Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — EuroPCR 2019
12 slides from Sequana Medical's conference presentation, May 17, 2019
Slide 1: Volume Management Through Direct Sodium Removal (DSR)
Volume Management Through Direct Sodium Removal (DSR) Ian Crosbie, CEO Sequana Medical NV
Slide 2: Potential Conflicts of Interest
Potential Conflicts of Interest Speaker's name : Ian Crosbie ☑ I have the following potential conflicts of interest to declare: CEO : Sequana Medical Stock shareholder: Sequana Medical
Slide 3: Fluid Overload in Heart Failure
Fluid Overload in Heart Failure • Key clinical consequence of heart failure(1) • One million HF hospitalisations / year in US(1) • 90% for fluid overload(1) • ¾ admitted to emergency room • Average length of stay 5 – 6 days(2) • 24% readmitted within 30 days and 50% within 6 months(3) • $13 Billion
Slide 4: Heart Failure: Can we do better than diuretics?
Heart Failure: Can we do better than diuretics? • Loop diuretics are standard therapy for prevention and treatment • Resistance is very common(1) • Directly cause neuro-hormonal activation, worsen renal function, and are associated with adverse outcomes(2) • Long list of failed cardio-renal therapeu
Slide 5: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Remove Administer Infusate extracted Body restores sodium–free extracts sodium from balance by infusate to sodium from peritoneal eliminating peritoneal the body cavity excess fluid cavity • With a zero sodium solution, we should be able to get much more sodium removal wi
Slide 6: DSR – Pig proof of concept study
DSR – Pig proof of concept study • Sodium-Free Infusate: 1 liter of 10% dextrose in water (“D10”) • Dwell period: 2 hours • 15 anesthetized 80kg pigs with peritoneal dialysis catheters implanted • 10 healthy pigs • 5 heart failure pigs • Experimental acute warm / wet heart failure; created by cardia
Slide 7: DSR – Pig proof of concept study
DSR – Pig proof of concept study 2 Hour Dwell 2 Hour Dwell peritoneal fluid Volume of Ultrafiltration Amount of Sodium Removed 8000 20 p < 0.0001 p < 0.0001 6000 15 Volume (mL) Sodium (g) 4000 10 2000 5 0 0 Normal HF Normal HF N = 10 N=5 N = 10 N=5 Plus no significant serum electrolyte impact Presen
Slide 8: DSR - first in human proof of concept
DSR - first in human proof of concept • Conducted by Dr. Jeff Testani, Yale University • Up to 20 patients receiving PD • Randomization to DSR Solution or standard PD solution, with crossover 1 week later • DSR Solution: Sodium-free 10% dextrose • Standard PD Solution: 4.25% dextrose standard PD sol
Slide 9: alfapump DSR: Fully implantable system
alfapump DSR: Fully implantable system • Due to low volumes and long ultrafiltration time, fully implantable system possible • Fluid instilled through sub-q port • Removed from peritoneum by pump into bladder
Slide 10: Leverage proven alfapump technology
Leverage proven alfapump technology • Fully implanted, automatic, wirelessly charged, programmable smart alfapump • Approved in EU for refractory ascites • Over 700 patient implants and over 400 hundred of patient-years of experience • Pump can also: • Remove spontaneously generated peritoneal fluid
Slide 11: DSR – A New Therapy for Volume Overload?
DSR – A New Therapy for Volume Overload? • Healthy & HF pig studies demonstrate DSR efficacy & safety • First-in-man single dose DSR study will report shortly • First-in-main repeated dose DSR study with implanted alfapump planned for next 12 months • alfapump DSR may provide a: • Convenient • Techn
Slide 12: PCR By and For you PCRonline.com
PCR| By and For you PCRonline.com | wW EAPCI