Creative Medical Technology Holdings, Inc.

PHOENIX--( BUSINESS WIRE )-- Creative Medical Technology Holdings, Inc., (NASDAQ:CELZ) , a leader in biotech innovation, today announced a major stride in combating Type 1 Diabetes Mellitus (T1D). The company has secured FDA authorization for an expanded access therapy using CELZ-201, a pioneering cell-based program in managing abnormal glucose tolerance and preventing T1D in high-risk individuals. This groundbreaking therapy uses CELZ-201 to potentially prevent T1D onset and is believed to be a first in medical history. This personalized medicine approach, focusing on a single high-risk patient, demonstrates the company's dedication to innovative, tailored healthcare solutions. Tim Warbington, CEO of Creative Medical Technology Holdings, Inc. shared his vision: "This is a historic moment. CELZ-201, developed after extensive research, represents our commitment to changing the T1D landscape. FDA clearance for this therapy underscores our drive to pioneer new pathways in disease prevention. Where there are no current treatments, we are hoping to provide new options." CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a T1D precursor, at the cellular level. It embodies hope for high-risk individuals, offering a proactive defense against T1D development. This aligns with the company's ethos of addressing diseases before they manifest, leveraging cutting-edge science for preventative care. Timothy Warbington added, "CELZ-201 symbolizes our dedication to safe, innovative treatments that have the power to change lives. This therapy is just the beginning of our journey to reshape the future of medical care for at-risk populations globally." About Creative Medical Technology Holdings, Inc. 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 . Special Note Regarding Forward Looking Statements NASDAQ Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. 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 .

PHOENIX--( BUSINESS WIRE )-- 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. Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is dedicated to progressing CELZ-101 through the necessary regulatory pathways, with the goal of transforming the therapeutic landscape for patients in need of islet transplantation. This achievement underscores the company's dedication to leveraging the natural regenerative capabilities of the human body to create lasting health solutions. About Creative Medical Technology Holdings, Inc. Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) 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. Creative Medical Technology Holdings is at the vanguard of regenerative medicine, focusing on the development and commercialization of breakthrough therapies for unmet medical needs. With a robust portfolio of innovative treatments, Creative Medical Technology Holdings is reshaping the future of healthcare by marrying advanced scientific research with the body's natural healing mechanisms. For further information about the Company, please visit www.creativemedicaltechnology.com . Special Note Regarding Forward Looking Statements NASDAQ Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. 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 .

PHOENIX, AZ / ACCESSWIRE / December 20, 2023 / Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a biotechnology company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative StemSpine® treatment known as AlloStem™. This study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT, a proprietary, ready-to-use cell line developed by the company. The trial will focus on individuals with chronic lower back pain, providing them with an AlloStem™ injection surrounding the affected disc(s) using an ultrasound-guided, non-surgical procedure that is radiation-free. This delivery method aims to repair and remodel the surrounding tissue, improving the blood supply to the affected area and potentially alleviating the chronic pain symptoms experienced by the patient. What sets AlloStem™ apart is its unique immunomodulatory formula derived from allogeneic perinatal cells. These cells have shown promise in tissue repair and can influence cytokine pro 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. The economic consequences of chronic back pain are also substantial, with billions of dollars spent each year on medical treatments, reduced productivity, and disability payments. According to a report by the National Institutes of Health, approximately $200 billion is spent annually on managing back pain. "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," said Timothy Warbington, CEO of Creative Medical Technology. "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." CELZ-201-DDT is unique because it 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 - paving the way for further research in regenerative medicine in areas of immunotherapy, endocrinology, gynecology, urology and orthopedics. "Chronic lower back pain is an increasing cause of disability globally," shared Courtney Bartlett, Director of Clinical Development. "This clinical trial sets the foundation to potentially help patients with a safer alternative therapy for chronic lower back pain as the procedure can be performed in the outpatient setting under direct ultrasound guidance, without any radiation exposure." The trial seeks to enroll approximately 30 individuals, and the company is hopeful that the study will provide the necessary information to move toward a new, innovative treatment for chronic lower back pain in the future. With the necessary endorsement from the FDA and an ongoing clinical trial, Creative Medical Technology's recent developments potentially set the stage for innovative treatment options that could significantly improve the lives of patients grappling with chronic pain and other diseases. Featured photo by Otto Norin on Unsplash. Contact: Apex The Equity Group Inc., Devin Sullivan dsullivan@equityny.com SOURCE: Creative Medical Technology Holdings, Inc. View the original press release on accesswire.com