Latest news with #cLDD
Yahoo
09-06-2025
- Business
- Yahoo
BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025
– 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 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 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 KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@
Associated Press
16-04-2025
- Business
- Associated Press
BioRestorative Therapies Receives FDA Fast Track Approval For BRTX-100 To Treat Chronic Lumbar Disc Disease
By Meg Flippin Benzinga DETROIT, MICHIGAN - April 16, 2025 ( NEWMEDIAWIRE ) - When it comes to treating back pain, particularly chronic lumbar disc disease (cLDD), the industry is falling short. Sure there's surgery, but that's an invasive option that isn't always a success. Pain pills are another option, but that can lead to addiction and a severe change in a patient's quality of life. With more than 16 million Americans suffering from chronic back pain, curing it is a big need that has yet to be met. It's why the progress BioRestorative Therapies Inc. (NASDAQ: BRTX) is making with BRTX-100, its treatment for chronic back pain, is encouraging. The regenerative medicine company focused on stem cell-based therapies and products was just granted Fast Track designation by the U.S. Food and Drug Administration for BRTX-100, its developmental treatment for cLDD. Giving It A Speedier In FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions where there is an unmet medical need. Companies granted Fast Track status are able to have more frequent meetings and written communications with the FDA to discuss the drug's developmental plan, the design of proposed clinical trials and the use of biomarkers. Fast Track designation may also make the company's drug eligible for Priority Review and Accelerated Biologics License Application (BLA) approval. 'We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'Achieving Fast Track designation is an important milestone for BioRestorative, enabling us to work more collaboratively with the FDA as we continue to advance our lead BRTX-100 clinical program toward BLA approval to bring this important and novel stem cell therapy to the millions of cLDD patients waiting for effective pain relief and functional improvement.' Chronic Back Pain Costs Americans Billions Without a doubt, cLDD fits the bill for a disease with an unmet need, and many large companies like Pfizer, Abbott Laboratories and Eli Lilly are working on solutions. In the U.S. alone around 80% of adults experience at least one episode of lower back pain in their lifetime. What's more, low back pain is the most common cause of disability among adults 45 to 65 and imposes the highest economic burden on the U.S. healthcare system. Pain-related conditions cost the U.S. economy a staggering $635 billion annually in medical expenses and lost productivity. Back pain is by far the biggest culprit. Currently, there is no clinical therapy targeting the reversal of disc degeneration or that addresses intervertebral disc cell homeostasis, reports BioRestorative. It's also a big market opportunity for BioRestorative. The stem cell therapeutics market is projected to reach $54.7 billion by 2033, growing at a CAGR of 12.6% between now and then. It is being driven by demand for regenerative therapies and research grants in this area. BRTX-100's Promising Results BRTX-100 is an autologous stem cell product for chronic lower back pain. It uses a patient's stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of cLDD have been encouraging, reported BioRestorative. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose (40X10 6 cells) limiting toxicity at 26-52 weeks. At 26 weeks 70% of the patients reported a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, the company is confident it will hit its efficacy endpoints for the phase 2 trial. Chronic back pain is costly and greatly reduces the quality of life for the more than 16 million Americans who are suffering. BioRestorative wants to change that and believes BRTX-100 holds the answer. With Fast Track designation the company is working closely with the FDA to hopefully get this treatment in the hands of patients sooner, giving millions of people much-needed relief. Featured photo byGioele FazzerionUnsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere. View the original release on
