Core Insights - The U.S. FDA has granted Fast Track designation to Creative Medical Technology Holdings' investigational therapy CELZ-201-DDT for treating degenerative disc disease (DDD), which is a significant cause of chronic lower back pain and disability [1][2]. Company Overview - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, targeting unmet needs in various medical fields including neurology, urology, orthopedics, and autoimmune diseases [7]. Product Details - CELZ-201-DDT is an allogeneic perinatal cell therapy delivered through minimally invasive, ultrasound-guided intramuscular injections, showing a favorable safety profile and early signs of efficacy in clinical trials [3][4]. - The therapy is part of the proprietary AlloStem platform and aims to address the underlying cellular degeneration and inflammation associated with DDD [3][5]. Market Potential - The global spinal disorders treatment market is projected to exceed $20 billion by 2030, indicating substantial commercial opportunities for innovative therapies like CELZ-201-DDT [5]. Regulatory and Development Strategy - Fast Track designation allows the company to benefit from accelerated FDA interactions, rolling Biologics License Application submissions, and eligibility for priority review, potentially speeding up the path to market [2][4]. - The company plans to publicly post its expanded access policy for CELZ-201-DDT within 15 days of the announcement, in compliance with federal regulations [6].