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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, 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.
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