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): February 8, 2021
| Creative Medical Technology Holdings, Inc. |
|---|
| (Exact name of registrant as specified in its charter) |
| Nevada | 000-53500 | 87-0622284 |
|---|
| (State or other jurisdiction<br> <br>of incorporation) | (Commission<br> <br>File Number) | (I.R.S. Employer<br> <br>Identification Number) |
211 E Osborn Road, Phoenix, AZ 85012
(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 |
|---|
| 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 February 8, 2021, Creative Medical Technologies, Inc. (the “Company”), issued a press release announcing the recruitment of Dr. Caigan Du, Associate Professor at the University of British Columbia to the Company’s Scientific Advisory Board.
On February 10, 2021, the Company issued a press release reporting on data relating to the mechanisms of action of its patented OvaStem® female infertility/ovarian failure treatment
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit 99.1 | Press Releases issued by the Company dated February 8, 2021 |
|---|---|
| Exhibit 99.2 | Press Releases issued by the Company dated February 10, 2021 |
| 2 |
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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. | ||
|---|---|---|
| Date: February 12, 2021 | By: | /s/ Timothy Warbington |
| | | Timothy Warbington,<br> <br>Chief Executive Officer |
| 3 |
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celz_ex991.htm EXHIBIT 99.1
Creative Medical Technology Holdings Recruits Internationally Renowned Kidney Expert to Scientific Advisory Board
Clinical Stage Regenerative Medicine Company Plans to Develop Clinical Programs for Major Uses of ImmCelz® Regenerative Immunotherapy
February 8, 2021 Phoenix, AZ (OTC-CELZ) Creative Medical Technology Holdings Inc. announced today recruitment of Dr. Caigan Du, Associate Professor at the University of British Columbia to the Company’s Scientific Advisory Board.
Dr. Du is a top researcher in the area of molecular and immunological understanding of kidney failure and transplant rejection. Dr. Du is funded by numerous national and international organizations including the Kidney Foundation and the Canadian Institutes of Health Research.
“I am honored to work with Creative Medical Technology Holdings in this fascinating field of leveraging reprogrammed immune cells for regenerating injured kidneys.” Said Dr. Du. “To date people think about regenerative medicine and immunology as separate fields. It is very exciting to consider the possibility that immune cells can act as a catalyst for regenerative processes: this is the basis of the ImmCelz® product.”
ImmCelz® is a personalized cell therapy generated by incubation of patient cells with allogeneic JadiCell stem cells under proprietary conditions. The JadiCell possess potent ability to reprogram the immune system, as exemplified in part by their ability to significantly extend survival of COVID patients in an FDA double blind, placebo controlled, clinical trial^1^. ImmCelz® has been demonstrated effective in animal models of rheumatoid arthritis^2^, liver failure^3^, stroke^4^, type 1 diabetes^5^ and kidney failure^6^. Scientific studies suggest ImmCelz® functions through secretion of a fundamentally important molecule called Hepatocyte Growth Factor^7^, as well as stimulation of T regulatory cells, a type of immune system cell that suppresses pathological immunity^8^.
“As a clinical-stage biotechnology company, having already commercialized other stem cell products, we understand the key to any success is based on the ability to attract scientific key opinion leaders.” Said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “Dr. Du is a visionary and pioneer in understanding of kidney diseases and we wholeheartedly look forward to him joining our scientific advisory board.”
The Advisory Board of Creative Medical Technology Holdings includes internationally renowned neurologist Santosh Kesari MD, Ph.D, the former head of cardiology at Cedar Sinai Medical Center Timothy Henry, MD and our Director Dr. Amit Patel, inventor of the JadiCell and the first physician to have implanted stem cells into the human heart.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed 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
ImmCelz.com
_________________
^1^ Umbilical cord mesenchymal stem cells for COVID‐19 acute respiratory distress syndrome: A double‐blind, phase 1/2a, randomized controlled trial - Lanzoni - - STEM CELLS Translational Medicine - Wiley Online Library
^2^ Creative Medical Technology Holdings Reports Positive Preclinical Data on ImmCelz® Immunotherapy Product in Rheumatoid Arthritis Model | BioSpace
^3^ Creative Medical Technology Holdings Announces Reversion of Liver Failure Using ImmCelz® Personalized Cellular Immunotherapy in Preclinical Model | Nasdaq
^4^ Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz® Stroke Regenerative Activity (prnewswire.com)
^5^ Creative Medical Technology Holdings Announces Positive Data and Patent Filing Using ImmCelz® to Treat Type 1 Diabetes (prnewswire.com)
^6^ Creative Medical Technology Holdings Files Patent based on Positive Data on Renal Failure using ImmCelz® Regenerative Immunotherapy (prnewswire.com)
^7^ Creative Medical Technology Holdings Identifies and Files Patent on Novel Mechanism of ImmCelz® Therapeutic Activity (apnews.com)
^8^ Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz® Stroke Regenerative Activity (prnewswire.com)
celz_ex992.htm EXHIBIT 99.2
Creative Medical Technology Holdings Identifies Cellular Mechanism of Patented OvaStem® Female Infertility/Ovarian Failure Treatment
Company Advances Towards Clinical Trial to Address Premature Ovarian Failure Patients
February 10, 2021 Phoenix, AZ (OTC-CELZ) Creative Medical Technology Holdings announced today new data explaining mechanisms of action of its patented OvaStem® female infertility/ovarian failure treatment. OvaStem®, which is covered by issued patent #10,792,310, involves injection of stem cells into dysfunctional ovaries and has been demonstrated to induce fertility, as well as restore hormone levels.
The data, which are covered in a newly filed patent application, demonstrate that mesenchymal stem cell injection results in generation of T regulatory cells. These cells are a type of immune cell which the Company has previously patented for regeneration of lumbar discs (US Patent #10,842,815). Importantly, depletion of T regulatory cells resulted in negation of the beneficial effects of stem cells, whereas exogenous administration of T regulatory cells are capable of restoring ovarian function.
“Cellular therapy is making significant advances in the treatment of cancer, degenerative diseases, and autoimmunity.” Said Dr. Amit Patel, Board Member of the Company and co-inventor of the patent. “We are pleased to discover this interesting interaction between mesenchymal stem cells and T regulatory cells in prevention of ovarian failure and restoration of function. By elucidating mechanisms, we feel we are making progress towards eventual filing with the FDA for initiation of clinical trials.”
Although the menopause market is believed to be approximately $600 billion^1^, the Company is focusing on the initial indication of premature ovarian failure. Premature ovarian failure occurs in woman under 40 who experience degeneration of ovaries from a variety of conditions. The Company has demonstrated efficacy of autologous (patient’s own stem cells) and allogeneic (universal donor) in animal models of this condition.
“Despite having a wide variety of cellular products in development, there appears to be a common theme of interaction between mesenchymal stem cells and T regulatory cells.” Said Timothy Warbington, President and CEO of the Company. “Today’s discovery that T regulatory cells are effective in treatment of ovarian failure lends more scientific support to OvaStem®, which we hope will accelerate our path towards FDA clinical trials to treat this condition.”
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed 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
www.ImmCelz.com
www.OvaStem.com
________________
^1^ Why More Startups And VCs Are Finally Pursuing the Menopause Market: ‘$600B Is Not ‘Niche’’ – Crunchbase News