Welcome to our dedicated page for Creative Med Technology Hldgs news (Ticker: CELZ), a resource for investors and traders seeking the latest updates and insights on Creative Med Technology Hldgs stock.
Creative Medical Technology Holdings, Inc. develops regenerative medicine and immune-cell therapies as a clinical-stage biotechnology company trading under CELZ. Company news centers on CELZ-201, or olastrocel, an allogeneic/perinatal tissue-derived cell therapy evaluated in the FDA-cleared ADAPT trial for chronic lower back pain associated with degenerative disc disease, and on platform extensions such as Ultrasome for knee osteoarthritis.
Recurring updates also cover WHO International Nonproprietary Name activity for cell-therapy assets, CELZ-101 Treg immunotherapy work, and BioDefense Inc., a wholly owned subsidiary focused on burn pit exposure research using iPSC technology, AI-enabled molecular modeling, and regenerative countermeasure development.
Creative Medical Technology Holdings (NASDAQ: CELZ) filed its Form 10-K for FY 2022 on March 31, 2023, detailing significant clinical and financial developments. The company reported cash reserves of $18.4 million and working capital of $15.4 million, sufficient to fund operations through March 2024. Despite unchanged gross revenue of $0.1 million, gross profit improved to $0.1 million. R&D expenses surged to $6.3 million due to various initiatives, leading to an operating loss of $10.2 million. Notably, the company advanced its clinical trials, including a Phase 1/2 trial for early Type 1 Diabetes, and gained Orphan Drug Designation for Brittle Type 1 Diabetes.
Creative Medical Technology Holdings (NASDAQ: CELZ) has filed an application with the U.S. FDA for Orphan Drug Designation (ODD) for its ImmCelz® platform, aimed at treating Brittle Type 1 Diabetes. Currently, there are no FDA-approved therapies providing a cure for this condition, which affects approximately 1.6 million people in the U.S. The application could grant benefits such as market exclusivity, exemption from application fees, and tax credits for clinical trials. The ImmCelz® platform is designed to enhance patient immune response without the need for immunosuppression, addressing the limitations of existing treatments like human islet cell transplantation.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced third-party validation of its ImmCelz® (CELZ-100) development program, highlighting a 400% increase in clinical grade cell production yield at the same cost as its first-generation ImmCelz line. The studies demonstrated effective suppression of effector T cells crucial for autoimmune patients while retaining a high number of functional T regulatory cells. The advancements allow for broader treatment options and improved safety for patients, accelerating clinical applications. The company's focus extends to multiple indications including Type I diabetes and heart disease.
Creative Medical Technology Holdings (NASDAQ: CELZ) has engaged Syneos Health (NASDAQ: SYNH) as the contract research organization for its Phase 1/2 clinical trial of CELZ-201, aimed at treating Type 1 Diabetes. This trial, set to begin in Q1 2023, follows Institutional Review Board approval and FDA clearance for the investigational new drug. CELZ-201 utilizes Perinatal Tissue Derived Cells to potentially address unmet medical needs in diabetes care. The company's CEO highlighted this milestone as a reflection of their commitment to innovative therapies. The economic impact of Type 1 Diabetes in the U.S. is significant, with costs reaching $14.4 billion.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced positive three-year follow-up data from its StemSpine® pilot study, showing continued efficacy for treating chronic lower back pain. The study, which utilizes a patient's own bone marrow aspirate, reported an 87% efficacy rate with no serious adverse effects. Notably, no patients required re-dosage or surgical intervention since the last follow-up. The patent also covers the use of allogenic cells, expanding treatment options for millions suffering from chronic pain. CEO Timothy Warbington emphasized the procedure's potential to repair and improve blood supply around the disc.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced on Feb. 8, 2023, that it received Institutional Review Board (IRB) approval to proceed with its Phase 1/2 clinical trial for the CELZ-201 cell therapy aimed at treating Type 1 Diabetes. This approval follows the FDA's clearance of their Investigational New Drug (IND) application within 30 days. The trial, conducted in collaboration with the University of Miami Health System, aims to assess the efficacy of CELZ-201, which is based on Perinatal Tissue Derived Cells (PRDC). The company sees potential in CELZ-201 to offer a breakthrough in Type 1 Diabetes treatment, which currently has limited options beyond insulin.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced FDA clearance of its Investigational New Drug (IND) application for AlloStem™, the first allogenic cellular therapy targeting Type 1 Diabetes (T1D) in the U.S. This milestone allows for the initiation of clinical trials (CELZ-201), expected to begin patient recruitment in Q1 2023. AlloStem™ utilizes Perinatal Tissue Derived Cells, offering potential benefits in treating T1D, which currently affects 1.6 million Americans. The company is committed to developing innovative immunotherapies to address unmet medical needs.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced the development of an allogenic cell line, AlloStem™, which includes a Master Cell Bank and a Drug Master File. This filing is intended for FDA registration, enhancing the company's immunotherapy and regenerative medicine initiatives. CEO Timothy Warbington emphasized the benefits of internal development over licensing agreements, reducing risk for various therapeutic programs, including those targeting Type 1 diabetes. The Drug Master File will aid in Orphan Drug Development and does not expire, offering a significant advantage in the biotechnology sector.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced positive two-year follow-up results from its StemSpine® study, demonstrating an 87% efficacy rate in treating chronic lower back pain. The procedure, using the patient's bone marrow aspirate, reported no serious adverse effects up to two years post-treatment. The company emphasizes this may help address the opioid crisis by offering a non-surgical option for millions suffering from chronic pain.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced positive results from a three-year follow-up study of its OvaStem® procedure, aimed at treating Primary Ovarian Insufficiency (POI). The study revealed a **90% efficacy** in improving hormonal function and a **70% success rate** in delivering healthy babies using the patients' own eggs. Importantly, there were **no serious adverse effects** reported. This innovative procedure, utilizing the patient's own bone marrow aspirate, represents a potential advancement in fertility treatment for women with POI, who typically face low chances of conception.