FDA Approves Orgenesis IDE for Pilot Clinical Trial of its Tissue Genesis Icellator2(R)

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, announces it has been granted Investigational Device Exemption (IDE) approval by the United States Food and Drug Administration (FDA) to conduct a first-in-human feasibility study of the Tissue Genesis Icellator2(R) to treat Acute Respiratory Distress Syndrome (ARDS) resulting from COVID-19 infection.

The Tissue Genesis Icellator2 is a point-of-care cell isolation device that rapidly recovers high yields of stromal and vascular cells (“SVF”) from adipose tissue (fat) to be used therapeutically. The SVF derived from the Icellator2 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patient’s lungs and other peripheral sites of inflammation. Published nonclinical and clinical evidence indicate that SVF from the Icellator2 may potentially: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect. Orgenesis believes the multiple mechanisms of action of the SVF derived from the Icellator2 are important to treat ARDS and other inflammatory disorders.

The FDA IDE approval covers 21 patients at one clinical site in the United States. This is the first trial approved by the FDA for intravenous administration of the SVF produced by the Icellator2.

The rates of hospitalized patients in the U.S. suffering from ARDS resulting from COVID-19 has declined significantly in recent months. Orgenesis will monitor and evaluate current clinical needs prior to initiating this approved pilot trial.   Orgenesis may consider amending its clinical development plan to target treatment of non-COVID-19 related ARDS or treatment of patients who have not recovered from prior COVID-19 infections (so called “long haulers”).

Matthew Lehman, U.S. POCare General Manager, stated, “We believe that the FDA’s IDE authorization of the Tissue Genesis Icellator2 clinical trial is a significant milestone for the Company. We are excited to move forward with clinical development of the Icellator to treat ARDS, COVID-19-related complications, and other serious conditions. Our interactions with the FDA through the IDE process will inform our development plans. We look forward to providing further updates on the progress of our Icellator2 clinical trial.”