Sedana Medical applies for market approval in Italy

Sedana Medical applies for market approval in Italy

PR Newswire

STOCKHOLM, Dec. 22, 2021

STOCKHOLM, Dec. 22, 2021 /PRNewswire/ -- Sedana Medical AB (publ) (Stockholm:SEDANA) today announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy.

"With the application in Italy, we are hoping to bring our Sedaconda products to yet another important European market. Having received market approval in 14 European countries to date, we are aiming to receive further approvals in Poland, Italy, Switzerland, and the UK during 2022. This would allow us to offer the first and only on-label therapy for inhaled sedation of mechanically ventilated intensive care patients in all major European markets." said Johannes Doll, CEO of Sedana Medical.

Sedaconda (isoflurane), which is administered via the medical device Sedaconda ACD, has shown important benefits over intravenous sedation in Sedana Medical's pivotal phase III study SED001, including reducing the need of opioids, facilitating spontaneous breathing, and enabling a faster and more predictable awakening. To date, Sedaconda (isoflurane) has been approved in Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Portugal, Slovenia, Spain, and Sweden.

For additional information, please contact:
Johannes Doll, CEO, +46 76 303 66 66
Susanne Andersson, CFO, +46 73 066 89 04
ir@sedanamedical.com

Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

About Sedana Medical

Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.

Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.

Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

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https://news.cision.com/sedana-medical/r/sedana-medical-applies-for-market-approval-in-italy,c3477287

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https://mb.cision.com/Main/15764/3477287/1513703.pdf

PR Sedana Medical (publ) Submission Italy 211222

 

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