BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease

Data showed 50% or more of patients reporting >50% improvement in key pain and function scales 

No adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells

Presented at the 2026 Orthopaedic Research Society Annual Meeting

MELVILLE, N.Y., March 30, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX,” or the “Company”) (Nasdaq:BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities. Importantly, the Phase 2 study efficacy endpoint is a greater than a 30% improvement in both the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success. Chronic lumbar disc disease is a leading cause of chronic lower back pain and disability, affecting millions of patients globally and representing a significant unmet need for non-surgical regenerative therapies.

These data were presented at the 2026 Orthopaedic Research Society Annual Meeting on March 28, 2026 at the Charlotte Convention Center in Charlotte, North Carolina. The Company delivered these data in a presentation titled, “Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update.”

“These blinded data further support the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology, with patients demonstrating meaningful improvements across key pain and functional outcome measures,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Even with blinded data, this signal provides us with confidence in the ultimate outcome of the study, and optimism moving forward with regard to the ultimate potential for meeting a medical need that has, to date, been inadequately addressed.

“Importantly, the results also continue to reinforce the favorable safety and tolerability profile observed to date. In addition, following our recent Type B meeting with the U.S. Food and Drug Administration, we achieved alignment on key elements of a potential Phase 3 clinical trial for BRTX-100, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework. The agency did not raise safety concerns and confirmed that our CMC framework is appropriate for late-stage development.

“Taken together, these developments position the Company to transition from clinical evaluation toward registrational planning. As we move toward the planned unblinding of the Phase 2 study, we have begun preparing for the next stage of clinical development, including protocol planning and other Phase 3 readiness activities, while continuing to generate additional clinical data that may support the advancement and potential commercialization of BRTX-100,” concluded Mr. Alstodt.

Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the Visual Analog Scale (“VAS”), Oswestry Disability Index (“ODI”), Roland-Morris Disability Questionnaire (“RMDQ”), and Functional Rating Index (“FRI”), with responses sustained for up to two years in patients with longer-term follow-up.

On the VAS for pain, 53.57% of patients reported greater than 50% improvement at 26 weeks (n=28), with the percentage of patients that reported greater than 50% improvement increasing to 75% at 52 weeks (n=12) and remaining 75% at 104 weeks (n=4).

Similar improvements were observed on the ODI, a widely used measure of functional impairment associated with spinal disorders. Blinded results from the abstract showed 53.57% of patients achieved greater than 50% improvement at 26 weeks (n=28), increasing to 74.63% of patients at 52 weeks (n=12), with 50% of patients maintaining that level of improvement at 104 weeks (n=4).

Improvements were also observed on the RMDQ, with 57.14% of patients experiencing greater than 50% improvement at 26 weeks (n=28), 50% of patients at 52 weeks (n=12), and 75% of patients at 104 weeks (n=4).

FRI demonstrated continued improvement over time, with 35.71% of patients achieving greater than 50% improvement at 26 weeks (n=28), increasing to 66.67% of patients at 52 weeks (n=12) and 50% of patients at 104 weeks (n=4).

Finally, at 26 weeks (n=28) 41% of patients reported a 50% improvement in both ODI and VAS, 55% of patients achieved a 50% improvement in both ODI and VAS at 52 weeks (n=12), and at 104 weeks (n=4) 57% of patients met a 50% improvement in both ODI and VAS.

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 products are formulated and manufactured in our cGMP, ISO-7 certified clean room facility. Each product features a cell-based secretome enriched with exosomes, proteins, growth factors, peptides, and other carefully selected active ingredients. This proprietary biologic portfolio has been thoughtfully engineered to support skin health and longevity while addressing visible signs of aging and enhancing overall cosmetic performance. 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:
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Released March 30, 2026