Martinez, Calif. – September 10, 2018 – Robert Ward, CEO of ExThera Medical Corporation, a developer of device-based therapies for removing bacteria and viruses from blood, today presented clinical results of the Seraph®100 Microbind®Affinity Blood Filter(Seraph) at the 2018 Polymers in Medicine and Biology Forum sponsored by the American Chemical Society Division of Polymer Chemistry.
Ward’s keynote presentation in a session on New Approaches in Biomaterials explained the innovative polymer technology that enables Seraph to provide effective intervention in bacterial and viral bloodstream infections. Seraph is designed to reduce the duration and intensity of infections to improve clinical outcomes. It is the first and only broad-spectrum filter that removes pathogens from whole blood. By using immobilized heparin with a unique molecular architecture, Seraph mimics the heparan sulfate binding sites on endothelial cells that are targeted by invading pathogens. Seraph’s high surface area quickly removes large amounts of drug-resistant and drug-susceptible bacteria, viruses, toxins, and sepsis mediators from flowing blood.
ExThera recently completed its CE Mark registration clinical trial, which evaluated the safety and performance of the filter in dialysis patients with bloodstream infections. Interim results from this trial, most recently presented at the Military Health System Research Symposium (MHSRS) in August, demonstrated that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures.
The U.S. Food and Drug Administration granted Seraphinclusion in its 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. On June 1, 2018, ExThera announced the successful completion of the CE Mark registration trial evaluating the safety and performance of Seraph in renal replacement therapy patients who developed bacteremia. ExThera will submit its EU Clinical Evaluation Report in the fourth quarter of 2018. EU product introduction is expected to begin in the first half of 2019 pending EU approval/CE Mark.
About the Seraph®Microbind®Affinity Blood Filter
As a patient's blood flows through the Seraph Microbind Affinity Blood Filter, it passes over tiny 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 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 may be useful in certain bloodstream infections that progress to endotoxemia. The Seraph filters have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory.
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 devices to treat patients in the hospital or clinic, or on the battlefield. Led by an accomplished management team with extensive experience developing and commercializing 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 successful 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.
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