8-K - CELZ - Equibles

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): March 3, 2021

Creative Medical Technology Holdings, Inc.

| (Exact name of registrant as specified in its charter) |

Nevada	000-53500	87-0622284

| (State or other jurisdiction | (Commission File Number) | (I.R.S. Employer |

| of incorporation) | | 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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ 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 ☐

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. ☐

Item 8.01. Other Events.

On March 3, 2021, Creative Medical Technologies, Inc. (the “Company”), issued a press release providing an update with respect to the filing of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration for the treatment of stroke using its ImmCelz® regenerative immunotherapy.

On March 4, 2021, the Company issued a press release announcing the publication of data from its clinical trial of perispinal injection of bone marrow cells in patients with disc degenerative disease.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit 99.1	Press Release issued by the Company dated March 3, 2021
Exhibit 99.2	Press Release issued by the Company dated March 4, 2021

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: March 5, 2021	By:	/s/ Timothy Warbington

| | | Timothy Warbington, Chief Executive Officer |

celz_ex991.htm EXHIBIT 99.1

Creative Medical Technology Holdings Provides Update on ImmCelz® FDA Application

March 3, 2021 – Phoenix, AZ (OTC-CELZ) Creative Medical Technology Holdings announced today that due to COVID related technical changes in the FDA’s submission requirements, the Company’s ImmCelz® Investigational New Drug Application (IND) for the treatment of Stroke will be resubmitted to the FDA in electronic form to comply with such requirements. Previously, the FDA had accepted IND applications in hard copy submitted by mail.

Due to the complexity of the new requirements, Creative Medical Technology Holdings has retained the services of an FDA consulting firm with the expertise to assist it with the FDA’s electronic submission procedures, which include formatting, hyperlinking, and tagging requirements. The Company believes that retaining a third party firm experienced in FDA electronic submissions will better equip the Company to navigate and comply with the FDA’s new requirements.

Resubmission of the Company’s ImmCelz® IND will not change the substance of the Company’s application to the FDA. As previously reported, the IND seeks approval from the FDA to initiate the first clinical trial using cellular immunotherapy for treatment of stroke, using the Company’s ImmCelz® product.

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

celz_ex992.htm EXHIBIT 99.2

Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using StemSpine® Personalized Adult Stem Cell Therapy

Commercial Stage Regenerative Medicine Company Expands it’s Hold “Ready to Commercialize” Autologous Bone Marrow Procedures

March 4, 2021 Phoenix, AZ (OTC - CELZ) Creative Medical Technology Holdings announced today a publication in the pre-print server SSRN describing data from its first 15 patients treated in a clinical trial evaluation perispinal injection of bone marrow cells in patients with disc degenerative disease. Evaluation of patients at 30,60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score . The mean pain changed from 8.9 at baseline to 4.3 at 30 days and sustained to 1.8 at 6 months and 1.3 at 12 months with a gradual reduction in overall pain medication utilization guided by their healthcare team. No serious adverse effects were noted with some short-term bruising in two patients at the harvest site and no long term adverse events where reported related to the procedure.

“This publication, which is “pre-peer review” describes what to our knowledge is the first demonstration of a signal of clinical efficacy by injecting stem cells in areas surrounding the disc.” Said Dr Amit Patel, Board Member and Co-Founder of the Company. “While others have intra-disc injection may help disc pain, the current work regenerates the blood supple to the disc, allowing the disc to heal itself.”

The autologous utilization of bone marrow falls under the “minimal manipulation exception” and can be commercialized rapidly, in the same manner that the Company commercialized Caverstem® for treatment of erectile dysfunction.

Granted United States Patent #9,598,673 which is owned by the Company covers the use of any mesenchymal stem cells, both from the patient or from donors, for reduction of lower back pain when injected into the major muscles of the lower back.

“Disc degenerative disease represents a multi-billion dollar market for which current medical solutions do not address the underlying cause, while surgery is expensive and not applicable for a significant number of patients.” Said Timothy Warbington, President and CEO of the Company. “We are excited to follow the path we did with CaverStem® and initiate commercialization of this technology for American patients.”

To view our Publication: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3797402

Timothy Warbington, CEO CEO@CreativeMedicalHealth.com