Creative Medical Technology Holdings announced that the U.S. Food and Drug Administration has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for treating degenerative disc disease, a major cause of chronic lower back pain and disability. The designation positions the therapy among a select group recognized for addressing serious medical conditions with high unmet need.
Regulatory Advantages and Development Acceleration
The Fast Track designation brings several tangible benefits to the development program. The company will now enjoy more frequent interactions with FDA reviewers, eligibility for rolling BLA submissions allowing sections to be submitted and reviewed as they're completed rather than waiting for the entire application, and potential priority review which can reduce approval timelines from 10 months to 6 months.
"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."
Novel Regenerative Therapeutic 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.
What makes this approach particularly noteworthy is its targeting of underlying cellular degeneration in disc disease rather than just masking symptoms. The company's approach targets the underlying cellular degeneration and inflammation, aiming to restore function and improve quality of life, representing a potential paradigm shift from current treatment options.
Market Opportunity and Unmet Medical Need
Degenerative disc disease impacts millions of patients globally, with current options often limited to pain management, anti-inflammatories, physical therapy, or invasive surgical procedures. The global spinal disorders treatment market is projected to surpass $20 billion by 2030, highlighting the significant commercial potential for novel, effective therapies.
Warbington noted that as the company nears final enrollment in its FDA cleared clinical trial, CELZ-201-DDT has the potential to transform patient care while driving shareholder value through accelerated development timelines.
Expanded Access and Next Steps
In alignment with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act, Creative Medical Technology will publicly post its expanded access policy for CELZ-201-DDT within 15 days of the announcement. The expanded access policy suggests the company is preparing pathways for patients with serious conditions to access the treatment outside of clinical trials, which aligns with regulatory expectations for promising therapies addressing significant unmet needs.
