ExThera's Seraph® 100 Filter Secures FDA's Multiple Breakthrough Device Designations
Wednesday, October 04, 2023
ExThera Medical Corporation, a healthcare firm dedicated to advancing extracorporeal pathogen technologies, has proudly announced its reception of multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for its innovative Seraph® 100 Microbind® Affinity Blood Filter, commonly known as Seraph 100.
The Seraph 100 is an ingenious blood filtration system equipped with a biomimetic surface, inspired by the human circulatory system. This pioneering technology serves a crucial role in eliminating pathogens that can otherwise lead to severe and critical illnesses in patients.
The issuance of multiple Breakthrough Device Designations represents formal recognition by the FDA, underscoring the urgency of advancing the development of Seraph for the benefit of patients.Importantly, the Breakthrough Device Designation grants immediate coverage through the Centers for Medicare and Medicaid Services (CMS) via the New Technology Add-On Payment (NTAP) program.
Seraph 100's operational concept is groundbreaking. As a patient's blood flows through the filtration system, it passes over specialized beads with receptors that mimic those found on human cells, which pathogens typically target during infection.
These beads quickly capture and remove harmful substances from the bloodstream. Notably, Seraph does not introduce foreign substances into the bloodstream but instead specifically targets the pathogens responsible for the infection. It also binds and eliminates harmful substances generated by the pathogen and the body's response to the infection.
Central to Seraph's effectiveness is its proprietary adsorption media, the beads, offering a versatile platform. These beads employ immobilized heparin for their established blood compatibility and possess a unique capability to bind circulating tumor cells, bacteria, viruses, fungi, and key sepsis mediators associated with organ failure during sepsis. This multifaceted approach holds immense promise for transforming the treatment of life-threatening infections and significantly improving patient outcomes.