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): April 30, 2019
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: (833) 336-7636
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. ¨
Securities registered pursuant to Section 12(b) of the Act: None
| Item 8.01 | Other Events |
On April 30 and May 6, 2019, Creative Medical Technology Holdings, Inc., a Nevada corporation (the “Company”), issued press releases to update shareholders on recent business activities.
The press releases, furnished as Exhibits 99.1 and 99.2 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, 2018, 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 April 30, 2019 | |
| 99.2 | Press Release dated May 6, 2019 |
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: May 7, 2019 | By: | /s/ Timothy Warbington |
| Timothy Warbington, Chief Executive Officer | ||
Exhibit 99.1
Creative Medical Technology Holdings, Inc. April 2019 Shareholder Update
9:15 AM ET 4/30/19 | PR Newswire
PHOENIX, April 30, 2019 /PRNewswire/ -- (OTCQB-CELZ) Creative Medical Technology Holdings, Inc. announced today an update of its activities:
As we are releasing updates on a regular basis, we will only cover new activities. The absence of reporting on a specific area of our business should not be construed as a lack of concentration in that area but due to the short window of time between shareholder updates. We appreciate our shareholders' desire for "real time" information but some aspects of our business take time.
CaverStem(TM) domestic activities: We are continuing marketing to physicians across the United States. Since our last shareholder update an additional five physicians have expressed interest in joining CaverStem(TM). We are currently vetting those physicians and will submit contracts for their review and signature. Once contracts are in place, we will schedule training and begin marketing for patient awareness.
These physicians came to us through our physician marketing program. We are continuing to use this marketing tool with mailers and emails with follow up telephone communication with physicians across the country.
As previously disclosed, we have and will continue to use social media to build patient awareness with the use of Google Ad Words and banner advertising. We believe social media is a great resource as 80% of patients find us, using their phones and tablets. In order to continue to grow patient awareness print advertising is now being used and we are continuing to develop our television commercial which will be edited to direct patients to each physician in their area.
Dr. Narayan and his staff at North Florida Urology were trained on April 24(th) with five patients successfully treated. Training for Dr. Liu in San Francisco is scheduled on May 2(nd) and Dr. Sanderson in Honolulu will be trained in May. Other physicians are scheduled the first of June.
Patient testimonials discussing the procedure and the positive results are being filmed and will be posted on our caverstem.com website and our social media pages.
CaverStem(TM) International activities: We are continuing to treat patients in Italy and the first patients treated within the past 2 months have expressed positive results. This will be covered in a separate press release by Dr. Antonini and the company.
Additionally, our electronic patient registry is complete and is being forwarded to physicians. This registry is intended to include data from our clinical trial, data from treating physicians using centrifuge technology with a 30cc to 60cc bone marrow aspiration and our second generation, needle only, mini bone marrow aspiration technology drawing a maximum of 20cc of bone marrow. Recent publications have disclosed that with the second generation needle technology a larger amount of pure cell product is harvested because of a reduction in dilution of blood, thus requiring a reduced bone marrow aspiration. The registry will enable the company to gather and maintain ongoing HIPAA compliant information on patient demographics, history and treatment progress. Patient names and addresses will not be included on the registry or disclosed to the company.
We have received positive feedback from treating physicians in the United States and Europe of a 70% to 100% efficacy in their patients. This percentage may fluctuate depending on the age and health of the patients and cause and severity of their erectile dysfunction.
FemCelz(TM): as previously announced, we are progressing with the development of the FemCelz(TM) procedure for the treatment of female sexual dysfunction. The first patients are scheduled for May 2(nd) in San Francisco. Additional patients are being scheduled in other cities.
We continue to move forward on all aspects of our business. The dedication of our team towards building the fundamentals of the company and shareholder value remain as strong as ever and the addition of medical industry veterans allows us to grow the company on a domestic and international level at a faster pace than at any time since inception of the company.
We would also like to thank our shareholders for their support, including the many shareholders from the medical field who have expressed positive feedback on our progress.
We are currently finalizing our Q1 financials and expect to file by the May 15, 2019 deadline.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to www.creativemedicaltechnology.com. For more information on our Caverstem(TM) procedure please go to www.caverstem.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.
