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): October 18, 2017
Creative Medical Technology Holdings, Inc.
(Exact name of registrant as specified in its charter)
| Nevada | 000-53500 | 87-0622284 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
2017 W Peoria Avenue, Phoenix, AZ 85029
(Address of principal executive offices)
Registrant’s telephone number, including area code: (602) 680-7439
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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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 October 18, 2017, Creative Medical Technology Holdings, Inc. (the “Company”) issued a press release announcing the completion of the safety data analysis on 20 patients with pharmacologically-resistant erectile dysfunction treated with the Company’s patented CaverStemTM procedure. The press release also announced the launch for the commercialization of the Caverstem procedure.
The press release, furnished as Exhibit 99.1 to this Form 8-K, may contain forward-looking statements. Such forward-looking statements are based on information presently available to the Company’s management and are current only as of the date made. Actual results could also differ materially from those anticipated as a result of a number of factors, including, but not limited to, those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and subsequent reports filed by the Company with the Securities and Exchange Commission (the “Commission”). For those reasons, undue reliance should not be placed on any forward-looking statement. The Company assumes no duty or obligation to update or revise any forward-looking statement, although it may do so from time to time as management believes is warranted or as may be required by applicable securities law. Any such updates or revisions may be made by the registrant by filing reports with the Commission, through the issuance of press releases or by other methods of public disclosure.
| Item 9.01. | Financial Statements and Exhibits |
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Press Release dated October 18, 2017 |
SIGNATURES
Pursuant to the requirements of the Securities 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: October 18, 2017 | By: | /s/ Timothy Warbington | |
| Timothy Warbington, Chief Executive Officer | |||
Exhibit 99.1
Creative Medical Technology Holdings Announces Commercialization of patented Stem Cell Procedure for Erectile Dysfunction.
Trial Results Support Initiation of Urologist Outreach and Commercialization
October 18, 2017 Phoenix, AZ, Creative Medical Technology Holdings (OTCQB – CELZ) announced today completion of the safety data analysis on 20 patients with pharmacologically-resistant erectile dysfunction treated with the Company’s patented CaverStemTM procedure.
The trial, sponsored by Creative Medical Technology Holdings, was conducted at the University of California Los Angeles Harbor Hospital/LA Biomed under Institutional Review Board (IRB) approval. An independent medical safety monitor was also appointed to review the patient data for safety and feasibility of administering bone marrow derived stem cells into patients with erectile dysfunction. The goal of this procedure is to regenerate blood vessels and smooth muscle, parts of the penis that are not functioning properly in this patient population.
“Based on establishment of safety of the CaverStemTM procedure in a formal university-based clinical trial, and independent confirmation of efficacy in an European clinical trial1, we have launched commercialization for the Caverstem procedure,” said Timothy Warbington, President and Chief Executive Officer of Creative Medical Technology Holdings. “Amongst other top urologists, we have recruited a world-renowned urologist as a lead physician to roll-out the procedure. We anticipate that the procedure will be available to patients that meet the eligibility criteria within the next 60 days.”
According to the National Institutes of Health, approximately 30 million men in the United States suffer from Erectile Dysfunction2, of which 9 million do not respond to pharmacological treatments such as Viagra, Levitra and Cialis.
“The CaverStemTM procedure involves obtaining a small amount of bone marrow from the patient, purifying the stem cells using a closed system device that is FDA cleared, and then administering these cells in the same procedure into the patient’s penis,” said Thomas Ichim, Ph.D, Chief Scientific Officer and Co-Founder of the Company. “Having published the first peer-reviewed paper on this procedure back in 2013 together with internationally renowned urologists and stem cell experts3, it is very exciting for me to watch this translate from bench to bedside.”
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to creativemedicaltechnology.com.
| 1 | Yiou et al. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial.Eur Urol Focus. 2017 Jun 24. pii: S2405-4569(17)30160-8 https://www.ncbi.nlm.nih.gov/pubmed/28753830 |
| 2 | https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/definition-facts |
| 3 | Ichim et al. Intracavernous administration of bone marrow mononuclear cells: a new method of treating erectile dysfunction? J Transl Med. 2013 Jun 9;11:139. https://www.ncbi.nlm.nih.gov/pubmed/23758954 |
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, 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.
SOURCE Creative Medical Technology Holdings, Inc.
Related Links
http://creativemedicaltechnology.com
http://caverstem.com
Contact:
Timothy Warbington, CEO
Tel: 480-789-9939
ceo@creativemedicalhealth.com