder catheter and implantation procedure, which are now ready for in-vivo V&V and subsequent clinical trial.
- Produced the Gen 1.5 system to support an 8-patient clinical trial
Under WP4, the company:
- Validated the Gen1.5 IPUD and its implantation procedure in-viitro and in-vivo.
- Implemented successful simulation and pre-clinical testing.
- Confirmed that the device meets its design specifications and is safe and effective for its intended use before clinical deployment, thanks to the engineering V&V tests.
- Launched the CLEAR-HF clinical trial as a pilot study with the Gen1.5 FILBERT system
- Obtained all the necessary ethics and regulatory approvals for the incoming trials
- Activated 4 trial sites in Europe
Growing chronic diseases and the spiraling costs of treating them in hospital, create an urgent need for technology that enables remotely-managed treatment, and not just monitoring. There is currently no technological solution available to treat recurring congestion on an outpatient basis. Emerging remote monitoring products cannot solve this need as they only provide physicians with information, not therapy options. FILBERT system can make the giant leap in remote care by introducing an active system, with remote therapeutic capabilities that goes way beyond the monitoring.
In the long run, FILBERT has the potential to become the future gold standard device for fluid overload management. In the short term, FILBERT has the potential to improve the quality of life of millions of CHF patients dealing with fluid congestion every day, while dramatically reduciing the cost of caring for these patients, by eliminating avoidable rehospitalizations.
This will have an enormous impact on the current market dynamics, dominated by a few key players with established brands, of which none is offering a commercial product directly targeting volume reduction. FILBERT has the unique opportunity to strengthen Europe's sovereignty within the CHF industry, as Paragate may become the leading global provider of outpatient fluid-overload prevention therapy in any clinical application where this is required.
In the long run, FILBERT has the potential to become the future gold standard device for fluid overload management. In the short term, FILBERT has the potential to improve the quality of life of millions of CHF patients dealing with fluid congestion every day, while dramatically reduciing the cost of caring for these patients, by eliminating avoidable rehospitalizations.
This will have an enormous impact on the current market dynamics, dominated by a few key players with established brands, of which none is offering a commercial product directly targeting volume reduction. FILBERT has the unique opportunity to strengthen Europe's sovereignty within the CHF industry, as Paragate may become the leading global provider of outpatient fluid-overload prevention therapy in any clinical application where this is required.