View original content:http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-inc-april-2019-shareholder-update-300840743.html
SOURCE Creative Medical Technology Holdings, Inc.
/CONTACT: Timothy Warbington, Chief Executive Officer, Tel: (480) 789-9939
Exhibit 99.2
CaverStem Stem Cell Treatment Of Erectile Dysfunction Receives Additional International Exposure
7:45 AM ET 5/6/19 | PR Newswire
PHOENIX and ROME, May 6, 2019 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (OTCQB-CELZ) announced today coverage of its patented CaverStem(R) technology for treatment of erectile dysfunction using the patient's own non-manipulated and non-expanded stem cells in multiple Italian publications.
"We are pleased that our CaverStem(R) procedure has gained such international exposure in the few months since Prof. Gabriele Antonini MD, PhD has begun treating patients in Italy," said Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc.
The publications include: Adnkronos, Momento Italia, DottNet and Secolo de Italia. Excerpts of the interview with Dr. Antonini, translated from Italian to English are as follows:
"A natural, non-invasive and permanent treatment to regenerate blood vessels and smooth muscles within the sexual organ of patients with erectile dysfunction. A real 'bombshell' to revive their sex life. It's called CaverStem(R) and is a patented medical protocol in the United States, also available in Italy," emphasizes the Adnkronos Salute Gabriele Antonini, urologist-andrologist from Rome.
"In the field of biomedical research, regenerative medicine has successfully established itself in the last decade through the development of new strategies and alternative treatments to conventional therapies, using growth factors and other intercellular signals capable of stimulating the natural process of healing of the human body," remarks Dr. Antonini.
So, how does 'bombing' with stem cells work? "We use hematopoietic, mesenchymal and endothelial progenitor cells present in the patient's bone marrow," explains Dr. Antonini. "The administration of stem cells directly into the penis can reverse the pathophysiological changes that lead to erectile dysfunction, in addition to treating the symptoms effectively. In about 15 minutes, the urologist specialist proceeds with local anesthesia to extract a small amount of autologous material from the iliac crest from the patient and obtains a concentrated cellular product that is injected into the corpus cavernosum of the patient's penis.
"The CaverStem(R) procedure, scientifically already validated in the USA, allows for a safe, fast and free of collateral effects in an outpatient procedure," highlights Dr. Antonini. "Only three months after implantation, an increase in duration and frequency of erection was detected, in addition to maintaining it until orgasm was reached."
"The side effects are practically absent, and no post-procedure complication has occurred," explains Dr. Antonini. "CaverStem(R) shows a truly rosy future for the non-invasive and non-surgical treatment of erectile dysfunction."
"The patient progress in Italy is indicative of reports by physicians in the United States. We are continuing to bring on board other domestic and international physicians and are highly optimistic with the future of CaverStem(R) in the United States and Internationally," said Timothy Warbington.
CaverStem(R) is a registered trademark in the United States and a pending trademark in The European Union.
For more information on our erectile dysfunction technology please go to www.Caverstem.com.
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 OTCQB under the ticker symbol CELZ. For further information about the company go to 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.
Publications cited:
https://www.adnkronos.com/salute/medicina/2019/05/04/dagli-usa-italia-staminali-bombita-contro-disfunzione-erettile_JgeCu0fOCt6ChtwQ4XDEGN.html?refresh_ce
https://www.dottnet.it/articolo/27651/contro-la-disfunzione-erettile-trattamento-con-staminali/
https://www.secoloditalia.it/2019/05/sanita-ce-il-si-del-ministero-in-italia-la-bombita-per-rilanciare-la-vita-sessuale/
https://www.momentoitalia.it/sesso-dagli-usa-in-italia-le-staminali-bombita-contro-disfunzione-erettile/61549/
View original content:http://www.prnewswire.com/news-releases/caverstem-stem-cell-treatment-of-erectile-dysfunction-receives-additional-international-exposure-300844049.html
SOURCE Creative Medical Technology Holdings, Inc.
/CONTACT: Creative Medical Technology Holdings, Inc., ceo@creativemedicalhealth.com, Tel: 480-789-9939