BioRestorative Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain

Core Viewpoint - BioRestorative Therapies, Inc. has received FDA clearance for its Investigational New Drug application for BRTX-100, marking a significant advancement in the treatment of chronic cervical discogenic pain and expanding its clinical pipeline for chronic lower back and neck pain [1][2] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies, with its lead product BRTX-100 targeting chronic cervical discogenic pain and chronic lumbar disc disease [1][6] - The company utilizes autologous cultured mesenchymal stem cells from patients' bone marrow for its therapies, aiming to provide non-surgical treatment options for disc disorders [6][7] Clinical Pipeline - The FDA's IND clearance for BRTX-100 allows the company to conduct a Phase 2 study to evaluate the safety and preliminary efficacy of intradiscally injected BRTX-100 for patients with chronic cervical discogenic pain [2][7] - The company is also advancing its FDA Fast Track-designated program for BRTX-100 in chronic lumbar disc disease [2] Market Context - Chronic cervical discogenic pain is a significant public health issue, with a prevalence rate between 16% to 41%, making it one of the top five chronic pain conditions [4] - The condition is associated with structural disruptions and inflammatory reactions in cervical discs, which are rich in nerve fibers [4] Upcoming Events - BioRestorative will host a webcasted conference call to discuss its clinical pipeline and recent developments related to BRTX-100 [3]