Direct Biologics

Direct Biologics is a biotechnology company specializing in regenerative medicine, specifically using extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address various diseases. Their primary product, ExoFlo, is an investigational treatment currently undergoing clinical trials for multiple indications, including COVID-19-associated ARDS, ulcerative colitis, Crohn's disease, and perianal fistulizing Crohn's disease. Direct Biologics is committed to innovation, research, and patient safety, with a mission to be the global leader in regenerative medicine by delivering safe and effective treatments.

The company operates under a cGMP manufacturing model and has multiple facilities including its headquarters in Austin, Texas, an R&D facility at the University of California, San Diego, and an operations center in San Antonio, Texas. Their team possesses extensive experience in biologics research, development, and commercialization, making them a leader in the evolving field of biotherapeutics. Direct Biologics is actively pursuing additional clinical applications for ExoFlo through the FDA's investigational new drug application process, demonstrating their commitment to advancing regenerative medicine and improving patient outcomes.

Direct Biologics is a late-stage biotechnology company dedicated to becoming the global leader in regenerative medicine. They achieve this by using innovative science and rigorous research to discover, develop, and deliver safe and effective regenerative therapies that address multiple disease indications. Their mission is to be the global leader in regenerative medicine through discovery, innovation, advancement of science, and treatment of patients.

Direct Biologics promotes a culture focused on innovation, patient safety, and a commitment to scientific advancement. They prioritize research and development, emphasizing the use of cutting-edge technologies to improve patient outcomes. This is evident in their dedication to rigorous quality control measures, cGMP manufacturing processes, and the pursuit of multiple clinical trials across various disease indications. Their team boasts extensive experience in biologics research, development, and commercialization, reflecting their dedication to pushing the boundaries of regenerative medicine.