Presentation marks first time Seraph 100 data presented in the U.S.
Martinez, Calif. – August 22, 2018 – ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced results from a prospective, non-randomized clinical trial evaluating the safety and performance of the Seraph®100 Microbind®Affinity Blood Filter (Seraph) in renal replacement therapy patients who developed bacteremia. The results were presented today in a session at the Military Health System Research Symposium (MHSRS).
“These findings from the Seraph 100 trial support our belief that the Seraph filter has the potential to change the landscape for treating bloodstream infections, impacting a significant unmet need for new treatment options,” said Bob Ward, CEO, ExThera Medical. “In 2011, the federal government first envisioned that such a technology could be applicable to the military, and these efficacy and safety data support that vision for the future treatment of bloodstream infections in a multitude of settings.”
In the study, patients on renal replacement therapy who developed bacteremia had the Seraph filter included in the dialysis circuit for four hours, with regular monitoring to measure the reduction of bacteria in the blood passed through the filter (secondary outcome measure), followed by a 14-day monitoring period to assess for adverse events (primary outcome measure).
Interim safety and performance data showed that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures. In patients who exhibited measurable bacteremia at the time of treatment, despite an adequate dose of antibiotics, a decrease in bacterial count was observed by an increase in time to positivity (TTP) measured by automated blood culture, comparing contemporaneous post- to pre-Seraph blood samples. In addition, there have been no device or treatment related adverse events reported during the entire trial, with vital signs, including heart rate, blood pressure, and cardiac output, all being stable and reproducible.
Preliminary data from the trial were presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels, and MHSRS marks the first time these findings have been presented in the U.S.
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 completion of the CE Mark registration trial evaluating the safety of the Seraph® 100 Microbind®Affinity Blood Filter (Seraph) in renal replacement therapy patients who developed bacteremia. ExThera Medical expects to move forward with the regulatory submission of CE Mark data in the European Union (EU) in the fourth quarter of 2018.
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 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 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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Caution: The Seraph®Microbind® Affinity Blood Filter is currently undergoing clinical evaluation and is not available for commercial sale.
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