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):August 23, 2018
DTHERA SCIENCES
(Exact Name of Registrant as Specified in Charter)
| Nevada | 333-191175 | 90-0925768 |
| (State or Other Jurisdiction of Incorporation) | Commission File Number | (IRS Employer Identification No.) |
| 7310 Miramar Rd Suite 350., San Diego, CA | 92126 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:(858) 215-6360
____________________________________________________
(Former name or former address, if changed since last report.)
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 |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act |
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
☐ 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 7.01 | Regulation FD Disclosure. |
| Item 8.01 | Other Events. |
Press Release – FDA Grants Breakthrough Device Designation to DTHR-ALZ
Dthera Sciences, a Nevada corporation (the “Company”), announced on August 23, 2018, that the U.S. Food and Drug Administration (the “FDA”) has granted Breakthrough Device designation to the Company’s development-stage product, DTHR-ALZ.
Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with medical device developers to expedite regulatory review in order to give patients more timely access to a Breakthrough Device. A “Breakthrough Device” is a device that may be more effective at treating or diagnosing a life-threatening or irreversibly debilitating disease or condition compared to the current standard of care. Additional information is included in the release.
The Company’s press release included as Exhibit 99.1 will be deemed to be “furnished” rather than “filed,” pursuant to the rules of the Securities and Exchange Commission.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated August 23, 2018 |
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.
| Dthera Sciences | |
| Date: August 23, 2018 | |
| By: /s/ Edward Cox | |
| Name: Edward Cox | |
| Title: Chief Executive Officer |