Creative Medical Technology (US:CELZ) Globenewswire·2026-01-13 14:15Core Insights - The article highlights positive interim results from the FDA-cleared ADAPT clinical trial for CELZ-201 (Olastrocel), showing significant improvements in functional disability and pain, alongside a strong safety profile [1][10]. Clinical Outcomes - At the 180-day follow-up, there was a mean improvement of −15.3 percentage points in functional disability (ODI%) with a p-value of 0.0003, indicating a large effect size. Approximately 79% of patients experienced clinically meaningful functional improvement [10]. - Pain levels, measured on a 0–10 scale, showed a mean reduction of −3.9 points at 180 days with a p-value of less than 0.00005, also indicating a large effect size. About 79% of patients achieved at least a 2-point reduction in pain [10]. - An independent Data Safety Monitoring Board (DSMB) confirmed no serious adverse events and no treatment-related safety signals, maintaining a 4:1 treatment to placebo blinding [2][10]. Market Opportunity - Chronic lower back pain affects over 16 million Americans, representing a multi-billion-dollar annual market. Current treatments primarily rely on opioids, steroid injections, or invasive surgeries, which offer limited durable solutions [4]. Strategic Positioning - With the safety profile established and evidence of human efficacy, CELZ-201 (Olastrocel) is moving from execution risk to a phase focused on data-driven value creation. The company is preparing for late-stage regulatory engagement, strategic partnerships, and commercialization planning [5]. Company Overview - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company specializing in regenerative medicine therapies derived from adult and perinatal stem cell technologies. The company's pipeline targets large, underserved markets across various medical fields, aiming to provide scalable, disease-modifying solutions for patients with significant unmet medical needs [6].