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Outstanding Shares - 137,678,812
Safety and Efficacy of Caverstem TM Procedure
On October 18, 2017 we announced the completion of the safety data analysis on 20 patients in our erectile dysfunction clinical trial. Based on establishment of safety of the CaverStem TM procedure in a formal university-based clinical trial, and independent confirmation of efficacy in a European clinical trial we launched commercialization for the Caverstem TM procedure.
(January 31, 2018 – Phoenix, AZ) Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today the continued positive response and recruitment of physicians for its patented and clinically tested Caverstem™ procedure for the treatment of erectile dysfunction using the patient’s own bone marrow derived stem cells.
“Since commercialization of our Caverstem™ procedure began in December 2017, we’re pleased that our early results in bringing in experienced medical doctors in our initial area of sales in the Southwest United States has been very positive. Recruitment of medical doctors in Los Angeles, Orange County, San Diego and Las Vegas NV is just the start of what we believe will be a rapid growth as we expand into other areas of the country” said Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc.
“Patient understanding and interest in our stem cell technology has also been positive. The physicians involved with the Caverstem™ procedure are treating patients and as the patient outreach is expanded we are excited by the ongoing and increased growth in the number of patient’s seeking our treatment.”
Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections. The Caverstem™ procedure is a natural alternative for many of these patients.
“There is much excitement about stem cells revolutionizing many aspects of medicine. I am enthusiastic to be treating my patients using this cutting edge procedure,” Stated by Dr. Alexander Gershman. “Numerous publications and a recent clinical trial at the Los Angeles Biomedical Institute at Harbor – UCLA Hospital in Torrance, CA, support the safety and feasibility of the Caverstem™ procedure. The biological basis of the bone marrow based treatment is that in patients with drug non-responsive erectile dysfunction, there is a deficit in function of smooth muscle and blood vessel cells. By administering the patient’s own stem cells we aim to rebuild these damaged tissues, and thereby restore erectile function.”
“We are pleased that after several years of development and testing we are now realizing the overwhelming acceptance of our Caverstem™ procedure by highly credible physicians and their patients.” Said Thomas Ichim PhD, co-inventor of the Caverstem™ procedure and Director of Creative Medical Technology Holdings Inc.
Stem Cells as Medicine: The Promise of Universal Donor Adult Stem Cells Continues to Attract Optimism
Creative Medical Technology Holdings, Inc (OTCQB:CELZ) provides the following discussion on a recent US News and World Report article 1 addressing advances of adult stem cells and its own patented stem cell technologies.
Stem cells are broadly categorized into “embryonic” and “adult” stem cells. Embryonic stem cells are derived from fertilized eggs and hold potential to generate every major tissue in the body. Unfortunately, embryonic stem cells are difficult to control due to their very immature state. This limits their ability to be used in patients, which has accounted for a lack of commercial success. In contrast, adult stem cells, which are classified as every type of stem cell that is not embryonic , are the basis of the technology of the two publicly traded biotech companies referenced in the article, Mesoblast and Athersys. Currently, Mesoblast is developing stem cells based on bone marrow stem cells from donors, primarily for treating heart failure, which is in the most advanced phases of clinical trials, termed Phase III. Additionally, Athersys is also using bone marrow derived stem cells from donors, primarily for use in stroke, which is also in Phase III clinical trials.
“We at Creative Medical Technologies are encouraged by this promising article that highlights the important advances being made by adult stem cell companies in addressing the significant unmet medical needs in degenerative conditions such as stroke and heart failure.” Said Timothy Warbington, President and CEO of Creative Medical Technology Holdings.
“For the past 7 years, we have been working on developing two types of adult stem cell therapies which are protected by issued US patents.”
Our first type of technology is based on a more immediate commercialization, these therapies use the patient’s own unexpanded and minimally manipulated stem cells, termed autologous stem cells, that can be rapidly implemented because of the long safety record of this type of procedure.
Our Caverstem TM procedure, involves using the patient’s own bone marrow derived stem cells to treat drug-resistant erectile dysfunction. This clinically tried procedure is already being performed by doctors on the West Coast.
Our second autologous bone marrow stem cell procedure for the treatment of degenerative disc disease, termed StemSpine TM is in the process of commercialization.
