Sepsis is caused by an uncontrolled spread of infectious pathogens and the release of toxins that can lead to systemic inflammation, insufficiency of various organs, and even death. The pathogens responsible for causing sepsis are often difficult to identify and patients are routinely treated with broad-spectrum antibiotics.
However, dead pathogens that remain in the bloodstream release toxic fragments called pathogen-associated molecular patterns, or PAMPS, that can trigger the inflammatory cascade that leads to sepsis and death. To address this, researchers at the Wyss Institute of Biologically Inspired Engineering in Boston developed a device that can filter these deadly pathogens directly from our blood.
We reported on this technology again 2014 i 2015 when it was first conceptualized, and it’s exciting to see the progress of the device, which has been named GARNET and which BOA Biomedical is further developing. We recently had the opportunity to interview the Director of Operations, Ms. Nisha Varma, to understand more about the device’s applications and their future potential.
Rukmani Sridharan, Medgadget: Can you detail GARNET’s capabilities for pathogen filtration? What range of pathogens can be detected?
Mrs. Nisha Varma, BOA Biomedical: GARNET is an extracorporeal blood cleansing therapeutic device capable of removing pathogens and their toxic residues that cause inflammation directly from a patient’s blood. BOA platform technology has demonstrated the ability to successfully capture and eliminate PAMP and more than 100 clinically relevant bacteria, fungi, parasites, toxins, and viruses, including SARS-CoV-2.
Medgadget: How does the GARNET device filter blood pathogens?
Nisha Varma: GARNET uses a currently marketed dialysis filter that has fibers that have been coated with BOA’s patented engineering protein called FcMBL. Pathogens present in the blood are passed through this standard dialysis filter and can bind to this proprietary protein and therefore be captured in the filter during treatment. As blood continues to seep through GARNET, pathogens are captured and removed from the bloodstream.
Medgadget: How much blood can you process in a minute and how long would it take to filter an average person’s blood?
Nisha Varma: GARNET is designed to process blood at a rate of 200-600 ml / min. We expect the treatment to take 3-4 hours.
Medgadget: Can you tell us how the GARNET device was used in the COVID-19 pandemic?
Nisha Varma: Responding to the unmet medical needs of patients with a serious or life-threatening illness or condition is important for BOA Biomedical. BOA Biomedical maintains an expanded access program for circumstances in which a patient with a life-threatening illness, such as COVID-19, requires treatment and the treating physician believes that GARNET technology may be beneficial.
Medgadget: The device has recently received FDA approval for an early clinical trial. Can you explain what you will look for in this test?
Nisha Varma: BOA has obtained U.S. FDA approval to conduct an early feasibility study under an investigative device exemption (FDI) for GARNET. This is a first clinical safety study in humans that is prospective, multicenter and single-arm. The study will initially enroll up to 15 subjects in a maximum of five places. GARNET is intended for use in subjects with a confirmed or suspected infection of the bloodstream. The main goal of the study is safety. Additional data related to the performance of GARNET in the removal of pathogens and PAMP from the blood will also be acquired.
Medgadget: Are there other companies developing similar devices and when do you want the GARNET device to hit the market?
Nisha Varma: There are a small number of companies that develop or have developed filtration products with the intention of treating bloodstream infections. These products often use technologies that attempt to eliminate proteins or house pro- and anti-inflammatory mediators, the consequences of which are not fully understood. BOA’s approach is to eliminate pathogens and toxins with the goal of preventing an extreme downstream immune response: it addresses the root cause of the patient’s uncontrolled inflammatory response.