8-K
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. (CELZ)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 22, 2020
| Creative Medical Technology Holdings, Inc. |
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| (Exact name of registrant as specified in its charter) |
| Nevada | 000-53500 | 87-0622284 |
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| (State or other jurisdiction | (Commission File Number) | (I.R.S. Employer |
| of incorporation) | | Identification Number) |
| 211 E Osborn Road, Phoenix, AZ 85012 |
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| (Address of principal executive offices) |
(833) 336-7636
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
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| N/A | N/A | N/A |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o ****
Item 8.01. Other Events
On December 22, 2020, Creative Medical Technologies, Inc. (the “Company”), issued a press release identifying one of the primary mechanisms of action of its ImmCelz® product in the treatment of stroke.
On December 29, 2020, the Company issued a press release reporting on data and a related patent filing with respect to the ability of ImmCelz® to reverse liver failure in the carbon tetrachloride preclinical model of hepatocyte necrosis.
On December 31, 2020, the Company issued a press release reporting on a patent filing based on positive preclinical data using ImmCelz® in the treatment of a model of heart attack.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Creative Medical Technology Holdings, Inc. | ||
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| Date: January 4, 2021 | By: | /s/ Timothy Warbington |
| | | Timothy Warbington, Chief Executive Officer |
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celz_ex991.htm EXHIBIT 99.1
Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz® Stroke Regenerative Activity
Company Reports Superior Production of Growth Factors and Therapeutic Immune Cells as Compared with Other Stem Cell Types
December 22, 2020 – Phoenix, AZ Creative Medical Technology Holdings Inc. (OTC – CELZ) announced today data identifying one of the primary mechanisms of action of its ImmCelz® product in the treatment of stroke. The Company reported that animals having previously been treated with ImmCelz® have an increase in what is called “endogenous neurogenesis”. This process allows for certain parts of the brain to heal themselves more effectively after injury, for example, such as in stroke. The stimulation of endogenous neurogenesis was approximately 85% higher than in animals treatment with a popular type of stem cell termed mesenchymal stem cells. Additionally, the Company reported that depletion of animals of T regulatory cells resulted in suppression of endogenous neurogenesis.
“These findings are continuation of work initiated years ago in which we sought to dissect not only immunological mechanisms of ImmCelz® activity, but also other physiological systems, including the nervous system.” Said Dr. Amit Patel, Board Member of the Company. “The elucidation of a mechanism of action makes ImmCelz® an increasingly viable candidate for FDA IND application and initiation of clinical trials.”
In contrast to stem cell based approaches, ImmCelz® is an immunotherapy product in which stem cells are used to “educate” immune cells to endow them with regenerative activity.
The Company believes that “educated” immune cells may be superior to stem cells because of their: a) ability to replicate and form “memory” cells; b) substantially smaller size, which allows for superior biodistribution than stem cells; and c) adeptness at surviving in conditions such as hypoxia or acidosis, which would inactivate stem cells.
“I would like to thank my colleagues who have steadily worked tirelessly on this project for years. The possibility of immune cells being coaxed into possessing regenerative activity is quite a revolutionary concept, which thanks to these recent experiments appears to be becoming a reality.” Said Thomas E Ichim, Ph.D, Chief Scientific Officer and co-inventor of ImmCelz®.
“Stroke represents a significant unmet medical need for which numerous other approaches have failed.” Said Timothy Warbington, President and CEO of the Company. “By understanding the biological switches that ImmCelz® activates to reduce stroke in animals, we believe that our path through the FDA will be less challenging, as well as our road to eventual commercialization.”
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com. ****
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Forward Looking Statements
OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission’s website at www.sec.gov.
Timothy Warbington, CEO
CEO@CreativeMedicalHealth.com
Creativemedicaltechnology.com
www.StemSpine.com
www.Caverstem.com
www.Femcelz.com
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celz_ex992.htm EXHIBIT 99.2
Creative Medical Technology Holdings Announces Reversion of Liver Failure Using ImmCelz® Personalized Cellular Immunotherapy in Preclinical Model
Company Files Patent on Approaching 10 Billion Dollar Liver Disease Market Using “Reprogrammed” Immune Cells
December 29, 2020 – Phoenix, AZ (OTC-CELZ) Creative Medical Technology Holdings Inc. announced today novel data and patent filing No. 63131261 describing the ability of ImmCelz® to reverse liver failure in the carbon tetrachloride preclinical model of hepatocyte necrosis.
These findings are the basis for a patent filing covering various means of generating the ImmCelz® product in a hepatoprotective specific manner. The Company has previously reported that ImmCelz® is capable of treating animal models of stroke^1^, as well as inducing “immunological tolerance” in a model of autoimmune rheumatoid arthritis^2^.
The work is an extension of previously published findings of Dr. Thomas E. Ichim, in which mesenchymal stem cells were capable of inhibiting progression of liver failure^3^.
“I am proud of the work the team at Creative Medical Technologies is conducting in advancing the concept of immunologically-mediated regeneration.” Said Dr. Ichim, Co-inventor of the patent. “ImmCelz® is an advancement on our previous liver failure work due to the fact that we have shown transfer of regenerative activity from the stem cell to the immune cell. Immune cells possess ability to home to injured tissues faster than stem cells due to their smaller size. Additionally, immune cells possess immunological memory, which we believe may be applied to the concept of regeneration.”
