The US Food and Drug Administration (FDA) has approved Sequana Medical’s alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis.
The agency’s greenlight makes Sequana’s product the first implantable device of its kind for patients with the condition.
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The Belgium-based company expects to launch alfapump in the US in the second half of 2025, with sales initiatives focused on liver transplant centres.
Shares in Brussels-listed Sequana opened 41.5% higher at market open compared to a pre-announcement market close. The company has a market cap of $68.9m.
Recurrent or refractory ascites is a severe condition characterised by the build-up of fluid – in some cases an extra 15 litres – in the abdomen. Over 7 in 10 cases of ascites is caused by liver cirrhosis, according to the British Liver Trust.
The alfapump system automatically collects the fluid and moves it to the bladder to be eliminated through urination. The current standard of treatment involves invasive procedures that use a needle to drain ascites from the abdomen.
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By GlobalDataThe FDA based its decision on results from the pivotal POSEIDON study. The trial (NCT03973866), which enrolled 69 patients with recurrent or refractory ascites due to liver cirrhosis, met its primary effectiveness endpoints and primary safety endpoints.
Sequana estimates that its product, which has been granted six new current procedural terminology (CPT) codes, has entered a market opportunity worth $2bn. The company forecasts 70,000 patients in the US with recurrent or refractory ascites in 2025. The increase in the prevalence of non-alcoholic steatohepatitis (NASH) / metabolic dysfunction-associated steatohepatitis (MASH) is a key driver of the market, with around 130,000 patients forecast to have the disease by 2032, according to Sequana.
Sequana’s alfapump system has already been in use in Europe for over a decade, having received CE mark approval for the same indication in 2011. It received breakthrough device designation by the FDA in 2019.
Sequana’s chief commercial officer Martijn Blom said: “There is a clear need for improved treatment options, and we are putting in place the commercial team to deliver our novel therapy. Preparations for commercial launch are underway, and we are already working with target centers for the initial commercial launch planned for H2 2025.”
Sequana’s other lead candidate is a sodium-free dextrose/icodextrin solution for clearing sodium in patients with heart failure. The company has released positive results throughout 2024 for the product, called DSR 2.0.
