MARTINEZ, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, the leading developer of innovative devices that remove bacteria and viruses from blood, today announced that the Defense Advanced Research Projects Agency (DARPA) will continue to fund safety and efficacy testing of its Seraph® 200 Microbind® Affinity Blood Filter (Seraph 200). The fourth and final phase of testing begins this month at Battelle and will be funded by DARPA’s Dialysis-Like Therapeutics (DLT) program. This testing will employ Good Laboratory Practices to produce preclinical results for submission to the U.S. Food and Drug Administration (FDA). ExThera recently completed the third phase of DARPA safety and efficacy testing with several drug-resistant bacteria.
DARPA is also funding ExThera to participate in a pre-clinical pneumonia study at Duke University. Duke is using Seraph 200 to treat pneumonia in a dialysis-like therapy to filter pathogens from the circulating blood. If this non-human trial demonstrates that the approach is successful, it could advance research into a new way for treating pneumonia.
Seraph 200 is the only production-ready device capable of removing a broad range of sepsis-causing bacteria, viruses, toxins, and pro-inflammatory cytokines from whole blood. Validated in preclinical studies and currently under evaluation in a promising European clinical trial, a related device (Seraph 100) promises to address significant unmet needs for the rapid treatment of bloodstream infections caused by a long list of pathogens, including many that are drug-resistant.
Although similar in appearance, Seraph is very different from other blood filters, which are offered for the treatment, but not the prevention, of sepsis. Whereas other devices can remove only cytokines or endotoxins, and in one case viruses, Seraph quickly removes many bacteria, bacterial toxins, viruses, fungi, and cytokines simultaneously using a blood-contacting surface that does not injure the blood. As such, Seraph is designed to quickly treat blood stream infections to prevent their progression to life-threatening sepsis and septic shock. Seraph 200 also binds endotoxins created by gram-negative bacteria that may originate in the gut.
“ExThera Medical is focused on developing simple devices for the rapid treatment of life-threatening bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide,” said Robert Ward, CEO of ExThera Medical. "Effective treatments for preventing and treating sepsis are critically needed, especially for members of our military for whom risk of exposure is significant. We are pleased to have been chosen for this important final phase of testing, and to contribute to the collective efforts to save lives and healthcare dollars.”
About the Seraph® Microbind® Affinity Blood Filter
As a patient's blood flows through the Seraph Microbind Affinity Blood Filter, it passes over proprietary microspheres coated with molecular receptor sites that mimic the receptors on human cells that pathogens use when they invade the body. Harmful substances are quickly captured and adsorbed onto the proprietary surface and are thereby removed from the bloodstream without adding anything to the blood, which is returned to the patient with blood cells intact. The adsorption media is a flexible platform using chemically-bound, immobilized heparin for its blood compatibility, and its unique binding capacity for pathogens. Seraph may be configured with optional supplemental adsorbents to remove other toxins and evolved pathogens. For example, Seraph 200 adds endotoxin binding to Seraph 100, which will be useful in bloodstream infections that progress to endotoxemia. The Seraph filters have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory, and which has been demonstrated to be safe in other medical devices and implants.
About ExThera Medical
Based in Martinez, Calif., ExThera Medical is a privately held medical device company developing innovative, single-use blood filters capable of capturing and removing a broad range of bacteria, viruses, parasites, toxins or other harmful substances from whole blood. The company develops therapeutic products to treat patients in the clinic or hospital, and also devices that can purify transfused blood prophylactically. Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has a well-protected set of patents and a growing body of data from independent laboratory studies, in addition to its participation in DARPA’s Dialysis-Like Therapeutics program. For more information, visit www.extheramedical.com.
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Caution: The Seraph® Microbind® Affinity Blood Filter is currently undergoing clinical evaluation and is not available for commercial sale.