Sequana Medical Marks alfapump Milestone

alfapump commercialization has begun in the United States, thanks to the device’s initial implantation at Mount Sinai Hospital in New York, N.Y.

Sequana Medical’s alfapump System is the first active implantable medical device approved in the United States to treat recurrent or refractory ascites due to liver cirrhosis that automatically and continuously removes ascites fluid from the abdomen into the bladder.

The first implantation was completed by a team specializing in advanced procedures for patients with liver disease. Sequana Medical is executing its focused commercialization strategy through a specialty salesforce initially targeting the 90 U.S. liver transplant centers that perform more than 90% of liver transplants. In August, CMS approved a New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting (effective Oct. 1).

Recurrent or refractory ascites is a severe condition characterized by abdominal fluid accumulation. 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.¹ Sequana Medical estimates there are approximately 70,000 U.S. patients with recurrent or refractory ascites, representing a market opportunity of more than $2 billion for the alfapump, forecast to reach 130,000 patients and over $5 billion by 2035, primarily driven by NASH/MASH and alcoholic liver disease.²

“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,” said Dr. Rahul Patel, assistant professor of Radiology and Surgery at Mount Sinai’s Icahn School of Medicine. “With the alfapump system, patients have this done automatically and continuously, avoiding the punctures and the hospital visits, and maintaining a flat abdomen. This technology offers our patients the potential for improved quality of life and reduced hospital visits, which is transformative for managing this condition.”

Sequana Medical received U.S. Food and Drug Administration (FDA) approval last December for the alfapump System to treat recurrent or refractory ascites due to liver cirrhosis, following FDA Breakthrough Device Designation in 2019. In Sequana Medical’s POSEIDON study—conducted within 18 centers in the United States and Canada—the pivotal 40-patient cohort implanted with the alfapump showed at six and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life.^3,4

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published last spring in the European Journal of Heart Failure support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE—a U.S. randomized controlled multi-center Phase 1/2a clinical study—have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements.⁵ The independent Data Safety Monitoring Board approved the start of a randomized 30-patient MOJAVE cohort, which is dependent on securing additional financing.

“This marks a pivotal moment in Sequana Medical’s journey with our first commercial U.S. implant. 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,” Sequana Medical CEO Ian Crosbie stated. “Having recently returned from the annual meeting of the AASLD (American Association for the Study of Liver Diseases) in Washington D.C., I am more excited than ever about the U.S. market opportunity for the alfapump. At the meeting, I met with many U.S. 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 21st 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.”

DSR therapy is still in development and is currently not approved in any country. Its safety and effectiveness has not been established.

Sequana Medical NV considers itself a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure, and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing, and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable, or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs, and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump and DSR are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

Sequana Medical is listed on the regulated market of Euronext Brussels and headquartered in Ghent, Belgium.

References
¹ Wong F, Bendel E, Sniderman K, et al. Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump. Liver Transpl. 2020;26(5):651-661. doi:10.1002/lt.25724
² Based on US and Canada market assessment conducted by highly experienced international consulting group
³ alfapump system SSED (summary of safety and effectiveness) PMA 230044
⁴ as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)
⁵ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period