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Continuous direct sodium removal in heart failure and diuretic resistant patients

Ghent, Belgium – April 3, 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (“”company” or “SequanamedicineThe company, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announced results from two proof-of-concept studies of its DSR therapy in diuretic-resistant patients, RED DESERT and SAHARA. The study was published in the prestigious peer-reviewed journal “European Journal of Heart Failure”.I. Publications can be accessed here.

Dr. Jeffrey Testani, associate professor at Yale University and lead author of this publication, commented:“Cardiorenal syndrome is a major clinical challenge in heart failure, and there is clearly an unmet therapeutic need to effectively and durably address congestion and cardiorenal dysfunction. The mainstay of treatment is loop diuretics, which actually worsen sodium intake and cardiorenal syndrome. In the RED DESERT and SAHARA studies, patients’ loop diuretics were completely replaced with DSR therapy for several weeks; As a result, numerous indicators of cardiorenal health were improved, and diuretic responsiveness and chronic loop diuretic requirements were dramatically and permanently improved. This data is truly revolutionary. , represents the first and only new therapy to treat diuretic resistance and cardiorenal syndrome in heart failure.”

Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “We are pleased with Dr. Testani’s publication highlighting DSR as a potential treatment for cardiorenal syndromes and highlighting the need to break the vicious cycle of loop diuretic therapy. Diuretic-resistant heart failure and cardiopulmonary syndromes There is a clear need for new treatments that can improve clinical outcomes beyond loop diuretics and are a large and growing market both in the US and the rest of the world. We believe DSR’s ability to virtually eliminate the need is a breakthrough in treatment options that addresses one of the key drivers of health care costs.”

A total of 18 heart failure patients receiving high-dose oral loop diuretics were enrolled in the RED DESERT and SAHARA clinical studies, with DSR of up to 4 and 6 weeks, respectively, while loop diuretics were discontinued. received therapy. Data from these studies showed that DSR can i) safely, effectively and rapidly eliminate fluid overload and restore true blood volume without the need for loop diuretics; ii) Significant benefits for patients’ heart and kidney health. iii) Produces a dramatic and sustained improvement in diuretic responsiveness, thereby dramatically reducing the need for oral loop diuretics for many months after treatment. In both the RED DESERT and SAHARA studies, there were no congestion-related readmissions, all patients improved their NYHA status by at least one class, and the clinical benefits observed in clinical studies resulted in predicted 1-year hospitalizations. Duration reduced by 75%. Patient mortality before and after intensive DSR treatment based on the Seattle Heart Failure Model.

For more information, please contact us below.

Sequana Medical

Rhys Vaneste
Director Public Relations Activities for Investors
E: IR@sequanamedical.com
Phone: +32 (0)498 053579

About DSR, a disease-modifying heart failure drug therapy that addresses cardiorenal syndrome (CRS)

Cardiorenal syndrome is an important clinical challenge in heart failure, resulting from the combination of a vicious cycle of cardiac and renal dysfunction. Despite the complex pathophysiology, the resulting clinical profile is characterized by decreased glomerular filtration, increased renal sodium binding capacity, and congestion, despite increasing doses of diuretics. It is thought to manifest as a reinforcing negative feedback cycle.

Current treatments have not been shown to improve patient outcomes in this complex and poorly understood indication. Although decongestion is a key component of treatment, loop diuretics exacerbate many of the core mechanisms thought to underlie CRS. DSR has the potential to break the negative feedback cycle of this clinical challenge by effectively controlling volume status over long periods of time and avoiding the adverse effects of loop diuretics.

Extensive analysis of patients in the RED DESERT and SAHARA studies showed that i) volume status, ii) normalization of diuretic response and significant reduction in loop diuretic dosage, iii) improvement in renal function, and iv) neurohormonal status and signaling. The benefits of DSR therapy regarding transmission have been shown. v) Cardiovascular parameters. These patients had no congestion-related readmissions, a one-class improvement in NYHA status, and a 75% reduction in estimated 1-year mortality (based on the Seattle Heart Failure Model). Initial data from a non-randomized cohort of the US MOJAVE study supports these findings, showing that DSR is safe and well-tolerated, restores diuretic response, and improves heart and kidney health. Ta.

About Sequana Medical

Sequana Medical NV is a pioneer in the treatment of fluid overload, a serious clinical complication that frequently occurs in patients with liver disease, heart failure, and cancer. This causes serious medical problems, including increased mortality, repeated hospitalizations, severe pain, difficulty breathing, and limited mobility. Diuretics are standard treatment, but for many patients, diuretics stop working, can’t be tolerated, or make the problem worse. Effective treatment options are limited, resulting in poor clinical outcomes, high costs, and a significant impact on quality of life. Sequana Medical seeks to provide innovative treatment options to this large and growing “diuretic-resistant” patient population. alphaPump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering significant clinical and quality of life benefits to patients and reducing costs to healthcare systems. Masu.

Our Pre-Market Approval (PMA) Application alphaThe pump was submitted to the U.S. Food and Drug Administration in December 2023 and accepted for substantive review in January 2024, and received initial and Positive data for secondary endpoints were reported.

Results from our RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action in breaking the vicious cycle of cardiorenal syndrome. All three patients in the non-randomized cohort of MOJAVE, a US randomized controlled multicenter Phase 1/2a clinical study, were successfully treated with DSR, resulting in dramatic improvements in diuretic response. , the need for loop diuretics was virtually eliminated. An independent data safety monitoring board approved the initiation of a randomized MOJAVE cohort of up to 30 additional patients. alphaPump US PMA approved.

Sequana Medical is listed on Euronext Brussels (ticker: SEQUA.BR) and is headquartered in Ghent, Belgium. For more information, please visit www.sequanatical.com.

Important regulatory disclaimer

of alphaThe Pump® System is not currently approved in the United States or Canada. In the US and Canada, alphaThe pump system is currently in clinical research (POSEIDON trial) in adult patients with refractory or recurrent ascites due to liver cirrhosis. Please note that DSR® Therapy is still under development and any statements regarding safety and efficacy are derived from ongoing preclinical and clinical studies that have not yet been completed. There is no link between DSR therapy and ongoing research. alphaEuropean, US, or Canadian pump systems.

Note: alphaPump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain projections, estimates or other information that may be considered forward-looking statements.

Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent Sequana Medical’s current judgment about what the future will hold and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to publicly update or revise any forward-looking statements in this press release, except as specifically required by law or regulation. You should not place undue reliance on forward-looking statements, which reflect Sequana Medical’s opinion only as of the date of this press release.


I The impact factor of European Journal of Heart Failure (EJHF) in 2022 is 18.2. EJHF publishes reviews and editorials that improve the understanding, prevention, investigation, and treatment of heart failure, including molecular biology, cell biology, pathology, physiology, electrophysiology, pharmacology, clinical science, social science, and population science. Published.

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