Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its financial results for the year ended 31 December 2022, and provides a business update and outlook for 2023.

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “2022 was a landmark year for Sequana Medical achieving excellent results in both our alfapump liver and DSR heart failure programs. All primary endpoints were met in POSEIDON, our pivotal North American alfapump study, allowing us to prepare for PMA filing and US commercial launch planned for 2024. We believe that there is a clear need for improved treatment options for the large and growing number of patients suffering from recurrent or refractory ascites due to liver cirrhosis. The North American market is forecast to grow between 6-7% annually reaching over 170,000 patients in 2035, representing a total addressable market for the alfapump of over US $2.5bn[2].”

“Our DSR therapy demonstrated substantial long-lasting clinical benefits in decompensated heart failure patients. Top-line data from our SAHARA study showed the safe, effective and rapid elimination of persistent congestion, important improvements in cardiovascular and renal health, and the restoration of diuretic response of the kidney. We are very excited by the great potential of DSR as a disease-modifying therapy that could help the estimated 200,000 US heart failure patients suffering from diuretic-resistant congestion. We have moved swiftly with our second-generation DSR product, successfully completing GLP pre-clinical safety studies, dosing the first patients in our Phase 1 single-dose studies and we are looking forward to starting MOJAVE, our US Phase 1/2a randomized controlled multi-center study in patients with congestive heart failure in Q2 2023.”

“As we prepare for commercialization of the alfapump in North America, we have continued to strengthen our Board with the addition of Doug Kohrs and Alexandra Clyde, two seasoned US medtech executives who bring with them invaluable knowledge and expertise in light of the next stage of Sequana Medical’s development.”

“We are also pleased to welcome Rosetta Capital, an experienced long-term life sciences investor, as shareholders following the purchase of the shares held by Neomed V.”

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