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Inflammatix Secures $57 Million to Advance TriVerity Sepsis Test

• Inflammatix has raised $57 million to support regulatory filing and commercialization of its TriVerity rapid blood test for acute infection and sepsis. • The TriVerity system measures gene expression levels in blood related to immune response, providing results in about 30 minutes using machine learning. • The FDA granted breakthrough device designation to TriVerity, intended to expedite clearance and Medicare coverage; regulatory submission is already underway. • Inflammatix plans to expand its commercial team and conduct clinical studies while awaiting FDA clearance for the TriVerity test in the coming months.

Inflammatix, a molecular diagnostics company, has secured $57 million in a Series E financing round to advance its TriVerity acute infection and sepsis test system. The funds will support the regulatory filing and early commercialization of the rapid blood test, designed for the earlier detection of acute bacterial infections, viral infections, and sepsis.
The TriVerity system, Inflammatix’s lead product, measures gene expression levels in blood related to immune response. Utilizing machine learning-derived algorithms, the test delivers results in approximately 30 minutes. This rapid assessment aims to aid in evaluating a patient’s illness severity and determining the necessity for intensive care unit (ICU) treatment.

Addressing Critical Needs in Sepsis Diagnosis

According to Inflammatix, faster diagnosis through the TriVerity system has the potential to save lives and optimize hospital resource allocation. Timothy Sweeney, CEO and co-founder of Inflammatix, stated that the company hopes to assist hospitals in improving their compliance with sepsis detection and treatment protocols, as well as optimizing patient throughput.

Regulatory Pathway and Future Plans

The TriVerity system, comprising the Myrna instrument and TriVerity test, received breakthrough device designation from the FDA in November. This designation is designed to accelerate clearance and Medicare coverage for medical devices that demonstrate the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Inflammatix recently submitted a regulatory packet to the FDA for the test and anticipates receiving clearance from the agency in the coming months.
"The newly raised funds will help us to expand our commercial team and plan clinical interventional and health economic studies as we await FDA clearance over the coming months," said Sweeney.

Expanding Diagnostic Pipeline

In addition to the TriVerity test, Inflammatix is developing tests for emerging infectious diseases, autoimmune diseases, tropical infections, transplant rejection, and other conditions. The Series E financing round was led by Khosla Ventures and Think.Health, with participation from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare, and RAW Ventures. To date, Inflammatix has raised over $200 million in private capital, along with more than $50 million in grants and contracts from government agencies and foundations.
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Reference News

[1]
Inflammatix raises $57M to advance test for infection, sepsis | MedTech Dive
medtechdive.com · Sep 13, 2024

Inflammatix raised $57 million to support its rapid blood test for acute infection and sepsis, aiming to improve diagnos...

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