Creative Medical Technology Holdings Highlights 93% Patient Response Rate and 65% Reduction in Average Pain Scores in Ultrasome™ Knee Osteoarthritis Study

Ultrasome™ shows 93% response and 65% pain reduction in small knee osteoarthritis study.

What the company is saying

Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is emphasizing strong interim clinical results for its investigational cell-free regenerative platform, Ultrasome™, following a presentation in Lima, Peru. The company highlights that 93% of 30 patients with bilateral knee osteoarthritis met study-defined response criteria over six months. Management stresses a 65% reduction in average pain score and a 52% reduction in WOMAC scores, framing these as meaningful improvements. The release also points to a 35-point increase in quality-of-life scores and the absence of serious adverse events, presenting the findings as a milestone for the platform. CEO Timothy Warbington is quoted to reinforce confidence in the scalability and biological activity of Ultrasome™, while acknowledging the study's open-label, single-arm design. The announcement positions these results as a rationale for further development and peer-reviewed publication, but does not claim regulatory approval or commercial readiness.

What the data suggests

The disclosed figures show that 28 of 30 patients (93%) met pre-defined clinical improvement criteria in a six-month, open-label pilot study for bilateral knee osteoarthritis. The average pain score for the group declined by 65% from baseline, and the average WOMAC score, which measures pain, stiffness, and physical limitations, dropped by 52%. Quality-of-life scores improved by about 35 points. No serious adverse events were reported during the follow-up period. Laboratory data are described as showing significant reductions in biomarkers for cartilage degradation and inflammation, but no quantitative values or statistical analyses are provided for these endpoints. The study lacks a control group, limiting the ability to attribute improvements solely to the intervention. The absence of financial, regulatory, or commercial data means the announcement is focused entirely on early clinical and laboratory signals.

Analysis

The announcement presents positive interim clinical results from a 30-patient open-label pilot study, with specific numerical improvements in pain, WOMAC, and quality-of-life scores, and no serious adverse events. However, the study lacks a randomized or sham-controlled comparator, and the product is not FDA-approved, limiting the immediate investment relevance. While most claims are realised and supported by disclosed data, some statements about laboratory findings and product characterization are qualitative and lack quantitative backing. Forward-looking language is present but limited, mainly relating to anticipated peer-reviewed publication and potential future advantages of the platform. The tone is optimistic, but the absence of financial data and the early-stage, non-comparative nature of the study mean the signal is at most weak_positive. The gap between narrative and evidence is moderate, with some inflation in describing the findings as a 'milestone' and emphasizing future potential without regulatory or commercial milestones achieved.

Risk flags

• ●The study is open-label and single-arm, with only 30 patients and no randomized or sham-controlled comparator, which increases the risk that observed improvements are due to placebo effect or selection bias rather than true efficacy.
• ●Ultrasome™ is not FDA-approved for knee osteoarthritis or any other indication, so there is no regulatory pathway or commercial timeline established, and future studies may not replicate these results.
• ●Laboratory findings and product characterization are described only qualitatively, with no quantitative biomarker or potency data disclosed, making it difficult to independently assess the robustness or reproducibility of the scientific claims.

Bottom line

Creative Medical Technology Holdings reports promising early clinical results for Ultrasome™ in knee osteoarthritis, with 93% of patients meeting response criteria and a 65% reduction in average pain scores over six months. The absence of serious adverse events and improvements in quality-of-life metrics are positive, but the study's small size, lack of a control group, and qualitative laboratory data limit the strength of the evidence. No regulatory progress or commercial milestones are reported, and the product remains investigational and unapproved. Investors should recognize that these results, while encouraging, are preliminary and require confirmation in larger, controlled studies before any commercial or regulatory value can be realized. The most important takeaway is that Ultrasome™ shows potential, but the pathway to approval and commercialization remains long and uncertain.

Announcement summary

(NASDAQ:CELZ) Creative Medical Technology Holdings, Inc. highlighted additional clinical and laboratory findings for Ultrasome™, its investigational cell-free regenerative medicine platform, following a presentation at the Annual Meeting of Experts in Cell and Gene Therapy on October 10, 2026, in Lima, Peru. The study evaluated 30 patients with bilateral knee osteoarthritis over six months. 28 of 30 participants (93%) met the study-defined response criteria for clinical improvement. The group’s average reported pain score declined by approximately 65% from baseline to six months. The 65% figure refers specifically to the reduction in the group-average pain score, not the percentage of patients reporting improvement. The average WOMAC score, reflecting osteoarthritis-related pain, stiffness, and physical limitations, was reduced by 52% over six months. The group’s average knee-related quality-of-life score increased by approximately 35 points. No serious adverse events were reported during six months of follow-up. Laboratory studies demonstrated significant reductions in biological markers associated with cartilage degradation and inflammatory signaling. Product characterization and functional potency testing provided encouraging findings supporting further evaluation of manufacturing quality controls and product consistency. The company anticipates that the full scientific findings, including detailed potency analyses, statistical evaluations, tables, and figures, will be included in a manuscript planned for peer-reviewed publication. Ultrasome™ builds upon Creative Medical’s regenerative medicine technology platform associated with CELZ-201 (Olastrocel), using extracellular-vesicle-rich secretome material in an investigational cell-free therapeutic approach. The company believes this strategy may offer potential future advantages in manufacturing, distribution, and development across osteoarthritis and other degenerative conditions. Timothy Warbington, President and Chief Executive Officer of Creative Medical Technology Holdings, stated that the findings represent an encouraging milestone for Ultrasome™ and reinforce the company’s focus on a scalable, biologically active regenerative medicine platform. The 30-patient study was an open-label, single-arm pilot without a randomized or sham-controlled comparator. Ultrasome™ is not FDA-approved for knee osteoarthritis or other indications.

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