{"id":440174,"date":"2024-01-02T19:00:00","date_gmt":"2024-01-03T00:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace\/"},"modified":"2024-01-03T05:58:32","modified_gmt":"2024-01-03T10:58:32","slug":"sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace\/","title":{"rendered":"Sequana Medical granted US CPT\u00ae III reimbursement codes for alfapump\u00ae system | BioSpace","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<ul>\n<li><strong><em>Strengthens US reimbursement position<\/em><\/strong><\/li>\n<li><strong><em>Builds upon PMA application submitted to the US FDA on 27 December 2023 <\/em><\/strong><\/li>\n<\/ul>\n<p><strong>Ghent, Belgium \u2013 03 January 2024\u2013 <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.biospace.com\/employer\/542425\/sequana-medical-\/\">Sequana Medical NV<\/a> (Euronext Brussels: SEQUA) <\/strong>(the &#8220;<strong>Company<\/strong>&#8221; or &#8220;<strong>Sequana<\/strong><strong>Medical<\/strong>&#8220;), 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 <strong>alfa<\/strong>pump system, an important step in facilitating reimbursement for the Company\u2019s innovative medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.<\/p>\n<p>The Premarket Approval (PMA) application for the <strong>alfa<\/strong>pump system was submitted to the US Food and Drug Administration (FDA) on 27 December 2023<sup>i<\/sup>, based on the successful execution of Sequana Medical\u2019s pivotal POSEIDON study.<\/p>\n<p><strong><em>Martijn Blom, Chief Commercial Officer at Sequana Medical, commented:<\/em><\/strong><em> \u201cWe are delighted with the issuance of six new Category III CPT codes by the American Medical Association for our <\/em><strong><em>alfa<\/em><\/strong><em>pump 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 <\/em><strong><em>alfa<\/em><\/strong><em>pump system, paving the way for broader adoption and supporting our commercial roll-out in the US.\u201d<\/em><\/p>\n<p><strong><em>Ian Crosbie, Chief Executive Officer of Sequana Medical, added: <\/em><\/strong><em>\u201cToday&#8217;s announcement marks another important milestone in our US commercial strategy for the <\/em><strong><em>alfa<\/em><\/strong><em>pump 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<\/em><sup><em>ii<\/em><\/sup><em>. We believe that the <\/em><strong><em>alfa<\/em><\/strong><em>pump 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.\u201d <\/em><\/p>\n<p><u>Six new CPT III codes for the <\/u><strong><u>alfa<\/u><\/strong><u>pump system<\/u><\/p>\n<p>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 1<sup>st<\/sup>, 2024 for procedures related to the <strong>alfa<\/strong>pump system, including implantation, revision, removal and programming of the pump system, replacement of the pump and the catheters<sup>iii<\/sup>.<\/p>\n<p><strong>For more information, please contact:<\/strong><\/p>\n<p><strong>Sequana Medical<\/strong><\/p>\n<p>Lies Vanneste<br \/>Director Investor Relations<br \/>E: <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=LvbEnIeSW4tj3PPXl4chGkEz-q-awje8kOTbBiTtKbsEBRB2HRp4KjeojxF71rS2pHaQVdJwUQI9rsBpqUUfasqsnya5zpOSdpkGpB9bEdo=\">IR@sequanamedical.com<\/a><br \/>T: +32 (0)498 053579<\/p>\n<p><strong>About alfapump in recurrent or refractory ascites due to liver cirrhosis<\/strong><\/p>\n<p>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 <strong>alfa<\/strong>pump 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.<\/p>\n<p>The PMA application was submitted to the US FDA in December 2023 and was based on the successful execution of Sequana Medical\u2019s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the <strong>alfa<\/strong>pump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort<sup>iv<\/sup> exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations<sup>v<\/sup>. 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\u2019 quality of life<sup>vi<\/sup>.<\/p>\n<p>Data from the patient preference study and a matched cohort analysis of the NACSELD<sup>vii<\/sup> registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the <strong>alfa<\/strong>pump vs standard paracentesis procedures and that the safety profile of the <strong>alfa<\/strong>pump is comparable to standard of care.<\/p>\n<p>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 <strong>alfa<\/strong>pump of over $2.5 billion by 2035, with NASH being the major driver of growth<sup>viii<\/sup>. To date, over 1,000 <strong>alfa<\/strong>pump systems have been implanted.<\/p>\n<p><strong>About Sequana Medical<\/strong><\/p>\n<p>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 \u201cdiuretic-resistant\u201d patient population. <strong>alfa<\/strong>pump\u00ae and DSR\u00ae are Sequana Medical&#8217;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.<\/p>\n<p>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 <strong>alfa<\/strong>pump in recurrent or refractory ascites due to liver cirrhosis.<\/p>\n<p>Results of the Company\u2019s RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR\u2019s 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.<\/p>\n<p>Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=eze8ah5O9nvsZIv5MN7NQ-Yr6kj7eiyzBsPJHeEq8Bj_v7PijVd39sRLT-jUOCwJ8uLgEs7KO0Fz9O2tCHWs6D4Atmzx8qZyjcpbmZoV3Wg=\">www.sequanamedical.com<\/a>.