Creative Medical Technology Holdings Expands ADAPT Trial Under New FDA Clearance and Rapidly Advances Toward Phase 3 Planning for Olastrocel in Chronic Lower Back Pain

PHOENIX, June 22, 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 the U.S. Food and Drug Administration (FDA) has cleared an expansion of the Company’s FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel) for chronic lower back pain associated with degenerative disc disease.

Under the amended protocol, the Company is enrolling an additional 15 patients receiving less than 90 mg per day in morphine equivalents to further characterize safety and efficacy in patients with ongoing opioid use associated with the treatment of chronic lower back pain.

The new cohort is already more than 85% enrolled and leverages the Company’s newly implemented, patient-centric AI pain medication monitoring system to capture rapid, accurate patient-reported outcome measures and analgesic-use patterns in real time.

This expansion follows previously reported completion of enrollment in the original ADAPT study population and positive interim 180-day data demonstrating statistically significant, clinically meaningful improvements in functional disability (ODI%) and pain, together with an excellent safety profile.

The 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.

“The FDA’s clearance of this expansion cohort represents another important step in the clinical and strategic maturation of Olastrocel,” said Timothy Warbington, President and CEO of Creative Medical Technology. “With enrollment in our original ADAPT population completed, encouraging safety and efficacy signals, and the new less-than-90 mg morphine-equivalent cohort already largely enrolled, we believe we are rapidly building a robust, real-world data package around chronic lower back pain patients who urgently need non-opioid, disease-modifying options.

“We are now actively preparing for Phase 3 discussions with the FDA focused on a broader chronic lower back pain indication,” Mr. Warbington continued. “Our priority is disciplined execution: completing this expansion cohort, fully leveraging our AI-enabled, patient-centric monitoring platform, and positioning Olastrocel as a scalable, allogeneic regenerative solution in a market that still relies heavily on opioids, injections and invasive surgery. We believe this strategy has the potential to create significant value for patients and for our shareholders as we transition from a purely clinical story to a data-driven, late-stage development opportunity.”

Clinical and Technology Highlights

• ADAPT trial momentum: The ADAPT study previously met its interim 180-day endpoints with statistically significant and clinically meaningful reductions in functional disability (ODI%) and pain, alongside an excellent safety profile.
• Original cohort completed: Enrollment of the original FDA-cleared cohort was completed in December 2025 following a positive DSMB safety review.
• New under-90 mg morphine-equivalent cohort: The newly cleared cohort of 15 patients focuses on individuals receiving less than 90 mg morphine equivalents per day, providing a controlled view into Olastrocel’s performance in patients with ongoing but moderate opioid use.
• Rapid enrollment: Enrollment of this expansion cohort is already greater than 85%, and the Company anticipates completing enrollment before the end of summer 2026.
• AI-enabled monitoring: The expansion cohort incorporates the Company’s new AI-driven pain medication monitoring and patient-reported outcome system, designed to enhance data granularity, improve adherence to electronic diaries, and accelerate high-quality data capture for both pain and functional endpoints.

Addressing a Persistent Opioid and Chronic Pain Crisis

Chronic lower back pain remains one of the most common and disabling conditions in the United States, with limited durable treatment options for many patients. Current 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, and opioids continue to account for the majority of overdose deaths in the United States. Creative Medical believes the development of new non-opioid therapeutic approaches for chronic pain remains a critical medical and societal priority.

Olastrocel (CELZ-201) is designed as an off-the-shelf, allogeneic regenerative cell therapy intended to deliver a scalable, non-surgical treatment option for patients with chronic lower back pain associated with degenerative disc disease. The therapy is administered via a minimally invasive, ultrasound-guided intramuscular procedure.

Financial and Operational Positioning

The Company currently expects to complete enrollment of the 15-patient expansion cohort before the end of summer 2026 using existing resources and does not anticipate the need for additional resources to execute this specific trial expansion. The Company plans to use the expanded dataset, together with existing ADAPT safety and efficacy data, to support upcoming regulatory planning and Phase 3 discussions with the FDA. These discussions are expected to focus on the design of a potential pivotal program and the opportunity to evaluate CELZ-201 in a broader chronic lower back pain population.

“Every step forward in ADAPT brings us closer to our goal of changing the treatment paradigm for patients who have too few durable options today,” Mr. Warbington added. “Our mission is to advance CELZ-201 with discipline, transparency and urgency, while building a development pathway that can create meaningful value for patients, physicians and shareholders.”

The Company intends to continue operating in a capital-disciplined manner as it advances regulatory engagement, potential strategic partnerships, and broader commercialization planning around Olastrocel.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, the safety and efficacy of CELZ-201 (Olastrocel), the timing and completion of clinical trial enrollment, the design and impact of the AI pain medication monitoring system, the Company’s expectations regarding additional resource needs, its plans and timing for potential Phase 3 discussions and broader indications, and its views of market size and opportunity. These statements are based on current expectations, estimates and projections and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Risks and uncertainties include, but are not limited to, risks related to clinical trial conduct and outcomes, patient enrollment rates, regulatory review and feedback, manufacturing and supply, competition, macroeconomic conditions, capital markets, and the Company’s ability to execute its strategy. Additional information about these and other risk factors is contained in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. The Company undertakes no obligation to update any forward-looking statements except as required by law.

About CELZ-201 (Olastrocel)

CELZ-201 (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. CELZ-201 is designed to be an off-the-shelf therapy administered through a minimally invasive, ultrasound-guided intramuscular procedure.

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 CELZ-201 (Olastrocel) positioned as a lead clinical asset for chronic lower back pain and as the backbone for additional platform programs.

For more information, visit www.creativemedicaltechnology.com.

Contact
Creative Medical Technology Holdings, Inc.
Investor Relations: IR@CreativeMedicalTechnology.com

Devin Sullivan, Managing Director – The Equity Group Inc.
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Conor Rodriguez, Associate – The Equity Group Inc.
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