Amarex Helps Client Obtain Breakthrough Device Designation from U.S. FDA
Germantown, MD, USA (July 18, 2022) – Amarex Clinical Research, LLC, an NSF company, is pleased to announce the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to its longtime client Spectral Medical Inc. for their therapeutic hemoperfusion device Toraymyxin™ (“PMX”) which is designed to selectively remove endotoxin from circulating blood through direct hemoperfusion, thereby reducing the risk of developing sepsis.
Amarex’s regulatory team provided key direction to prepare and submit the Request for Breakthrough Device Designation on Spectral’s behalf. Dr. Kazem Kazempour, President & CEO of Amarex states, “Our Regulatory department worked diligently and in partnership with Spectral colleagues to obtain Breakthrough Device Designation status, which will accelerate patient access to Spectral’s innovative hemoperfusion device.” Data provided to FDA showed that the PMX cartridge has the potential to substantially improve survival for critically ill patients with septic shock.
Amarex also provided all regulatory and clinical trial services to Spectral for their Phase III EUPHRATES trial and is currently conducting their TIGRIS trial.
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
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