All patients enrolled and treated across original and FDA-cleared expansion cohorts
Positive safety and early efficacy signals continue to support late-stage development planning for Olastrocel in chronic lower back pain
With enrollment and treatment completed, ADAPT-related clinical execution expenses are expected to decrease as the program transitions into follow-up, data maturation and regulatory planning
Company believes reduced enrollment- and treatment-related expenditures should help preserve capital, extend operating runway and support continued Phase 3 preparation without the immediate need for additional fundraising
Company remains fully engaged in patient follow-up, data collection, RMAT evaluation and preparation for Phase 3 discussions with FDA for a broader chronic lower back pain population
Olastrocel positioned as a potential non-surgical, non-opioid regenerative therapy for a large underserved market
PHOENIX, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced that all patients have now been enrolled and treated across the Company’s entire FDA-cleared ADAPT clinical trial evaluating CELZ-201 / Olastrocel, including the original study cohorts and the FDA-cleared opioid expansion cohort.
CELZ-201, also known as Olastrocel, is the Company’s proprietary perinatal tissue-derived, allogeneic regenerative cell therapy candidate being evaluated for chronic lower back pain associated with degenerative disc disease. The ADAPT trial is designed to evaluate the safety, tolerability and preliminary efficacy of CELZ-201 administered through a minimally invasive, ultrasound-guided intramuscular procedure.
The completion of enrollment and treatment across all ADAPT cohorts represents a major clinical, operational and financial milestone for Creative Medical. The program now transitions from an active enrollment and treatment phase into a focused follow-up, data maturation and regulatory planning phase. The Company expects ADAPT-related expenses associated with patient recruitment, screening, enrollment and treatment administration to decrease meaningfully as the study advances through follow-up and analysis.
Creative Medical believes this transition should help preserve capital, extend the Company’s operating runway and allow management to continue advancing Olastrocel toward RMAT (Regenerative Medicine Advanced Therapy) evaluation and Phase 3 planning in a disciplined and capital-efficient manner.
“Completing enrollment and treatment across the entire ADAPT trial, including the opioid cohort, is a defining achievement for Creative Medical and for the Olastrocel program,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “We believe the totality of data generated to date - including favorable safety observations, encouraging early efficacy signals and the ability to treat patients with ongoing opioid use -positions us to advance toward RMAT evaluation and prepare for Phase 3 discussions with the FDA for a broader chronic lower back pain population.”
Mr. Warbington continued, “Importantly, with enrollment and treatment now complete, we expect ADAPT-related clinical execution costs to decrease as we move into follow-up, data analysis and regulatory preparation. This should allow us to preserve capital, extend our operating runway and continue advancing Olastrocel in a highly disciplined manner. We believe this is exactly the type of milestone investors want to see: strong clinical execution, positive early signals, reduced near-term trial execution burden and a clearer path toward late-stage regulatory engagement.
“Chronic lower back pain remains one of the most significant drivers of disability, opioid exposure and healthcare utilization in the United States,” Mr. Warbington added. “Patients and physicians urgently need durable, scalable, non-surgical and non-opioid options. Olastrocel was developed to address that need, and we believe ADAPT is moving us closer to a potential new treatment paradigm for patients who have too few meaningful alternatives today.”
Building on Completed Enrollment, Positive DSMB Review and Interim Efficacy Signals
Creative Medical previously announced completion of enrollment in the original FDA-cleared ADAPT trial following a positive independent Data Safety Monitoring Board review. The DSMB confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial.
The Company subsequently announced positive interim 180-day follow-up data from ADAPT, including statistically significant and clinically meaningful improvements in functional disability and pain.
Previously reported interim outcomes included:
Functional Disability: Mean improvement in ODI% of −15.3 percentage points at 180 days, with approximately 79% of patients achieving clinically meaningful functional improvement.
Pain Reduction: Mean reduction of −3.9 points on a 0–10 pain scale at 180 days, with approximately 79% of patients achieving at least a 2-point reduction in pain.
Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals to date.
The Company believes these results, combined with the completed treatment of all ADAPT patients, strengthen the clinical foundation for Olastrocel and support the Company’s continued regulatory and strategic planning.
Opioid Cohort Completed and Treated
In June 2026, Creative Medical announced that FDA cleared an expansion of the ADAPT trial to enroll an additional cohort of patients with ongoing opioid use. The purpose of this cohort was to further characterize the safety, tolerability and potential clinical benefit of Olastrocel in a patient population that more closely reflects the real-world burden of chronic lower back pain, where opioid therapy remains common despite the urgent need for safer and more durable alternatives.
All patients in the FDA-cleared opioid expansion cohort have now been enrolled and treated. The Company remains actively engaged in follow-up and data capture, including patient-reported outcomes, pain-medication monitoring, functional-disability assessments and safety evaluations.
“The completion of treatment in the opioid cohort is particularly important because it allows us to evaluate Olastrocel in a clinically relevant population where the unmet need is significant,” said Mr. Warbington. “The opioid crisis continues to highlight the limitations of current chronic pain management, and our goal is to generate the type of rigorous data needed to support a differentiated, non-opioid regenerative therapy for patients suffering from chronic lower back pain.”
Capital-Efficient Transition to Follow-Up and Regulatory Planning
With enrollment and treatment complete across all ADAPT cohorts, Creative Medical expects the program’s near-term cost profile to shift meaningfully. The Company believes that expenses associated with patient identification, screening, recruitment, enrollment logistics and treatment procedures should decrease as the trial transitions into patient follow-up, data collection, statistical analysis and regulatory preparation.
