BOA™ Biomedical's GARNET™ Therapeutic Demonstrates Safety Endpoint and Promising Results During Initial First in Human Use
CAMBRIDGE, Mass., July 8, 2021 /PRNewswire/ -- BOA Biomedical, a Miraki™ Innovation focused on rapidly diagnosing and treating the world's deadliest infectious diseases, has announced the first subject enrolled in the company's Early Feasibility Study (EFS) IDE clinical trial for its GARNET blood filtration system. This prospective, multi-center, single-arm study will initially enroll up to 15 subjects at up to five sites.
GARNET is an extracorporeal blood cleansing therapeutic device designed to remove a significant number of pathogens and their toxic inflammation-triggering debris directly from a patient's blood. The BOA system uses a proprietary, engineered protein with a number of unique capabilities that result in the potential to revolutionize diagnosis, monitoring, and treatment of infectious diseases. BOA's platform technology has demonstrated the ability to capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses, including SARS-CoV-2 (the COVID-19 virus).
The investigational system, consisting of the GARNET filter and its companion diagnostic device, AGATE™, was used on a dialysis patient with a suspected bloodstream infection as part of the BOA EFS IDE clinical trial. The subject was treated with GARNET in accordance with the clinical protocol, with two consecutive dialysis sessions. No adverse events were reported during treatments or within 24 hours following each of the two sessions. Nisha Varma, BOA's Chief Operating Officer, commented: "The initial results with GARNET are very encouraging. As our first in human clinical trial continues, we look forward to continuing to validate GARNET's safety and documenting the reported clinical benefits received by patients enrolled in the study."
Christopher Velis, Founder and Executive Chairman of Miraki Innovation and BOA Biomedical shared "We are pleased with the early results with GARNET. Our platform was designed to address the cause and not just the symptoms of infectious diseases. BOA's solutions are rapid, and span across all classes of pathogens, making the platform the world's first pan-pathogen countermeasure. It holds the hope of protecting us from pandemics, biothreats and drug resistant infectious diseases. It's serious stuff." Christopher also founded Auris Health in 2007, which was acquired in Feb 2019 by Johnson & Johnson, valued at $5.75 billion (inclusive of milestone payments).
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SOURCE BOA Biomedical