Inflammatix Secures $57 Million to Advance Novel Diagnostic for Patients with Suspected Infections or Sepsis

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Sep 12, 2024, 07:45 ET

Fundraise brings lead product, TriVerity™ Test, closer to commercialization following recent submission to FDA

SUNNYVALE, Calif., Sept. 12, 2024 /PRNewswire/ -- Inflammatix, a pioneering molecular diagnostics company, announced today the closing of $57 million in Series E financing, led by Khosla Ventures and Think.Health. The funds will support regulatory filing and early commercialization of the company's lead product, the TriVerity™ Acute Infection and Sepsis Test (TriVerity).

TriVerity is a blood test that is intended to fill a critical need in the emergency department (ED) setting. Each year, 20 million people arrive at the hospital suspected of having an acute infection or sepsis. Recent company-sponsored clinical studies^1,2 validate previous research^3-5 suggesting that physician assessment and vital-signs-based scoring underestimate severity in up to half of patients suspected of acute infection or sepsis. With an annual incidence of 2.7 million cases and an annual mortality rate of 350,000⁶, sepsis is a leading cause of death in U.S. hospitals and costs the Centers for Medicare and Medicaid Services (CMS) $53 billion each year, making it the most costly diagnosis among Medicare beneficiaries.⁷

"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 Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. "TriVerity is bringing the promise of machine learning and AI to infection and sepsis care. We hope to help hospitals improve their performance in terms of complying with sepsis detection and treatment protocols and optimizing patient throughput. We greatly appreciate the strong investor confidence in TriVerity and are excited to be very close to offering this novel test to physicians."

In addition to the leading investors Khosla Ventures and Think.Health, the Inflammatix Series E funding round included participation from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare, RAW Ventures, and others. The funding round brings Inflammatix's total private capital raised to more than $200 million, in addition to more than $50 million in grants and contracts from various government agencies and foundations.

Novel diagnostic approach to spur earlier detection of infection and sepsis

TriVerity, a blood test performed on Inflammatix's novel Myrna™ Instrument, is uniquely designed to simultaneously determine whether an infection is present, and how likely a patient will need ICU-level interventions. Getting to an accurate diagnosis faster would not only save lives but would also dramatically improve hospital efficiency as well as health system resource allocation. Earlier and more accurate diagnoses may also help hospitals comply with the CMS SEP-1 Bundle, a value-based payments quality measure intended to ensure rapid sepsis detection and treatment.

"Despite incremental improvements in patient outcomes, the death toll from sepsis remains disproportionately high among vulnerable populations," said Alex Morgan, partner at Khosla Ventures. "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. This is a step-change in life-saving care that physicians have been wanting for decades."

After receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in November 2023 and completing the SEPSIS-SHIELD study [NCT04094818], Inflammatix recently submitted a regulatory packet to the FDA for the TriVerity Test. The company hopes to receive FDA clearance later this year.

About the TriVerity™ Acute Infection and Sepsis Test

The TriVerity Acute Infection and Sepsis Test (TriVerity), Inflammatix's lead product, is performed on the Myrna™ Instrument, the company's proprietary, cartridge-based, benchtop analyzer. TriVerity is a blood test that measures 29 messenger RNAs (mRNAs) to rapidly "read" the body's immune response to infection using machine learning-derived algorithms. The test is designed to inform on the two "axes" of sepsis -- presence of infection and risk of progression to severe illness -- in adult patients with suspected acute infection or sepsis in the emergency department setting. TriVerity thus aims to help physicians to confidently make treatment decisions, including selection of antimicrobial therapy, administering additional diagnostic testing, and whether to admit or discharge the patient.

The Myrna Instrument is capable of multiplex sample-to-answer quantitation of mRNAs in about 30 minutes. With its less than one-minute operator hands-on time and simple maintenance, the Myrna Instrument is designed for ease of use and low resource requirements.

The TriVerity Acute Infection and Sepsis Test is not for sale. It is currently pending FDA clearance and has not received marketing approval or clearance from regulatory authorities in any jurisdiction.

About Inflammatix
Inflammatix, Inc., a pioneering molecular diagnostics company headquartered in Sunnyvale, California, USA, is developing novel diagnostics that rapidly read a patient's immune system to improve patient care and reduce major public health burdens. The Inflammatix tests will be developed to run on the company's sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The company's funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, Iberis Capital, and Vesalius BioCapital. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc).

Inflammatix product development has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.

TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the U.S. and other countries and regions.

References

Whitfield N, Michelson EA, Steingrub J, et al. Host response severity score for ICU level care prediction in emergency patients with suspected sepsis. (2024), SAEM24 Abstracts. Acad Emerg Med, 31: 8-401. https://doi.org/10.1111/acem.14906
Data on file, Inflammatix, Inc.
Askim A, Moser F, Gustad LT, et al. Poor performance of quick-SOFA (qSOFA) score in predicting severe sepsis and mortality – a prospective study of patients admitted with infection to the emergency department. Scand J Trauma Resusc Emerg Med. 2017;25(1):56. doi: 10.1186/s13049-017-0399-4.
Tiwari AT, Jamshed N, Sahu AK, et al. Performance of qSOFA score as a screening tool for sepsis in the emergency department. J Emerg Trauma Shock. 2023;16(1):3-7. doi: 10.4103/jets.jets_99_22.
Freund Y, Lemachatti N, Krastinova E, et al. Prognostic accuracy of Sepsis-3 criteria for in-hospital mortality among patients with suspected infection presenting to the emergency department. JAMA. 2017;317(3):301-308. doi: 10.1001/jama.2016.20329.
Sepsis. U.S. Department of Health and Human Services, National Institutes of Health, National Institute of General Medical Sciences; 2024. https://www.nigms.nih.gov/education/fact-sheets/Pages/sepsis.aspx?ref=prendi-il-controllo-della-tua-salute.com#:~:text=Each%20year%2C%20according%20to%20the,350%2C000%20die%20as%20a%20result.
Frank CE, Buchman TG, Simpson SQ, et al. Sepsis among Medicare beneficiaries: 4. Precoronavirus Disease 2019 Update January 2012-February 2020. Crit Care Med. 2021;49(12):2058-2069. doi: 10.1097/CCM.0000000000005332.