Sedana Medical receives approval for AnaConDa in Japan

Sedana Medical AB (publ) (Sedana Medical or the company) announces today that the company has received market approval for AnaConDa from the Ministry of Health, Labour and Welfare (MHLW) in Japan.  Through the approval, AnaConDa can now be marketed, sold and used in intensive care for the administration of volatile anaesthetics for mechanically ventilated patients. Sedana Medical and their Japanese distributor, who will promote the product, are now preparing for market launch in Japan during 2019.

AnaConDa is Sedana Medical’s product for administration of volatile anaesthetics for mechanically ventilated patients in intensive care, and the Japanese approval means that the company´s distributor now is able to sell the product in Japan. Japan is the world’s third largest life science market, in terms of market value.

Sedana Medical estimates the number of mechanically ventilated patients in intensive care to correspond to slightly above 1 million 24-hour treatments annually. The company will approach the Japanese market with the same strategy as in Europe and primarily build up the use of AnaConDa in parallel to initiate an evaluation of the registration process for Sedana Medical’s drug candidate, IsoConDa (isoflurane).

"Of course, we are proud of the Japanese approval, which is in line with our strategy; to ensure that the use of AnaConDa and IsoConDa will become a global golden standard method for sedation of mechanically ventilated patients in intensive care. I am glad that we can now start selling in Japan, but the work still remains to get our drug IsoConDa registered. It's a process that can take several years, but with today's approval we can take care of the Japanese market seriously, "says Christer Ahlberg, CEO of Sedana Medical.

Sedana Medical’s market in brief

Sedana Medical's market consists primarily of mechanically ventilated intensive care patients. The market for sedation of mechanically ventilated intensive care patients today consists of established drugs that are administered intravenously. The target group the company is focusing on are those patients who are ventilated for more than 24 hours, a target group that globally amounts to between two and four million patients per year. In total, the company consider this to be a market of SEK 10-20 billion per year, of which Europe accounts for about SEK 6 billion.

For additional information, please contact:

Christer Ahlberg, CEO, Sedana Medical AB

Mobile: +46 70 675 33 30, E-mail: Christer.ahlberg@sedanamedical.com

Sedana Medical is listed on Nasdaq First North in Stockholm and Erik Penser Bank (+46 8 463 83 00) is certified adviser to Sedana Medical.

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on November 2, 2018 at 08:45 a.m. (CET).

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Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane)

Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.