BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (“cLDD”). The Type B meeting is scheduled for mid-December.

“During the Type B meeting with the FDA, we plan on discussing the consistently positive safety and efficacy signals from our ongoing Phase 2 clinical trial of BRTX-100 in cLDD, as demonstrated by every new data analysis completed to-date,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “We also intend to request an accelerated timeline for entering a Phase 3 trial to support our BLA application.”

In accordance with standard industry practice, BioRestorative plans to wait to provide investors with further updates on the Type B meeting until such time that it has received and reviewed the written meeting minutes from the FDA.

About Fast Track Designation

The FDA granted Fast Track designation to the BRTX-100 Phase 2 clinical trial for the treatment of cLDD in February 2025. This FDA program is aimed to facilitate the development, and expedite the review, of investigational treatments that are designed to treat serious conditions and have the potential to address significant unmet medical needs. Benefits of the program include early and frequent interactions with the FDA during the clinical development process, and stem cell product candidates with Fast Track designation may also be eligible for Priority Review and Accelerated BLA Approval.

About Chronic Lumbar Disc Disease

cLDD is a common, often confounding problem for patients and physicians. In the United States, at least 80% of adults experience at least one episode of lower back pain during their lifetime. Low back pain is the most common cause of disability among Americans between 45 and 65 years of age and imposes the highest economic burden on the U.S. healthcare system. The standard of care for treating cLDD involves conservative non-surgical approaches or surgical interventions that target symptomatic relief and musculoskeletal stabilization. Currently, there is no clinical therapy targeting the reversal of disc degeneration or that addresses intervertebral disc cell homeostasis.