Our second type of technology is a “universal donor” stem cell that is similar to stem cells developed by Athersys and Mesoblast. In contrast to other universal donor stem cell types, the stem cell developed by Creative Medical Technology Holdings, Inc., termed “AmnioStem TM is derived from amniotic fluid, which possesses a higher ability to regenerate tissues as compared to other stem cell types. Our AmnioStem TM , universal donor stem cell is being developed as a treatment for stroke, with an FDA Investigational New Drug Application (IND) filing planned to initiate clinical trials.
“I am very impressed with the speed, agility, and precision that the team at Creative Medical Technology Holdings has displayed in advancing both autologous and allogeneic stem cell therapies.” Said Dr. Santosh Kesari, MD, PhD, FANA, FAAN, Director of the Neuroscience Research Center at the Pacific Neuroscience Institute and Member of Creative Medical Technology Holdings, Inc. Scientific Advisory Board. “I look forward to working with the Company in advancing its adult stem cell therapy products, which aim to address numerous unmet medical needs.”
Intellectual Properties/Patents
Erectile Dysfunction
Link to patent #: 8372797 on the USPTO web page
Methods, cells and compositions of matter are provided for treatment of erectile dysfunction using stem cell therapy. In particular, various stem cells are modified or administered freshly isolated in order to induce smooth muscle regeneration, neural regeneration, and restoration of endothelial function. In some embodiments endogenous stem cells are mobilized or activated to achieve therapeutic benefit. In other embodiments compositions derived from stem cells are utilized for treatment of erectile dysfunction.
Male Infertility
Infertility License Agreement. Effective January 29, 2016, we entered into a License Agreement with Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (“LABIOMED”) granting us an exclusive license in the U.S. and its territories and possessions to make and market products or services authorized under LABIOMED’s U.S. Patent Application 14/508,763 (filed October 7, 2014, and claiming priority back to U.S. Ser. No. 60/790,085 filed on 4/7/2006)
Female Sexual Dysfunction
Patent Application. Drs. Patel and Ichim, two of our directors, have assigned to CMT for nominal consideration use their patent application (U.S. Patent Application 62319753) for the use of regenerative cells as a treatment option for women who experience sexual desire, but have difficulty reaching the arousal stage. The patent application was filed with the U.S. Patent and Trademark Office on April 7, 2016. This patent was assigned to CMT on August 28, 2016.
Multipotent Amniotic Fetal Stem Cells
License Agreement. On August 25, 2016, CMT entered into a License Agreement dated August 25, 2016, with The Regents of The University of California, represented by its San Diego campus of the University of California, San Diego, Office of Innovation and Commercialization. This license agreement grants to CMT the exclusive right to all products derived from U.S. Patent No. 7,569,385 for use of multipotent amniotic fetal stem cells composition of matter throughout the world during the period ending on the expiration date of the longest-lived patent rights under the patent. The license agreement also permits CMT to grant sublicenses. Under the terms of the license agreement, CMT is required to diligently develop, manufacture, and sell any products licensed under the agreement. We are required to pay the University an initial license fee within 30 days of entering into the agreement. We are also required to pay annual license maintenance fees on each anniversary date of the agreement, which maintenance fees would be credited toward any earned royalties for any given period. The License Agreement provides for payment of various milestone payments, which in the aggregate are estimated at approximately $2,000,000, and earned royalties on the net sales of licensed products by CMT or any sublicensee of between approximately 5% and 20%. CMT is also required to reimburse the University for any future costs associated with maintaining the patent. CMT may terminate the license agreement for any reason upon 90 days’ written notice and the University may terminate the agreement in the event CMT fails to meet its obligations set forth therein, unless the breach is cured within 30 days of the notice from the University specifying the breach. CMT is also obligated to indemnify the University against claims arising due to the exercise of the license by CMT or any sublicensee. CMT is also required to maintain adequate general liability insurance.
Multipotent Amniotic Fetal Stem Cells for Stroke Therapy
On Dec. 13, 2016 CMT filed US patent application #62/400557 entitled “Treatment of Stroke by Amniotic Fluid Derived Stem Cell Conditioned Media and Products Derived Thereof.”. The patent application covers the use of the Company’s newly licensed AmnioStem stem cell as a production means for generation of nanoparticles termed “exosomes,” which regenerate damaged brain tissue after stroke.
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