Creative Medical Technology Reports 93% Response Rate for Ultrasome™ in Knee Osteoarthritis Pilot Study
Key Insights
Ultrasome™ (search), a cell-free regenerative therapy derived from CELZ-201, achieved a 93% response rate in a knee osteoarthritis (search) pilot study with no serious adverse events reported.
The therapy leverages GMP-produced CELZ-201 (Olastrocel) (search) biological signaling components in a cell-free format, enabling scalable manufacturing and off-the-shelf availability.
Osteoarthritis affects over 30 million adults in the United States, representing a multi-billion-dollar market with limited treatment options beyond symptom management and invasive procedures.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) announced breakthrough positive results from its pilot study of Ultrasome™ (search), 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 93% of patients demonstrating clinically meaningful improvements in mobility and pain reduction, with the therapy well-tolerated and no serious adverse events reported.
The results position Ultrasome™ (search) as a potentially transformative option in a market where over 30 million adults in the United States suffer from osteoarthritis, representing a significant multi-billion-dollar opportunity. Current treatments remain limited to symptom management and invasive procedures, underscoring the unmet need for disease-modifying alternatives.
Platform Strategy: From Cell-Based to Cell-Free Regenerative Therapy
Ultrasome™ (search) is derived from the company's GMP-manufactured cell therapy product CELZ-201 (Olastrocel) (search), which is currently being evaluated in the FDA-cleared ADAPT clinical trial for chronic lower back pain (search) associated with degenerative disc disease (search). This relationship establishes a direct connection between CELZ's clinical-stage biologic platform and its next-generation cell-free regenerative strategy.
By leveraging the biological signaling components of CELZ-201 in a cell-free format, Creative Medical aims to enable scalable manufacturing, reduced cost of production, off-the-shelf availability, and simplified execution across outpatient settings. Ultrasome™ (search) 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."
Clinical Momentum Across the Pipeline
The Ultrasome™ (search) results arrive amid broader clinical momentum for Creative Medical. The company's ADAPT trial evaluating CELZ-201 (Olastrocel) (search) in chronic lower back pain (search) has completed enrollment of its original FDA-cleared cohort and reported positive interim 180-day data demonstrating statistically significant, clinically meaningful improvements in functional disability (ODI%) and pain, alongside an excellent safety profile.
The FDA has also cleared an expansion of the ADAPT trial, with an additional 15-patient cohort focused on patients receiving less than 90 mg per day in morphine equivalents. This expansion cohort is already more than 85% enrolled and leverages a newly implemented AI-driven pain medication monitoring system to capture rapid, accurate patient-reported outcome measures and analgesic-use patterns in real time.
The ADAPT trial remains supported by a favorable independent Data Safety Monitoring Board (DSMB) review, which reported no significant adverse events and recommended continued advancement of the program.
Addressing Unmet Needs in Osteoarthritis and Chronic Pain
Osteoarthritis and chronic lower back pain (search) represent two of the most prevalent and disabling conditions in the United States, with limited durable treatment options. Chronic lower back pain treatment pathways often include physical therapy, oral analgesics, steroid injections, chronic opioid use, or invasive spine procedures, yet many patients continue to experience persistent pain and functional impairment.
Drug overdose remains one of the nation's most urgent public health challenges, with opioids continuing to account for the majority of overdose deaths. Creative Medical believes the development of new non-opioid therapeutic approaches for chronic pain remains a critical medical and societal priority.
Next Steps and Strategic Outlook
Following the positive Ultrasome™ (search) pilot results, Creative Medical plans to expand clinical execution of the program, generate additional clinical data across regenerative platforms, and evaluate strategic pathways toward commercialization and partnerships.
On the ADAPT front, the company is actively preparing for Phase 3 discussions with the FDA focused on a broader chronic lower back pain (search) indication. The company expects to complete enrollment of the 15-patient expansion cohort before the end of summer 2026 using existing resources.
"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."