bioAffinity Technologies, Inc. is a clinical-stage medical device company developing an extracorporeal immunoadsorption platform intended to treat Gram-negative sepsis and other severe inflammatory conditions. The company’s technology employs specialized sorbent cartridges designed to selectively bind and remove circulating endotoxins and inflammatory mediators from the bloodstream, with the goal of supporting critical care interventions and improving patient outcomes.
In preclinical studies, bioAffinity’s hemoperfusion devices have demonstrated the ability to capture lipopolysaccharides released by Gram-negative bacteria, leading to reductions in pro-inflammatory cytokines and enhanced survival rates in animal models. Building on these results, the company has initiated early‐phase human trials in collaboration with clinical research centers to assess the safety, tolerability and preliminary efficacy of its lead immunoadsorption cartridge in sepsis patients.
bioAffinity Technologies is pursuing regulatory clearances in North America and Europe, working toward U.S. Food and Drug Administration authorization and CE marking for its blood purification system. To support these efforts, the company partners with hospitals and research institutions to conduct clinical evaluations and optimize manufacturing processes for scalable production ahead of potential commercialization.
Founded with a mission to address unmet needs in critical care, bioAffinity leverages a leadership team with expertise in biomedical engineering, immunology and critical care medicine. The company remains focused on advancing its pipeline, forging strategic collaborations within the healthcare industry and ultimately delivering its innovative blood purification therapies to patients worldwide.
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