Sequana Medical NV announced positive results from its Phase 1 single-center, single-arm, single-dose trial (CHIHUAHUA) with its second-generation DSR product (DSR 2.0). This Phase 1 trial was conducted in ten stable peritoneal dialysis patients, who received a single treatment of Sequana Medical's proprietary DSR 2.0 product, administered via their pre-existing peritoneal dialysis catheter, over a 24-hour dwell period. The purpose of the trial was to evaluate the safety and tolerability profile of DSR 2.0, as well as to understand the dosing dynamics of DSR 2.0. DSR 2.0 was generally safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events.

No patient showed a clinically relevant change in serum sodium levels or progressive hyponatremia, a further proof of safety of DSR 2.0. On average, a total of approximately 3L of fluid was removed per patient including 9g of sodium following a single treatment with 0.5L DSR 2.0 and a 24-hour dwell period.