Sepsis is caused by an uncontrolled spread of infectious pathogens and release of toxins that can lead to systemic inflammation, multi-organ failure, and even death. The pathogens responsible for causing sepsis are usually difficult to identify, and patients are routinely treated with broad spectrum antibiotics.
However, dead pathogens remaining in the bloodstream still release toxic fragments called Pathogen Associated Molecular Patterns, or PAMPS, that can trigger the inflammatory cascade leading to sepsis and death. To address this, researchers from Wyss Institute of Biologically Inspired Engineering in Boston developed a device that can filter these deadly pathogens directly from our blood.
We reported about this technology back in 2014 and 2015 when it was first conceptualized, and it is exciting to see the progress of the device, which has been named GARNET and is being further developed by BOA Biomedical. We recently had the opportunity to interview the Chief Operating Officer Ms. Nisha Varma, to understand more about the applications of the device and its future potential.
Rukmani Sridharan, Medgadget: Can you detail the capabilities of GARNET for pathogen filtration? What range of pathogens can be detected?
Ms. Nisha Varma, BOA Biomedical : GARNET is an extracorporeal blood cleansing therapeutic device capable of removing pathogens and their toxic inflammation-triggering debris directly from a patient’s blood. BOA’s platform technology has demonstrated the ability to successfully capture and remove PAMPs and more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses, including SARS-CoV-2.
Medgadget: How does the GARNET device filter pathogens from the blood?
Nisha Varma: GARNET leverages a currently marketed dialysis filter which has fibers that have been coated with BOA’s proprietary engineered protein called FcMBL. The pathogens present in the blood are passed through this standard dialysis filter and can bind to this proprietary protein and are therefore captured in the filter during treatment. As the blood continues to filter through GARNET, pathogens are captured and removed from the bloodstream.
Medgadget: How much volume of blood can it process in one minute and how long would it take to filter an average person’s blood?
Nisha Varma: GARNET is designed to process blood at the rate of 200-600 ml/min. We expect treatment to take 3-4 hours.
Medgadget: Can you tell us how the GARNET device has been used in the COVID-19 pandemic?
Nisha Varma: Addressing the unmet medical needs of patients with a serious or life-threatening disease or condition is important to BOA Biomedical. BOA Biomedical does maintain an Expanded Access program for circumstances where a patient with a life-threatening illness, such as COVID-19, requires treatment and the treating physician believes that the GARNET technology may be of benefit.
Medgadget: The device has recently gotten approval from the FDA for an early clinical trial. Can you explain what you’ll be looking for in this trial?
Nisha Varma: BOA has obtained approval from the U.S. FDA to conduct an Early Feasibility Study under an Investigational Device Exemption (IDE) for GARNET. This is a first in human clinical safety study that is prospective, multi-center and single-arm. The study will initially enroll up to 15 subjects at up to five sites. GARNET is intended to be used in subjects with a confirmed or suspected bloodstream infection. The primary study endpoint is safety. Additional data relating to GARNET’s performance in removing pathogens and PAMPs from the blood will also be acquired.
Medgadget: Are there other companies developing similar devices and when do you expect the GARNET device to hit the market?
Nisha Varma: There are a small number of companies that are developing or have developed filtration products with the intent of treating bloodstream infections. These products often utilize technologies that try to remove the proteins or host pro- and anti-inflammatory mediators, the consequences of which are not fully understood. BOA’s approach is to remove the pathogens and toxins with a goal of preventing extreme downstream immune response-it treats the root cause of the patient’s uncontrolled inflammatory response.