Periodic Reporting for period 1 - IPUD (IPUD – An Implantable Peritoneal Ultrafiltration Device that actively and continuously prevents fluid overload in diuretic resistant heart failure patients.)
Reporting period: 2018-08-01 to 2018-11-30
Paragate is an Israeli company founded in 2016 with the mission to revolutionise congestive heart failure management by introducing the first implantable medical device that actively and continuously prevents fluid overload. Paragate offers a unique implantable peritoneal ultrafiltration device (IPUD), to improve clinical condition of diuretic resistant patients with fluid overload by continuously (24/7) removing extracellular fluids, operating non-aggressively and independently of the kidneys’ function. The controlled, moderate non-aggressive fluid removal eliminates the main complications associated with the acute and aggressive treatments that lead to hemodynamic shock, worsening of renal function, arrhythmia and metabolic instability.
The team is now working towards the optimisation of the implantable unit and the upgrade of the treatment management platform. The key objectives of the development are to miniaturize the implantable unit; to update the firmware and the online treatment management platform for wireless communication of the fluid removal unit and the physicians’ interface; to transfer production line to established CMOs; to perform the FIH study through a multicentre study and to prepare a large clinical trial with over 40 patients to apply for the CE mark and certification of the system as a medical device
The team is now working towards the optimisation of the implantable unit and the upgrade of the treatment management platform. The key objectives of the development are to miniaturize the implantable unit; to update the firmware and the online treatment management platform for wireless communication of the fluid removal unit and the physicians’ interface; to transfer production line to established CMOs; to perform the FIH study through a multicentre study and to prepare a large clinical trial with over 40 patients to apply for the CE mark and certification of the system as a medical device
Throughout the duration of the project, Paragate defined the users’ requirements for implantable unit, defined the backend and frontend software specifications and reviewed the system’s development plan, and scouted for hospitals and Contract Manufacturers (CMOs) to support in the validation and production stages. The market segments and opportunities have also been evaluated, defining the TAM and SAM. Paragate established a commercialisation strategy. The Phase 1 feasibility assessment has established that a development plan for the IPUD is technically and commercially viable, and that implementation of a commercialisation plan should be pursued. SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully.
Around 8 million people are affected by advanced CHF worldwide, and more than 1 million hospitalizations occur each year with fluid overload as predominant case. Each hospitalization for fluid removal costs €12k per patient, resulting in €60B annual cost in EU. Therefore, there is a critical need for more effective treatment that eliminate the frequent (12 times per year) and costly acute hospitalizations in the effected patients. Currently heart failure is the greatest burden on healthcare systems as it consumes around 2% of annual national budgets. The burden is expected to grow in the coming years due to aging of European population (more than 25% of current EU population) and risk factors such as tobacco, obesity and alcohol abuse. On the other hand, technological advancements have significantly reduced mortality rates due to fatal heart attacks or other structural and cardiovascular diseases. As consequence, there are more chronically ill heart failure patients requiring continuous attention. Currently, no available implantable device can continuously drain the accumulated fluids in excess and certainly cannot provide implantable ultrafiltration properties for patients with fluid congestion. In this context, IPUD is the first solution providing continuous monitoring and removal of extracellular fluids, hence reducing the hospitalizations and follow-up visits by 50%. It will also completely eliminate the need for aggressive and temporary intravenous diuretic therapy, and more importantly it will enable effective treatment for diuretic resistant population. The continuous fluid monitoring and removal will significantly improve quality of life of patients by preventing acute overload episodes, kidney failure and reducing the 50% death risk 5 years after the CHF diagnosis