Fully enrolled, randomized, double-blind, sham-controlled Phase 2 study has completed treatment administration in 99 patients; Company continues Phase 3 readiness activities following FDA Type B meeting alignment
MELVILLE, N.Y., May 26, 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 the last patient has been dosed in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for the treatment of chronic lumbar disc disease (cLDD), completing treatment administration in the Company’s lead clinical program and advancing the study into the next stage of blinded follow-up ahead of expected topline safety and efficacy data in Q2 2027.
The prospective, randomized, double-blind, sham-controlled, single-disc Phase 2 study enrolled approximately 99 patients across U.S. clinical sites and is designed to evaluate the safety and preliminary efficacy of BRTX-100 in patients with painful chronic lumbar disc disease. Subjects were randomized in a 2:1 ratio to receive either BRTX-100 or control treatment. The primary safety endpoints for the trial include the frequency and severity of adverse events and serious adverse events, as well as imaging-related findings. The primary efficacy responder endpoint is defined as at least a 30% improvement from baseline in both pain — as measured by the Visual Analog Scale — and function –as measured by the Oswestry Disability Index, at week 52. Study follow-up assessments are being conducted at weeks 2, 12, 26, 52 and 104, with MRI evaluations at baseline, week 52 and week 104.
“Completion of dosing in our Phase 2 BRTX-100 trial represents an important transition point for BioRestorative,” said Lance Alstodt, BioRestorative Chief Executive Officer. “We have now completed treatment administration in a rigorously designed, randomized, double-blind, sham-controlled study of our lead regenerative spine candidate, and the program is moving through blinded follow-up toward the 52-week efficacy assessment and expected topline safety and efficacy data in the second quarter of 2027. Importantly, this milestone also comes as we continue Phase 3 readiness activities following our Type B meeting with the FDA, where the agency did not raise clinical safety concerns and provided alignment on key elements of the late-stage development pathway.
“With Phase 2 dosing now complete, we believe BioRestorative is positioned to advance the next phase of BRTX-100 development while reducing expenses and redirecting operational focus and resources toward additional value-creation priorities, including the continued commercialization of our BioCosmeceutical platform,” Mr. Alstodt continued. “Our objective is to build from this milestone with discipline, clinical rigor and a clear focus on advancing our regenerative medicine platform across both therapeutic and commercial opportunities.”
BRTX-100 is BioRestorative’s proprietary autologous, hypoxically cultured mesenchymal stem cell therapy designed for delivery into the harsh, low-oxygen, low-nutrient environment of the intervertebral disc. Patients in the trial received a single intradiscal injection of BRTX-100 consisting of 40 x 10^6 cells administered in approximately 1.5 cc through a minimally invasive outpatient procedure.
Eligible patients enrolled in the study were required to have chronic low back pain persisting for at least six months, failure of conservative therapy for at least six months, MRI-confirmed single symptomatic lumbar disc disease and minimum baseline pain and disability thresholds. Major exclusion criteria included prior lumbar surgery at the index level and prior biologic or cellular disc interventions.
BioRestorative has previously reported favorable blinded safety and preliminary efficacy data from the ongoing Phase 2 trial, including sustained improvements in pain and functional measures across multiple follow-up periods and MRI findings suggestive of potential disc remodeling in certain subjects. In previously disclosed blinded datasets, the Company reported clinically meaningful improvements across pain and function measures, including Visual Analog Scale, Oswestry Disability Index, Roland-Morris Disability Questionnaire and Functional Rating Index assessments. To date, the Company has reported no dose-limiting toxicities or serious adverse events related to BRTX-100 in the safety cohorts evaluated. These blinded findings have been presented at scientific and industry conferences and disclosed through prior Company announcements.
BRTX-100 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of chronic lumbar disc disease. BioRestorative previously announced a positive outcome from a Type B meeting with the FDA regarding key elements of a potential Phase 3 program and a pathway toward future BLA-enabling activities. The Company expects to continue advancing Phase 3 preparation activities while blinded follow-up in the Phase 2 study continues, with topline safety and efficacy data expected in Q2 2027.
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, 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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