SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) November 13, 2017
AETHLON MEDICAL, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
(Commission File Number)
8910 University Center Lane, Suite 660
San Diego, California
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 459-7800
(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 (see General Instruction A.2 below):
|☐||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))|
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Indicate by checkmark 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
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. ☐
This Form 8-K and other reports filed by Registrant from time to time with the Securities and Exchange Commission (collectively, the "Filings") contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, Registrant's management as well as estimates and assumptions made by Registrant's management. When used in the Filings the words "anticipate,” "believe," "estimate," "expect," "future," "intend," "plan" or the negative of these terms and similar expressions as they relate to Registrant or Registrant's management identify forward-looking statements. Such statements reflect the current view of Registrant with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to Registrant's industry, Registrant's operations and results of operations and any businesses that may be acquired by Registrant. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Although Registrant believes that the expectations reflected in the forward-looking statements are reasonable, Registrant cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, Registrant does not intend to update any of the forward-looking statements to conform these statements to actual results.
ITEM 8.01 Other Events
On November 13, 2017, the Food and Drug Administration (“FDA”) confirmed receipt of Aethlon Medical, Inc.’s (the “Company”) Investigational Device Exemption (IDE) Final Report (IDE G070038/R3) concerning the use of the Aethlon Hemopurifier® Device in the treatment of chronic end-stage renal disease patients with Hepatitis-C (HCV) infection. The primary objective of the study was to determine whether therapy with the Hemopurifier is safe in health-compromised virally-infected individuals based on a relative absence of device-related adverse events. Based on the review of reported adverse events, there were no significant device related adverse events in enrolled subjects who met the study inclusion/exclusion criteria. Additionally, there was no significant difference in the hematology, clinical chemistry, and inflammatory marker results between the control period and treatment period of enrolled subjects. There were also no significant changes related to BMI or other vital signs when comparing pre-and post-treatment values. The clinical trial authorized by the above-referenced IDE was a single site study conducted at DaVita Medical Center in Houston, Texas. The study enrolled and treated eight subjects who met the inclusion/exclusion criteria and was concluded in March 2017.
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.
|AETHLON MEDICAL, INC.|
|By: /s/ James B. Frakes|
|James B. Frakes|
|Dated: November 16, 2017||Chief Financial Officer|