Innovations in Cellular Communication
Direct Biologics is a market leading innovator and cGMP manufacturer of regenerative biologic products, including ExoFlo™, a COVID-19 therapeutic geared solution, that leverages the regenerative properties of bone marrow mesenchymal stem cell (MSC)-derived extracellular vesicles. ExoFlo™ is currently used for investigational treatment of COVID-19 associated moderate-to-severe ARDS in an FDA approved clinical trial as well as an FDA approved Expanded Access Protocol for hospitals.
ExoFlo™ is an extracellular signal product and contains many important growth factors – proteins that provide communication between cells and instruct their function, from tissue repair to new blood vessel formation. ExoFlo™ is also an investigational product for COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).
The COVID Challenge
EXIT COVID-19 is a multi-center, randomized, double-blinded, placebo controlled trial investigating infusion treatment using bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicle product, ExoFlo™, in patients with COVID-19 associated moderate to severe Acute Respiratory Distress Syndrome (ARDS) at multiple research sites across the U.S. The primary efficacy endpoints will be all- cause mortality and median days to recovery.
Direct Biologics is also pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA’s investigational new drug (IND) application process.