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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 announced the recruitment of Dr. Camillo Ricordi to its Scientific Advisory Board. Dr. Ricordi will work alongside esteemed advisors to advance the ImmCelz® Regenerative Immunotherapy platform, currently seeking FDA clearance for IND # 27375 to treat stroke. The company has already made strides with its CaverStem® Procedure for erectile dysfunction and has proof of concept for its StemSpine® and OvaStem® treatments. Dr. Ricordi is recognized for his pioneering work in regenerative medicine and stem cell therapies.
Creative Medical Technology Holdings (CELZ) announced receipt of detailed correspondence from the FDA regarding IND #27375 for its ImmCelz® regenerative immunotherapy targeting stroke treatment. This innovative therapy employs a patient's own reprogrammed blood cells, demonstrating effectiveness in animal models for various conditions, including heart and kidney failure. The company's leadership expressed gratitude for the FDA's constructive feedback, essential for the IND proposal's progression. This marks a significant step in their journey towards obtaining regulatory approval for a pioneering treatment.
Creative Medical Technology Holdings (OTC: CELZ) plans to launch Virtual Physician™, a telehealth platform for regenerative medicine, this summer. The platform aims to educate, recruit, and retain patients for their proprietary procedures, such as CaverStem® for erectile dysfunction and FemCelz® for vaginal rejuvenation. As additional products like StemSpine® are commercialized, the platform will expand. The initiative is expected to create shareholder value through a Management Service Organization model, royalties from product promotions, and direct sales of ancillary products.
Creative Medical Technology Holdings (OTC: CELZ) announced the FDA issued IND Number 27375 for its clinical trial using ImmCelz® to treat stroke victims. ImmCelz® utilizes stem cells to reprogram immune cells, enhancing their regenerative capabilities. This milestone is seen as a significant step for the company as it moves toward clinical application. Timothy Warbington, President and CEO, expressed optimism about progressing with the FDA. The company specializes in regenerative medicine across various fields including immunotherapy and neurology.
Creative Medical Technology Holdings (OTC: CELZ) has initiated the recruitment of clinical sites for its StemSpine® procedure, aimed at treating Degenerative Disc Disease (DDD). This patented regenerative stem cell procedure has shown significant efficacy, reporting an 85% reduction in pain over 12 months from a baseline of 8.9. The company plans to geographically disperse sites across the USA to maximize patient access. The first 100 patients will be monitored at intervals of 30 days, 6 months, and 12 months, with results set for publication in a peer-reviewed journal.
Creative Medical Technology Holdings (OTC - CELZ) announced a significant publication on its clinical trial involving stem cell therapy for patients with disc degenerative disease. The study showed a mean pain score reduction from 8.9 at baseline to 1.3 at 12 months, with a noted decrease in pain medication use. The procedure was reported to have no serious adverse effects. The company is poised to commercialize this therapy, expanding its market in the multi-billion dollar industry.
Creative Medical Technology Holdings (OTC-CELZ) announced its plan to resubmit the ImmCelz® Investigational New Drug Application (IND) to the FDA due to COVID-related changes in submission requirements. The resubmission will be in electronic format to comply with the new regulations. The company has engaged an FDA consulting firm to assist with the electronic submission process. The resubmission will not alter the substance of the original application, which aims to initiate clinical trials on cellular immunotherapy for stroke treatment.
Creative Medical Technology Holdings (OTC – CELZ) announced the filing of a patent application for its ImmCelz® regenerative cell therapy, aimed at preventing organ transplant rejection. ImmCelz® works by stimulating T regulatory cells and producing Hepatocyte Growth Factor (HGF), potentially inhibiting chronic graft rejection, a leading cause of organ loss. The company has observed therapeutic effects of ImmCelz® in various conditions, including rheumatoid arthritis and kidney failure, and aims to expand its intellectual property portfolio in regenerative medicine.
On February 10, 2021, Creative Medical Technology Holdings (OTC-CELZ) revealed new data on its patented OvaStem® treatment for female infertility and ovarian failure. This treatment involves injecting stem cells to restore hormone levels and induce fertility, supported by patent #10,792,310. Recent findings show that mesenchymal stem cell injections generate T regulatory cells, enhancing ovarian function. The company aims to file for FDA clinical trials, focusing initially on premature ovarian failure, a condition affecting women under 40. The menopause market is estimated at $600 billion, highlighting significant potential.
Creative Medical Technology Holdings (OTC-CELZ) has appointed Dr. Caigan Du, an Associate Professor at the University of British Columbia, to its Scientific Advisory Board. Dr. Du is recognized for his research on kidney failure and transplant rejection, and has received funding from key organizations. He expressed enthusiasm about the potential of ImmCelz®, a regenerative therapy utilizing reprogrammed immune cells to aid kidney regeneration. This recruitment aims to enhance the company's scientific leadership in regenerative medicine.
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