CELZ News & Events

Creative Medical Technology Holding announced interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201, the Company's proprietary perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease. The study produced statistically significant, clinically meaningful improvements in both functional disability and pain at primary trial end point, confirming durable human efficacy alongside an excellent safety profile. The announcement of this data follows a previously announced study enrollment completion and positive independent Data Safety Monitoring Board safety review, which confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial. Key Clinical Outcomes at Interim Analysis: ODI%: Mean improvement of -15.3 percentage points at 180 days. Approximately 79% of patients achieved clinically meaningful functional improvement. Pain: Mean reduction of -3.9 points at 180 days. Approximately 79% of patients achieved greater than or equal to2-point pain reduction. Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals, remaining blinded 4:1 treatment: placebo.

Creative Medical Technology announced that its BioDefense Burn Pit Initiative has received regulatory approval to proceed, marking a significant milestone in the Company's mission to address the long-term health consequences of toxic burn pit exposure among U.S. military veterans. Importantly, the Company also confirmed that no additional fundraising is required to execute this initiative, as the program will be supported through existing strategic partnerships, infrastructure, and previously established vendor relationships, resulting in meaningful cost efficiencies. The newly granted regulatory approval enables BioDefense to formally advance its Burn Pit Program, which is designed to build one of the most comprehensive molecular and cellular databases ever assembled for veterans affected by burn pit-related toxic exposure. With this clearance, the Company may now initiate expanded data collection, AI-driven molecular modeling, and regenerative countermeasure development using its proprietary induced pluripotent stem cell platform and analytical technologies.

Creative Medical Technology announced the completion of patient enrollment in its FDA-cleared ADAPT clinical trial evaluating CELZ-201, the Company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease. Enrollment completion follows a previously announced positive independent Data Safety Monitoring Board safety review, which confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial.