Sequana Medical Announces First-in-Human Data of Direct Sodium Removal (DSR) Therapy Published in Circulation
Positive pre-clinical and clinical proof-of-concept data of Sequana Medical’s innovative DSR therapy published in top tier peer-reviewed cardiovascular journal
Data demonstrates potential for treatment of volume overload due to heart failure
GHENT, Belgium, Jan. 10, 2020 (GLOBE NEWSWIRE) -- Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the results of the pre-clinical and first-in-human single dose DSR proof-of-concept studies for volume overload due to heart failure have been published in the prestigious peer-reviewed journal Circulation1. The publication can be accessed here.
The studies, conducted by Dr. Jeffrey Testani of Yale University, demonstrated that single dose DSR therapy was safe and well-tolerated and resulted in a clinically relevant removal of sodium.
Volume overload is the driver of more than 90% of the one million heart failure hospitalizations in the U.S. each year (which in total account for $13 billion in costs). Re-hospitalization is common and approximately 24% of these patients are re-admitted within 30 days of discharge. Sequana Medical’s innovative DSR therapy removes sodium from the body, which in turn eliminates the associated fluid to restore sodium concentration, resulting in sustained fluid removal.
“Volume overload is the primary driver of morbidity and hospitalization in patients with heart failure and loop diuretics, the mainstay of therapy, have well recognized toxicities and loss of response is common. DSR represents a new potential therapy for non-renal sodium and fluid removal in oedematous disorders such as heart failure,” commented Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the Circulation publication. “Studies of single dose DSR therapy in pigs and humans demonstrated that substantial sodium removal via the peritoneal membrane was feasible, without significant discomfort and with minimal off-target solute removal. DSR represents a new and exciting potential chronic therapy for treatment of volume overload in heart failure patients and clearly warrants additional study.”
“The publication of these positive data in Circulation, one of the leading specialist cardiovascular journals, is further validation of the potential of our proprietary DSR therapy,” added Ian Crosbie, CEO of Sequana Medical. “Volume overload in heart failure is a huge clinical challenge, placing a tremendous burden on patients as well as on the healthcare system. We are driving forward the clinical development of alfapump® DSR, by combining our DSR therapy with the proven alfapump platform, to deliver a potential chronic therapy for heart failure patients who are not well controlled on diuretics. RED DESERT, our first-in-human repeated dose alfapump DSR study began in H2 2019 and we look forward to reporting results from this study during Q2 and Q3 2020.”
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About alfapump DSR (Direct Sodium Removal)
alfapump DSR is in clinical development as potential chronic therapy for patients with volume overload due to heart failure. Volume overload in heart failure is a major clinical problem and is the leading cause of hospitalizations for patients with heart failure. There are approximately one million hospitalizations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The estimated cost of heart failure-related hospitalizations in the U.S. alone is $13 billion per year. 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.
DSR therapy is a breakthrough approach that involves removing sodium from the body using diffusion via the peritoneal cavity with the use of a sodium-free solution known as DSR infusate. Once the sodium has been removed, the body eliminates excess fluid naturally through urination.
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. These studies demonstrated that DSR can result in the removal of large quantities of sodium and fluid in a safe, tolerable and consistent manner whilst having a negligible impact on the electrolyte concentrations in the bloodstream. Data from these studies have been published in the high impact clinical journal Circulation, indicating the potential of this therapeutic approach. A first alfapump DSR study, combining DSR therapy with our proven alfapump platform, began in H2 2019.
About Sequana Medical
Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fast-growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion within the next 10-20 years. The heart failure market for the alfapump DSR is estimated to be over €5 billion in U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.
In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study in recurrent and refractory ascites due to liver cirrhosis started in H2 2019 and a commercial launch in the U.S. is planned for H1 2022. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 700 alfapump systems have been implanted to date.
Building on its proven alfapump platform, Sequana Medical is developing alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study in heart failure patients has started with results expected in Q2 and Q3 2020.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump has not yet received regulatory approval in the U.S. and Canada. Any statement in this press release about safety and efficacy of the alfapump does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.
DSR therapy and alfapump DSR are still in development and it should be noted that any statements in this press release regarding safety and efficacy arise from pre-clinical studies and ongoing clinical investigations which have yet to be completed. There is no link between DSR therapy, alfapump DSR and ongoing investigations with the alfapump system in Europe, the U.S. and Canada.
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. 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.
1 Impact factor (2018) for Circulation is 23.054, the highest amongst The AHA Journals and second amongst journals in the Cardiac and Cardiovascular Systems category. Circulation publishes original research manuscripts, review articles, and other content related to cardiovascular health and disease, including observational studies, clinical trials, epidemiology, health services and outcomes studies, and advances in basic and translational research.
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