Creative Medical Technology Holdings Announces Mid-Term Follow-up Study Data Reporting Significant Reduction in Opioid Use by Chronic Lower Back Pain Patients Undergoing StemSpine® Procedure using AlloStem(TM)
MWN-AI** Summary
On February 14, 2025, Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) announced notable mid-term follow-up data from its pilot study on the StemSpine® procedure, utilizing the company's AlloStem™ cells to treat chronic lower back pain. The study revealed an impressive reduction in opioid dependency, with over 90% of participants reporting no opioid use for pain management three years post-procedure. Additionally, there was an 80% reduction in pain scores and over 60% improvement in the Oswestry Disability Index, indicating significant enhancements in functional mobility.
The StemSpine® procedure is a patented, non-surgical method leveraging ultrasound guidance and AlloStem™, an "off-the-shelf" allogenic cell therapy developed by Creative Medical Technology. This technique, which incorporates both autologous and allogenic cells, highlights its versatile clinical applications. Importantly, only one patient needed reintervention within the three-year timeframe, and no serious adverse events were reported, reinforcing the safety profile of the treatment.
Timothy Warbington, President and CEO of Creative Medical Technology, emphasized the importance of addressing opioid dependency in chronic lower back pain sufferers, commending the safety and clinical efficacy of AlloStem™ in facilitating tissue repair and improved vascularization. The encouraging data from the StemSpine pilot study aligns with the ongoing FDA-cleared Phase 1/2 ADAPT clinical trial of CELZ-201-DDT, which seeks further insights into addressing chronic lower back pain.
Creative Medical Technology continues to innovate within regenerative medicine, underscoring its commitment to developing non-surgical solutions for millions of Americans affected by chronic pain. Investors and stakeholders are encouraged to monitor the company's developments as it navigates the complexities of clinical trials and potential market opportunities.
MWN-AI** Analysis
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently reported groundbreaking data from its StemSpine® pilot study, showcasing a significant reduction in opioid use among chronic lower back pain patients treated with its AlloStem™ therapy. The results are particularly noteworthy, with over 90% of participants reporting no opioid use three years post-procedure, alongside substantial improvements in pain scores and functional mobility.
Investors should take several factors into account. First and foremost, the successful outcomes of the StemSpine® procedure could position Creative Medical Technology as a leader in the growing field of regenerative medicine, potentially attracting attention from healthcare providers and patients alike. The 80% reduction in pain scores and the low reintervention rate further solidify the treatment's efficacy and safety profile, which is critical for gaining regulatory approval and achieving wider market acceptance.
Additionally, the ongoing enrollment in the FDA-cleared Phase 1/2 ADAPT clinical trial for CELZ-201-DDT highlights the company's commitment to advancing its therapeutic pipeline. This diversification reduces dependence on a single product and mitigates risk, potentially positioning CELZ for rapid growth as these therapies move through clinical phases.
While the data is compelling, potential investors should also consider the inherent risks outlined in the company's forward-looking statements. The biotechnology sector is notoriously volatile, with regulatory approval processes and competitive pressures posing challenges. However, the favorable mid-term results can serve as a catalyst for stock performance in the near term.
In conclusion, Creative Medical Technology Holdings presents a promising investment opportunity for those seeking exposure to innovative healthcare solutions. As the medical community increasingly seeks alternatives to opioids, CELZ's advancements in chronic pain management may unlock significant market potential. Investors should closely monitor upcoming trials and broader industry trends to make informed decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PHOENIX, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ) , a pioneering biotechnology firm specializing in regenerative medicine solutions for immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced compelling mid-term follow-up data from its StemSpine ® pilot study utilizing its AlloStem™ cells for the treatment of chronic lower back pain.
The pilot study demonstrated a substantial reduction in opioid dependency and significant improvements in pain levels and functional mobility. Notably, over 90% of patients reported no opioid use for pain management three years post-procedure, with an 80% persistent reduction in pain scores and a greater than 60% improvement in Oswestry Disability Index scores. Only one patient required reintervention at the three-year follow-up mark, and no serious adverse events were reported, reinforcing the favorable safety profile of the StemSpine® procedure.
StemSpine® is a proprietary, patented, non-surgical, ultrasound-guided procedure that leverages AlloStem™, an "off-the-shelf" allogenic (donor-derived) cell therapy developed by the Company. The StemSpine ® patent encompasses the use of both autologous (patient-derived) and allogenic cells, broadening its clinical utility.
"Opioid dependency remains a pressing concern for individuals suffering from chronic lower back pain," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "These results underscore the safety and clinical efficacy of AlloStem™ in the StemSpine ® procedure by promoting repair, remodeling, and improved vascularization in the affected areas. This promising data supports our vision of providing innovative, non-surgical solutions for millions of Americans struggling with chronic lower back pain.”
The StemSpine pilot study data is independent of the Company’s ongoing FDA-cleared Phase 1/2 ADAPT clinical trial of CELZ-201-DDT for chronic lower back pain; however, these compelling findings continue to drive strong enrollment in the prospective, randomized, double-blind, dose-escalation ADAPT study, further reinforcing StemSpine ® as a groundbreaking advancement in regenerative medicine.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology, and orthopedics and is traded on NASDAQ under the ticker symbol CELZ. For further information about the Company, please visit www.creativemedicaltechnology.com.
Forward Looking Statements
This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.
Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com
FAQ**
What specific factors contributed to the reported over 90% of patients using no opioids for pain management in the Creative Medical Technology Holdings Inc. CELZ StemSpine® pilot study three years post-procedure?
How does the safety profile of Creative Medical Technology Holdings Inc. CELZ's StemSpine® procedure compare to traditional treatment options for chronic lower back pain?
In what ways will the compelling data from the StemSpine® pilot study influence the ongoing FDA-cleared Phase 1/2 ADAPT clinical trial for Creative Medical Technology Holdings Inc. CELZ-201-DDT?
What are the potential market implications for Creative Medical Technology Holdings Inc. CELZ following the positive mid-term results of the StemSpine® study in addressing chronic lower back pain treatment?
**MWN-AI FAQ is based on asking OpenAI questions about Creative Medical Technology Holdings Inc. (NASDAQ: CELZ).
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