IPUD SIGNED

Project "IPUD" data sheet

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 Partnership

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 Project objective

Pathologic fluid overload (congestion) is a medical condition when high volume of fluid (water) accumulates in the body leading to congestive heart failure (CHF). CHF is a severe global health problem affecting each year ~26 million people worldwide, of which 8 million are chronic and diuretic resistant patients. Current solutions for fluid overload in diuretic resistant patients such as infusion pump for intravenous (IV) diuresis, catheter-based device for ultrafiltration therapy and peritoneal dialysis all carry complications and are acute treatments which do not prevent recurrence. Paragate developed IPUD a unique implantable peritoneal ultrafiltration system for continuous monitoring and removal of extracellular fluids in CHF patients. It is minimally invasive (laparoscopic approach) and continuously (24/7) and slowly absorbs systemic isotonic extracellular fluid and drains it to the urinary system preventing recurred accumulation. In addition, IPUD guarantees a continuous monitoring of the fluid as well as the urinary system function thanks to a sensing system (embedded into the implantable system) and a treatment management platform. In this way, physicians have a direct control of the treatment and patient’s condition. 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. Thanks to IPUD, patients will improve their quality of life eliminating frequent hospitalizations with a more effective treatment and healthcare systems will significantly reduce the €100 billion/year cost for frequent hospitalizations and treatment costs. The Phase 2 project will enable Paragate to scale-up production, perform validation and verification activities including a preclinical study; and validate the safety and efficacy of IPUD in a pilot clinical trial.