BioRestorative Therapies to seek FDA approval to expand BRTX-100 application

BioRestorative Therapies announced that it has entered into an agreement with the Bruder Consulting & Venture Group. BCVG has been engaged to assist the Company in seeking FDA approval of the expansion of the clinical application of BRTX-100. BRTX-100 is the Company’s lead clinical candidate, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial in chronic lumbar disc disease. The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, including a specific release criteria of 40 million cells intradiscally injected into the nucleus of the lumbar disc. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.