Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development:

  • Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end
  • Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in validated clinical measures
  • Heart failure disease-modifying profile – safe, rapid and effective decongestion with no congestion-related heart failure re-hospitalizations observed
  • Clinical outcomes from RED DESERT and SAHARA result in a 75% reduction in predicted one-year mortality based on Seattle Heart Failure model[iii]
  • Heart failure development program to focus on Short Term DSR with DSR 2.0 alfapump® in North America:
  • Submission of Premarket Approval (PMA) to the US FDA expected in H2 2023

Webcast and conference call for investors/analysts today at 3:00 pm CEST / 9:00 am ET

Ghent, Belgium – 19 July 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, today announces the completion of enrollment in its Phase 2a SAHARA proof-of-concept study using its first-generation DSR product (“DSR 1.0”) as treatment for congestive heart failure. Sequana Medical intends to extend SAHARA to treat  a small number of patients with its proprietary second-generation DSR product (“DSR 2.0”) to support the US IND filing, expected by year end.

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