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

Rhea-AI Summary

BioRestorative (NASDAQ:BRTX) has been granted a Type B meeting with the U.S. FDA to discuss a potential accelerated BLA approval pathway for the Fast-Track-designated investigational therapy BRTX-100 in chronic lumbar disc disease (cLDD).

The meeting is scheduled for mid-December 2025. Management said Phase 2 analyses have shown consistently positive safety and efficacy signals to date and that the company will request an accelerated timeline to enter a Phase 3 trial to support a BLA. BioRestorative will provide investor updates only after it has received and reviewed the FDA's written meeting minutes.

Positive

• Fast-Track designation for BRTX-100
• FDA granted a Type B meeting with mid-December timing
• Company reports consistent positive safety and efficacy signals from Phase 2
• Plan to request an accelerated Phase 3 timeline to support BLA

Negative

• No quantitative Phase 2 data or endpoints disclosed
• BLA pathway remains potential and depends on FDA feedback
• Investor updates delayed until FDA written meeting minutes are reviewed

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.

About BRTX-100

BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT04042844.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform:

• Disc/Spine Program (brtxDISC^™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

• Metabolic Program (ThermoStem^®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com

FAQ

What is the purpose of BioRestorative's Type B meeting with the FDA for BRTX (BRTX-100)?

To discuss a potential accelerated BLA approval pathway and request an accelerated timeline to enter Phase 3 for BRTX-100 in cLDD.

When is BioRestorative (BRTX) scheduled to meet the FDA to discuss BRTX-100?

The Type B meeting with the FDA is scheduled for mid-December 2025.

What clinical evidence did BioRestorative cite for BRTX-100 in the FDA meeting request?

The company cited consistently positive safety and efficacy signals from its ongoing Phase 2 trial, without disclosing numeric data.

Does the Type B meeting mean BRTX-100 will get accelerated BLA approval?

No; the meeting is to discuss a potential accelerated pathway, and any pathway depends on FDA feedback and written meeting minutes.

Will BioRestorative provide immediate investor guidance after the FDA meeting for BRTX (BRTX-100)?

No; the company said it will wait to provide updates until it has received and reviewed the FDA's written meeting minutes.

What regulatory designation does BRTX-100 hold that could speed review for cLDD?

BRTX-100 holds a Fast-Track designation, which can support expedited development and review discussions with FDA.