10 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the results of the pre-clinical and first-in-human single dose DSR proof-of-concept studies for volume overload due to heart failure have been published in the prestigious peer-reviewed journal Circulation.

The studies, conducted by Dr. Jeffrey Testani of Yale University, demonstrated that single dose DSR therapy was safe and well-tolerated and resulted in a clinically relevant removal of sodium.

Volume overload is the driver of more than 90% of the one million heart failure hospitalisations in the U.S. each year (which in total account for $13 billion in costs). Re-hospitalisation is common and approximately 24% of these patients are re-admitted within 30 days of discharge. Sequana Medical’s innovative DSR therapy removes sodium from the body, which in turn eliminates the associated fluid to restore sodium concentration, resulting in sustained fluid removal.

“Volume overload is the primary driver of morbidity and hospitalisation in patients with heart failure and loop diuretics, the mainstay of therapy, have well recognised toxicities and loss of response is common. DSR represents a new potential therapy for non-renal sodium and fluid removal in oedematous disorders such as heart failure,” commented Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the Circulation publication. “Studies of single dose DSR therapy in pigs and humans demonstrated that substantial sodium removal via the peritoneal membrane was feasible, without significant discomfort and with minimal off-target solute removal. DSR represents a new and exciting potential chronic therapy for treatment of volume overload in heart failure patients and clearly warrants additional study.”

“The publication of these positive data in Circulation, one of the leading specialist cardiovascular journals, is further validation of the potential of our proprietary DSR therapy,” added Ian Crosbie, CEO of Sequana Medical. “Volume overload in heart failure is a huge clinical challenge, placing a tremendous burden on patients as well as on the healthcare system. We are driving forward the clinical development of alfapump® DSR, by combining our DSR therapy with the proven alfapump platform, to deliver a potential chronic therapy for heart failure patients who are not well controlled on diuretics. RED DESERT, our first-in-human repeated dose alfapump DSR study began in H2 2019 and we look forward to reporting results from this study during Q2 and Q3 2020.”