Creative Medical Technology Holdings, Inc. Receives FDA Orphan Drug Designation for CELZ-101 in Key Transplantation Therapy

Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a leader in the field of regenerative medicine with a focus on developing novel therapies in immunotherapy, endocrinology, urology, gynecology, and orthopedics, is pleased to announce the successful receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CELZ-101, ImmCelz^TM. This cutting-edge therapy is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation, a significant advancement for individuals dealing with brittle Type 1 diabetes, a condition characterized by extreme fluctuations in blood glucose levels.

CELZ-101, also known as Supercharged Treg Biologic Immunotherapy (ImmCelz^TM), represents a state-of-the-art approach in personalized medicine, utilizing the patient's own regulatory T cells (Tregs) to combat autoimmune and alloimmune responses that can destroy insulin-producing cells. This innovative therapy is based on a proprietary process that not only expands Tregs but also enhances their functionality, offering a promising solution to reduce the need for lifelong immunosuppression.

Timothy Warbington, CEO of Creative Medical Technology Holdings, stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores our commitment to developing groundbreaking therapies. This important milestone propels us closer to offering a lasting solution for those grappling with the everyday hurdles of brittle Type 1 diabetes, marked by erratic fluctuations in glucose levels. It harmonizes with our mission to better patients' lives through the forefront of regenerative medicine. "

Dr. Courtney Bartlett, DNP, AGACNP-BC, CCRP, Director of Clinical Development, commented, "The development of CELZ-101 is a major step forward in the realm of cell-based immunotherapy. It addresses the critical need for more effective treatments in brittle Type 1 diabetes by aiming for operational tolerance in islet cell transplantation, potentially freeing patients from the burden of lifelong immunosuppression. We believe this is the first orphan designated, synergistic cell-based immunotherapy for brittle Type 1 diabetes."

“The Orphan Drug Designation by the FDA highlights CELZ-101's potential to meet a significant unmet need in the prevention of allograft rejection during pancreatic islet cell transplantation which was recently approved by the FDA. This designation provides multiple important benefits to support the therapy's development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval,” added Timothy Warbington, CEO of the Company.