BioRestorative Therapies, Inc. unveiled promising preliminary data for BRTX-100, a stem cell therapy targeting chronic lumbar disc disease (cLDD), at the ISSCR 2025 Annual Meeting in Hong Kong.

BRTX-100 utilizes the patient's own cultured mesenchymal stem cells sourced from their bone marrow, classifying it as an autologous therapy.

The therapy aims to alleviate pain from lumbosacral disc degeneration through a minimally invasive outpatient procedure.

Key trial results revealed that over 74% of subjects experienced more than 50% improvement in function after 52 weeks, while over 72% reported a similar reduction in pain.

The data indicates significant improvements were consistent across all timepoints measured in the trial, enhancing confidence in BRTX-100's efficacy.

The number of evaluated subjects in the Phase 2 clinical trial increased from 15 to 36, moving toward a target enrollment of 99 subjects.

Importantly, no serious adverse events or dose-limiting toxicities were reported during the trial, highlighting an excellent safety profile for BRTX-100.

Despite the positive results, the FDA's requirement for over 30% improvement in function and pain reduction poses a regulatory challenge for the trial's success.

The FDA has granted Fast Track designation to BRTX-100, recognizing its potential to address an unmet medical need.

Skepticism surrounding stem cell therapies may impact investor confidence, despite the trial's encouraging data.

BioRestorative's CEO expressed optimism about the therapy's trajectory, emphasizing its potential to tackle chronic lower back pain, a significant global health issue.

As of June 13, 2025, BioRestorative's stock price stands at $1.865, reflecting a 6.75% decrease over the last five days, though it has increased by 30.71% since the start of the year.