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ExThera Medical Corporation

Organization Address
813 Heinz Ave
Berkeley, CA 94710-2754

Organization Phone
(510) 809-2500

Website
www.extheramedical.com

Industry
Bioscience

Organization Description
The mission of ExThera Medical is to develop and introduce life-saving medical devices that quickly and safely remove infectious agents from human blood. These include bacteria and their toxins, viruses, virulence factors and pro-inflammatory cell mediators that lead to a systemic inflammatory response. ExThera's initial focus is the treatment of bacteremia for the prevention of complicated metastatic infections and sepsis, a top-10 cause of death in the United States, and a significant healthcare problem across the globe. Sepsis ? and in its most severe stage, septic shock ? is an extremely dangerous, and frequently deadly affliction that results from bacterial, viral, and/or fungal infections. Pathogen concentration in blood and duration of bacteremia have been shown to be strongly correlated with high patient morbidity and mortality, and increased risk of metastatic infection, such as endocarditis and osteomyelitis. Since early diagnosis of the pathogens causing bacteremia is particularly challenging in the clinical setting, a broad-spectrum approach is needed to quickly reduce the level of many possible pathogens in a patient's bloodstream that are causing the infection, to avert the onset of a systemic inflammatory response. The game-changing, differentiator of ExThera Medical's technology? Seraph? (Selective Removal by Apheresis) ? is its ability to remove many different, harmful substances from the blood. No other single technology is known to have the potential to reduce such a wide range of harmful agents from the blood of infected patients. In addition to treating bacteremia, other potentially life-saving therapeutic applications of Seraph include treatment of CMV disease, malaria, dengue hemorrhagic shock and fever, and hepatitis C. Additional applications of ExThera's Seraph technology include improving the safety of the human blood supply, through removal of pathogens from blood and its component products. The Seraph? Microbind? Affinity Blood Filter is undergoing clinical evaluation and is not available for commercial sale. Our Technology Selective Removal by Apheresis (Seraph?) is based on the unique binding capacity of the naturally occurring molecule heparin that has been immobilized on a high surface area support. Disease-causing microorganisms use cell surface glycoconjugates ? such as heparan sulfates ? as receptor sites on cell membranes for attachment, to facilitate their invasion and colonization of tissue. Heparin, an FDA approved pharmaceutical analog of heparan sulfate, can be used as a substitute binding site for these pathogens, toxins and undesired cytokines when it is immobilized on microspheres by modified ?end-point attachment?. When a patient's blood is passed through a Seraph? device, pathogens and toxins are diverted from targeted cells to the biomimetic heparin surface. They are captured, sequestered and thereby removed from the bloodstream. ExThera Medical is continuing to investigate and optimize the clinical impact of the ability of its proprietary and patented technology to bind viruses, bacteria, exotoxins, and parasites in blood, while developing both therapeutic products to treat patients in the clinic, and devices that purify blood prophylactically before (re)perfusion. The technology uses a heparin-surface coating that is anti-thrombogenic and anti-inflammatory, which has been proven to be inherently safe in other blood contacting medical devices. The use of ?immobilized? heparin within a device is a novel way of delivering its therapeutic potential, while potentially minimizing the patient's risk of thrombocytopenia and hemorrhage, which can sometimes occur when the drug is administered systemically (in its soluble form). Seraph? has been engineered to operate with a low pressure drop at blood flow rates up to 300 ml/minute, offering efficiency in treatment, and economic use with existing equipment, thus avoiding capital expenditure by healthcare providers. Unlike other technologies which attempt to capture chemical messengers based on their size or antibody affinity, Seraph? uses the biological activity of naturally-occurring molecules to effect clinical improvement. Additional media are under development which will capture the pathogens and toxins that do not naturally bind to heparan sulfate.