Sequana Medical NV, a leader in treating fluid overload in liver disease, heart failure, and cancer, has announced a significant milestone in its quest for FDA approval of the alfapump® system. Following a Day 100 meeting with the FDA, the company received confirmation that the substantive review of its Premarket Approval (PMA) application is complete. The FDA has indicated that there are no further new questions regarding the clinical study or pre-clinical data, marking a pivotal step towards the anticipated marketing approval by Q1 2025.
The alfapump system, designed for patients suffering from recurrent or refractory ascites due to liver cirrhosis, represents a breakthrough in medical technology. It offers a fully implantable, wirelessly charged solution that automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated. This innovation could significantly improve the quality of life for patients, who currently rely on the invasive and burdensome procedure of therapeutic paracentesis.
The PMA application was based on the successful POSEIDON study, conducted across 18 centers in the US and Canada, involving 69 patients. The study demonstrated that the alfapump exceeded predefined thresholds for primary effectiveness endpoints at six months post-implantation, with safety data aligning with expectations. Furthermore, data at 12 months post-implantation showed a durable clinical profile, virtually eliminating the need for therapeutic paracentesis and offering a meaningful improvement in patients' quality of life.
Sequana Medical is now focused on addressing the FDA's non-clinical questions, with plans to submit additional information by the end of September 2024. The company has decided to exclude RPMS/DirectLink from the initial PMA application and commercial launch, opting instead to introduce a next-generation version post-approval. This decision reflects the company's commitment to ensuring the highest standards of safety and efficacy, in line with the rapidly evolving cybersecurity environment.
With the US commercial launch of the alfapump system planned for H2 2025, Sequana Medical is evaluating its financing options to support the approval process and prepare for the market introduction. The company's leadership has expressed gratitude for the collaborative discussions with the FDA and remains optimistic about the path forward for this groundbreaking device.
