Sedana Medical AB (publ) applies for registration of AnaConDa in Japan
Sedana Medical AB (”Sedana Medical” and “the Company”) has today submitted the application for registration of the medical device AnaConDa in Japan through its Japanese distributor.
AnaConDa is a patented medical device with a unique technology making it possible to sedate patients with volatile anaesthetics in intensive care units, so called inhalation sedation. AnaConDa was approved by the South Korean authority K-FDA on February 23, 2017, the first country in Asia to do so. Sedana Medical has today applied to the Japanese authority, the Pharmaceutical and Medical Devices Agency, for the registration of AnaConDa through its Japanese distributor. When approval is granted, Japan will therefore become the second country in Asia in which the AnaConDa is registered. The Company anticipates a registration process taking one to three years in Japan.
Sedana Medical previously signed an agreement with the Japanese distributor Mediconovus concerning rights to market and sell AnaConDa to Japanese hospitals.
“We are proud to be taking this step in our development. Japan is the second-largest market in Asia and is therefore important to us. This is entirely in line with our strategy of developing inhalation sedation therapy in intensive care. We are consequently taking a further major step towards realising our vision of making inhalation sedation with IsoConDa and the AnaConDa a global standard of care for the sedation of mechanically ventilated patients in intensive care,” says Christer Ahlberg, CEO of Sedana Medical AB (publ).
The 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: email@example.com
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 and Spain as well as external distributors in the rest of Europe, Middle East, Canada, Australia and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.