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Recent press releases and 8-K filings for CELZ.
Creative Medical Technology Holdings Announces Positive Interim Clinical Trial Data for CELZ-201
CELZ
New Projects/Investments
Revenue Acceleration/Inflection
- Creative Medical Technology Holdings announced positive interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), a perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease.
- The study demonstrated statistically significant and clinically meaningful improvements in both functional disability (ODI%) and pain, with a mean improvement of -15.3 percentage points in ODI% and a mean reduction of -3.9 points in pain at 180 days.
- An independent Data Safety Monitoring Board (DSMB) review confirmed a favorable safety profile for CELZ-201, with no significant adverse events.
- The company views this as a major corporate and clinical inflection point, transitioning CELZ-201 into a promising strategic asset, and is advancing toward late-stage regulatory engagement and strategic partnership discussions.
Jan 13, 2026, 2:15 PM
Creative Medical Technology Holdings Receives Regulatory Approval for Burn Pit Initiative
CELZ
New Projects/Investments
- Creative Medical Technology Holdings (CELZ) announced it has received regulatory approval for its BioDefense Inc. Burn Pit Initiative, which aims to address the long-term health consequences of toxic burn pit exposure among U.S. military veterans.
- The company confirmed that no additional fundraising is required to execute this initiative, as it will be supported through existing strategic partnerships and infrastructure, ensuring cost efficiencies and no incremental balance sheet pressure.
- This approval enables the company to advance expanded data collection, AI-driven molecular modeling, and regenerative countermeasure development using its proprietary induced pluripotent stem cell (iPSC) platform to build a comprehensive database for affected veterans.
Jan 6, 2026, 2:15 PM
Creative Medical Technology Holdings Completes Enrollment in ADAPT Trial
CELZ
New Projects/Investments
- Creative Medical Technology Holdings, Inc. (CELZ) has successfully completed patient enrollment in its FDA-cleared ADAPT clinical trial for CELZ-201 (Olastrocel), a cell therapy designed to treat chronic lower back pain associated with degenerative disc disease.
- This milestone follows a positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed a favorable safety profile for CELZ-201 with no significant adverse events.
- With enrollment now complete, the ADAPT program will transition to follow-up and data analysis, with the company anticipating topline safety and efficacy readouts and evaluating strategic pathways for late-stage development and commercialization.
Dec 17, 2025, 2:15 PM
Creative Medical Technology Holdings Issues Shareholder Letter Highlighting Clinical Progress and IP Strength
CELZ
New Projects/Investments
- Creative Medical Technology Holdings (CELZ) has evolved from proof-of-concept to clinical trials in 2025, leveraging its proprietary cellular platforms AlloStem, ImmCelz, and iPScelz for regenerative stem cell therapies.
- The company is advancing two FDA-cleared clinical programs: CELZ-201-DDT (ADAPT Trial) for chronic lower back pain, with topline results anticipated in the first half of 2026, and CELZ-201 (CREATE-1 Trial) for new-onset Type 1 Diabetes, with early data expected in 2026. These trials target markets estimated at approximately $11 billion and $35 billion annually, respectively.
- Creative Medical strengthened its intellectual property in Q3 2025 by securing two cornerstone U.S. patents expanding ImmCelz coverage to Type 1 Diabetes (expires 2043) and Heart Failure (expires 2042), contributing to a portfolio of over 60 patents and pending applications.
- The company is integrating Artificial Intelligence (AI) into its iPScelz platform to accelerate target discovery, optimize donor cell selection, and simulate in vivo behavior, positioning itself in "Regenerative Medicine 2.0".
Oct 27, 2025, 12:15 PM
CELZ Announces Patent Grants for Regenerative Immunotherapy
CELZ
New Projects/Investments
- Creative Medical Technology Holdings (CELZ) highlighted the 2025 Nobel Prize in Physiology or Medicine awarded for discoveries in regulatory T cells (Tregs), noting that its ImmCelz™ platform is designed to harness this biology.
- The company recently received two U.S. Patents for its proprietary ImmCelz™ platform: one for the prevention and/or treatment of Type 1 Diabetes (U.S. Patent Number 12931925B2, expires 2043-05-24) and another for the treatment of heart failure and/or post-infarct pathological remodeling (U.S. Patent Number 12385011B2, expires 2042-12-15).
- CEO Timothy Warbington stated that these patents establish an IP-fortified regenerative immunotherapy franchise with a runway extending to at least 2042, targeting significant market opportunities including over five million heart failure patients and six million refractory angina patients in the U.S..
- The Type 1 diabetes program aligns with the company's ongoing CREATE-1 clinical trial.
Oct 7, 2025, 1:15 PM
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