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BOA™ Biomedical’s GARNET™ Therapeutic Product Commences 1st In Human clinical trial

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March 18, 2021

BOA Biomedical, a Miraki™ Innovation company, focused on rapidly diagnosing and treating some of the world’s deadliest infectious diseases has announced that the company will begin its First in Human clinical trial for GARNET.

GARNET is an extracorporeal blood cleansing therapeutic capable of removing a significant number of pathogens and their toxic inflammation-triggering debris directly from a patient’s blood. BOA’s platform technology has both diagnostic and therapeutic applications and has demonstrated the ability to capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses, including SARS-CoV-2. Infectious diseases are a leading cause of death worldwide. COVID-19 has already claimed the lives of over 500,000 U.S. citizens and over 2.4 million worldwide. This major milestone advances BOA’s mission of revolutionizing the fight against infectious disease and sepsis, by providing governments, nurses and doctors with tools and technology to save lives.

When it comes to infectious disease, knowledge is power and speed is paramount. For each hour of delay in treating an advanced case of sepsis, fatality rates increase by up to 8%. BOA’s technology has the potential to effectively manage infectious disease throughout the patient journey—from diagnosis, to tracking to treatment. GARNET also addresses the growing emergence of antibiotic-resistant infection, a significant limitation of existing therapies, and is intended to serve as a medical countermeasure capable of responding to any infectious outbreak, even when the pathogen is unknown.

BOA’s extracorporeal blood filtration technology was developed at the Wyss Institute for Biologically Inspired Engineering at Harvard University and was funded by the U.S. Department of Defense (DOD) and Miraki Innovation. “Our team has developed this technology to provide a broad therapeutic capability to treat bloodstream infections and prevent sepsis that can be used in patients even when the pathogen cannot be identified or is resistant to antibiotics. It is extremely exciting and gratifying to see the enormous progress BOA has made in rapidly moving it into the clinic,” states Donald Ingber M.D., Ph.D., Founding Director of the Wyss Institute, faculty member at Harvard School of Medicine and Engineering, a scientific founder of BOA and a member of its board of directors.

BOA has obtained approval from the U.S. FDA to conduct an Early Feasibility Study under an Investigational Device Exemption (IDE) for GARNET.  This prospective, multi-center, single-arm study will initially enroll 15 subjects at up to five sites. GARNET is intended to be used in subjects with confirmed or suspected bloodstream infection. Nisha Varma, COO of BOA says “This clinical experience can also be extended for use in patients with SARS-CoV-2”.

According to Christopher Velis, Founder and Executive Chairman of Miraki Innovation and BOA Biomedical “In the U.S., every 20 seconds a patient is diagnosed with sepsis and $24 billion per year is spent on treating this life-threatening disease.  BOA’s aim is to put a stop to this. Our goal is to get the best minds in infectious disease to bring revolutionary, life-saving technologies to patients as soon as possible. This medical countermeasure aspires to intervene in pandemic outbreaks, bioterrorism and military operations”. 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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