PRESS RELEASE
REGULATED INFORMATION
23 February 2021, 06:00 pm CET
Ghent, BELGIUM – 23 February 2021 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces today in accordance with Article 14 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the "Belgian Transparency Act") that it received transparency notifications from the shareholders listed below, notifying the number of voting rights attached to shares mentioned next to their respective names in the table below.
Reason for notification | Shares and voting rights held | ||
Number | % of total outstanding shares(1) | ||
NeoMed IV Extension Limited / NeoMed Innovation V Limited(2) | Passive crossing of a threshold | 4,270,807 | 23.16% |
LSP Health Economics Fund Management B.V.(3) | Passive crossing of a threshold | 1,706,077 | 9.25% |
Venture Incubator AG / VI Partners AG(4) |
Passive crossing of a threshold Downward crossing of the lowest threshold(5) |
N/A(5) | N/A(5) |
Notes:
To access copies of the aforementioned transparency notifications, reference is made to Sequana Medical's website (https://www.sequanamedical.com/investors/shareholder-information/).
Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (FSMA) is required by all natural and legal persons in each case where the percentage of voting rights attached to the securities held by such persons in the Company reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.
For more information, please contact:
Sequana Medical
Lies Vanneste
Director Investor Relations
Tel: +32 498 05 35 79
Email: [email protected]
LifeSci Advisors
Chris Maggos
Tel: +41 79 367 6254
Email: [email protected]
About Sequana Medical
Sequana Medical is a commercial stage medical device company developing the alfapump® platform for the treatment of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. 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 with diuretic resistance being widespread in both of these indications. The U.S. market for the alfapump® resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR® (Direct Sodium Removal) is estimated to be over €5 billion annually in the 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 for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application of the alfapump® in the U.S. and Canada. 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 800 alfapump® systems have been implanted to date. Building on its proven alfapump® platform, Sequana Medical is developing the 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 further supported by strong interim safety and efficacy results from the ongoing repeated dose alfapump DSR® study (RED DESERT) in heart failure patients.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers:
The
alfa
pump® system is not currently approved in the United States or Canada. In the United States and Canada, the
alfa
pump® system 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 regarding the POSEIDON clinical study see
www.poseidonstudy.com
. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the
alfa
pump® system in Europe, the United States or Canada.
Note: alfapump® is a registered trademark. DSR ® and alfapump DSR ® are registered trademarks in the Benelux.
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