Sequana Medical AG (“Sequana Medical”), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, announces today positive findings from its Direct Sodium Removal (“DSR”) therapy proof of concept study in pigs.

Sequana Medical’s proprietary DSR therapy is a novel approach to the management of volume overload in heart failure, a major clinical problem and a significant burden on healthcare systems. The body’s response to heart failure causes sodium levels to increase, which in turn leads to the body retaining more fluid. Sequana Medical’s DSR therapy involves the removal of sodium via diffusion from the peritoneal cavity by administering a sodium-free solution (the infusate) into the abdomen. The infusate and the extracted sodium are then removed, resulting in the elimination of sodium from the body. The body responds by eliminating the associated fluid via osmotic ultrafiltration and/or urination.

The impact of administering a sodium-free infusate to the peritoneal cavity, and the resulting sodium and fluid removal, was evaluated in a preclinical study with 20 pigs, of which five had experimentally induced heart failure. The study demonstrated that DSR therapy is capable of removing large quantities of fluid and sodium whilst having a negligible impact on the sodium concentration in the bloodstream, indicating the potential of this therapeutic approach.

The findings of the study were presented by Principal Investigator Jeffrey Testani, MD MTR, Associate Professor, Yale University at the 22nd Annual Scientific Meeting of HFSA being held from 15-18 September in Nashville, Tennessee. The poster will be made available on the Sequana Medical website, under the news & events section.

Dr. Jeffrey Testani, Associate Professor at Yale University, commented: “Volume overload in heart failure is a major clinical challenge in the significant proportion of patients that no longer respond effectively to diuretic therapy. The concept of sodium and fluid removal via non-renal routes is an interesting approach given the limitations of existing therapies. These results show that by administering a relatively small volume of a sodium-free solution, DSR therapy can remove a clinically relevant amount of sodium and fluid.”

Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “Obtaining proof of concept in this preclinical study is an important step in the further development of DSR therapy and first in human studies are planned for later this year. Through leveraging our proven alfapump® platform, we are developing the alfapump® DSR system to deliver a convenient and fully implanted system for DSR therapy and intend to commence first in human studies with the system in the second half of 2019.”