Sequana Medical Announces 2023 Results and Advances alfapump and DSR Programs
核心洞察
Sequana Medical (搜索)'s alfapump (搜索) PMA application is under substantive review by the FDA, with extensive feedback being assessed for US market approval.
DSR (搜索) therapy shows promise for cardiorenal syndrome (搜索), demonstrating significant diuretic response and reduced diuretic requirements in heart failure (搜索) patients.
The company is preparing for the MOJAVE (搜索) study's randomized phase, focusing on diuretic-resistant heart failure (搜索) patients, with interim data expected in H2 2025.
Sequana Medical (搜索) NV (Euronext Brussels: SEQUA), a company focused on treating fluid overload in liver disease (搜索), heart failure (搜索), and cancer (搜索), has announced its financial results for the year ended December 31, 2023, alongside updates on its key programs, alfapump (搜索) and DSR (搜索) (Direct Sodium Removal) therapy.
alfapump Program Advances
The company's Pre-Market Approval (PMA) application for the alfapump (搜索), a device designed to manage recurrent or refractory ascites (搜索) due to liver cirrhosis, is currently under substantive review by the US FDA. Sequana Medical (搜索) recently received extensive feedback from the FDA and is working with external advisors to address the queries. A day-100 meeting is scheduled with the FDA on April 9, 2024, to discuss the application. The company believes that US commercialization is de-risked given its focus on liver transplant centers that address the large majority of target patients. The American Medical Association granted six new CPT category III reimbursement codes in January 2024, available for use by healthcare professionals and payors as of July 1st, 2024, for procedures related to the alfa pump system.
Data from the pivotal POSEIDON (搜索) study continues to support the alfapump (搜索)'s clinical profile, demonstrating virtual elimination of needle paracentesis, a robust safety profile, and clinically meaningful improvements in patients' quality of life. One-year follow-up data showed a survival probability of 70% at 12 and 18 months post-implant.
DSR Therapy Shows Promise in Heart Failure
Sequana Medical (搜索) is also advancing its DSR (搜索) therapy program for cardiorenal syndrome (搜索) in heart failure (搜索). Data from the RED DESERT and SAHARA clinical studies indicate that DSR can completely replace loop diuretics (搜索) during therapy and deliver a dramatic and durable improvement in diuretic responsiveness and reduction in chronic loop diuretic requirements.
The company plans to initiate the randomized phase of the US MOJAVE (搜索) study after alfapump (搜索) PMA approval. This phase will include up to 30 additional diuretic-resistant heart failure (搜索) patients, with interim data expected in the second half of 2025. Three-month follow-up data from all three patients in the MOJAVE non-randomized cohort confirmed dramatic improvement in diuretic response and virtual elimination of loop diuretics (搜索) following DSR (搜索) therapy.
Financial Highlights and Outlook
Sequana Medical (搜索) reported a revenue of €0.71 million for 2023, a decrease from €0.92 million in 2022, due to the decision to scale back European commercial activities. Operating expenses remained broadly unchanged at €30.04 million, primarily related to preparations for marketing approval of the alfapump (搜索) in the US. The company's cash position at the end of December 2023 was €2.6 million.
Looking ahead, Sequana Medical (搜索) is focused on securing PMA approval for the alfapump (搜索) and advancing the DSR (搜索) program. The company has extended its cash runway to the end of Q3 2024 through cost-saving measures and recent equity placements.