Sequana Medical Anticipates FDA Approval for Alfapump in Q1 2025, Highlights DSR Progress
核心洞察
Sequana Medical (搜索) expects FDA approval for its Alfapump (搜索) system in Q1 2025, with a US launch planned for H2 2025, targeting the $2.4 billion North American market.
The company's DSR (搜索) therapy showed promise in treating cardiorenal syndrome (搜索), with RED DESERT and SAHARA data published in the European Journal of Heart Failure (搜索).
Sequana Medical (搜索) secured up to EUR 6.1 million in shareholder financing to extend its cash runway towards Alfapump (搜索) FDA approval and is exploring direct financing options.
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), announced its H1 2024 results and provided a business update, highlighting progress with its Alfapump (搜索) and DSR (搜索) (Direct Sodium Removal) therapy programs. The company anticipates FDA approval for the Alfapump system in Q1 2025, with a US commercial launch planned for the second half of the year.
Alfapump Program
The Alfapump (搜索), designed to manage fluid overload in patients with liver disease (搜索), is on track for potential US market entry. The company's Premarket Approval (PMA) application was accepted for substantive review on January 29, 2024. While the FDA issued a “Day 90” major deficiency letter, Sequana Medical (搜索) addressed the concerns in a subsequent meeting. The company plans to submit additional information to the FDA, maintaining its timeline for approval by the end of Q1 2025.
Ian Crosbie, Chief Executive Officer at Sequana Medical (搜索), stated, “We are very pleased with our positive interactions with the FDA and look forward to finalising the remaining topics over the coming months. Regular meetings with US hepatologists have reaffirmed our belief in the clear demand for improved treatment options for this large patient universe driven by NASH / MASH and alcoholic liver disease (搜索) – we estimate the North American alfapump (搜索) market at $2.4 billion in 2025, growing at 9% per year.”
To support US commercialization, Sequana Medical (搜索) has secured six new Category III Current Procedural Terminology (CPT III) codes from the American Medical Association (AMA) for the Alfapump (搜索) system. The company has also applied for the US NTAP (new technology add-on payment) program, highlighting the Alfapump's FDA breakthrough device designation and anticipated device cost of $30,000.
Data from the North American pivotal POSEIDON study of the Alfapump (搜索), presented at the EASL Congress 2024, demonstrated similar safety outcomes but significantly improved quality of life compared to baseline in patients with refractory ascites (搜索) due to liver cirrhosis (搜索).
DSR Heart Failure Program
Sequana Medical (搜索)'s DSR (搜索) therapy is under development as a treatment for diuretic resistance and cardiorenal syndrome (搜索) in heart failure (搜索). Results from the RED DESERT and SAHARA proof-of-concept studies were published in the European Journal of Heart Failure, supporting DSR's mechanism of action in breaking the vicious cycle of cardiorenal syndrome.
The independent Data and Safety Monitoring Board (DSMB) approved the start of the randomized cohort in the MOJAVE US Phase 1/2a study of DSR (搜索) 2.0 for congestive heart failure (搜索), following review of safety data from the non-randomized cohort. Three-month follow-up data from the non-randomized cohort confirmed a dramatic and durable improvement in diuretic response and virtual elimination of loop diuretic requirements.
Corporate and Financial Highlights
Sequana Medical (搜索) secured EUR 14.5 million of financing in the first half of 2024 and announced additional support of up to EUR 6.1 million from existing investors. This financing extends the company's cash runway into Q1 2025, assuming the full EUR 6.1 million is received. The company is also exploring direct financing options for the Alfapump (搜索) and DSR (搜索) programs.
For the six months ended June 30, 2024, Sequana Medical (搜索) reported a net loss of EUR 11.08 million, compared to a net loss of EUR 16.46 million for the same period in 2023. Revenue decreased from EUR 0.38 million in H1 2023 to EUR 0.11 million in H1 2024 due to the termination of European commercial activities in Q1 2024. Total operating expenses decreased from EUR 15.92 million in H1 2023 to EUR 9.82 million in H1 2024, reflecting measures taken to reduce cash burn.
Sequana Medical (搜索) ended H1 2024 with a total liquidity position of EUR 4.15 million.