January 3, 2024 - Sequana Medical

Disclaimer

The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

[2] Quality of life as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)

[1] POSEIDON study results in SSED (PMA P230044, FDA approval letter on file) – 100% median reduction in number of therapeutic paracentesis per month in Pivotal Cohort

Disclaimers

The alfapump® system is currently not 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.
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 United States or Canada

Press team

IR@sequanamedical.com

Sequana Medical NV
Kortrijksesteenweg 1112
9051 Sint-Denijs Westrem
Belgium

Source

GlobalData NASH Epidemiology Forecast to 2026

Source

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

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

Source

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

Source

Runyon et al. (2009)

Source

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

Source

Ayantunde et al. (2006)

Source

Benjamin et al. (2013)

Source

Costanzo et al. (2007)

Source

Kilgore et al. (2017)

Source

Estes et al. (2018)

Source

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

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

Sequana Medical granted US CPT® III reimbursement codes for alfapump® system

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