BioRestorative Announces Positive Outcome from Type B Meeting with FDA

Core Viewpoint - BioRestorative Therapies, Inc. has received positive feedback from the FDA regarding an expedited Biologics License Application (BLA) approval pathway for its BRTX-100 program aimed at treating chronic lumbar disc disease (cLDD) [1][6] Group 1: FDA Interaction and Approval Pathway - The Type B meeting with the FDA provided clarity for an expedited BLA approval pathway for the BRTX-100 program in cLDD [2][6] - The FDA endorsed the proposed Phase 3 study design, including outcome assessments, dosing strategy, and eligibility criteria [6] - The company plans to submit the Phase 3 IND application in the second half of 2026 [2] Group 2: Clinical Trial and Product Details - BRTX-100 is a novel cell-based therapeutic targeting areas with low blood flow, currently evaluated in a Phase 2 clinical trial involving 99 subjects across 15 clinical sites in the U.S. [5][7] - The trial has a randomized 2:1 design for BRTX-100 versus placebo, with ongoing positive safety and efficacy results [5][6] - The standard treatment for cLDD currently lacks therapies that reverse disc degeneration or address intervertebral disc cell homeostasis [4] Group 3: Company Overview and Other Programs - BioRestorative develops therapeutic products using adult stem cells, focusing on disc/spine disease and metabolic disorders [7] - The company is also developing a metabolic program targeting obesity using brown adipose-derived stem cells [8] - BioRestorative operates a BioCosmeceutical platform, offering a cell-based secretome product aimed at cosmetic effectiveness [9]