Sequana Medical obtains MDSAP certification and expands its quality management system to North America
GHENT, Belgium, November 03, 2021 (GLOBE NEWSWIRE) – Sequana Medical NV (Euronext Brussels: SEQUA, the âCompanyâ), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that it has received Medical Device Single Audit Program (MDSAP) certification from its audit organization British Standards Institution (BSI), thus expanding its Quality Management System (QMS) to the United States and Canada.
The MDSAP enables competent auditors from recognized audit bodies, such as BSI, to perform a single audit of a medical device manufacturer’s quality management system, which meets the requirements of the various regulatory jurisdictions participating in the program. (currently Australia, Brazil, Canada, Japan and the United States). Sequana Medical’s QMS is now certified according to ISO 13485: 2016 criteria and the applicable requirements of the US Food and Drug Administration (FDA) and Health Canada as part of design, development, production and distribution of active implantable pump systems for the transport of fluids in the body.
Timur Resch, Global Vice President QM / QA / RA at Sequana Medical, said: âThis MDSAP certification is a major achievement and we are very proud to have implemented this certified QMS on a global scale. At Sequana Medical, we are fully committed to regulatory compliance and continually keep our processes and approvals up to date with changing and increasing standards around the world. We are currently working hard to obtain Medical Device Regulation (MDR) certification, the new regulatory framework for medical devices in Europe, for our alfapump system.
Ian Crosbie, Managing Director of Sequana Medical, added: âThis certification is an important achievement for our quality and regulation team and demonstrates the commitment of the entire organization to pursue the highest quality standards required by the various regulatory authorities. It is an important part of the package required for alfapump approval in the United States and Canada for patients with relapsing and refractory hepatic ascites. We look forward to completing recruitment into our North American Pivotal POSEIDON study by the end of this year and reporting the primary endpoint in Q4 2022 following strong interim results released earlier this year.
For more information please contact:
Investor Relations Director
Phone: +32 498 05 35 79
E-mail: [email protected]
Guillaume de Renterghem
Phone. : +41 76 735 01 31
E-mail: [email protected]
About Sequana Medical
Sequana Medical is a commercial-stage medical device company using its alfapumpÂ® and DSRÂ® (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-related cirrhosis and heart failure (non-alcoholic steatohepatitis), with resistance to diuretics being widespread. The American market for alfaThe pump resulting from NASH-related cirrhosis is expected to exceed â¬ 3 billion per year over the next 10 to 20 years. The heart failure market for RSD and alfaDSR pumpÂ® is estimated at more than 5 billion euros per year in the United States and in 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 removed through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and water overload through the use of a sodium-free infusion administered into the abdominal cavity.
In the United States, the Company’s main growth market, alfaThe pump has received revolutionary device designation from the FDA for recurrent or refractory ascites due to cirrhosis of the liver. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive results for all primary endpoints of the study and clinically important rapid and persistent improvement in quality of life. This study is intended to support a future commercialization application of alfapump in the United States and Canada. In Europe, the alfaThe pump is CE marked for the management of refractory ascites due to cirrhosis of the liver and malignant ascites and is included in major clinical practice guidelines. Over 850 alfapumping systems have been installed to date.
Sequana Medical has combined its alfapump and proprietary DSR therapy, and develops the alfaDSR pump, a revolutionary approach to fluid overload due to heart failure. RED DESERT, repeated dose alfaThe Pump DSR study in patients with diuretic resistant heart failure demonstrated that repeated DSR therapy is able to both manage the water and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal state. The study of the SAHARA DESERT alfaPump RSD in decompensated heart failure patients is ongoing.
Sequana Medical is headquartered in Ghent, Belgium. For more information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapumpÂ® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapumpÂ® is currently under clinical investigation (POSEIDON study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information on the POSEIDON clinical study, see www.poseidonstudy.com. The DSRÂ® the treatment is still under development and it should be noted that any statements regarding safety and efficacy arise from ongoing preclinical and clinical studies that have not yet been completed. The DSRÂ® the therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSRÂ® therapy and ongoing investigations with the alfapumpÂ® system in Europe, United States or Canada.
To note: alfapumpÂ® is a registered trademark. DSRÂ® and alfaDSR pumpÂ® are trademarks registered in Benelux, China, EU, UK and Hong Kong.
This press release may contain predictions, estimates or other information that could be considered as forward-looking statements. These forward-looking statements are not guarantees of future performance. These forward-looking statements represent Sequana Medical’s current judgment 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 commitment to publish any updates or revisions to any forward-looking statements contained in this press release, except as expressly required by law or regulation. You should not place undue reliance on forward-looking statements, which only reflect the views of Sequana Medical as of the date of this press release.