BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025
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Insights
BioRestorative's upcoming release of Phase 2 BRTX-100 data shows promising preliminary safety and efficacy signals for chronic lumbar disc disease.
BioRestorative Therapies is reaching a significant clinical milestone with their upcoming presentation of preliminary blinded data from 30 patients in their Phase 2 BRTX-100 trial at the prestigious ISSCR 2025 conference. This represents double the patient data previously reported, providing a more robust assessment of their lead candidate's performance.
The company's CEO statement that they're seeing "strong, consistent signals around both safety and functional improvement" is encouraging, though necessarily limited by the blinded nature of the data. This phrasing suggests positive trends, but investors should note that no specific efficacy metrics or statistical significance have been disclosed yet.
BRTX-100 represents an innovative approach using hypoxic-cultured, autologous mesenchymal stem cells to target damaged spinal discs with limited blood flow. The therapy's mechanism addresses a fundamental challenge in disc repair – poor vascularization – which has hindered many previous treatment approaches.
The Phase 2 trial design appears robust with its randomized, double-blinded, placebo-controlled structure and 2:1 randomization ratio, providing good statistical power. The planned enrollment of 99 patients across up to 16 U.S. sites represents a substantive clinical program for a company of BioRestorative's size.
The strategic selection of ISSCR 2025 – which draws nearly 4,000 leaders from academia, biotech, and pharma – maximizes visibility for these results within the scientific community. Notably, the company plans to issue a press release pre-market on June 13th, suggesting confidence in the data they'll be presenting.
– New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025 –
– ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma –
– BioRestorative to release new clinical data to the public prior to market open on June 13th –
MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the “Company”) (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong.
The highly anticipated presentation will be delivered by Francisco Silva, Vice President of Research and Development at BioRestorative, on Friday, June 13, at 5:00 p.m. HKT, as part of ISSCR 2025’s clinical innovations track. The Company will issue a press release pre-market that day, detailing the newly reported data.
“This represents a milestone moment for BioRestorative,” said Lance Alstodt, Chief Executive Officer. “With preliminary data from twice as many patients as previously shared, we are seeing strong, consistent signals around both safety and functional improvement. We are eager to bring this update to the global scientific community at the world’s most influential stem cell conference.”
BRTX-100 is BioRestorative’s lead clinical candidate — a hypoxic-cultured, autologous mesenchymal stem cell therapy designed to target areas of the body with limited blood flow, such as damaged spinal discs. The ongoing Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial evaluating BRTX-100 in patients with cLDD across up to 16 U.S. clinical sites. A total of 99 patients will be enrolled, randomized 2:1 to receive either BRTX-100 or placebo via a single intradiscal injection.
The presentation, titled “Stem Cell Therapy for Chronic Lumbar Disc Disease: Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,” will highlight key preliminary outcomes focused on patient-reported pain and function metrics, as well as safety endpoints.
About the ISSCR 2025 Annual Meeting
ISSCR 2025 is the largest and most influential gathering of stem cell scientists and regenerative medicine experts globally, attracting nearly 4,000 participants from over 80 countries. It serves as a key venue for groundbreaking clinical and translational research, offering BioRestorative a high-profile platform to share its latest advancements.
For more information on ISSCR 2025, visit www.isscr.org.
About BioRestorative Therapies, Inc.
BioRestorative (NASDAQ: BRTX) is a clinical-stage biotechnology company developing cell-based therapies using adult stem cells to address unmet needs in musculoskeletal and metabolic diseases. The Company’s pipeline includes BRTX-100, a novel therapy targeting chronic lumbar disc disease, and ThermoStem®, a platform focused on brown adipose (fat) biology for the treatment of obesity and metabolic disorders. The Company also operates a commercial BioCosmeceutical platform.
For more information, please visit www.biorestorative.com.
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.
Contact:
Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com
FAQ
What will BioRestorative Therapies present at ISSCR 2025 regarding BRTX-100?
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