Important Milestone for TriVerity™

Inflammatix Completes Technical Development for TriVerity™ Acute Infection and Sepsis Testing System Inflammatix, Inc., a leading molecular diagnostics company, announced that it has completed technical development of the TriVerity™ Acute Infection and Sepsis Testing System, which incorporates the company's Myrna™ Device, and the TriVerity™ Cartridge. TriVerity is intended for use in emergency department settings to assess bacterial infection likelihood, viral infection probability, and acute decompensation risk (need for intensive care unit-level care) in patients with suspected acute infection and sepsis. Timothy Sweeney, Chief Executive Officer and co-founder of Inflammatix, said, "Myrna will be the world's highest-plex point-of-care system capable of measuring RNA, enabling us to bring 'precision medicine' to acute care settings. The completion of technical development brings TriVerity one step closer to FDA submission and launch, and enables us to conduct critical clinical studies." The Myrna Device can quantify up to 64 messenger RNAs (mRNAs) from sample to result in approximately 30 minutes from whole blood or other sample types. It is designed to comply with Clinical Laboratory Improvement Amendments (CLIA) to enable point-of-care deployment. Single-use cartridges are expected to be stable at room temperature for up to 12 months. Dr. Sweeney stated, "With completion of the test system, we look forward to further exploring partnerships that bring existing RNA signatures to the Myrna ecosystem. This is particularly an actionable path given the anticipated changes in regulating laboratory-developed tests and increasing confidence in biomarker-focused approaches in immunotherapy development." TriVerity Acute Infection and Sepsis Test, Inflammatix's flagship product, comprises a panel of 29 mRNAs designed to "read" the body's immune response and thereby assist in diagnosing patients with suspected acute infection and sepsis. It is designed to potentially facilitate diagnosis in patients presenting to U.S. emergency departments with suspected infection. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates that approximately 20 million patients annually visit emergency departments with symptoms consistent with suspected infection. The company continues to complete clinical studies, including the SEPSIS-SHIELD study (NCT04094818), which is required for submission to the U.S. Food and Drug Administration (FDA). The multicenter study has already enrolled 955 of the estimated 1,500 patients needed. Inflammatix anticipates that study completion and FDA submission will occur by spring 2024. TriVerity Acute Infection and Sepsis Testing System is a product in development, not for sale, and has not received marketing approval or authorization from regulatory authorities in any jurisdiction.