With its infectious disease blood test currently under review at the FDA, Inflammatix has obtained $57 million in new financing to help it gear up for its pending commercial rollout.
The former Fierce Medtech Fierce 15 winner has been developing a cartridge-based, benchtop-sized machine to rapidly profile the body’s immune response to an invader—to help emergency department clinicians determine whether a patient has a bacterial versus viral infection, and if they may be at risk for developing sepsis.
With results available in about 30 minutes, the findings from Inflammatix’s molecular TriVerity test may aid in deciding if a patient should receive antibiotics, or potentially need more intensive care during their hospital stay.
Late last year, the company reported that it had completed the technical development of the TriVerity test and its multiplex Myrna instrument—which scans for up to 64 messenger RNA segments—and said it had received a breakthrough designation from the FDA, including for its use of artificial intelligence programs to analyze gene expression for evidence of an infection.
The latest proceeds will help grow Inflammatix’s commercial staff, as well as fund health economic studies on TriVerity’s potential impact. The company estimates about 20 million people each year enter emergency rooms with the symptoms of an acute infection while sepsis is a leading cause of death within hospitals and the most costly diagnosis among Medicare beneficiaries.
“TriVerity is bringing the promise of machine learning and AI to infection and sepsis care,” Inflammatix co-founder and CEO Timothy Sweeney said in a statement. “We hope to help hospitals improve their performance in terms of complying with sepsis detection and treatment protocols and optimizing patient throughput.”
The company’s series E venture capital round was led by Khosla Ventures and Think.Health, with additional backing from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare and RAW Ventures, among others.
Inflammatix previously raised $102 million in its 2021 series D financing, aimed at supporting its clinical development programs. The company’s pipeline also includes a separate test for classifying sepsis into subtypes that may respond differently to various treatment approaches, such as blood filtration or medications.
“Despite incremental improvements in patient outcomes, the death toll from sepsis remains disproportionately high among vulnerable populations,” said Khosla partner Alex Morgan. “The challenge is that existing diagnostics are not able to detect sepsis early enough to trigger timely intervention, and by the time noticeable clinical symptoms appear, it's often too late.”
“TriVerity takes a novel approach by detecting the RNA changes that occur in immune cells prior to the manifestation of disease, enabling clinicians to respond faster and sometimes before physiological symptoms are even present,” Morgan added. “This is a step-change in life-saving care that physicians have been wanting for decades.”
Inflammatix hopes to receive clearance from the FDA before the end of this year. The company has said the test’s first iteration will be laboratory-based, though a future version will seek a CLIA waiver allowing it to be used in the ER at the point of care.