0001019687-15-001376.txt : 20150409 0001019687-15-001376.hdr.sgml : 20150409 20150409171100 ACCESSION NUMBER: 0001019687-15-001376 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150406 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150409 DATE AS OF CHANGE: 20150409 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AETHLON MEDICAL INC CENTRAL INDEX KEY: 0000882291 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 133632859 STATE OF INCORPORATION: NV FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21846 FILM NUMBER: 15762036 BUSINESS ADDRESS: STREET 1: 9635 GRANITE RIDGE DRIVE, SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92123 BUSINESS PHONE: 858-459-7800 MAIL ADDRESS: STREET 1: 9635 GRANITE RIDGE DRIVE, SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92123 FORMER COMPANY: FORMER CONFORMED NAME: BISHOP EQUITIES INC DATE OF NAME CHANGE: 19930602 8-K 1 aethlon_8k.htm CURRENT REPORT

 

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 6, 2015

 

AETHLON MEDICAL, INC.

(Exact name of registrant as specified in its charter)

         

Nevada

(State or other jurisdiction of incorporation)

 

000-21846

(Commission File Number)

 

13-3632859

(IRS Employer Identification Number)

 

     

9635 Granite Ridge Drive, Suite 100

San Diego, California

(Address of principal executive offices)

 

92123

(Zip Code)

 

Registrant’s telephone number, including area code: (858) 459-7800

 

Not applicable

(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):

     
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 

 

FORWARD-LOOKING STATEMENTS

 

This Form 8-K and other reports filed by us from time to time with the Securities and Exchange Commission contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, our management as well as estimates and assumptions made by our management. When used in such filings, the words "anticipate,” "believe," "estimate," "expect," "future," "intend," "plan" or the negative of these terms and similar expressions as they relate to us or our management identify forward-looking statements. Such statements reflect our current view with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to our industry, our operations and results of operations and any businesses that we may acquire. 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 we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

ITEM 8.01 OTHER EVENTS.

 

On April 9, 2015, Aethlon Medical, Inc. (“we”) issued a press release announcing that we had submitted a Humanitarian Use Device (“HUD”) submission to the U.S. Food and Drug Administration (“FDA”) to support market clearance of the Aethlon Hemopurifier® as a treatment for Ebola virus. If the HUD application is designated by the FDA, we then may submit a Humanitarian Device Exemption marketing application to the Center for Devices and Radiological Health for marketing review. We cannot assure you that we will receive approval to market the Hemopurifier as a treatment for Ebola virus. A copy of the press release is filed as Exhibit 99.1 hereto.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

 

(d) EXHIBITS

 

EXHIBIT
NO.

DESCRIPTION

   
99.1

Press Release dated April 9, 2015

 

2
 

 

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.

 

 

        AETHLON MEDICAL, INC.
         
       

 

By: /s/ James B. Frakes

        James B. Frakes
Dated: April 9, 2015   Chief Financial Officer

 

 

 

 

 

 

 

 

 

3

EX-99.1 2 aethlon_8k-ex9901.htm PRESS RELEASE

Exhibit 99.1

 

 

Aethlon Medical Announces Ebola Humanitarian Use Device Submission to the FDA

 

SAN DIEGO, April 9, 2015 /PRNewswire/ --Aethlon Medical, Inc. (OTCQB:AEMD), a pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, announced today that it has submitted a Humanitarian Use Device submission to the United States Food and Drug Administration (FDA) to support potential market clearance of the Aethlon Hemopurifier® as a treatment for Ebola virus. The Hemopurifier is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. The device targets antiviral drug resistance and could serve as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.

 

A Humanitarian Use Device (HUD) is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. If the HUD application is designated by the FDA, Aethlon may then submit a Humanitarian Device Exemption (HDE) marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review. There is no assurance that Aethlon will receive HDE approval to market the Hemopurifier as a treatment for Ebola virus.

 

About Aethlon Medical, Inc.

 

Aethlon Medical creates medical devices that target unmet therapeutic needs in infectious disease and cancer.  The company's lead product is the Aethlon Hemopurifier®, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression.  Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders. Additional information can be found online at www.AethlonMedical.com and connect with the Company on Twitter, LinkedIn, Facebook and Google+.

 

Certain statements herein may be forward-looking and involve risks and uncertainties.  Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that Exosome Sciences, Inc. will not be able to commercialize its future products, including any that can be described as a liquid biopsy, that the FDA will not approve the initiation of the Company's future clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy or as a broad spectrum defense against viral pathogens, including Ebola, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

 

James A. Joyce
Chairman and CEO
(Office) 858.459.7800 x301

(Cell) 619-368-2000
jj@aethlonmedical.com

 

Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com 

 

 

 

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