BioRestorative Therapies announced that the U.S. Food and Drug Administration has granted the company a Type B meeting to discuss an accelerated Biologics License Application (BLA) pathway for its lead stem‑cell therapy, BRTX‑100, which targets chronic lumbar disc disease. The meeting is scheduled for mid‑December 2025 and will give the company a forum to present its Phase 2 data and request a faster review schedule for a Phase 3 trial.
The Phase 2 study, a randomized, double‑blind, placebo‑controlled trial involving 36 evaluable patients, showed that at 52 weeks post‑treatment more than 70 % of participants achieved a ≥50 % reduction in pain as measured by the Visual Analog Scale and a ≥50 % improvement in functional status on the Oswestry Disability Index. Safety data were favorable, with no serious adverse events related to the autologous mesenchymal stem‑cell injection. These results support the therapeutic benefit of BRTX‑100 and provide a strong evidence base for the accelerated approval request.
BRTX‑100 received Fast‑Track designation in February 2025, a status that allows for more frequent FDA interactions and eligibility for Priority Review. The Type B meeting is a critical step toward leveraging that designation to obtain an accelerated BLA, which could shorten the time to market by allowing approval based on surrogate endpoints and requiring post‑marketing confirmatory studies. An accelerated pathway would enable the company to bring a potentially transformative treatment to patients sooner and generate early revenue streams.
Chronic lumbar disc disease affects an estimated 10 % of adults in the United States, with an annual economic burden exceeding $30 billion in direct medical costs and lost productivity. Current standard therapies—surgery, physical therapy, and pain medication—often provide only temporary relief and carry significant risks. BRTX‑100’s stem‑cell approach offers a regenerative solution that could reduce the need for invasive procedures and improve long‑term outcomes, addressing a substantial unmet medical need in a large market.
Financially, BioRestorative recently completed a registered direct offering and a concurrent private placement to strengthen its balance sheet. While the company reported a net loss and negative operating margin in the most recent quarter, the new capital infusion and the projected revenue from a potential accelerated approval position the firm to fund the planned Phase 3 trial and support ongoing development activities. Management emphasized that the company’s cash runway is sufficient to sustain operations through the next 18 months, even with the additional costs associated with a Phase 3 program.
CEO Lance Alstodt said the Type B meeting “represents a pivotal moment in our journey to bring a regenerative therapy to patients with chronic lumbar disc disease. The data we will present demonstrate the safety and efficacy of BRTX‑100 and reinforce the FDA’s confidence in our accelerated approval strategy.” He added that the company remains focused on meeting regulatory milestones while maintaining disciplined capital management.
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