“While stem cell therapeutics are recognized as the future of medicine, I believe it is important to realize that many activities of stem cells are mediated by changes to the immune system.” Said Dr. Amit Patel, Board Member of the Company and Co-Inventor of the Patent Application. “ImmCelz® represents a fundamental advancement in regenerative medicine in that instead of administering stem cells in the body to induce immune modulation, we actually optimize the immune modulation in the laboratory before injecting immune cells into the patient.”
Being at the forefront in identifying novel regenerative treatment options, the Company possesses numerous issued patents in the area of cellular therapy, including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type.
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^1^Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz® Stroke Regenerative Activity (prnewswire.com)
^2^ Creative Medical Technology Holdings Reports Positive Preclinical Data on ImmCelz® Immunotherapy Product in Rheumatoid Arthritis Model | BioSpace
^3^ Human endometrial regenerative cells alleviate carbon tetrachloride-induced acute liver injury in mice | Journal of Translational Medicine | Full Text (biomedcentral.com)
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“Liver failure represents a significant unmet medical need and I am extremely excited that ImmCelz® has the potential to help the numerous patients on the liver transplant waiting list who currently have no other option.
With growing validation and acceptance of such technologies, the company intends to continue to broaden its intellectual property portfolio by compiling research data and filing patents, in order to record early filing dates and increase the likelihood of our receiving patent issue.
We continue to welcome opportunities with collaborators and Key Opinion Leaders as we are dedicated to accelerating the further development of our technology.”
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com. ****
Forward Looking Statements
OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission’s website at www.sec.gov.
Timothy Warbington, CEO
CEO@ CreativeMedicalHealth.com
Creativemedicaltechnology.com
www.StemSpine.com
www.Caverstem.com
www.Femcelz.com
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celz_ex993.htm EXHIBIT 99.3
Creative Medical Technology Holdings Announces Patent filing based on Preclinical Data in Model of Heart Attack using ImmCelz® Regenerative Immunotherapy ****
Clinical Stage Stem Cell Company Expands its Cellular Therapy Platforms
December 31, 2020 – Phoenix, AZ (OTC – CELZ) Creative Medical Technology Holdings Inc. announced today positive preclinical data using ImmCelz® in treatment of a model of heart attack.
Patent application #63/132472, entitled “Treatment of Heart Failure and/or Post Infarct Pathological Remodeling by Ex Vivo Reprogrammed Immune Cells” covers data in which mice with restricted blood flow to the heart had significantly improved survival when treated with ImmCelz® as compared to control mice.
“The role of the immune system in numerous aspects of regenerative medicine can not be overstated.” Said Dr. Amit Patel, Board Member of the Company and co-inventor of the patent. “The data described today, while preliminary, supports the belief that ImmCelz®, which is a “regenerative immunotherapy” can be applied across a broad range of conditions.”
The ImmCelz® product, based on decades of immunological research by Drs Thomas Ichim and Amit Patel, involves extraction of patient immune cells, “training” the immune cells to exhibit regenerative properties by incubation with regenerative cells outside of the body, followed by re-infusion of the patient’s own cells. To date the Company has demonstrated that ImmCelz® has therapeutic activity in stroke and liver failure.
“It is my honor that the work we initiated more than a decade ago is coming to fruition.” Said Thomas Ichim, Ph.D, coinventor of the patent. “Ten years ago, Dr. Patel, myself and a team of colleagues described the potent synergies that occur when various cell types are utilized in combination for treatment of heart failure^1^. ImmCelz® is the product of all these years of working and perfecting multi-cellular approaches to regenerative medicine.”
“As we round out 2020, we have significantly expanded our Intellectual Property portfolio based on many years of collaborative research and development. Utilizing the ImmCelz® technology for the treatment of heart failure is an excellent addition to this robust patent portfolio as it effects millions of patients in the U.S. alone. Patients with end stage heart failure in many cases have no options but heart transplantation, which is extremely limited.” Said Timothy Warbington, President and CEO of the Company. “We are excited with the progress that the Company is making in advancing ImmCelz®, which approaches regenerative medicine from a completely unique perspective. Given that the active cells in ImmCelz® are derived from the same patient, we anticipate an accelerated path to FDA Investigational New Drug (IND) clearance.”
“We encourage industry colleagues and other interested parties to review our early priority date patent filings to learn more about the ImmCelz® technology and how it applies to multiple indications” Mr. Warbington further said.
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^1^ Ichim et al. Combination stem cell therapy for heart failure. Int Arch Med. 2010; 3: 5. Combination stem cell therapy for heart failure (nih.gov)
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About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com. ****
Forward Looking Statements
OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology oldings, Inc. with the Securities and Exchange Commission and available on the Commission’s website at www.sec.gov.
Timothy Warbington, CEO
CEO@ CreativeMedicalHealth.com
Creativemedicaltechnology.com
www.StemSpine.com www.
Caverstem.com
www.Femcelz.com
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