<\/p>\n<p><strong><em>Important Regulatory Disclaimers<\/em><\/strong><\/p>\n<p><em>The <\/em><strong><em>alfa<\/em><\/strong><em>pump\u00ae system is currently not approved in the United States or Canada. In the United States and Canada, the <\/em><strong><em>alfa<\/em><\/strong><em>pump 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\u00ae 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 <\/em><strong><em>alfa<\/em><\/strong><em>pump system in Europe, the United States or Canada.<\/em><\/p>\n<p><em>Note: <\/em><strong><em>alfa<\/em><\/strong><em>pump\u00ae and DSR\u00ae are registered trademarks.<\/em><\/p>\n<p><strong><em>Forward-looking statements<\/em><\/strong><\/p>\n<p><em>This press release may contain predictions, estimates or other information that might be considered forward-looking statements.<\/em><br \/><em>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.<\/em><\/p>\n<hr>\n<p><sup>i<\/sup> See press release of <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=tUJqT0PgUeCSNIlcOsGdapya70RyGKD4PYEP8xKFYtHosjyLqbAG226L3zNXGl5qNakDDyXs8x4ZC4ilwdAR5Krf4g2N49ZLBLIQMCtUjx272tK5bJK_s4MDUBqPbzspl9R86rc11yHmyZJ-htbKUZMluJ0sZ0PsaPU7leuuLYmyJrZqXTuVkFiHmGyfkuna5Vf7ZPH0A5xTr-gKynzFrYEzcYLF9z27qqHRhjBnc2OrZpESXq07-RhasQ1gI8TIIP0tOt8qmq-SODCnMyBisIWUL1yhBY5tp8gHRnL6oVLO91XOCwtB5IH-nd4ssbdY\">28 December 2023<\/a><br \/><sup>ii<\/sup> non-alcoholic steatohepatitis (NASH) \/ metabolic dysfunction-associated steatohepatitis (MASH)<br \/><sup>iii<\/sup> See <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=Lvp9gCJnMVlapQuoLDid-KTS_aZ0HlegBqG6SX_89qpgwohyoy70IASNOwFYfgrvQYZ74Pj3YKejGuxwlwDEuFuQSDJODwPA5o927Op2Na9jA6aZxB2ZBqiROnrp7DTvwyypt3HlAgzt5TUmIyp_Xg==\">website of AMA<\/a> for the 6 new CPT III codes for the <strong>alfa<\/strong>pump system<br \/><sup>iv<\/sup> The Pivotal Cohort is used for the primary effectiveness endpoints and consists of 40 patients implanted with the <strong>alfa<\/strong>pump<br \/><sup>v<\/sup> Data reported in <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=knNSUw9XTuXJsbULtLlgEbupi94vBL99MlctgbpfU2oWTeD59lkmqTf19EwRtqE15TSPpDGCQANI7FVZ2RZ4FXdTabGX-WYMyohGkdcXGOJp7c34CQ-g3VNOckXNM-S5UFjp-KRVjPMPQ03YND9q4it1QDlSC31JqvZ_63LW2xqaFpkA3BZV7PVV98vW6a5j9Tt-CkzlVbM_OWoQvurgcbLHEHmwegXocX46izzQrdABZEkNkQeaikDiwqxzbxMyJfCyis0eAumTXym4Ayg3AfVT5CsGWLjdk9RAMLGLgHY=\">press release of 25 October 2022<\/a><br \/><sup>vi<\/sup> Data reported in <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=knNSUw9XTuXJsbULtLlgEfxlnQ-jShnMggWPKX2U-hp59gFt5F4JZLlhJgsU8v4g7lR3EmR1veIR_qBbPHoOk1ShgcKg8VQB6t7pL4-fDrE2fkrOwV7K20f_mIlai6sSmKjCacF5GQNIXFIMeAcdisIZzpMVSP_Pquc_0AvGNUYtusMMNePo4owGbV4trEWkbUGFat65aHe3estwH1KAzShVZsVJLMS6l1_LEYsxiGpummKyCkGapH0KiIfbzUAB4-D9R4xCovnSzn2V8jPGzMWFgjgMhwHvCYJeM_VWZV5B4BKu-WnlFZkLWtqdxq4_\">press release of 19 October 2023<\/a><br \/><sup>vii<\/sup> 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 <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=DzfkukOyn5HV5LLKyIk2Qju-OV8dBlh8syuTM57mxc379011_404m7VmInfvc5eetqsLIR7TL0LfquPYVfw8WDQdGl5F0DCnerMAFnIQpCs5wK-6xvLv5YXY4b8DTEj7wrjBBR8kl2WcXbGebQIjLMK5inyfsxBf7QV8mb3KXXLYD8Npbr2xJdWJAcPXUP0FaDBuN78LdAixL9lYeiLS3eiSBPHpeQ8cKQ7Q5Q9IJE4JTMzmlROKTZGy1ksctvLBdkQnIN2_JyrXcsU6IRPc_p8AvhLeboczLqvyz9Z5Xhw=\">19 October 2023<\/a><br \/><sup>viii<\/sup> 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 <strong>alfa<\/strong>pump<\/p>\n<p><strong>Attachments<\/strong><\/p>\n<p><img decoding=\"async\" alt class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace.gif\"><br \/><img decoding=\"async\" alt src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace-1.gif\"><\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/b5ba012f-32c9-4567-bb3a-c01eb27aa4b0\"><img decoding=\"async\" alt=\"Primary Logo\" border=\"0\" height=\"32\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace.png\" width=\"150\"><\/a><\/p>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. 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Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.biospace.com\/article\/releases\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system\/?s=93\">https:\/\/www.biospace.com\/article\/releases\/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system\/?s=93<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>Strengthens US reimbursement position Builds upon PMA application submitted to the US FDA on 27 December 2023 Ghent, Belgium \u2013 03 January 2024\u2013 Sequana Medical NV (Euronext Brussels: SEQUA) (the &#8220;Company&#8221; or &#8220;SequanaMedical&#8220;), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the American Medical Association [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":440179,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/440174"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=440174"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/440174\/revisions"}],"predecessor-version":[{"id":440178,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/440174\/revisions\/440178"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/440179"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=440174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=440174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=440174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}