Prenosis and Carle Health Mark Sepsis ImmunoScore® Clinical Deployment and First Patients Enrolled in OBSERVE-ARDS Clinical Study

Carle Health, a Prenosis investor and research partner, becomes the first site in Prenosis' ARDS clinical study program as Immunix^®-integrated sites accelerate future research

CHICAGO, Oct. 20, 2026 /PRNewswire/ -- Prenosis^®, a biology-based technology company delivering precision therapeutics, today announced three milestones in its ongoing relationship with Carle Health: the clinical deployment of Sepsis ImmunoScore^® in support of Prenosis' Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study; Carle Health's selection as the first site active in Prenosis' Observational study in Acute Respiratory Distress Syndrome (OBSERVE-ARDS); and the first patients enrolled in the OBSERVE-ARDS study.

Sepsis remains one of the most difficult conditions to diagnose and manage in the hospital, where many factors can delay recognition and treatment. Integrated directly into Carle Health's Electronic Health Record (EHR) system, Sepsis ImmunoScore analyzes 22 parameters, including vital signs, lab results, and immune biomarkers, to help clinicians identify patients who are at risk of having or developing sepsis within 24 hours. Prenosis' relationship with Carle Health – also an investor in Prenosis – dates to the earliest development stages for Sepsis ImmunoScore. Clinicians and researchers at Carle Health contributed data and expertise to the studies that helped build the underlying algorithm, participated in a silent-implementation study that tested the tool's impact on provider judgment, and now are among the first to run Sepsis ImmunoScore live within clinical workflow.

"Carle believes that the best solutions in medicine come from long-term partnerships between clinicians and innovators," said Ben Davis, MD, Principal Investigator and emergency medicine physician at Carle Foundation Hospital. "We've been with Prenosis at every stage of Sepsis ImmunoScore's development and seeing it go live in our clinical workflow is proof that this approach works. It's why we're eager to bring that same partnership to the OBSERVE-ARDS study. We're helping build tools that will improve care for patients well beyond Carle."

Carle Health is the first site active and has enrolled the first patients in Prenosis' OBSERVE-ARDS study. Carle Health also plans to participate in the company's Steroid Therapy Optimization for Prevention of Acute Respiratory Distress Syndrome (STOP ARDS) study. Both studies are part of BARDA's (Biomedical Advanced Research and Development Authority) Type to Treat Program which supports the development of comprehensive precision medicine platforms to guide the use of therapeutic medical countermeasures. Carle Health is the first of up to 40 academic medical centers to join Prenosis' precision therapeutics clinical trial network which will enable rapid identification and availability of patients with specific biological and physiological profiles for therapeutic clinical trials.

As part of the OBSERVE-ARDS study, Prenosis' Immunix^® platform is integrated with Carle's EHR system to facilitate screening and recruitment of patients, identify usable remnant samples, and gather study data. Because Carle is integrated on the Immunix platform, the health system will be able to move directly into subsequent clinical trial enrollment without the standard integration timeline required of a de novo, non-integrated, research site. Prenosis expects to repeat this template as it brings Immunix-enabled research to additional clinical trial sites and conditions.

"Carle Health has been part of this story since the very beginning, from the research that helped prove Sepsis ImmunoScore's science, to the validation work that led to its De Novo FDA authorization, to today, when their clinicians are using it at the bedside for real patients," said Bobby Reddy, Jr., PhD, CEO and Co-Founder of Prenosis. "That kind of sustained partnership is rare, and enables us to go further together. It's fitting that Carle is now the first site active in OBSERVE-ARDS and has enrolled the study's first patients. Because Carle is integrated on our Immunix platform, we can bring them into future trials in a fraction of the time it would take to start from scratch. Carle is a model for what we hope every long-term health system partner becomes."

This project has been supported in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50125C00016 and 75A50123C00019.

About Carle Health

At Carle Health, we're dedicated to delivering personalized care that patients and families can trust and count on at every step of their healthcare journey. Rooted in clinical excellence and guided by compassion, our care teams work to deliver consistent, connected care – where quality, accessibility and innovation come together to support health and well-being for all.

As one integrated health system with deep local roots, we strive to make exceptional healthcare more accessible for all the communities we serve. Founded nearly 100 years ago in Urbana, IL, our nearly 16,000 team members and providers work together to support patient care across central and southeastern Illinois. We've grown to include eight, award-winning hospitals and a multispecialty provider group with more than 1,500 doctors and advanced practice providers. We're developing the next generation of providers and healthcare professionals through Carle Illinois College of Medicine, the world's first engineering-based medical school, and Methodist College. And we continually advance healthcare through Stephens Family Clinical Research Institute, bringing innovative treatments closer to home.

About Prenosis, Inc.

Prenosis, Inc. is a biology-based technology company, building the precision therapeutics platform for acute illness, and diagnostics as infrastructure for therapeutic adoption. Our mission is to tailor healthcare to each patient's biology through the identification, clinical validation, and delivery of precision therapeutics. We use deep data and AI to develop tools that augment clinical diagnosis of critical conditions based on each patient's unique biological profile. Our Immunix^® platform powers the development of AI-biomarkers, including Sepsis ImmunoScore^®, the first FDA-authorized AI diagnostic tool for sepsis. For more information, visit us at prenosis.com.

Prenosis^®, Immunix^®, and Sepsis ImmunoScore^® are trademarks of Prenosis, Inc.

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SOURCE Prenosis