Direct Biologics
Direct Biologics is a leading innovator and manufacturer of regenerative biologic products, including ExoFlo™, an investigational treatment for COVID-19 associated ARDS and other conditions.
Company Overview
Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative biologic products. The company specializes in the production of extracellular vesicles and placental-based allografts. Direct Biologics operates in FDA-inspected, ISO:9001 certified facilities with advanced cGMP equipment to ensure the highest standards in their product manufacturing and processing.
Regenerative Product Platform
Direct Biologics offers a wide range of regenerative products derived from human tissues. These include extracellular vesicles and unique placental-based allografts. The AmnioWrap2 and AmnioWrap3 allografts, for example, provide a protective barrier with key components such as an intact extracellular matrix, regulatory growth factors, and cytokines. These products are designed to support regenerative medicine and advanced therapeutic applications.
ExoFlo™ Therapeutic Solutions
ExoFlo™ is one of Direct Biologics' flagship products, leveraging the regenerative properties of bone marrow mesenchymal stem cell-derived extracellular vesicles. It contains over 1,000 regulatory proteins and is involved in cell-to-cell communication. ExoFlo™ is currently used in FDA-approved investigational clinical trials for COVID-19 associated moderate-to-severe ARDS and has received clearance for trials in treating perianal fistulizing Crohn’s disease. The product is isolated from living human bone marrow MSCs donors and purified using proprietary cGMP processes.
Clinical Trials and Research
Direct Biologics is actively engaged in several clinical trials to explore further applications of its extracellular vesicle biologic products. This includes the global Phase 3 EXTINGUISH ARDS clinical trial for treating moderate-to-severe acute respiratory distress syndrome. Additionally, Phase 1 trials have been initiated for treating ulcerative colitis and Crohn’s disease. The company is also conducting expanded access trials in areas such as solid abdominal organ transplantation and severe ARDS.
Locations and Facilities
Direct Biologics operates multiple specialized facilities to support its research and manufacturing needs. They have an R&D facility at the Center for Novel Therapeutics on the University of California at San Diego campus. Additionally, they maintain an operations and order-fulfillment center in San Antonio, Texas. These facilities are strictly monitored for environmental factors like temperature and humidity, ensuring optimal conditions for tissue processing and storage.