Sequana Medical results with RED DESERT alfapump DSR®

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Ghent, BELGIUM – 6th July 2021Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announced the positive results of its RED DESERT study alfaDSR® (Direct Sodium Removal) pumps, which were presented as part of the Late Breaking Science Results at the Heart Failure 2021 Online Congress, were also selected for the highlights session of the congress, which will take place virtually on July 1, 2021.

DR. Jeffrey Testani, Associate Professor of Medicine and Director of Heart Failure Research at Yale University School of Medicine, commented:Iit was an honor for present the results of the RED DESERT study in heart failure 2021 On-line congress and be included in the the Highlights session. It is encouraging to see this recognition and we areankful to the congress team. These elegant and innovative therapeutic approach by alfapump DSR therapy shown a significant Improvement of the heart and kidney function and a dramatic and sustainable Improve diuretic response.

alfapump DSR is Sequana Medical’s proprietary therapy designed to treat diuretic-resistant congestion in patients with heart failure. In May 2021, strong results from the RED DESERT study in eight patients with diuretic-resistant heart failure were reported, showing that recurrence alfaPump DSR therapy could effectively replace high dose loop diuretics in patients and restore their diuretic response and overall cardiorenal status.

Presentation details:

  • Title: First human experience with the Alfapump DSR system in diuretic resistant chronic heart failure
  • Presenting: Dr. Jeffrey Testani
  • A replay of the presentation is available on request on the congress platform. To register, click here.
  • A copy of the presentation is available on the Sequana Medical website.

For more information, please contact:

Sequana Medical
Lies Vanneste
Director Investor Relations
Tel: +32 498 05 35 79
E-mail: [email protected]

LifeSci consultant
Guillaume van Renterghem
Tel: +41 76 735 01 31
E-mail: [email protected]

over alfapump DSR in heart failure patients with diuretic-resistant congestion

alfapump DSR is in clinical development as a potential long-term treatment for heart failure patients with diuretic-resistant congestion. Congestion, also known as fluid overload, accounts for more than 90% of the one million heart failure hospital admissions annually in the United States (costing $ 13 billion). Treatment options are severely limited in patients for whom diuretics are no longer effective, as evidenced by the resumption rate of 24% 30 days after discharge. Persistent congestion and deterioration in renal function are an important indicator of increased mortality in patients with acute decompensated heart failure.

Sequana Medical’s proprietary DSR therapy is a unique approach that removes sodium from the body by diffusion into the peritoneal cavity using a sodium-free solution known as DSR infusate. Once the sodium is removed, the body naturally eliminates excess fluids through urination to restore serum sodium levels. alfapump DSR combines the DSR therapy with the tried and tested alfaPump to deliver a fully implanted system for long-term DSR therapy. Strong top-line results from the RED DESERT study showed repeated ingestion alfaPump DSR therapy in diuretic-resistant heart failure patients is highly effective in regulating fluid and sodium levels and improving cardiorenal status. After the six-week study, there was a dramatic improvement in patients’ diuretic response and a significant long-term reduction in their need for oral loop diuretics. The SAHARA DESERT study by alfaPump DSR in patients with decompensated heart failure with residual congestion is currently being investigated and investigated how quickly intensive DSR therapy can clear persistent congestion, improve diuretic response and cardiorenal function, and how long these effects persist during DSR maintenance therapy. Interim results are expected by the end of 2021 and top-line results in H2 2022.

About Sequana Medical

Sequana Medical is a commercial medical device company that owns its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a common complication of many major diseases, including advanced liver disease caused by NASH (non-alcoholic steatohepatitis) -related cirrhosis and heart failure, with diuretic resistance being widespread. The US market for the alfaThe pump is projected to exceed $ 3 billion annually for the next 10-20 years due to NASH-related cirrhosis. The heart failure market for DSR and the alfapump DSR® is estimated at over 5 billion euros annually in the USA and the EU5 by 2026.

The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally expelled through urination. DSR is Sequana Medical’s proprietary approach to treating sodium and fluid overload through the use of a sodium-free infusate administered into the abdominal cavity.

In the USA, the company’s most important growth market, the alfaPump has been recognized by the FDA as the breakthrough product designation for recurrent or refractory ascites due to cirrhosis of the liver. Interim data from the ongoing North American pivotal trial (POSEIDON) showed positive results across all of the trial’s primary endpoints and a rapid and sustained clinically meaningful improvement in quality of life. This study is intended to be a future marketing application of the alfaPump in the US and Canada. In Europe it is alfaPump is CE marked for the treatment of refractory ascites due to cirrhosis of the liver and malignant ascites and is included in key clinical practice guidelines. Over 850 alfaPump systems have previously been implanted.

Sequana Medical has its proven alfaPump and proprietary DSR therapy and develops the alfaPump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfaPump DSR study in patients with diuretic-resistant heart failure showed that repeated DSR therapy can both control fluid and sodium levels in these patients, restore their diuretic response and improve their cardiorenal status. The SAHARA DESERT study by alfaPump DSR in patients with congestive heart failure is ongoing.

Sequana Medical is headquartered in Ghent, Belgium. For more information please visit www.sequanamedical.com.

Important regulatory disclaimers

The alfapump® System is currently not approved in the USA or Canada. In the United States and Canada, the alfapump® system is currently in clinical testing (POSEIDON study) and is being investigated in adult patients with refractory or recurrent ascites due to cirrhosis. For more information on the POSEIDON clinical study, see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that all statements on safety and effectiveness come from preclinical and clinical studies that have not yet been completed. DSR® therapy is currently not approved for clinical research in the United States or Canada. There is no connection between the DSR® therapy and ongoing examinations with the alfapump® system in Europe, the USA or Canada.

Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux countries.

Forward-Looking Statements

This press release may contain predictions, 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 assessment of the future and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or obligation to post updates or revisions to any forward-looking statements in this press release except as required by law or statute. You should not place undue reliance on any forward-looking statements, which represent only the opinions of Sequana Medical as of the date of this press release.

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