Aethlon Medical Inc (AEMD)

[Truthteller]

JJ Speaks!!!


Aethlon Medical Releases Shareholder Update

News provided by
Aethlon Medical, Inc.

24 Apr, 2017, 09:25 ET

Share this article

SAN DIEGO, April 24, 2017 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), today released the following shareholder update authored by its Chairman and CEO, Jim Joyce.

Dear Shareholders,

I first want to express my appreciation for your overwhelming participation in our annual meeting, which was held in Houston on March 30th. I am pleased to report the participation of 93.5% or 7,441,591 of the 7,961,923 shares that were entitled to vote. There were no votes cast against our slate of directors and just 62,256 shares cast against the reappointment of our auditors.

Additionally, if you did not see the 8-K that was filed with the SEC on March 22nd, we disclosed that we sold 575,000 shares of our common stock at $3.50 to a single life science-focused institutional investor. The resulting net proceeds of approximately $1.85 million will augment our March 31st fiscal year-end balance sheet, which will be reflected in our annual 10-K filing.

As you are likely aware, we disclosed on March 13th that we concluded our FDA-approved feasibility study of our Hemopurifier®. We have since provided FDA with a summary report of the study and are now assembling a detailed final report for submission back to the agency. We believe the Hemopurifier can address a significant unmet need in global health and biodefense. More specifically, it provides a therapeutic strategy to address a broad-spectrum of viral pathogens that are not addressed with antiviral drug therapies, including natural occurring pandemic threats and agents of bioterrorism.

In regards to next steps with FDA, we have placed a high priority on leveraging regulatory pathways that have recently emerged to accelerate the advancement of medical devices in the United States.

In this regard, 2016 represented the first full year of operation for the FDA's Expedited Access Pathway (EAP) program, which was created to speed the development and availability of medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly-debilitating diseases or conditions.

On December 13, 2016, the EAP program was further enhanced when the 21st Century Cures Act was signed into law. The legislation established a designation for "breakthrough" technologies that address diseases or conditions for which no cleared or approved alternatives exist and whose availability is in the best interest of patients.

We plan to submit an FDA application to advance our Hemopurifier under the EAP program as a broad-spectrum treatment countermeasure against life-threatening viruses that are not addressed with an approved antiviral drug. Of the hundreds of viruses that are infectious to humans, only nine are addressed with an approved antiviral drug agent. While there is no assurance that we will receive an EAP designation, I can assure you that our application will reflect our mission to address unmet needs in global health and biodefense.

To learn more about our device and the need for therapies to address life-threatening and irreversibly-debilitating viruses, I encourage you to review the report entitled, "Human Viruses & the Limitation of Antiviral Drug Agents," which can be accessed at: http://aethlonmedical.investorroom.com/file.php/155/Human+Viruses-final.pdf.

Since bringing our feasibility study to a conclusion, we have also requested a meeting with the Biomedical Advanced Research and Development Authority (BARDA). BARDA is a U.S. government agency whose mission is to develop and procure medical countermeasures for the Strategic National Stockpile that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) incidents. This includes pandemic strains of influenza and other high-threat viral pathogens.

You may recall that one of our stated objectives is to fulfill the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2016 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. Based on previous pre-clinical and human clinical outcomes, we believe our Hemopurifier is a leading broad-spectrum candidate to address viral pathogens that remain beyond the reach of traditional disease-specific drugs and vaccines. In this regard, the HHS PHEMCE initiative is managed by BARDA.

Prior to closing out my letter, I encourage you to listen to an interview on National Public Radio that was conducted earlier this month. The interview is quite informative as it provides the historic backdrop of our exosome research, references our first data in Alzheimer's disease and discusses a forthcoming study of Chronic Traumatic Encephalopathy (CTE) in former NFL players that will be conducted by our Exosome Sciences subsidiary.

The 27-minute interview begins at minute six of the program and ends at minute 33 and can be accessed online at https://www.podomatic.com/podcasts/technation/episodes/2017-03-31T04_14_59-07_00.

About Aethlon Medical, Inc.