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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) 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.
Creative Medical Technology Holdings (NASDAQ: CELZ) has signed an agreement with Greenstone Biosciences for the development of a human induced pluripotent stem cell (iPSC) pipeline, termed iPScelzTM, enhancing its ImmCelz® platform. This collaboration aims to leverage Greenstone's expertise in iPSC technology to improve patient care across various conditions such as stroke and diabetes. The agreement signals potential advancements in regenerative medicine, with the iPScelzTM project poised to enable sustainable large-scale production while reducing costs. The partnership is viewed positively by both companies' leadership.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has entered into a securities purchase agreement for a private placement, issuing 7,555,556 shares of common stock priced at $2.25 per share, with gross proceeds expected around $17 million. In addition, the company will issue warrants to purchase up to 15,111,112 shares, exercisable at $2.00 each. The funds will support ongoing clinical studies for their StemSpine® and ImmCelzTM platforms, among other initiatives. The deal is set to close on or about May 3, 2022.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) announced advancements in producing its ImmCelz® product, achieving higher volumes in under 72 hours through a novel cell-free supercharging solution. This method consistently maintains the potency of ImmCelz®, which uses adult stem cells to enhance immune response. The company is focusing on stroke first, seeking FDA approval for clinical trials. Future applications may address Type I diabetes, heart, liver, and kidney diseases, signaling strong potential for improving patient outcomes.
Creative Medical Technology Holdings (NASDAQ: CELZ) will showcase its patented CaverStem® procedure at the American Urological Association Annual Meeting on May 13-16, 2022, in New Orleans. This procedure utilizes patients' own stem cells to effectively treat erectile dysfunction. The company highlights landmark clinical trial results published in the Journal of Translational Medicine, demonstrating strong efficacy without major adverse effects. CaverStem® has garnered a growing physician network and offers optimized protocols that reduce costs and streamline treatment.
Creative Medical Technology Holdings (NASDAQ: CELZ) announced a Master Collaboration Agreement with the University of Miami to enhance the ImmCelz® Supercharged Autologous Immunotherapy Platform. This partnership aims to optimize the platform, involving adult stem cells to improve patients' immune response. The company is focusing on advancing therapies for conditions like stroke, type I diabetes, heart, liver, and kidney diseases. ImmCelz® is currently under FDA review for stroke clinical trials. The initiative seeks to accelerate research and clinical translation of promising results.
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