The company is discussing the late summary of DSR remedy for congestion of heart failure within the 2019 congress of coronary heart failure
Gent, BELGIUM – 21 May 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), a business stage medical system firm targeted on creating progressive remedy solutions for the remedy of liver illness, coronary heart failure, malignant ascites and other fluid imbalances; 19659002] Sequana's medical administration and main researcher Dr. Jeffrey Testani hold a telephone convention with a stay webcast at 14.00 CEST / 08:00 ET Monday, May 27, 2019.  For on-line broadcasting, please visit the Sequana Medical website https: //www.sequanamed ical.com/buyers/. To take part in Q&A, call the numbers under with verification code 676873. Webcast and convention call might be in English and playback shall be obtainable on Firm's website shortly thereafter.  Belgium: +32 2 792 0434
Switzerland: +41 43 456 9986
The Netherlands: +31 20 794 8426
UK: +44 20 3003 2666
US: +1 866 966 5335  About Heart Failure 2019 Congress
Heart Failure 2019 might be held from 25 to 28 May 2019 in Athens, Greece. It’s the 6th World Congress of Acute Heart Failure organized by the European Affiliation of Cardiology of Coronary heart Failure
Results of a first-person single-dose DSR research on congestive coronary heart failure
Identify: Late-breaking trial III – Progressive and System Care
Date: Monday, May 27, 2019
Time: 08:30 – 10:00 native time (Athens)
Late presentation of the title: "First human experience of direct sodium depletion using zero sodium peritoneal solution: new candidate therapy for volume overload"
Rapporteur: Dr. Jeffrey Testani, Docent of Yale University
Presentation: 09:30 local time (Athens) / 08:30 CEST (Belgian time)
Room: Trianti – lecture corridor (Megaron – Athens International Conference) Middle)
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Concerning the First-Individual One-Dose DSR Concept Research
Analysis (clintrials.gov NCT03801226 ) was carried out by Dr. Testani at the University of Yale, with as much as 20 sufferers receiving peritoneal dialysis. randomization and crossover to DSR (sodium free cell) peritoneal dialysis (PD) answer. One liter of either DSR or standard-containing PD answer was infused into the peritoneum and left to reside for two hours earlier than removing. The patient repeated the process with an alternate answer one week later. The first endpoints are security and tolerability, defined as the top of a two-hour keep without vital discomfort or uncomfortable side effects. The secondary endpoint of the research is the difference between the DSR infusion and the standard PD answer in sodium depletion
About DSR remedy
Sequana Medical's personal DSR remedy is underneath improvement and is a new strategy to volume congestion administration for coronary heart failure, vital medical drawback and vital burden on healthcare methods. The body's response to coronary heart failure causes a rise in sodium levels, which in flip leads to the body retaining more fluid. Sequana Medical's progressive DSR remedy consists of removing of sodium by diffusion from the body into the stomach cavity by administering a sodium-free answer (“DSR infusate”) to the abdomen. The DSR infusion and extracted sodium are then removed to remove sodium from the physique. The physique reacts by eliminating the associated fluid by osmotic ultrafiltration (water motion along with sodium, blood circulate to the stomach cavity) and / or urination.
The effect of administering a sodium-free answer to the peritoneal cavity and the resulting sodium and fluid depletion have been evaluated in a preclinical research of 15 pigs, 5 of which had experimentally brought about cardiac failure. The research showed that DSR remedy is capable of eradicating giant amounts of fluid and sodium whereas having little effect on sodium focus within the bloodstream, indicating the potential of this therapeutic strategy.
Congestive heart failure is a main medical drawback. An estimated 6.5 million adults with coronary heart failure in america are expected to extend to eight.0 million by 2030. In america, there are about a million hospitalizations per yr for coronary heart failure and 90% as a consequence of volume overload. . Remedy options are very limited in patients who are not effective in diuretic remedy. This restriction happens from the 24% hospitalization fee 30 days after the discharge. The price of heart failure hospitalizations within the US is $ 13 billion per yr
About Sequana Medical
Sequana Medical is a business medical gadget company that focuses on creating revolutionary remedy solutions for liver disease. , heart failure, malignant ascites and other fluid imbalances
Sequana Medical's know-how is predicated on its personal alfapump® platform, a absolutely implantable, programmable, wireless rechargeable, battery-powered system that eliminates fluid and steady fluid removing. abdomen, relevant to many life-threatening issues. Alpha pumps are bought in Europe for remedy of refractory ascites (continual abdomen fluid in the stomach) because of liver cirrhosis and malignant ascites. The variety of refractory liver ascites sufferers is predicted to increase dramatically because of the growing incidence of NASH (non-alcoholic steatohepatiitis).
Over 700 alfapump techniques have been planted thus far. Alfapump has been accredited in accordance with the remedy tips, together with the EASL (European Liver Research Affiliation) tips for medical decompensated cirrhosis from April 2018 and the German Remedy Tips (DGVS) for liver cirrhosis problems since May 2019. , The FDA granted a breakthrough system designation for alpha pumps for repeated or refractory liver ascites. Alfapump has not yet acquired a license from the US and Canada, and the company expects to launch POSEIDON, a key North American analysis in the second half of 2019, to help the alpha pump in recurring or refractory funds.
Alfapump is among the first protected and efficient long-term options to large-scale Parasentes (LVP) for treating ascites, which offers vital advantages for sufferers, docs and healthcare techniques. Routinely and constantly shifting with ascites into the bladder, the place the body naturally removes it via urination, alfapump prevents fluid accumulation and attainable problems, improves patient's quality of life and vitamin, and probably reduces hospital visits and healthcare costs. With Alfapump DirectLink know-how, physicians can acquire pump efficiency info and extra effectively manage patients treated by the alpha pump.
Sequana Medical has utilized its alfapump experience and develops alfapump DSR to offer a handy and absolutely implanted system for DSR remedy, its novel and its own strategy to congestion administration of heart failure volume. Knowledge from animal checks introduced in EuroPCR 2018 and HFSA 2018 present that DSR remedy is efficient and protected. The primary-person one-dose DSR idea research has been carried out by Dr. Testani on the College of Yale in the USA, and the results will probably be introduced in heart failure in 2019 27.5.2019. Conceptual research is predicted to start out in the second half of 2019.
The headquarters of Sequana Medical is situated in Ghent, Belgium. Additional info may be found at www.sequanamedical.com .
Essential Regulatory Disclaimers
All info within the press release on security and efficacy does not apply to the USA and Canada because
DSR remedy continues to be evolving and it ought to be noted that the statements made on this press launch on safety and efficacy medical trials and ongoing medical trials nonetheless to be carried out. completed. There isn’t a connection between DSR and ongoing analysis in the alpha-pump system in Europe, america and Canada.
This press release might include forecasts, estimates, or different info that could be thought-about future statements. Such forward-looking statements don’t guarantee future efficiency. These forward-looking statements symbolize Sequana Medical's present judgment on what's in the future and are subject to risks and uncertainties that may cause a vital difference in actual results. Sequana Medical expressly disclaims all obligations or commitments to launch updates or modifications to future press releases until required by regulation or regulation. You should not unnecessarily use dependence on forward-looking statements that mirror the views of Sequana Medical until the date of publication of this release.
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