Sequana Medical, a specialist in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, has announced the successful completion of the first commercial implantation of the alfapump System in the United States.
This is a key milestone in Sequana Medical’s U.S commercial roll-out following receipt of Premarket Approval (PMA) from the FDA. The alfapump System is the first active implantable medical device approved in the U.S. for the treatment of recurrent or refractory ascites due to liver cirrhosis that automatically and continuously removes ascites fluid from the abdomen into the bladder.
The successful implantation was completed at Mount Sinai Hospital in New York where the team specialises in advanced procedures for patients with liver disease. Sequana Medical is executing its focused commercialisation strategy through a specialty salesforce initially targeting the 90 U.S. liver transplant centres that perform more than 90% of liver transplants.
Sequana Medical continues to make strong progress in the roll-out of this strategy as demonstrated by the number of hospitals trained and the progress in approvals to implant at these centres.
Recurrent or refractory ascites is a severe condition characterised by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle.
This procedure often needs to be repeated weekly or monthly, requiring frequent hospital visits and causing significant disruption to patients’ daily lives. Sequana Medical estimates there are approximately 70,000 patients in the U.S. with recurrent or refractory ascites, representing a market opportunity in excess of $2 billion for the alfapump according to the company.
Dr. Rahul Patel, Assistant Professor of Radiology and Surgery at Icahn School of Medicine at Mount Sinai, said: “The alfapump represents a significant advancement for our patients suffering from recurrent ascites. For too long, these patients have had to put up with repeated needle punctures, burdensome procedures to drain the ascites fluid. With the alfapump system, patients have this done automatically and continuously, avoiding the punctures and the hospital visits, and maintaining a flat abdomen. This groundbreaking technology offers our patients the potential for improved quality of life and reduced hospital visits, which is truly transformative for managing this challenging condition.”
Ian Crosbie, Chief Executive Officer of Sequana Medical added: “Today marks a pivotal moment in Sequana Medical’s journey with our first commercial US implant. We are proud that it is taking place at Mount Sinai Hospital in New York, a top-tier US hospital with such a strong reputation in the field of hepatology and interventional radiology. Following years of investment in clinical development and laying the commercial foundations, we are positioned to deliver a breakthrough in the treatment of recurrent or refractory ascites due to liver cirrhosis.
“Having recently returned from the annual meeting of the AASLD (American Association for the Study of Liver Diseases) in Washington DC, I am more excited than ever about the US market opportunity for the alfapump. At the meeting, I met with many US hepatologists and time after time I heard they share our vision of the alfapump replacing repeated puncture paracentesis in many of their patients. alfapump is a twenty-first century solution for the large and growing patient population that has clear unmet clinical needs and I am confident that we can capture significant market share and drive meaningful revenue growth.”
