Sedana Medical AB (publ) announced that the company has received approval from the central ethical committee for its pivotal phase 3-study in Germany, IsoConDa, to continue to use the original study protocol after certain clarifications. This means that the study will resume in full after it was restricted in April this year. The central ethical committee for the pivotal phase 3-study IsoConDa, in Saarbrûcken, Germany, has given its final approval to the changes in the study protocol suggested by Sedana Medical following remarks made in connection with an inspection and was communicated by the Company on April 10th this year. These changes are mainly clarifications concerning the patients and the methods for obtaining their consent to participate. The adjusted protocol was also approved by the above-mentioned inspectors as well as by the German medical authority BfArM. The company can now resume the study with full patient inclusion as soon as the participating medical centers have been educated on the updated study protocol. Sedana Medical expects to be able to communicate the result of the forthcoming interim analysis before year end 2018. The interim analysis will determine how many patients will be ultimately needed in order to show the result required to apply for an IsoConDa marketing approval in Europe.