Amy Lightner

Direct Biologics is a late-stage biotechnology company specializing in regenerative medicine through the development of extracellular vesicle (EV) therapies. The company's lead product candidate, ExoFlo, is a bone marrow-derived mesenchymal stem cell (MSC) exosome therapy designed to modulate the immune system and promote tissue repair. Direct Biologics is currently advancing ExoFlo in a pivotal Phase 3 trial (EXTINGuish) for severe COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) and is exploring its potential in inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. Dr. Amy Lightner, a prominent surgeon and researcher, serves as the Chief Medical Officer, overseeing the clinical advancement of the company's regenerative platform. The company's technology leverages the signaling properties of MSC-derived exosomes to address complex inflammatory conditions with high unmet medical need.