Creative Medical reported promising results for Ultrasome™, showing 93% patient response and 65% pain reduction in knee osteoarthritis study.
Quiver AI Summary
Creative Medical Technology Holdings, Inc. announced promising results from a clinical study of its investigational cell-free regenerative medicine platform, Ultrasome™, presented at a recent conference. The study involved 30 patients with bilateral knee osteoarthritis over six months, revealing that 93% of participants met predefined response criteria, with an average pain score reduction of approximately 65%. Additionally, significant improvements in symptoms and quality of life were reported, along with no serious adverse events observed. Supporting laboratory findings showed reduced biological markers tied to cartilage degradation. The company sees potential for Ultrasome™ in scalable regenerative medicine solutions for osteoarthritis. CEO Timothy Warbington expressed optimism around these findings, which will be part of future peer-reviewed publications.
Potential Positives
- 93% of participants in the study met criteria for clinical improvement, showcasing the effectiveness of the Ultrasome™ platform.
- The average pain score of participants decreased by approximately 65%, indicating significant pain relief for patients with knee osteoarthritis.
- No serious adverse events were reported during the six-month follow-up, highlighting the preliminary safety of the treatment.
- The company plans to publish detailed scientific findings in a peer-reviewed journal, which could enhance credibility and attract further interest in their research.
Potential Negatives
- Results were derived from a small open-label, single-arm pilot study, limiting the reliability of the findings compared to randomized or sham-controlled trials.
- Ultrasome™ is not FDA-approved for knee osteoarthritis or other indications, indicating that the product is still in a developmental stage with uncertain market availability.
- The Company acknowledges potential risks in reproducing preliminary findings in controlled studies and other challenges related to regulatory decisions and manufacturing, which may affect future progress.
FAQ
What are the key results from the Ultrasome™ study?
The study showed a 93% patient response rate with an average 65% reduction in pain over six months.
How many patients were involved in the Ultrasome™ study?
The study involved 30 patients with bilateral knee osteoarthritis.
What is the significance of the 65% pain score reduction?
The 65% pain reduction indicates a substantial improvement in the average pain experienced by patients after treatment.
What further findings support the development of Ultrasome™?
Laboratory studies showed significant reductions in biological markers linked to cartilage degradation and inflammation.
Is Ultrasome™ FDA-approved for knee osteoarthritis?
No, Ultrasome™ is currently not FDA-approved for knee osteoarthritis or any other indications.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
PHOENIX, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) ("Creative Medical" or the "Company") , a clinical-stage biotechnology company advancing regenerative medicine technologies, today 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 held October 10, 2026, in Lima, Peru.
The study evaluated 30 patients with bilateral knee osteoarthritis over six months and found that 28 of 30 participants (93%) met study-defined response criteria. Importantly, the group’s average reported pain score declined by approximately 65% from baseline to six months. The 65% figure refers to the reduction in the group-average pain score - not the percentage of patients reporting improvement.
Clinical Results: 93% Response and Meaningful Average Symptom Improvement
- 93% patient response: 28 of 30 participants met the study-defined criteria for clinical improvement.
- 65% reduction in average pain score at six months post intervention.
- 52% reduction in average WOMAC score: Mean scores reflecting osteoarthritis-related pain, stiffness and physical limitations improved over six months.
- Improved quality of life: The group’s average knee-related quality-of-life score increased by approximately 35 points.
- Preliminary safety: No serious adverse events were reported during six months of follow-up.
Additional Scientific Findings Support Ultrasome™ Platform Development
Complementing the clinical observations, laboratory studies demonstrated significant reductions in biological markers associated with cartilage degradation and inflammatory signaling. Product characterization and functional potency testing also 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.
A Scalable Cell-Free Regenerative Medicine Opportunity
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.
“These findings represent an encouraging milestone for Ultrasome,” said Timothy Warbington, President and Chief Executive Officer of Creative Medical Technology Holdings. “With 93% of patients meeting study-defined response criteria and an approximately 65% reduction in the group’s average pain score, we believe the results strengthen the rationale for further development. The additional potency findings reinforce our focus on a scalable, biologically active regenerative medicine platform with significant long-term opportunity.”
The 30-patient study was an open-label, single-arm pilot without a randomized or sham-controlled comparator.
About Ultrasome™
Ultrasome™ is Creative Medical’s investigational cell-free regenerative medicine platform utilizing extracellular-vesicle-rich secretome material. Ultrasome™ is not FDA-approved for knee osteoarthritis or other indications.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company developing regenerative medicine technologies, including cell-based and cell-free approaches, targeting significant unmet medical needs. For more information, visit www.creativemedicaltechnology.com .
Forward-Looking Statements
This press release contains forward-looking statements concerning Ultrasome™, future research, clinical development, regulatory pathways, manufacturing, potential applications and commercialization opportunities. Actual results may differ materially due to risks including the possible failure to reproduce preliminary findings in controlled studies, regulatory decisions, manufacturing challenges, financing needs and other factors described in the Company’s SEC filings. The Company undertakes no obligation to update these statements except as required by law.
Investor & Media Contacts
Creative Medical Technology Holdings, Inc.
[email protected]
www.creativemedicaltechnology.com
Investor Relations / The Equity Group Inc.
Devin Sullivan
[email protected]
Conor Rodriguez
[email protected]