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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 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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