August 22, 2012
DARPA Renews Aethlon Medical’s Sepsis Therapy Contract
Aethlon Medical, Inc. (OTC:AEMD), a medical device company that has developed a patented blood filtration system for the treatment of infectious disease and cancer, recently announced the renewal of a multi-million dollar contract with the federal government. This contract is intended to fund the development of a portable device that will reduce the incidence of sepsis through the rapid elimination of sepsis promoting factors from the entire circulatory system. Sepsis is the tenth most common cause of death in the United States and accounts for as much as 25% of ICU bed utilization. Worldwide the problem is even more severe.
Aethlon continues to advance large market extracorporeal therapy applications beyond the treatment of renal failure (read ‘dialysis’), which is addressed by organizations such as Davita, Inc. (NYSE:DVA) and Fresenius Medical Care (NYSE:FMS). The company’s therapeutic platform has shown promise across indications, including sepsis, hepatitis C and cancer.
This contract is good news for Aethlon on several fronts. It provides a significant revenue stream and improves the visibility of the Aethlon ADAPT™ system as a platform technology that could support the therapeutic interests of other government health agencies. If successfully completed, the project could lead to significant orders from the U.S. Military for field treatment of soldiers (up to 10% of combat wounds end in sepsis, and in 2009 more than 500 troops died as a result of sepsis). This potential business could certainly expand far beyond the military if proven effective. Coupled with AEMD’s recent developments in the treatment of hepatitis C, this news makes the company’s $14 million market cap look incredibly small.
Aethlon Medical, Inc. (AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that the Defense Advanced Research Projects Agency (DARPA) has exercised an option agreement to proceed with year-two of a five-year $6.8 million contract that was awarded to Aethlon on September 30, 2011 under DARPA’s Dialysis-Like Therapeutics (DLT) program.
As a result, Aethlon is able to initiate work toward year-two contract milestones ahead of the schedule. The second year of Aethlon’s DLT contract contains eight milestones representing a potential of $1,617,446 in revenue opportunity. To date, Aethlon has invoiced $1,758,300 to DARPA for achieving seven of eight milestone objectives targeted in year-one of the DLT program. Aethlon further disclosed that it has completed its eighth year-one milestone objective worth $216,747, but has not yet invoiced DARPA.
The Company also disclosed that it has teamed with two larger organizations in response to a follow-on DLT contract opportunity entitled DARPA BAA-12-36. The announcement of DARPA BAA-12-36 contract awards is anticipated later this fall.
The goal of the DLT program is to develop a portable device that removes “dirty” blood from the body, separates harmful agents, and returns “clean” blood to the body in a manner similar to dialysis treatment of kidney failure. The resulting device would decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States annually. In the DLT program, Aethlon has been contracted to utilize the Aethlon ADAPT™ system to create an extracorporeal blood purification cartridge that selectively eliminates sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The Aethlon ADAPT™ converges advanced plasma membrane technology with high affinity drug agents to allow the selective yet rapid clearance of disease targets from the entire circulatory system without damaging blood cells or removing particles essential for health. Aethlon has also been contracted to develop a novel blood circulatory instrument that will deliver ADAPT™ based and other therapeutic filtration devices without systemic anticoagulants normally required in extracorporeal therapies.
Beyond the civilian need for anti-sepsis therapies, the device proposed in the DLT program would play an important role in saving the lives of wounded U.S. military personnel, as infection leading to sepsis is a significant cause of mortality. When sepsis is complicated by shock, approximately half of patients do not survive for 30 days, even if effective antibiotics are used. Unfortunately, the fatality rate from sepsis can be high, given that antibiotic-resistant bacteria are an increasing problem for injured warfighters and military treatment facilities. Bio-agents engineered for resistance against antibiotics also represent a significant threat to both warfighters and citizens. Current culture-based methods of identifying blood-borne pathogens can take 48 hours or longer to identify the offending pathogen, and some blood-borne pathogens do not propagate in culture. Pending these culture results, septic patients are treated with protocol-based broad-spectrum antibiotics. In the event the offending pathogen is resistant to the empirically chosen antibiotic, the fatality rate may increase as much as 9% per hour.
About Aethlon Medical, Inc.
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
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 the FDA will not approve the initiation of the Company’s 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, 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.
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