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October, 5th

Sequana Medical announces FDA approval to expand patient enrolment in North American pivotal alfapump® study (POSEIDON)

Sequana Medical announces FDA approval to expand patient enrolment in North American pivotal alfapump® study (POSEIDON)



  • Completion of patient enrolment expected before end of year
  • Primary endpoint read-out due in Q4 2022
  • 59 patients already recruited in the Pivotal Cohort
Ghent, Belgium – 4 October 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that is has received approval from the U.S. Food and Drug Administration (FDA) to expand patient enrolment to 70 (an increase of 10) in the Pivotal Cohort of POSEIDON, the North American pivotal study of thealfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. This patient enrolment expansion was requested by Sequana Medical to compensate for the higher rate of attrition between study enrolment and alfapump implantation in the Pivotal Cohort, with the objective to reach 50 patients implanted with the alfapump.To date, 59 patients have been enrolled in the Pivotal Cohort. The Company expects completion of patient enrolment by end of year with primary endpoint read-out in Q4 2022, on time for FDA regulatory submission mid-2023.Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: "We welcome the approval from the FDA to expand patient recruitment in POSEIDON and look forward to announcing completion of enrolment. We will now resume our efforts to enrol these additional patients, having had to pause these pending this approval. The interim POSEIDON data has produced strong results which indicate the potential of the alfapump to provide an efficacious treatment that can dramatically improve the quality of life for patients with recurrent or refractory liver ascites. We will continue to work diligently to bring the alfapump one step closer to the growing number of patients that need a 21st century treatment for this terrible disease."

About the POSEIDON study
POSEIDON is a single-arm, open-label, within subject cross-over study of the alfapump in patients with recurrent or refractory ascites due to liver cirrhosis and is being conducted in approximately 20 centres across the U.S. and Canada. Patients are being enrolled in the Pivotal Cohort, entering into the pre-implant observation period, allowing for up to 50 patients to be implanted with the alfapump for primary endpoint analysis. The study allows for up to 35 patients to be enrolled in a Roll-In Cohort, to ensure centres are experienced with the alfapump implantation prior to enrolment of patients in the Pivotal Cohort. Pivotal Cohort patients enter into a three month pre-implant observation period in which they receive standard of care therapy (consisting of therapeutic paracentesis) before the alfapump is implanted. Patients from the Roll-In cohort are immediately implanted with the alfapump.A detailed review of study enrolment in H1 2021, including an analysis of attrition between study enrolment and planned alfapump implantation, identified a higher rate of attrition than forecast when the study was planned. The cause of this included a number of patients whose alfapump implantation was delayed for COVID-related matters and subsequently failed to meet re-evaluation of study inclusion / exclusion criteria prior to implantation, likely due to disease progression. The review concluded that approximately 10 additional patients would need to be enrolled in the Pivotal Cohort in order to implant up to 50 patients with the alfapump following the three-month observation period, leading the Company to submit a protocol amendment to the FDA to extend patient enrolment.The primary effectiveness outcomes of the study include the proportion of patients with a 50% reduction in the overall average frequency of therapeutic paracentesis per month in the post-implant observation period (month four to month six after implantation) as compared to the pre-implant observation period. The primary safety endpoint is the rate of alfapump related re-interventions adjudicated by the Clinical Events Committee. Patients will be followed for up to two years for analysis of secondary outcome measurements including safety (device and/or procedure-related adverse events), quality of life (assessed by general SF36 as well as disease-specific Ascites Q questionnaires), patients’ nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).In July 2021, the Company reported the second positive interim analysis of the POSEIDON study. Data from 26 patients in the Roll-In Cohort reconfirmed positive outcomes against all primary endpoints1 and demonstrated (i) over 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline, (ii) all patients having at least a 50% reduction in mean frequency of TP per month versus baseline, (iii) clinically important improvement in quality of life maintained even up to 12 months post-implantation and (iv) safety profile in line with expectations.About Sequana MedicalSequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.In the U.S., the Company's key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study and a rapid and persistent clinically important improvement in quality of life. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 850 alfapump systems have been implanted to date.Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status. The SAHARA DESERT study of alfapump DSR in decompensated heart failure patients is ongoing.Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux, China, the EU, United Kingdom, and Hong Kong.

Forward-looking statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.