Strengthens US reimbursement position
Builds upon PMA application submitted to the US FDA on 27 December 2023
Ghent, Belgium – 03 January 2024 – 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 the American Medical Association (AMA) has issued six new Category III Current Procedural Terminology (CPT III) codes for the alfapump system, an important step in facilitating reimbursement for the Company’s innovative medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.
The Premarket Approval (PMA) application for the alfapump system was submitted to the US Food and Drug Administration (FDA) on 27 December 2023[i], based on the successful execution of Sequana Medical’s pivotal POSEIDON study.
Martijn Blom, Chief Commercial Officer at Sequana Medical, commented: “We are delighted with the issuance of six new Category III CPT codes by the American Medical Association for our alfapump system, which is a further important step in our US commercialization strategy and augments the existing ICD-10 procedure codes. Upon FDA approval, healthcare professionals will be able to submit claims for the alfapump system, paving the way for broader adoption and supporting our commercial roll-out in the US.”
Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “Today’s announcement marks another important milestone in our US commercial strategy for the alfapump and follows the recent submission of our PMA application. We are stepping up preparations for the US commercial launch of this breakthrough therapy for the treatment of recurrent or refractory ascites due to liver cirrhoisis, a significant patient population that is growing at 6-7% annually due to NASH / MASH[ii]. We believe that the alfapump will transform the treatment options for these patients, virtually eliminating the need for needle paracentesis, improving quality of life and delivering benefits to payors and healthcare systems.”
Six new CPT III codes for the alfapump system
In the US, CPT codes are used by public and private health insurance programs and offer doctors and health care professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures and services. The six CPT III reimbursement codes will be available for use by healthcare professionals and payors as of July 1st, 2024 for procedures related to the alfapump system, including implantation, revision, removal and programming of the pump system, replacement of the pump and the catheters[iii].
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About alfapump in recurrent or refractory ascites due to liver cirrhosis
Recurrent or refractory ascites is a severe condition characterized 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 over an extended period. If approved by the FDA, the alfapump could become the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated through urination.
The PMA application was submitted to the US FDA in December 2023 and was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort[iv] exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations[v]. Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering a clinically meaningful improvement in patients’ quality of life[vi].
Data from the patient preference study and a matched cohort analysis of the NACSELD[vii] registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the alfapump vs standard paracentesis procedures and that the safety profile of the alfapump is comparable to standard of care.
The North American market of recurrent and refractory ascites due to liver cirrhosis is forecast to grow 6-7% per year, from 78,000 patients in 2025, reaching a market opportunity for alfapump of over $2.5 billion by 2035, with NASH being the major driver of growth[viii]. To date, over 1,000 alfapump systems have been implanted.
About Sequana Medical
Sequana Medical NV is 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, untolerable 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, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems.
The Company submitted a Pre-Market Approval (PMA) application to the US FDA in December 2023 having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study of the alfapump in recurrent or refractory ascites due to liver cirrhosis.
Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. MOJAVE, a US randomized controlled multi-center Phase 1/2a DSR clinical study is ongoing, seeking to confirm the strong efficacy seen in the RED DESERT and SAHARA studies. All three patients from the non-randomized cohort have been successfully treated and the randomized cohort of up to a further 30 patients will start following DSMB approval, planned for Q1 2024.
Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. 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. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.
Note: alfapump® and DSR® are registered trademarks.
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.
[ii] non-alcoholic steatohepatitis (NASH) / metabolic dysfunction-associated steatohepatitis (MASH)
[iv] The Pivotal Cohort is used for the primary effectiveness endpoints and consists of 40 patients implanted with the alfapump
[vii] NACSELD is the North American Consortium for the Study of End Stage Liver Disease. A matched cohort analysis was conducted by an independent group comparing outcomes of decompensated cirrhosis patients from the NACSELD-III registry to those from the POSEIDON study; see press release of 19 October 2023
[viii] Based on US and Canada market assessment conducted by highly experienced international consulting group, estimating over 170,000 patients with recurrent or refractory ascites in North America by 2035, with estimated incidence of 60% and based on $25K for price of alfapump