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ExThera’s Seraph 100 hits the (CE) Mark
MARTINEZ, CA—ExThera Medical Corporation, 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, announced a few days ago that it has completed its CE Mark registration trial evaluating the safety of the Seraph 100 Microbind Affinity blood filter (Seraph) in renal replacement therapy patients who developed bacteremia.
The prospective, non-randomized study enrolled 15 patients across four trial sites in Germany and the final follow-up day for the last patient enrolled in the trial was June 7, 2018. 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. In addition, the U.S. Food and Drug Administration (FDA) has granted Seraph inclusion 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.
“The completion of the European trial represents an exciting step forward in our effort to make a simple, device-based treatment like Seraph available for bloodstream infections,” said Bob Ward, CEO of ExThera Medical. “With the lack of effective antibiotics for many bloodstream infections and limited new anti-infectives in development, there is a significant unmet need for new approaches that can help treat drug-resistant infections, especially in patients at high risk like those undergoing dialysis.”
The primary outcome measure of the study is to demonstrate the safety of Seraph in a hemodialysis circuit assessed by rate of adverse events (time frame: 14 days). The secondary outcome measure is the reduction of bacteria in blood passed through the Seraph filter (time frame: 4 hours). In the study, patients on renal replacement therapy who developed bacteremia had the Seraph filter included in the dialysis circuit for 4 hours, with hourly monitoring. Patients were monitored for 14 days following treatment.
Interim safety and performance data from the trial was presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels, and showed that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures. Final results from the trial are currently being analyzed and are expected to be available in October 2018. To date, there have been no device or treatment related adverse events reported during the trial.
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. The Seraph Microbind Affinity blood filter is currently undergoing clinical evaluation and is not available for commercial sale.
“Our preclinical studies and the interim data from this study suggest that Seraph is well tolerated when used during dialysis as a treatment to quickly reduce the level of blood-borne pathogens in bacteremia patients,” said Kathleen White, VP and COO of ExThera Medical. “We look forward to analyzing the complete study results as we continue our work on making this novel device, that uses biomimetic adsorption media to treat bloodstream infections, available in Europe.”