Based in Belgium, Sequana Medical develops products to treat diuretic-resistant fluid overload, a frequent complication of liver disease and heart failure (HF). Its proprietary alfapump and Direct Sodium Removal (DSR) approaches aim to provide significant clinical and quality-of-life benefits.

Given positive efficacy data in Q422 from its POSEIDON North American registration study for the alfapump in recurrent and refractory ascites, we expect Sequana to submit a US Premarket Approval application in H223, with US approval anticipated in 2024. Following encouraging data including sustained improvements in diuretic response from its Phase IIa SAHARA DSR study in HF patients with persistent congestion, and recent FDA IND clearance, the company plans to start the MOJAVE US Phase I/IIa study in Q223 using its second-generation product (DSR 2.0) in a similar patient population. Data from MOJAVE’s non-randomized cohort is anticipated by the end of 2023, which could provide an early signal of treatment effect.