Sequana Medical announces presentation of positive DSR clinical proof-of-concept data demonstrating potential in volume overload due to heart failure

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A key problem in treating patients with volume overload is that the removal of fluid without the removal of the associated sodium only results in a temporary benefit. Sequana Medical’s innovative DSR therapy removes the sodium and then the body eliminates the associated fluid to restore the sodium concentration, resulting in sustained fluid removal. Data from this study demonstrate that DSR can result in the removal of large quantities of sodium and fluid in a safe and tolerable manner. This underscores the potential of Sequana Medical’s pump DSR to deliver a new and convenient treatment option for patients with volume overload due to heart failure.

The results have been presented during the late-breaking abstract session at the Heart Failure 2019 congress in Athens, Greece, today at 08:30 CEST (09:30 local time in Athens), by Dr. Jeffrey Testani, Associate Professor and Director of Heart Failure Research at Yale University. The abstract and presentation are available on the .

DSR therapy was safe and well-tolerated during a single dose administration and met its primary endpoint of non-discontinuation of the protocol due to discomfort or adverse events, with similar tolerability to standard PD solution. Sodium removal with DSR was substantial, equating to approximately five grams (which is 2.5 days of dietary sodium) removed with a single two hour treatment, and significantly higher (p<0.0001) than what is achievable with standard PD solutions. Unlike what is typically seen with loop diuretics, the inter-patient variability was very low with DSR therapy. The fluid removal through ultrafiltration was also higher with DSR compared to standard PD solution (p<0.0001). As a result of the convincing positive and consistent results between patients, the study could be halted after ten subjects (initially planned for up to 20 subjects).

Individual safety parameters such as change in blood pressure, plasma potassium, bicarbonate, calcium and magnesium were similar between both solutions (p>0.35 for all). There was a borderline significant 1 mmol/L decrease in serum sodium from baseline to 120 minutes in the DSR group (p=0.05) but this resolved by 60 minutes after draining the solution (p=0.34). Plasma glucose increased with both DSR and standard PD solution (p<0.3 for both), but this was not different between solutions at 120 minutes (p=0.08). There was negligible removal of off-target non-sodium electrolytes such as potassium, magnesium, phosphorus and calcium with DSR.

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Volume overload in heart failure is a major clinical problem. There are approximately one million hospitalisations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The treatment options are severely limited in those patients for whom diuretic therapy is no longer effective. This limitation is evident from the 24% hospital re-admission rate at 30 days from discharge. The estimated cost of heart failure-related hospitalisations in the U.S. alone is $13 billion per year.

Sequana Medical’s proprietary DSR therapy is under development and is a novel approach to the management of volume overload in patients suffering from heart failure. DSR therapy involves the removal of sodium via diffusion from the body into the peritoneal cavity by administering a sodium-free solution (the DSR infusate) into the abdomen. As a result, the body responds to restore the sodium concentration in the body by eliminating the associated fluid via osmotic ultrafiltration (the movement of water, together with sodium, from the bloodstream to the peritoneal cavity) and/or urination, resulting in a sustained level of fluid loss.

The impact of administering a sodium-free solution to the peritoneal cavity, and the resulting sodium and fluid removal, was evaluated in a preclinical study with 15 pigs (of which five had experimentally induced heart failure) and in a first-in-human single dose DSR proof-of-concept study (from which results are reported today). These studies demonstrated that DSR can result in the removal of large quantities of sodium and fluid in a safe and tolerable manner whilst having a negligible impact on the electrolyte concentrations in the bloodstream.  

Sequana Medical's technology is based on its proprietary pump platform, a fully implantable, programmable, wirelessly-charged, battery-powered system for automatic and continuous removal of fluid from the abdomen, which is applicable across multiple life-threatening disorders. The pump is being commercialised in Europe for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and malignant ascites due to cancer. The number of patients with refractory liver ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).

Over 700 pump systems have been implanted to date. The pump has been endorsed by key independent third parties in Europe and has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis, the German treatment guidelines (DGVS) for complications of liver cirrhosis and the U.K. NICE interventional procedure guidance for treatment of refractory ascites caused by cirrhosis. In January 2019, the U.S. FDA granted Breakthrough Device designation to the pump for the treatment of recurrent or refractory liver ascites. The Company expects to start POSEIDON, the North American pivotal study, in the second half of 2019 to support approval of the pump in recurrent or refractory liver ascites.

Sequana Medical has leveraged its pump experience and is developing pump DSR (Direct Sodium Removal) to deliver a convenient and fully implanted system for DSR therapy. Data from the first-in-human single dose DSR proof-of-concept study presented at Heart Failure 2019 demonstrated that DSR can result in the removal of large quantities of sodium and fluid in a safe and tolerable manner. The first clinical study of pump DSR in patients with volume overload due to heart failure is expected to start in the second half of 2019.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit .

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Globe Newswire: 07:30 GMT Monday 27th May 2019

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