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.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the 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, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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, 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.
James A. Joyce
Chairman and CEO
Chief Financial Officer
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