Progress in Japan
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the first patient in Japan has been treated with AnaConDa and that the registration work for IsoConDa in Japan has been initiated. The Japanese market potential is estimated at EUR 300 million annually.
At the Shiga University Hospital, Shiga University of Medical Science Hospital, SUMS, the first patient has now clinically been treated with AnaConDa.
"The first patient in Japan is of course a milestone, but in addition, the AnaConDa treatment is currently being evaluated by the ethical committees of five university hospitals and signals are positive." said Christer Ahlberg, CEO of Sedana Medical.
Since November 2018, AnaConDa has market approval in Japan, but since the candidate drug IsoConDa (isoflurane) is not yet approved for sedation, the treatment - as in Europe - is classified as an "off-label" treatment. Therefore, the treatment must initially be approved by ethical committees at each hospital.
Sedana Medical and its Japanese Distributor's strategy for the Japanese market is the same as for the European market; the use of AnaConDa is increased in parallel with the registration work to get IsoConDa approved for inhalation sedation in intensive care. Sedana Medical is now starting preparations for a pre-IND meeting with Japanese authorities that is expected to be held next year.
"We are now in the starting blocks to now seriously get started with the registration work of IsoConDa. That being said, it is only after the pre-IND meeting that we know more about what will be required. If the authorities require a study in Japan, it could possibly be combined with the American study. I also expect that we will benefit greatly from our European dossier - in the Japanese market, but also in many other markets.” continues Ahlberg.
In connection with the initial registration work, Sedana Medical has updated the estimate of the Japanese market and now estimates that mechanically ventilated intensive care patients at Japanese ICU:s add up to three million ventilated treatment days annually (previous forecast just over one million), which gives an annual market potential of EUR 300 million.
For additional information, please contact:
Christer Ahlberg, CEO, Sedana Medical AB
Mobile: +46 70 675 33 30
Peter Sackey, CMO, Sedana Medical AB
Mobile: +46 70 771 03 64
Sedana Medical is listed on Nasdaq First North in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, 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, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.