On Apr. 13, 2020, Athersys announced the FDA has authorized the Company to initiate a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStemﾮ therapy in subjects with moderate to severe acute respiratory distress syndrome (ARDS) induced by the novel coronavirus disease (COVID-19).

This program falls under the current Investigational New Drug (IND) application for the Companyﾒs completed MUST-ARDS study and, therefore, a new IND does not need to be filed. The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter.