DIRECT BIOLOGICS LLC

Company Overview

Direct Biologics LLC is a late-stage biotechnology company that manufactures regenerative biologic products. Direct Biologics’ proprietary extracellular vesicle (EV) products are isolated from human bone marrow mesenchymal stem/ stromal cells (MSCs) and contain growth factors and EVs, including exosomes. These products have anti-inflammatory and immunomodulatory properties and can heal damaged tissue through cellular regeneration.

Direct Biologics is currently conducting the global Phase 3 clinical trial of ExoFlo (a bone marrow mesenchymal stem cell-derived extracellular vesicles and exosome product) for treating hospitalized adults with moderate-to-severe acute respiratory distress syndrome (ARDS). ARDS is a common cause of respiratory failure and often complicates critical illness.

In addition, the company has initiated Phase 1 and 2 clinical trials with ExoFlo for the treatment of multiple diseases, including inflammatory bowel disease (ulcerative colitis and Crohn’s disease), perianal fistula, postviral syndrome, COVID-19, and dyspnea.

Company's Business Segments

• Regenerative Biologic : The company provides regenerative biologic products and new clinical and scientific information through thorough and rigorous research for healthcare providers and patients.