Sequana Medical NV, has announced that it has received Premarket Approval (PMA) from the US Food and Drug Administration (FDA) to market alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis in the United States.
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With this major regulatory milestone, achieved earlier than market expectations, alfapump is the "first" active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder. The Company estimates there will be approximately 70,000 patients in the US with recurrent or refractory ascites, representing a market opportunity in excess of $2 billion for the alfapump in 2025. This population is forecast to reach 130,000 patients by 2032, primarily driven by NASH/MASH and alcoholic liver disease.
Dr. H.E. Vargas, M.D., professor of Medicine for the Mayo Clinic College of Medicine (Phoenix, Arizona, US), POSEIDON Study Principal Investigator, said: “The approval of alfapump by the FDA opens the door to a breakthrough therapeutic option for patients with ascites. The introduction of the system will be welcome by patients, families and their care providers as this technology not only provides effective treatment, but also has been shown to improve quality of life.”
Ian Crosbie, chief executive officer of Sequana Medical, said: "With a standard of care that has seen minimal change in thousands of years, today marks a huge milestone for the large and growing liver ascites community in the US. Our vision is to transform the lives of these patients. Recurrent or refractory liver ascites is a devastating condition with a terrible impact on the lives of our patients and their caregivers, not only for the painful and burdensome paracentesis procedure itself but also in the weeks leading up to each drainage. The POSEIDON clinical study results demonstrate that the alfapump can virtually eliminate the need for therapeutic paracentesis, and improve patient quality of life, with a safety profile comparable to standard of care, delivering a twenty-first century solution that can allow these patients to take back their lives. We wish to thank all the patients and investigators who made this possible by participating in the POSEIDON study. With over 1,000 alfapump systems implanted to date, we look forward to starting commercialisation in H2 2025, bringing this innovative solution to many more patients in need.”
The Company is preparing for the US commercial launch of the alfapump System in H2 2025, through a focused specialty sales force concentrating on the 90 liver transplant centres that represent the large majority of target customers. The Company has received FDA Breakthrough Device Designation for the alfapump System and has applied, and expects to receive, NTAP (new technology add-on payments) which should facilitate patient access to the device. In addition to the existing ICD-10 procedure codes for the alfapump procedure, the American Medical Association has granted six new CPT III reimbursement codes, available for use by healthcare professionals and payors since July 1st, 2024, for procedures related to the alfapump System.
“We are highly encouraged by the enthusiastic feedback for the alfapump that we are receiving from the clinical community – 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. It is a huge privilege to bring such a breakthrough in therapy to the clinical and patient communities, and we are excited to work with them to establish alfapump as the new standard of care” commented Martijn Blom, chief commercial officer of Sequana Medical.
Timur Resch, global vice president QM/QA/RA at Sequana Medical, who has been leading the regulatory process since 2016, said: “The receipt of the PMA approval for our alfapump System is a major milestone for our company and reflects many years of diligent work by the Sequana team. We wish to thank the FDA for its collaboration and support in bringing this highly important breakthrough device to US patients who will be very grateful for this new treatment option.”
The Company will be hosting a further webcast with key opinion leaders on 8th January 2025 at 3pm CET, 9am ET to discuss the US FDA approval of alfapump, the clinical need and the planned commercial US roll-out.