1,000th alfapump® implant completed
- Extensive real world alfapump experience derisks planned US & Canadian launch
- Strong clinical alfapump profile demonstrated in North American POSEIDON study
- All approvals received to commence US MOJAVE study of DSR 2.0
Ghent, Belgium – 06 July 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that it has implanted the 1,000th alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis and malignant ascites.
The Company also reports that it has received all administrative clearances to start the US MOJAVE study of DSR 2.0 in congestive heart failure patients and expects to enroll the first patient imminently.
Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “We developed the alfapump to transform the lives of patients with recurrent and refractory ascites due to liver disease. For too long they have had to rely upon large volume paracentesis, a therapy developed by the ancient Egyptians and with little improvement in the last two thousand years. This important patient population is forecast to grow strongly due to the increasing prevalence of NASH[i] / fatty liver disease, one of the key health challenges in North America today. We believe that the data recently presented at the EASL Liver meeting demonstrates the potential for alfapump to transform patient lives – virtually eliminating needle paracentesis and delivering clinically important improvement in patient quality of life.
“We look forward to submit our Pre-Market Approval to the US FDA later this year and are preparing for commercial launch of the alfapump in North America through our own specialty salesforce.”
A 63-year old alfapump patient from Canada said: “The alfapump changed my life. I thought I was going to die. I got lucky with the alfapump, my daily routine is getting back, with no pain and suffering, just feeling good about taking care of myself. My approach to life totally changed since the alfapump. I look at it as a second chance in life.”
alfapump – continuous ascites removal to the bladder
Sequana Medical’s alfapump is a fully implantable, wirelessly charged device that continuously collects ascites as it forms in the abdominal cavity and moves it into the bladder, where it is naturally passed from the body through urination. Since the first alfapump was implanted at the end of 2008, there has been a steady increase in the number of patients benefiting from the improved quality of life that the alfapump brings. During that time, more than 100,000 liters of ascites have been removed safely with the alfapump.
Strong clinical alfapump profile demonstrated in pivotal POSEIDON study
Highlights from the Company’s flagship POSEIDON study, which met all primary endpoints, were recently presented at the EASL Liver meeting in Vienna[ii]:
- alfapump was effective in the control of ascites, virtually eliminating the need for large volume paracentesis
- Safety was in line with expectations, particularly given disease progression in these patients.
- Six pumps were explanted: three due to skin erosion and three due to moderate bladder discomfort
- Similar number of Major Adverse Events and comparable number of serious infections in pre-and post-implant period
- Stable kidney function over long-term follow-up
- Clinically meaningful and statistically significant improvement in patients’ quality of life at six months post-implantation
- One-year survival probability of 70%, comparing favorably to literature citing a survival rate of 50% at one year in this patient population.[iii]
[i] NASH: non-alcoholic steatohepatitis, also referred to as MASH (metabolic dysfunction-associated steatohepatitis) as per new fatty liver disease nomenclature (Hepatology, June 2023)
[ii] Reported in press release of 21 June 2023
[iii] Biggins et al., Hepatology, Vol. 74, No. 2, 2021, AASLD Practice Guidance; Moreau R et al., Liver International 2004: 24: 457-464