Creative Medical believes this transition is important for shareholders because it allows the Company to continue advancing Olastrocel while reducing the direct clinical execution costs associated with active enrollment and treatment. The Company expects this capital-efficient phase to support a longer operating runway and provide additional flexibility as it prepares for potential RMAT evaluation, Phase 3 discussions with FDA and broader strategic-development opportunities.
The Company remains focused on disciplined spending, transparent data development and maximizing the value of the Olastrocel program without unnecessary dilution.
Preparing for RMAT Evaluation and Phase 3 Discussions
With all ADAPT patients now enrolled and treated, Creative Medical is advancing a multi-pronged late-stage development strategy for Olastrocel. The Company’s near-term priorities include:
- Continuing patient follow-up across all ADAPT cohorts;
- Completing data collection and analysis for safety, pain, functional improvement and opioid-use endpoints;
- Evaluating whether the emerging ADAPT dataset may support a request for Regenerative Medicine Advanced Therapy designation;
- Preparing for Phase 3 discussions with FDA for a broader chronic lower back pain indication;
- Assessing strategic and partnership pathways to support late-stage development and potential commercialization;
- Maintaining capital discipline as ADAPT transitions from enrollment and treatment into follow-up and analysis; and
- Preserving capital and extending operating runway while advancing Olastrocel toward late-stage regulatory engagement.
FDA’s RMAT pathway is intended for qualifying regenerative medicine therapies that are being developed for serious conditions and have preliminary clinical evidence indicating the potential to address unmet medical needs. Creative Medical believes the ADAPT dataset, once matured, may provide a strong basis to evaluate potential RMAT strategy and late-stage development opportunities for Olastrocel.
“ADAPT is no longer just an enrollment story - it is now a data, regulatory and execution story,” Mr. Warbington said. “Our team remains fully engaged in the follow-up phase, and we are focused on building the most complete package possible for regulatory engagement, RMAT evaluation and Phase 3 planning. We believe this program has the potential to create substantial value for patients, physicians and shareholders.”
A Large Market with High Unmet Need
Chronic lower back pain remains one of the most common and disabling medical conditions in the United States. Current treatment pathways often rely on physical therapy, oral analgesics, repeated steroid injections, chronic opioid use or invasive spine surgery, yet many patients continue to experience persistent pain, functional limitations and reduced quality of life.
Creative Medical believes Olastrocel is differentiated by several key attributes:
- Off-the-shelf allogeneic design, supporting scalability and consistency;
- Perinatal tissue-derived regenerative biology, designed to address inflammation and tissue-degeneration pathways;
- Minimally invasive administration, avoiding the burden of open surgery;
- Potential applicability across a broad chronic lower back pain population;
- Relevance to patients with ongoing opioid exposure;
- A development pathway supported by human clinical safety and early efficacy data; and
- A capital-efficient transition into follow-up and regulatory planning following completion of enrollment and treatment across the full ADAPT trial.
- The Company believes these attributes position Olastrocel as a potentially important therapeutic candidate in a large underserved market where durable, non-surgical and non-opioid solutions remain limited.
Strategic Outlook
Creative Medical believes the completion of enrollment and treatment across all ADAPT cohorts marks a major transition point for the Company. With the full treated population now in follow-up, the Company is focused on disciplined execution, transparent data development and regulatory preparation.
The Company expects that the matured ADAPT dataset may support multiple potential value-creation opportunities, including Phase 3 planning, RMAT evaluation, strategic partnering discussions and broader commercialization planning. At the same time, the Company believes that the completion of active enrollment and treatment should reduce near-term ADAPT-related clinical execution expenditures, helping preserve capital and extend the Company’s operating runway as it prepares for the next stage of development.
“Our mission is clear,” Mr. Warbington concluded. “We are working to advance Olastrocel from a promising clinical program into a potential late-stage regenerative medicine platform for chronic lower back pain. We believe the completion of treatment across the entire ADAPT trial brings Creative Medical meaningfully closer to that goal while placing the Company in a stronger capital-efficient position for the next phase of regulatory and clinical development.”
About CELZ-201 / Olastrocel
CELZ-201, also known as Olastrocel, is Creative Medical’s proprietary perinatal tissue-derived, allogeneic regenerative cell therapy candidate being evaluated for chronic lower back pain associated with degenerative disc disease. Olastrocel is designed as an off-the-shelf therapy administered through a minimally invasive, ultrasound-guided intramuscular procedure.
Olastrocel remains investigational and has not been approved by the U.S. Food and Drug Administration for any indication. Safety and efficacy have not been established.
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. The Company’s pipeline targets large, underserved markets across orthopedics, immunotherapy, endocrinology, urology and gynecology, with a mission to deliver scalable, disease-modifying solutions for patients with high unmet medical needs.
For more information, visit www.creativemedicaltechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding clinical development, patient follow-up, data collection, safety and efficacy signals, opioid-use monitoring, RMAT evaluation, regulatory strategy, potential FDA interactions, Phase 3 planning, strategic partnerships, commercialization potential, market opportunity, the potential therapeutic benefit of CELZ-201 / Olastrocel, the Company’s expected clinical-trial expenditure profile, the expectation that ADAPT-related enrollment and treatment costs will decrease, the Company’s ability to preserve capital, the potential extension of operating runway and the Company’s ability to execute its clinical and corporate strategy.
These forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Factors that could cause actual results to differ include, but are not limited to, clinical trial outcomes, patient follow-up and retention, data quality, regulatory decisions and timing, FDA feedback, the Company’s ability to obtain RMAT or other regulatory designations, manufacturing and supply considerations, costs associated with Phase 3 preparation, strategic-development activities, availability of capital, competitive dynamics, market conditions and other risks described in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to update forward-looking 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
