Innovations in Cellular Communication

Discover the newest generation of naturally bioactive products for regenerative therapies. Direct Biologics offers a platform of regenerative products, including extracellular vesicles and placental-based allografts.

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.

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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.

Learn more about our Direct Biologics

We welcome your questions and inquiries – contact us today!