Strong data from Sequana Medical's DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction. Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome. In the RED DESERT and SAHARA studies, patients’ loop diuretics were completely replaced by DSR therapy for several weeks, resulting in an improvement in a multitude of metrics of cardiorenal health and a dramatic and durable improvement in their diuretic responsiveness and chronic loop diuretic requirements. This data is truly revolutionary, representing really the first and only novel therapeutic approach to treat diuretic resistance and cardiorenal syndrome in heart failure.”

Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “We are delighted with Dr. Testani’s publication highlighting DSR as a potential treatment for cardio-renal syndrome, highlighting the need to break the vicious cycle of loop diuretic therapy. Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics. We believe DSR’s ability to virtually eliminate the need for loop diuretics for many months post-treatment represents a breakthrough in treatment options, and address one of the leading drivers of healthcare costs.”

In total, 18 patients with heart failure on high dose oral loop diuretics were enrolled in the RED DESERT and SAHARA clinical studies and received DSR therapy for up to four and six weeks respectively, whilst their loop diuretics were withheld. Data from these studies indicated that DSR could i) safely, effectively and rapidly eliminate fluid overload and restore euvolemia without the need of any loop diuretics; ii) deliver a considerable benefit in patients’ cardiorenal health; and iii) deliver a dramatic and sustained improvement in diuretic responsiveness, thereby dramatically reducing the need for oral loop diuretics for many months post-therapy. In both RED DESERT and SAHARA studies, there were no congestion-related hospital readmissions, all patients improved their NYHA status by at least one class, and the clinical benefits observed in the clinical studies resulted in a 75% reduction in predicted one-year mortality of patients pre- vs. post-intensive DSR therapy based on the Seattle Heart Failure Model.