Creative Medical Technology Holdings, Inc. Reports Breakthrough 93% Response Rate in Ultrasome™ Knee Osteoarthritis Program, Expanding CELZ-201 Platform into Scalable Cell-Free Regenerative Therapies
Rhea-AI Summary
Creative Medical Technology Holdings (NASDAQ: CELZ) reported pilot results for Ultrasome™, a cell-free therapy derived from GMP-produced CELZ-201, showing a 93% response rate for clinically meaningful pain and mobility improvement in knee osteoarthritis and no serious adverse events.
The program links CELZ-201 to scalable, off-the-shelf cell-free manufacturing and the company plans expanded clinical work, additional data generation, and evaluation of commercialization and partnership pathways.
Positive
- 93% response rate in pilot study for clinically meaningful pain and mobility improvements
- No serious adverse events reported in the Ultrasome™ pilot
- Ultrasome™ derived from GMP CELZ-201, creating platform continuity with ongoing ADAPT trial
- Cell-free, off-the-shelf approach enables scalable manufacturing and reduced production cost
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
Pre-news, CELZ was down 0.87% with modestly elevated volume, while only one close peer, INAB, appeared on the momentum scanner, up about 5.13% without news. Other peers showed mixed single‑digit moves, suggesting the CELZ setup looked stock‑specific rather than part of a broad sector drive.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 10 | INN milestone | Positive | +1.6% | WHO proposed INN etaroleucel for CELZ‑101, reinforcing multi‑program positioning. |
| Jan 13 | Clinical interim data | Positive | -11.2% | Positive 180‑day ADAPT interim results for CELZ‑201 in chronic lower back pain. |
| Jan 06 | Regulatory approval | Positive | +9.3% | Regulatory approval for national BioDefense Burn Pit Initiative for veteran data collection. |
| Dec 17 | Trial enrollment complete | Positive | +1.2% | Completion of enrollment in FDA‑cleared ADAPT trial for CELZ‑201 Olastrocel. |
| Dec 02 | INN approval | Positive | -11.8% | WHO approval of olastrocel as INN for lead allogeneic cell therapy CELZ‑201. |
Positive clinical and regulatory milestones have produced mixed reactions, with both meaningful gains and double‑digit declines following upbeat news.
Over the last several months, CELZ has repeatedly highlighted progress for its CELZ‑201 platform. WHO INN milestones for olastrocel and etaroleucel in Dec 2025 and Feb 2026, completion of ADAPT trial enrollment on Dec 17, 2025, and positive ADAPT interim data on Jan 13, 2026 all underscored clinical advancement. Regulatory approval for the BioDefense Burn Pit Initiative on Jan 6, 2026 expanded its footprint. Today’s Ultrasome™ osteoarthritis data extends this CELZ‑201 foundation into cell‑free applications.
Regulatory & Risk Context
An effective S-3 shelf dated Nov 21, 2025 registers 2,790,340 common shares for resale by existing investors upon warrant exercise. The company will not sell shares in this offering and receives no proceeds from resales, though it would receive cash from warrant exercises. The prospectus notes that large secondary sales over time could pressure the share price.
Market Pulse Summary
This announcement highlights a strong clinical signal for Ultrasome™, with a 93% response rate and no serious adverse events in knee osteoarthritis, while strategically extending the CELZ‑201 platform into cell‑free therapies. Context from recent filings shows 2025 operating losses of about $6.1 million, minimal $6,000 revenue, and cash of roughly $7.2 million, underscoring ongoing funding needs. Investors may watch for larger, controlled trials, regulatory feedback, and how CELZ manages dilution and warrant‑related overhang.
Key Terms
osteoarthritis medical
AI-generated analysis. Not financial advice.
Ultrasome™ Demonstrates Strong Clinical Signal While Leveraging GMP-Produced CELZ-201 (Olastrocel) to Target Large, Underserved Osteoarthritis Market
PHOENIX, April 28, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced breakthrough positive results from its pilot study of Ultrasome™, the Company’s proprietary cell-free regenerative therapy for the treatment of osteoarthritis (OA) of the knee.
The study achieved its primary endpoint with an industry-leading
Ultrasome™ is derived from the Company’s GMP-manufactured cell therapy product CELZ-201 (Olastrocel), which is currently being evaluated in the Company’s FDA-cleared ADAPT clinical trial. This relationship establishes a direct connection between CELZ’s clinical-stage biologic platform and its next-generation cell-free regenerative strategy, expanding the potential applications of CELZ-201 into broader, high-volume indications.
Platform Expansion: Extending CELZ-201 into Cell-Free Regenerative Therapies with Ultrasome™
Creative Medical is leveraging the biological signaling components of CELZ-201 in a cell-free format, enabling scalable manufacturing, reduced cost of production, off-the-shelf availability, and simplified execution across outpatient settings. Ultrasome™ is designed to address osteoarthritis through targeted modulation of inflammatory signaling, suppression of cartilage degradation, and promotion of regenerative activity.
“This represents a significant evolution of our platform,” said Timothy Warbington, President and CEO. “By building on CELZ-201, we are advancing a cell-free regenerative approach that improves scalability and accessibility.”
A Large, Underserved Market with Clear Differentiation
Osteoarthritis affects over 30 million adults in the United States and represents a significant multi-billion-dollar opportunity. Current treatments are limited to symptom management and invasive procedures.
What Comes Next
Following these positive pilot results, Creative Medical plans to:
- Expand clinical execution of the Ultrasome™ program
- Generate additional clinical data across regenerative platforms
- Evaluate strategic pathways toward commercialization and partnerships
Management believes these initiatives represent multiple near-term value creation opportunities as the Company continues to execute on its regenerative medicine strategy.
“We are entering a phase where execution and data generation will drive value,” Warbington concluded. “Our objective is to leverage our platform across both cell-based and cell-free therapies to deliver meaningful outcomes for patients while building long-term shareholder value.”
About Ultrasome™
Ultrasome™ is Creative Medical’s proprietary cell-free regenerative therapy platform, derived from CELZ-201 (Olastrocel), designed to deliver biologically active regenerative signals through a minimally invasive procedure for the treatment of osteoarthritis and other degenerative conditions.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine therapies derived from adult and perinatal stem cell technologies. With a diversified pipeline spanning orthopedics, immunotherapy, endocrinology, urology, and gynecology, the Company is committed to translating cutting-edge science into transformative, accessible therapies for patients with high unmet medical needs. For more information, please visit www.creativemedicaltechnology.com
Forward-Looking Statements
This press release contains forward-looking statements regarding regulatory pathways, clinical development milestones, potential therapeutic applications, and the Company’s strategic outlook. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual outcomes to differ materially. These risks include, but are not limited to, clinical trial results, regulatory decisions, manufacturing challenges, market conditions, and other factors described in the Company’s filings with the Securities and Exchange Commission. Creative Medical Technology assumes no obligation to update such statements except as required by law.
Investor & Media Contacts
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
www.creativemedicaltechnology.com
Investor Relations
Devin Sullivan — The Equity Group Inc.
dsullivan@theequitygroup.com
Conor Rodriguez — The Equity Group Inc.
crodriguez@theequitygroup.com
