Summary: Paragate Medical develops the first ever fully implantable device to actively and continuously prevent fluid overload in diuretic resistant chronic heart failure patients. Pathologic fluid overload is a major problem and cause of clinical distress in growing epidemics of heart failure (HF) and chronic kidney disease (CKD).  Current solutions are limited to acute aggressive in-clinic treatments that don’t prevent recurrence and associated with huge economic burden. There is a significant need for chronic setting solution for volume overload. Paragate’s solution acts as a mechanical bypass to the kidneys. The system is based on a minimally invasive (laparoscopic approach) flat absorption device that interfaces intraperitoneal membranes. By applying hydrostatic pressure gradient, systemic extracellular fluid is drawn and slowly drained to the urinary system, thus preventing recurred accumulation. Key Features: •Systemic fluids, not limited to ascites• Continuously excretes isotonic fluid, unlike diuretics •No circulation interface •Externally configurable •Monitoring abilities •Low infection risk ; Medical Significance: •QoL improvement and symptoms reduction •Burden: reduced hospitalization rate and delayed dialyses •Less complexities of excess diuretics and BP fluctuations  •Improving total renal function •Reduced patient mgmt. workload

Need: Pathologic fluid overload is a major symptom and cause of clinical distress in growing epidemics of heart failure (HF) and chronic kidney disease (CKD) that suffer from diuretic resistance. It is associated with shortness of breath, peripheral edema and the need for frequent hospitalization for acute intravenous excess diuretics and dialysis. The available acute treatments carry complications, burden and huge costs – but most importantly – don’t prevent recurrence of congestion. There is a significant need for a chronic setting, out-of-hospital device that can actively prevent fluid retention and keep patients balanced, thus reducing the burden from both patient and healthcare system.

Value: Paragate offers the first of its kind, a truly out-of-hospital, continuous active solution to prevent chronic fluid overload, keeping the heart and kidney failure patients balanced at home. •For the Patient: improved quality of life, reduced symptoms and heart failure exacerbation, delayed need for dialysis •For the Physician: a solution for diuretic resistant cases, reduced patient management burden •For the Hospital: reduced rehospitalization rate and associated incurred penalties  •For the Insurer: significant economic saving