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):
September 8, 2017
AETHLON MEDICAL, INC.
(Exact name of registrant as specified in its
charter)
|
Nevada
(State or other jurisdiction
of incorporation)
|
|
001-37487
(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))
|
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.
¨
FORWARD-LOOKING STATEMENTS
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 August 11, 2017, we submitted an Expedited Access Pathway (EAP)
program submission to The Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (FDA).
A criterion for EAP program eligibility includes medical devices
that represent breakthrough technologies with the potential to address life threatening disease conditions for which no approved
or cleared treatment alternatives exist. In our EAP submission, we proposed the “indication for use” for our lead
therapeutic candidate to be,
"The Hemopurifier is a single-use device indicated for the treatment of life-threatening
highly glycosylated viruses that are not addressed with an approved treatment."
On September 8, 2017, we received a letter from the FDA informing
us that our combination product and proposed “indication for use” meets the EAP criteria and that our Hemopurifier
has been granted EAP designation. Under the EAP program, we will work collaboratively with FDA to design a data development plan
and regulatory pathway intended to achieve FDA-approval of the device, and through this process, we believe the regulatory advancement
of our device with the FDA will be accelerated.
The FDA established
the EAP program for medical devices that demonstrate the potential to address unmet medical needs for life
threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket
notification (510[k]) or requests for De Novo designation.
Under EAP, the FDA works with
device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval
standard of reasonable assurance of safety and effectiveness.
The Aethlon Hemopurifier is a medical
device designed for the single-use removal of viral pathogens from circulatory system of infected individuals. Based
on clinical and preclinical study outcomes, the Hemopurifier is a candidate to treat a broad-spectrum of life threatening
viruses
for which no approved or cleared treatment alternatives exist.
ITEM 9.01 Financial
Statements and Exhibits
(d) Exhibits
99.1
Letter from the FDA to the Registrant, dated September 8, 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.
|
|
|
|
|
AETHLON MEDICAL, INC.
|
|
|
|
|
|
|
|
|
|
|
|
By:
/s/ James B. Frakes
|
|
|
|
|
|
James B. Frakes
|
|
|
|
Dated: September 12, 2017
|
|
Chief Financial Officer
|
Exhibit 99.1
|
|
DEPARTMENT OF HEALTH & HUMAN SERVICES
|
Public Health Service
|
|
|
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
|
September 8, 2017
Aethlon Medical, Inc.
℅ Ronald S. Warren
Senior Director Regulatory Affairs
Experien Group, LLC
224 Airport Parkway, Suite 250
San Jose, CA 95110
|
Re:
|
Q171414
|
|
|
Trade/Device Name: Aethlon Hemopurifier
|
|
|
Received: August 14, 2017
|
Dear Ronald S. Warren:
The Center for Devices and Radiological Health (CDRH) of the Food
and Drug Administration (FDA) has received the above submission dated August 11, 2017, including your request for Expedited Access
Pathway (EAP) designation. The proposed indications for use includes "The Hemopurifier is a single-use device indicated for
the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment." We are pleased
to inform you that your combination product and proposed indication for use meets the criteria and has been granted EAP designation.
Please refer to the guidance entitled, "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet
Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions" available at
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM393978.pdf
and section 3051 of the 21st Century Cures Act for additional information. As noted in the EAP
Guidance, "Combination products may raise unique scientific and regulatory challenges."
We recommend you use the Pre-Submission review process, as described
in the Pre-Submission guidance, to request any additional feedback from FDA on any issues related to this submission. When submitting
any new requests, please reference Q171414. Any new submission should include two copies (one hardcopy and a valid ecopy), the
FDA reference number for this submission, and should be submitted to the following address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
IDE Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
You are reminded that it is imperative that the information used
to support a premarket submission meets the requirements of valid scientific evidence (21 CFR 860.7). You are further advised that
the granting of EAP designation and priority review does not guarantee that the application will ultimately be approved.
If you have any questions, please contact Elizabeth Gonzalez, Ph.D.
at (301) 796-6826 or
Elizabeth.Gonzalez@fda.hhs.gov
.
|
|
Sincerely,
|
|
|
|
|
|
/s/ Joyce M. Whang - S
|
|
for
|
|
|
|
Benjamin R. Fisher, Ph.D.
|
|
|
Director
|
|
|
Division of Reproductive, Gastro-Renal,
|
|
|
and Urological Devices
|
|
|
Office of Device Evaluation
|
|
|
Center for Devices and Radiological Health
|