Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain
PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.
This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables the Company to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.
Transformative Regenerative Approach
CELZ-201-DDT, part of the Company's proprietary AlloStem® platform, is an allogeneic perinatal cell therapy administered via minimally invasive, ultrasound-guided intramuscular injections. The Fast Track designation was awarded based on compelling clinical data demonstrating a favorable safety profile and early signs of efficacy, marking a potentially significant step forward in redefining treatment standards for patients suffering from chronic back pain due to DDD.
"Fast Track designation from the FDA is both a validation of our scientific approach and a catalyst for value creation," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "Lower back pain from degenerative disc disease remains a leading cause of disability worldwide, and the opioid crisis underscores the urgent need for new, non-addictive solutions. As we near final enrollment in our FDA cleared clinical trial, we believe CELZ-201-DDT has the potential to transform patient care while driving shareholder value through accelerated development timelines."
Addressing a Large and Growing Market
DDD impacts millions of patients globally, with current options often limited to symptom management or invasive surgery. The Company's approach targets the underlying cellular degeneration and inflammation, aiming to restore function and improve quality of life. The global spinal disorders treatment market is projected to surpass $20 billion by 2030, highlighting the significant commercial potential for novel, effective therapies.
Next Steps and Expanded Access
In alignment with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), Creative Medical Technology will publicly post its expanded access policy for CELZ-201-DDT within 15 days of this announcement, with details available on the Company's website.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company advancing a pipeline of cell and immune therapies targeting unmet needs in neurology, urology, orthopedics, and autoimmune diseases. The Company leverages proprietary regenerative platforms and a robust regulatory strategy to accelerate development.
Forward Looking Statements
This press release contains forward-looking statements regarding regulatory milestones, clinical development, and the Company's strategic plans. Actual results may differ due to a range of factors, including regulatory risks and clinical outcomes. Creative Medical Technology assumes no obligation to update these statements, except as required by law.
| Contact: | ||
| Creative Medical Technology Holdings, Inc. | ||
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| www.creativemedicaltechnology.com | ||
| Investor Relations: | ||
| Devin Sullivan, Managing Director | Dave Gentry | |
| The Equity Group Inc. | RedChip Companies | |
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| Conor Rodriguez | ||
| Associate | Paul Kuntz | |
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