U.S. FDA Grants Breakthrough Device Designations to ExThera's Seraph® 100 Filter
ExThera Medical Corporation, a healthcare firm specializing in extracorporeal pathogen technologies, has secured multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for its Seraph® 100 Microbind® Affinity Blood Filter, commonly known as the Seraph 100. This cutting-edge blood filter, designed to mimic the human circulatory system's surface, effectively removes pathogens that are often the culprits behind severe illnesses.
The receipt of these Breakthrough Designations is a clear indication of the FDA's recognition of the urgency in expediting the development of Seraph for enhanced treatment of life-threatening diseases. These include those caused by antibiotic-resistant sepsis and severe SARS-CoV-2 (COVID-19) infection. Additionally, this designation opens the door to immediate coverage through the Centers for Medicare and Medicaid Services (CMS) via the New Technology Add-On Payment (NTAP), providing vital financial support during the initial commercialization phase.
Beyond its immediate implications, these Breakthrough Designations also underscore the device's importance in addressing current healthcare challenges and bolstering preparedness for future pandemics. The Seraph 100 operates by passing a patient's blood over receptors that mimic the targets of invading pathogens. These receptors efficiently capture and remove harmful substances, effectively cleansing the bloodstream.
It's worth noting that the Seraph system does not introduce any foreign substances into the patient's bloodstream. Instead, it focuses on eliminating the pathogens responsible for the infection while binding and removing harmful substances produced by both the pathogen and the body's response to the infection. The Seraph's proprietary adsorption media, consisting of chemically bonded heparin-coated beads, offers excellent blood compatibility and the capacity to bind a wide range of harmful agents, including circulating tumor cells, bacteria, viruses, fungi, and sepsis mediators known to contribute to organ failure during sepsis.