Creative Medical Technology Granted FDA Clearance for Chronic Back Pain Clinical Trial

Creative Medical Technology Holdings, Inc. (Nasdaq: CELZ) has received FDA clearance to conduct a phase 1/2 clinical trial using the company’s innovative StemSpine® treatment known as AlloStem™ (CELZ-201-DDT).

Timothy Warbington, CEO of Creative Medical Technology, said, “The FDA’s clearance and IRB approval allowing us to pursue this clinical trial is another milestone event for Creative Medical Technology and a validation of our commitment to developing and advancing novel regenerative therapeutics that can improve patient lives. An estimated 20% of Americans suffer from chronic lower back pain, with many of these individuals relying on opioids as the standard of care for relief. With an opioid crisis in the United States, we believe that CELZ-201-DDT is potentially a more effective, sustainable, and safer non-surgical pain management option compared to opioids, and we look forward to advancing these studies.”

Highlights

The company expects to enroll approximately 30 individuals with chronic lower back pain. Participants will receive an AlloStem™ injection surrounding the affected disc(s) using an ultrasound-guided, non-surgical, radiation-free procedure. The study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT.

CELZ-201-DDT uses a customized immunomodulatory formula made of perinatal cells derived from donors. Initial studies have shown that this formula has the potential for tissue repair and to change cytokine profiles, which play a crucial role in the body’s immune response and tissue healing processes.

Chronic back pain affects around 80% of adults. This long-lasting pain can greatly affect a person’s quality of life, causing limited mobility, challenges in performing daily tasks and an increased likelihood of depression and anxiety.

About Creative Medical Technology

Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel immediately deployable FDA registered 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.