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

New blinded data from ~45 patients to date in key pain and function scales and safety and tolerability of the Company’s proprietary hypoxic-cultured mesenchymal stem cells to be unveiled on March 28th at the 2026 Orthopaedic Research Society Annual Meeting

MELVILLE, N.Y., March 19, 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 that new blinded data on approximately 45 patients from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease will be presented at the 2026 Orthopaedic Research Society Annual Meeting. The meeting will be held March 27-31, 2026, at the Charlotte Convention Center in Charlotte, North Carolina.

Francisco Silva, BioRestorative’s Vice President of Research and Development, will present its poster, titled, “Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update,” on March 28, 2026. The Company will issue a press release pre-market that day, detailing the newly reported data. 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.

“The highly anticipated presentation of these blinded data will continue to generate interest around the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Following our recent Type B meeting with the U.S. Food and Drug Administration, we achieved alignment on key elements of a future Phase 3 clinical trial for BRTX-100, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework (subject to final review of a Phase 3 investigational new drug (IND) application submission). The agency did not raise safety concerns and confirmed that our CMC framework is appropriate for late-stage development. Therefore, we believe that the discussion around these blinded data, combined with our planned unblinding of the Phase 2 study, continues our progress towards the next stage of clinical development, including protocol planning and other Phase 3 readiness activities, which may support the advancement and potential commercialization of BRTX-100.”

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.

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