Press releases

Disclaimer

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® 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 alfapump® system in Europe.

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GlobalData NASH Epidemiology Forecast to 2026

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Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370

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Kilgore et al. (2017); Ambrosy et al. (2014)

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Ginès et al. (2004) (déclarant que l’ascite réfractaire apparaît chez 5 à 10% des patients souffrant d’ascite)

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Runyon et al. (2009)

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World Health Organization International Agency for Research on Cancer 2018 (website) (estimated number of new breast and ovarian cases in 2018 (crude rate))

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Ayantunde et al. (2006)

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Benjamin et al. (2013)

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Costanzo et al. (2007)

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Kilgore et al. (2017)

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Estes et al. (2018)

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European Association for the Study of the Liver. EASL clinical practice guideliones on the management of ascites, spontane bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journel of Hepatology. 2010 vol. 53. 397-417. p. 402

Disclaimers

The alfapump® is still under clinical investigation in the US and Canada and therefore any statements regarding safety and efficacy do not apply in these territories.

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.

There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe, the US and Canada.

Sources

U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (https://www.cdc.gov/nchs/data/hus/hus16.pdf#020)
GlobalData NASH Epidemiology Forecast to 2026
Runyon et al. (2009)
Ginès et al. (2004) (stating refractory ascites occurs in 5 to 10 percent of patients with ascites)
European Association for the Study of the Liver. EASL clinical practice guideliones on the management of ascites, spontane bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journel of Hepatology. 2010 vol. 53. 397-417. p. 402
World Health Organization International Agency for Research on Cancer 2018 (http://gco.iarc.fr/today/home) (estimated number of new breast and ovarian cases in 2018 (crude rate))
World Health Organization International Agency for Research on Cancer 2018 (http://gco.iarc.fr/today/home) (estimated number of new breast and ovarian cases in 2018 (crude rate))
Benjamin et al. (2013)
Costanzo et al. (2007)
Kilgore et al. (2017)
Kilgore et al. (2017); Ambrosy et al. (2014)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370

Source

U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (web site)

Press team

IR@sequanamedical.com

Lies Vanneste
Director IR
Direct: +32 9 298 2864
Mobile: +32 498 053579

Sequana Medical NV
Technologiepark 122
9052 Zwijnaarde, Belgium

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