Sequana Medical Reveals Promising POSEIDON Study Outcomes

Sequana Medical Reports Exciting Findings from POSEIDON Study

Sequana Medical NV, a pioneer in treatments for fluid overload due to liver disease and other conditions, recently presented compelling results from the POSEIDON study at the American Association for the Study of Liver Diseases (AASLD) conference. This milestone event showcased significant 24-month outcomes that underline the efficacy of the alfapump system.

Alfapump: A Game Changer for Patients

The alfapump system demonstrated remarkable effectiveness in managing ascites, as evident from the results shared at the conference. By significantly reducing the need for large volume paracentesis (LVP), alfapump has the potential to transform patient care. Clinicians underlying the study have reported that sustained monitoring and timely treatment are essential for managing potential complications such as Acute Kidney Injury (AKI) or infections.

Study Insights from the POSEIDON Team

Dr. H.E. Vargas, from the Mayo Clinic, highlighted that patients can experience considerable relief through the alfapump, resulting in improved quality of life. The study found that overall survival rates reached 62% at 24 months post-implantation, setting a new standard in patient management.

Governmental Approvals and Future Outlook

Sequana Medical announced that they are in continuous discussions with the FDA, aiming for premarket approval (PMA) for the alfapump by early 2025. The clinical insights gained from both the pivotal and roll-in cohorts have built a strong case for the device, emphasizing both safety and effectiveness.

Patient Demand and Market Potential

The increasing prevalence of liver cirrhosis, exacerbated by conditions such as NASH and MASH, creates a pressing need for innovative treatments like the alfapump. The market for managing recurrent and refractory ascites is projected to grow significantly in the coming years, which further underscores the potential for Sequana Medical's solutions.

Beyond Ascites: The Broad Scope of Sequana Medical

Sequana Medical’s innovations extend past the alfapump, as they are also advancing treatments for heart failure through their DSR technology. This robust pipeline positions the company as a leader in addressing fluid management complexities across various medical conditions.

Commitment to Patient Quality of Life

The alfapump helps bridge a critical gap in treatment options for patients suffering from lifethreatening fluid overload, improving their daily experiences while eliminating more invasive procedures like paracentesis. The feedback from healthcare professionals illustrates a clear demand for modern solutions like alfapump.

Conclusion and Contacts

Sequana Medical's commitment to innovative treatments continues to flourish, with its strong clinical evidence paving the way for future advancements. With a clear strategy towards gaining regulatory approval and an increased market presence, Sequana Medical aims to revolutionize patient care in fluid management.

For further inquiries and information regarding Sequana Medical's initiatives, please contact:

Sequana Medical
Investor relations
Email: IR@sequanamedical.com
Phone: +32 (0)9 496 17 27

Frequently Asked Questions

What is the alfapump system?

The alfapump is an innovative device designed to continuously remove ascitic fluid from the abdomen, allowing it to be naturally eliminated through urination.

What were the main results of the POSEIDON study?

The POSEIDON study highlighted a 62% overall survival rate at 24 months and demonstrated significant improvements in the management of ascites without the need for frequent paracentesis.

Why is the FDA approval important for Sequana Medical?

FDA approval would enable wider use of the alfapump in the US, significantly enhancing treatment options for patients with refractory ascites.

What are the next steps for Sequana Medical?

Sequana Medical is focused on finalizing their PMA application and plans for a commercial launch of the alfapump in the US, expected in the latter half of 2025.

How is the market for liver disease treatment evolving?

The market for treatments targeting liver disease and related fluid overload conditions is expected to grow, driven by rising prevalence rates of conditions like NASH and liver cirrhosis.

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