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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) supports President Donald J. Trump’s executive order to expand access to in vitro fertilization (IVF). This aligns with their OvaStem® program, which has shown an 85% improvement in hormonal function and a 70% success rate in delivering healthy babies using a patient’s own eggs, with no safety concerns up to five years post-treatment. OvaStem® offers a novel alternative to traditional IVF by using a patient’s own cells, particularly benefiting those with Primary Ovarian Insufficiency (POI), who typically face a 5-10% chance of spontaneous pregnancy.
OvaStem® integrates the company's AlloStem® platform, already in two FDA-cleared U.S. clinical trials. Creative Medical Technology Holdings has also filed for Orphan Drug Designation for POI. The executive order, signed on February 18, 2025, mandates recommendations within 90 days to lower IVF costs, currently ranging from $12,000 to $25,000 per cycle. This initiative aims to make advanced fertility technologies more accessible.
CEO Timothy Warbington and Clinical Operations Director Courtney Bartlett emphasized the company’s commitment to providing safe, effective, and affordable infertility solutions. The company continues to advance its portfolio of regenerative medicine technologies to empower families and drive shareholder value.
Creative Medical Technology Holdings (NASDAQ: CELZ) has released mid-term follow-up data from its StemSpine® pilot study using AlloStem™ cells for chronic lower back pain treatment. The study showed remarkable results with over 90% of patients reporting no opioid use three years after the procedure, alongside an 80% reduction in pain scores and over 60% improvement in Oswestry Disability Index scores.
StemSpine® is a non-surgical, ultrasound-guided procedure utilizing AlloStem™, an 'off-the-shelf' donor-derived cell therapy. The procedure demonstrated strong safety with only one patient requiring reintervention at the three-year mark and no serious adverse events reported. The company is currently conducting an FDA-cleared Phase 1/2 ADAPT clinical trial, which is seeing strong enrollment driven by these positive pilot study results.
Creative Medical Technology Holdings (NASDAQ: CELZ) has announced promising one-year follow-up data from its AlloStem™ (CELZ-201) Type 2 Diabetes pilot study. The trial demonstrated an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported.
The study involved 20 patients, split equally between CELZ-201 treatment and optimized medical therapy. The treatment utilized the same infusion procedure approved for the company's FDA-cleared Type 1 Diabetes clinical trial. CELZ-201 is an off-the-shelf, universal allogenic cell line developed by the company.
Based on these results, Creative Medical Technology plans to advance AlloStem's development for late-stage Type 2 Diabetes treatment and explore additional therapeutic applications to expand their pipeline, which includes CELZ-201 for early-stage Type 1 Diabetes and CELZ-101 for brittle Type 1 Diabetes.
Creative Medical Technology Holdings (NASDAQ: CELZ) has expanded its collaboration with Greenstone Biosciences to enhance its iPSC platform development for diabetes treatment. The partnership will leverage Artificial Intelligence to advance their proprietary hypoimmune iPSC technology, including iPSC-derived pancreatic islet cells currently in clinical trials.
The collaboration aims to identify small molecules that enhance insulin secretion and implement multi-gene editing to develop next-generation hypoimmune iPSC lines with improved stealth, survival, and differentiation capabilities. The company expects this AI-driven approach to reduce R&D time by approximately 50% and generate millions in cost savings.
A key focus is addressing the challenge of immunosuppression in stem cell-based therapies, which can cause severe side effects. The development of multi-gene edited hypoimmune iPSCs aims to eliminate the need for immunosuppression, potentially improving patient outcomes in cell-based regenerative therapies.
Creative Medical Technology Holdings (NASDAQ: CELZ) has reported positive initial data from the first cohort of its Phase 1/2 clinical trial of CELZ-201-DDT, a stem cell-based treatment for chronic back pain caused by degenerative disc disease (DDD). The first cohort, consisting of 8 treated patients and 2 placebo recipients, completed the study phase successfully with no dose-limiting toxicities or serious adverse events.
The blinded preliminary data indicates promising therapeutic potential in pain relief and functionality improvement. The independent Data Safety Monitoring Board (DSMB) has recommended proceeding to the next cohort as planned. Enrollment for the second cohort is expected in Q1 2025.
Creative Medical Technology Holdings announced a successful independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial of CELZ-201, a perinatal tissue derived cell product for chronic lower back pain treatment. The DSMB reviewed safety data from the first five dosed patients and approved trial continuation, following a 30-day dose-limiting toxicity assessment. The ADAPT trial is a double-blind, randomized, placebo-controlled, dose-escalation study evaluating CELZ-201's safety and efficacy when administered intramuscularly. The treatment targets approximately 16 million US patients suffering from chronic lower back pain associated with degenerative disc disease.
Creative Medical Technology Holdings (NASDAQ: CELZ) has announced a $1.85 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 418,552 shares at $4.42 per share. Additionally, in a concurrent private placement, the company will issue warrants to purchase up to 837,104 shares with an exercise price of $4.42 per share, exercisable upon stockholder approval and valid for five years. Roth Capital Partners is the exclusive placement agent. The proceeds will be used for working capital and general corporate purposes. The closing is expected around October 23, 2024.
Creative Medical Technology Holdings (NASDAQ: CELZ) has initiated a program to diagnose and treat patients exposed to biological and chemical weapons. The program combines Artificial Intelligence (AI) with the company's proprietary human induced pluripotent stem cells (iPSC) from its iPSCelz® program. AI will be used to identify damage in exposed patients, and based on the clinical diagnosis, the company's validated iPSC Inducible Pluripotent Mesenchymal Cells will be used for personalized treatment. This initiative aligns with Creative Medical Technology's focus on regenerative approaches to immunotherapy, urology, neurology, and orthopedics.
Creative Medical Technology Holdings (NASDAQ: CELZ) has provided a corporate update, highlighting significant developments in 2024. The company has produced over six billion clinical-grade AlloStem™ cells, filed a Drug Master File with the FDA, and received multiple IND clearances and Orphan Drug Designation for CELZ-101. Key clinical trials for Type 1 Diabetes and Chronic Lower Back Pain are actively recruiting. Additionally, the company announced the successful generation of human insulin-producing cells via its iPSCelz™ program and expects to report $7.5 million in cash with no long-term debt as of June 30, 2024. An annual stockholders meeting is scheduled for July 19, 2024, with a significant proposal to increase the number of authorized shares from 5 million to 25 million.
Creative Medical Technology Holdings (NASDAQ: CELZ) has successfully generated human insulin-producing Islet Cells derived from induced pluripotent stem cells (iPSC) under its iPSCelz® program. This development is validated by Greenstone Biosciences and utilized in several FDA-cleared clinical programs in the U.S. The creation of these cells marks a significant milestone for the company, potentially accelerating clinical applications and saving years of research and development. CEO Timothy Warbington highlighted the cost-efficiency and regulatory adherence of the company's multiple programs while maintaining a lower burn rate compared to peers.
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