Sequana Medical’s alfapump set for FDA review

Sequana Medical has submitted a premarket approval (PMA) software to the US Meals and Drug Administration (FDA) for its implantable alfapump gadget.

The pending approval is to be used in sufferers with recurrent or refractory ascites as a consequence of liver cirrhosis, in accordance with a 28 December press launch.

A call by the company is anticipated within the second half of 2024, in accordance with Sequana’s CEO Ian Crosbie.

Belgium-based Sequana’s alfapump system has already been in use in Europe for over a decade, having obtained CE mark approval for a similar indication in 2011. It obtained breakthrough gadget designation by the FDA in 2019.

The pending software for US market approval is supported by the results of a pivotal POSEIDON study. The trial (NCT03973866), which enrolled 69 sufferers with recurrent or refractory ascites as a consequence of liver cirrhosis, met its major effectiveness endpoints and first security endpoints.

Recurrent or refractory ascites is a extreme situation characterised by the build-up of fluid – in some circumstances an additional 15 litres – within the stomach. The alfapump system routinely collects the fluid and strikes it to the bladder to be eradicated by means of urination. Sequana says the gadget might grow to be the primary lively implantable medical gadget within the US to conduct this activity.

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Presently, remedy entails invasive procedures that use a needle to empty ascites from the stomach.

Sequana’s CEO Ian Crosbie mentioned: “Knowledge from our North American pivotal research reveal the potential for alfapump to rework the lives of those sufferers by just about eliminating the necessity for paracentesis and delivering clinicially necessary enhancements in high quality of life. We anticipate FDA approval within the second half of 2024.”

Sequana states that the North American marketplace for recurrent or refractory ascites as a consequence of liver cirrhosis is estimated at 78,000 sufferers in 2025. This quantity is anticipated to develop at 6-7% per yr, reaching over 170,000 sufferers in 2035. The rise within the prevalence of non-alcoholic steatohepatitis (NASH) / metabolic dysfunction-associated steatohepatitis (MASH) is a key driver of the market.

In July 2023, the corporate introduced plans to increase focus on its other lead candidate for congestive coronary heart failure sufferers. Sequana’s MOJAVE is a randomised Part I/IIa trial within the US to guage using its direct sodium removing (DSR) platform. The trial obtained Investigational New Drug (IND) clearance in Might 2023.


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