Welcome to our dedicated page for Creative Medical Technology Holdings news (Ticker: CELZ), a resource for investors and traders seeking the latest updates and insights on Creative Medical Technology Holdings stock.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a pioneering biotechnology holding company dedicated to advancing regenerative medicine. Headquartered in Phoenix, Arizona, the company was incorporated in 1998 and operates as a subsidiary of Creative Medical Health, Inc. It leverages innovative stem cell research to develop therapeutic applications aimed at treating male and female sexual dysfunction, infertility, miscarriages, and related health issues.
The company's flagship product, marketed under the brand name CaverStem, specifically addresses erectile dysfunction (ED). CaverStem is offered to physicians to help patients suffering from ED through stem cell-based therapies.
In recent developments, Creative Medical Technology Holdings has seen notable success in the allogeneic cell therapy market. In Q4 2022, the company unveiled the development of AlloStem™, a cell line derived from human perinatal tissue, which incorporates a Master Cell Bank and a Drug Master File. The FDA has granted approval for the CELZ-201 program, allowing it to be used in early clinical trials for type 1 diabetes. The AlloStem™ line is also being employed in the company's StemSpine® procedure to treat chronic back pain, demonstrating significant reductions in narcotic usage and pain scores among treated patients.
Allogeneic cell therapy, a cornerstone of the company's research, involves using donated cells from a healthy individual to treat patients with otherwise intractable diseases. These therapies have shown great potential in providing curative options where traditional treatments have failed.
Creative Medical Technology is heavily involved in multiple clinical trials and continues to secure necessary regulatory approvals. The company’s financial health remains robust, with significant cash reserves and no long-term debt. Furthermore, Creative Medical Technology has built a strong intellectual property portfolio with over 68 patents and pending applications.
As of the latest updates, the FDA has cleared the company to proceed with a Phase 1/2 clinical trial of StemSpine® using AlloStem™ (CELZ-201-DDT) for chronic lower back pain. The IRB approval has been received, paving the way for a placebo-controlled study that will assess the safety, efficacy, and tolerability of the treatment.
Overall, Creative Medical Technology Holdings is poised at the forefront of regenerative medicine, leveraging cutting-edge stem cell technologies to develop transformative therapies for chronic and debilitating conditions. The company’s ongoing clinical trials and strategic partnerships underline its commitment to medical innovation and improving patient outcomes globally.
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.
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