BioRestorative Therapies (OTCMKTS:BRTX) is a clinical-stage regenerative medicine company based in Fort Lauderdale, Florida, focused on advancing stem cell-based therapies to address unmet medical needs. Established in 2005, the company leverages a proprietary platform of adipose‐derived mesenchymal stem cells (MSCs) to develop treatments with potential immunomodulatory and anti‐inflammatory properties. BioRestorative’s research and development activities encompass preclinical and clinical programs designed to harness the regenerative capacity of MSCs for a range of serious conditions.
The company’s lead program, ORBCEL‐C, targets steroid‐refractory acute graft‐versus‐host disease (GvHD) in pediatric patients. ORBCEL‐C has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration, reflecting the program’s potential to offer a novel approach where existing therapies have limited efficacy. BioRestorative has also advanced Brio™‐RK, an investigational treatment for dry eye disease, through a pivotal clinical trial pathway, aiming to provide a single‐dose, cell‐based solution that addresses underlying pathology rather than only symptoms.
Beyond its lead assets, the company maintains a diverse pipeline that includes ORBCEL‐M for potential use in multiple sclerosis and additional early‐stage projects exploring MSC applications in ulcerative colitis and neurological disorders. BioRestorative collaborates with contract development and manufacturing organizations to produce clinical‐grade MSCs under Good Manufacturing Practice (GMP) conditions. These partnerships support scalable production and quality control as programs advance toward pivotal trials and potential commercialization.
BioRestorative serves the U.S. market while evaluating global expansion opportunities through strategic alliances. The company is led by President and CEO William Foley and a management team with extensive experience in biotechnology research, clinical development, and regulatory affairs. With a commitment to scientific rigor and patient impact, BioRestorative Therapies continues to pursue innovative stem cell therapies aimed at transforming treatment paradigms for challenging diseases.
