Technology Could Address Significant Need for
Better Treatment of Bloodstream Infections Caused by Drug-resistant Microbes
Martinez, CA. – January 25, 2018 – ExThera Medical Corporation, the leading developer of innovative therapies for removing bacteria and viruses from blood, today announced that the safety and effectiveness of its Seraph® 200 Microbind® Affinity Blood Filter (Seraph 200) has been demonstrated in pre-clinical testing. The fourth phase of DARPA’s Dialysis-Like Therapeutics (DLT) program was successfully completed in November by Battelle scientists. This final phase of testing employed Good Laboratory Practices to produce results for submission to the U.S. Food and Drug Administration (FDA). The written report, which is pending, confirms safety and efficacy of Seraph in the removal of drug-resistant pathogens from whole blood.
Seraph is a unique production-ready device that is 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 the significant unmet need for rapid treatment of bloodstream infections caused by a long list of pathogens, including many that are drug-resistant. Seraph 100 was recently designated by FDA for inclusion in the Expedited Access Pathway (EAP) program. EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases.
Although similar in appearance, Seraph is very different from other blood filters, which are offered for the treatment, but not the prevention, of bacterial 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-compatible surface that does not injure the blood. As such, Seraph is designed to treat bloodstream infections quickly to prevent their progression to life-threatening sepsis and septic shock. Seraph 200 also binds endotoxins created by gram-negative bacteria.
ExThera Medical is focused on developing easy-to-use 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.
"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 DLT testing, and to contribute to the collective efforts to save lives and healthcare dollars,” said Robert Ward, CEO of ExThera Medical.
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 hospital or clinic, or on the battlefield. Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has strong patent protection 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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Disclaimer: All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.
Caution: The Seraph® Microbind® Affinity Blood Filter is currently undergoing clinical evaluation and is not available for commercial sale.
ExThera Medical Contact:
Robert S. Ward
Approved for Public Release, Distribution Unlimited