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. (CELZ) is a biotechnology innovator advancing stem cell therapies for sexual health, chronic pain, and endocrine disorders. This page provides investors and industry observers with timely updates on clinical developments, regulatory milestones, and strategic partnerships driving the company’s regenerative medicine pipeline.
Access verified press releases and news articles covering CELZ’s research progress, including updates on its hypoimmune iPSC platform, AlloStem therapies, and licensing agreements. Content spans clinical trial results, intellectual property announcements, and collaborations in AI-driven drug discovery.
Key updates include advancements in non-invasive treatments for erectile dysfunction, infertility solutions, and chronic pain management protocols. Users will find essential information on FDA communications, trial design approvals, and peer-reviewed study publications.
Bookmark this page for centralized access to CELZ’s latest innovations in cellular therapy. Check regularly for objective reporting on developments impacting the company’s position in regenerative medicine markets.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has announced positive one-year follow-up results for CELZ-001, a treatment for Type 2 Diabetes, showing an overall efficacy of 93% among treated patients with a significant reduction in insulin requirements. The study involved 30 participants, of whom 15 received CELZ-001, with no serious adverse effects reported. This data supports the continued development of CELZ-001 in the context of the U.S. FDA cleared CELZ-201 clinical trial. The company plans to share these results at an upcoming endocrinology conference, indicating a commitment to advancing its unique cell-based therapeutic approaches for diabetes management.
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.
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