Ghent, Belgium – 3 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator within the therapy of diuretic-resistant fluid overload in liver illness, malignant ascites and coronary heart failure, immediately publicizes it has acquired Medical Device Single Audit Program (MDSAP) certification from its auditing organisation British Standards Institution (BSI), thereby increasing its Quality Management System (QMS) in direction of the U.S. and Canada.
The MDSAP permits competent auditors of recognised auditing organisations, resembling BSI, to conduct a single audit of a medical system producer’s QMS, which satisfies the necessities of the totally different regulatory jurisdictions collaborating to the programme (at present being Australia, Brazil, Canada, Japan and the U.S.). Sequana Medical’s QMS has now been licensed based on the ISO 13485:2016 standards and the relevant necessities of the U.S. Food and Drug Administration (FDA) and Health Canada inside the scope of design, growth, manufacturing and distribution of energetic implantable pump methods to move fluids inside the physique.
Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “This MDSAP certification is a serious accomplishment and we’re very pleased with having this globally licensed QMS in place. We at Sequana Medical are absolutely dedicated to regulatory compliance and constantly hold our processes and approvals updated with altering and growing requirements worldwide. We are actually working arduous in direction of securing the Medical Device Regulation (MDR) certification, the brand new regulatory framework for medical units in Europe, for our alfapump system.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “This certification is a major achievement for our high quality and regulatory crew and demonstrates the dedication of your entire organisation in pursuing the best high quality requirements required by the totally different regulatory authorities. It types an essential ingredient of the package deal required for alfapump approval within the U.S. and Canada for sufferers with recurrent and refractory liver ascites. We look ahead to finishing enrolment in our North American pivotal POSEIDON research by the top of this yr and reporting on the first endpoint in This autumn 2022 following the robust interim outcomes reported earlier this yr.”
For extra data, please contact:
Director Investor Relations
Tel: +32 498 05 35 79
Guillaume van Renterghem
Tel: +41 76 735 01 31
About Sequana Medical
Sequana Medical is a business stage medical system firm using its proprietary alfapump® and DSR® (Direct Sodium Removal) applied sciences to develop revolutionary remedies for fluid overload in liver illness, malignant ascites and coronary heart failure the place diuretics are now not efficient. Fluid overload is a frequent complication of many giant illnesses together with superior liver illness pushed by NASH (non-alcoholic steatohepatitis)-related cirrhosis and coronary heart failure, with diuretic resistance being widespread. The U.S. marketplace for the alfapump ensuing from NASH-related cirrhosis is forecast to exceed €3 billion yearly inside the subsequent 10-20 years. The coronary heart failure marketplace for DSR and the alfapump DSR® is estimated to be over €5 billion yearly within the U.S. and EU5 by 2026.
The alfapump is a singular, absolutely implanted wi-fi system that routinely pumps fluid from the belly cavity into the bladder, the place it’s naturally eradicated by means of urination. DSR is Sequana Medical’s proprietary strategy to managing sodium and fluid overload by means of use of a sodium-free infusate administered into the belly cavity.
In the U.S., the Company’s key progress market, the alfapump has been granted breakthrough system designation by the FDA for recurrent or refractory ascites as a consequence of liver cirrhosis. Interim knowledge from the continuing North American pivotal research (POSEIDON) confirmed constructive outcomes in opposition to all major endpoints of the research and a speedy and protracted clinically essential enchancment in high quality of life. This research is meant to assist a future advertising and marketing software of the alfapump within the U.S. and Canada. In Europe, the alfapump is CE-marked for the administration of refractory ascites as a consequence of liver cirrhosis and malignant ascites and is included in key medical apply pointers. Over 850 alfapump methods have been implanted thus far.
Sequana Medical has mixed its confirmed alfapump and proprietary DSR remedy, and is creating the alfapump DSR, a breakthrough strategy to fluid overload as a consequence of coronary heart failure. RED DESERT, the repeated dose alfapump DSR research in diuretic-resistant coronary heart failure sufferers has demonstrated that repeated DSR remedy is ready to each handle the fluid and sodium steadiness of those sufferers in addition to restore their diuretic response and enhance their cardio-renal standing. The SAHARA DESERT research of alfapump DSR in decompensated coronary heart failure sufferers is ongoing.
Sequana Medical is headquartered in Ghent, Belgium. For additional data, please go to www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system will not be at present permitted within the United States or Canada. In the United States and Canada, the alfapump® system is at present below medical investigation (POSEIDON Study) and is being studied in grownup sufferers with refractory or recurrent ascites as a consequence of cirrhosis. For extra data concerning the POSEIDON medical research see www.poseidonstudy.com. The DSR® remedy remains to be in growth and it ought to be famous that any statements concerning security and efficacy come up from ongoing pre-clinical and medical investigations which have but to be accomplished. The DSR® remedy will not be at present permitted for medical analysis within the United States or Canada. There is not any hyperlink between the DSR® remedy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered emblems within the Benelux, China, the EU, United Kingdom, and Hong Kong.
This press launch might include predictions, estimates or different data that is likely to be thought-about forward-looking statements. Such forward-looking statements will not be ensures of future efficiency. These forward-looking statements signify the present judgment of Sequana Medical on what the longer term holds, and are topic to dangers and uncertainties that would trigger precise outcomes to vary materially. Sequana Medical expressly disclaims any obligation or endeavor to launch any updates or revisions to any forward-looking statements on this press launch, besides if particularly required to take action by legislation or regulation. You shouldn’t place undue reliance on forward-looking statements, which mirror the opinions of Sequana Medical solely as of the date of this press launch.
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