MELVILLE, N.Y., June 25, 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 the successful completion of manufacturing for its BRTX-100 Phase 2 clinical trial, marking a key milestone in the development of its lead cell therapy candidate and underscoring the strength of the Company’s vertically integrated regenerative medicine platform.
BioRestorative Therapies Announces Completion of BRTX-100 Phase 2 Manufacturing, Highlighting Integrated Regenerative Biologics Platform
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BioRestorative TherapiesBRTX-100chronic lumbar disc diseaseregenerative medicinestem cell based therapiesstructural disc repair
Manufacturing of the BRTX-100 clinical supply was completed in the Company’s cGMP ISO-7 certified facility, supporting ongoing clinical development for the treatment of chronic lumbar disc disease.
“This milestone reflects more than operational execution — it highlights the strategic advantage of our integrated manufacturing and biologics platform,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “We have built internal capabilities spanning cell sourcing, processing, formulation, and manufacturing, allowing us to control quality, consistency, and scalability across both our therapeutic and commercial programs.”
BioRestorative’s platform leverages a common biological foundation across multiple applications, including:
BRTX-100, a clinical-stage cell therapy targeting structural disc repair
BioCosmeceuticals, a commercial regenerative biologics platform utilizing secretome-derived components such as exosomes, growth factors, and cytokines
This shared infrastructure enables the Company to translate its cell-based technologies into both therapeutic candidates and commercially available biologic products.
“Our ability to control the full manufacturing lifecycle — from cell processing through final formulation — is a key differentiator,” said Suranga Suraweera, Director of Quality & Compliance. “This ensures traceability, reproducibility, and high biological integrity across all of our products, whether for clinical use or commercial applications.”
The Company believes this approach provides several strategic advantages:
Consistent, high-quality biologic production across multiple product formats
Scalable manufacturing infrastructure supporting both clinical development and commercialization
Proprietary process and formulation expertise, contributing to product differentiation and potential intellectual property protection
Dual-path value creation, combining near-term commercial opportunities with long-term clinical development
Completion of manufacturing positions BRTX-100 for continued clinical execution, while reinforcing the Company’s broader strategy of advancing regenerative biologics across both therapeutic and aesthetic markets. It also contributes to reduced manufacturing-related expense, translating into improved operating costs and margin.
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:
Investors
CORE IR
investors@biorestorative.com
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
BioRestorative Therapies completed manufacturing for its BRTX-100 Phase 2 clinical trial, leveraging a vertically integrated regenerative medicine platform. This strategy enhances quality control, consistency, and scalability for both therapeutic and commercial programs, reducing manufacturing costs. The dual-path approach combines long-term clinical development with near-term commercial opportunities in regenerative biologics, positioning the company for market differentiation and improved operating margins.
- The integrated manufacturing platform provides strategic advantages in quality, consistency, and scalability across therapeutic and commercial offerings.
- This approach supports dual-path value creation, combining clinical development for BRTX-100 with commercial BioCosmeceuticals, impacting market strategy.
PhD Lens: Clinical and outcomes impact
BioRestorative Therapies completed manufacturing for BRTX-100, an autologous mesenchymal stem cell therapy for chronic lumbar disc disease, in its cGMP ISO-7 facility. This clinical-stage product aims for structural disc repair via injection into damaged discs. The company's platform also includes ThermoStem for metabolic disorders and BioCosmeceuticals utilizing secretome-derived components, demonstrating broad application of cell-based technologies.
- BRTX-100 is an autologous mesenchymal stem cell product, manufactured in a cGMP ISO-7 facility, targeting structural disc repair in chronic lumbar disc disease.
- The platform leverages shared infrastructure for therapeutic candidates like BRTX-100 (Phase 2) and commercial biologics, ensuring traceability and biological integrity.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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