EQS-News: 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 by Gioele Fazzeri on Unsplash.

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