BioRestorative Therapies, Inc. announced that it has signed a clinical trial agreement with Northwell Health and Northwell's Feinstein Institutes for Medical Research. The signing of the agreement will allow Northwell Health to participate in BioRestorative Therapies ongoing Phase 2 clinical trial targeting chronic lumber disc disease (cLDD). BRTX-100, the Company's lead clinical candidate, is 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 to treat cLDD. The BRTX-100 approach involves an office based injection procedure which introduces the patient's own cells which have been uniquely expanded and conditioned to result in therapeutic impact within the harsh environment of the intervertebral disc and for an all too common pain which is otherwise not reliably treated. 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. 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. BioRestorative recently completed enrollment for the safety run-in phase of its Phase 2 trial.

Northwell Health is New York State's largest health care provider and private employer, with 21 hospitals, 850 outpatient facilities and more than 12,000 affiliated physicians. The partnership will enable Northwell to participate in BioRestorative's clinical trial targeting patients suffering from chronic lumbar disc disease.