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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
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"By Meg Flippin Benzinga\nDETROIT, 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. \n 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. \nGiving It A Speedier In \nFDA'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. \n\"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.\"\nChronic Back Pain Costs Americans Billions \nWithout a doubt, cLDD fits the bill for a disease with an unmet need, ...