4 January 2021 - - The first patient has been treated under US-based Direct Biologics, LLC's expanded access protocol for ExoFlo Infusion Treatment for COVID-19 Associated ARDS (EXIT COVID-19), the company said.

The expanded access protocol is an open label study to treat patients who often have more advanced disease under a "compassionate use" application.

This study is under the same IND application utilizing bone marrow-derived extracellular vesicles to treat COVID-19-associated ARDS.

Extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) have been studied extensively in preclinical studies of lung disease and inflammation and are notable for their ability to downregulate inflammation and upregulate tissue repair.

ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells.

ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.

Direct Biologics is headquartered in Austin, Texas, with a recently expanded R and D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri.

Direct Biologics is a cGMP manufacturer of regenerative medical products, including a line of extracellular vesicle-based biological products.