The company's therapeutic product candidate, ExoFlo, is designed to be a next-generation biologic utilizing its proprietary EV platform technology to reduce inflammation, promote healing at the cellular level, and repair tissues by activating self-repair and regenerative pathways.

Direct Biologics is currently conducting a Phase III EXTINGuish registrational clinical trial of ExoFlo for the treatment of hospitalized adults with severe or critical COVID-19 induced Acute Respiratory Distress Syndrome (ARDS). In addition, the company has initiated Phase I clinical trials with ExoFlo for the treatment of ulcerative colitis and Crohn’s disease and expanded access trials in solid abdominal organ transplant and severe COVID-19 ARDS patients.

The US biotech intends to pursue additional clinical applications including all-cause ARDS.