BioRestorative has FDA Fast Track designation for BRTX-100 and is pursuing an accelerated BLA pathway, with a Type B meeting with the FDA planned for mid-December to discuss timelines.

The mid-December Type B meeting will explore accelerating from Phase 2 toward a Phase 3 trial to support a BLA, leveraging the Fast Track status already granted.

Chronic lumbar disc disease (cLDD) is a common, costly condition with limited disease-modifying options, and current therapies mainly relieve symptoms rather than reversing disc degeneration or restoring cell homeostasis.

The article notes the lack of therapies that reverse disc degeneration or restore intervertebral disc cell homeostasis in cLDD, underscoring an unmet medical need.

Background details include cLDD context, BRTX-100’s production process, and the trial identifier NCT04042844 registered on ClinicalTrials.gov.

Phase 2 analyses to date report consistently positive safety and efficacy signals for BRTX-100, according to BioRestorative management.

BRTX-100 is an autologous cell therapy using a patient’s cultured mesenchymal stem cells from bone marrow, designed for non-surgical treatment of disc disorders, evaluated in a Phase 2 randomized, double-blind, placebo-controlled trial across up to 16 U.S. sites with up to 99 subjects.

The therapy targets disc degeneration-related back pain and is intended for outpatient injection into the damaged disc, with Phase 2 trial parameters including randomization and blinding.

The press release states plans to update investors after receiving FDA meeting minutes and includes standard forward-looking statements and investor relations contact information.

BioRestorative’s broader portfolio includes ThermoStem for obesity/metabolic disorders and a BioCosmeceuticals platform, with BRTX-100 as the lead candidate in the Disc/Spine program.

No numeric Phase 2 data or endpoints were disclosed in the release; the accelerated pathway depends on FDA feedback and the written minutes.

BioRestorative emphasizes consistently positive safety and efficacy signals from Phase 2 for BRTX-100 and intends to push for an accelerated timeline into Phase 3 to support the BLA.