Sequana Medical NV announced announces that it has implanted the 1,000 alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis and malignant ascites The Company also reports that it has received all administrative clearances to start the US MOJAVE study of DSR 2.0 in congestive heart failure patients and expects to enroll the first patient imminently. Sequana Medical’s alfapump is a fully implantable, wirelessly charged device that continuously collects ascites as it forms in the abdominal cavity and moves it into the bladder, where it is naturally passed from the body through urination. Since the first alfapump was implanted at the end of 2008, there has been a steady increase in the number of patients benefiting from the improved quality of life that the alfapump brings.

During that time, more than 100,000 liters of ascites have been removed safely with the alfapump. Strong clinical alfapump profile demonstrated in pivotal POSEIDON study Highlights from the Company’s POSEIDON study, which met all primary endpoints, were recently presented at the EASL Liver meeting in Viennaii: alfapump was effective in the control of ascites, virtually eliminating the need for large volume paracentesis. Safety was in line with expectations, particularly given disease progression in these patients.

Six pumps were explanted: three due to skin erosion and three due to moderate bladder discomfort Similar number of Major Adverse Events and comparable number of serious infections in pre-and post-implant period. Stable kidney function over long-term follow-up. Clinically meaningful and statistically significant improvement in patients’ quality of life at six months post-implantation.

One-year survival probability of 70%, comparing favorably to literature citing a survival rate of 50% at one year in this patient population.