Cytovale’s IntelliSep Test Shows 19% Sepsis Mortality Drop in Multicenter Health-System Study

New updates have been reported about Cytovale.

Cytovale reported new real-world, multicenter data showing that its IntelliSep rapid sepsis diagnostic drove significant and reproducible clinical and operational gains after expansion across four additional hospitals in the Franciscan Missionaries of Our Lady Health system. In a one-year pre‑ and post‑implementation review of more than 34,000 emergency department patients with suspected infection, broader use of IntelliSep was linked to more than a 20% reduction in both sepsis-related mortality and resource utilization.

The findings, presented at the Society of Critical Care Medicine’s 2026 Critical Care Congress, indicate IntelliSep can deliver scalable, consistent impact from large tertiary centers to smaller community hospitals, an important validation for Cytovale’s commercialization strategy. Across the four sites, the study documented a 19% relative reduction in sepsis mortality and a 22% relative mortality reduction in patients initially thought to have sepsis but ultimately found not to be septic, underscoring the value of quickly stratifying and redirecting care.

Operationally, IntelliSep adoption correlated with a 20% increase in emergency department discharges without a corresponding rise in seven‑day revisit rates, suggesting improved throughput rather than premature discharge. The test also enabled a 30% decrease in blood culture utilization, concentrated in patients who did not have sepsis, while maintaining more than 90% culture use in confirmed sepsis cases, pointing to lower diagnostic costs without compromising care quality.

Clinician feedback from participating hospitals emphasized IntelliSep’s role in earlier risk identification, faster initiation of life‑saving therapies, and more precise resource deployment in emergency settings. Cytovale positions IntelliSep, which is cleared by the U.S. Food and Drug Administration as the first sepsis diagnostic specifically authorized for emergency department use, as a rapid eight‑minute test that applies advanced microfluidics and machine learning to assess dysregulated immune response and generate an objective sepsis risk score.

This is the first multicenter evaluation of IntelliSep’s real‑world performance across hospitals serving varied communities, broadening its evidence base beyond the initial high‑volume site at Our Lady of the Lake Regional Medical Center. The consistent mortality and efficiency improvements observed across a 78‑bed community facility, multiple regional medical centers, and a 570‑bed tertiary hospital strengthen Cytovale’s value proposition for health systems facing sepsis‑driven mortality, capacity pressures, and diagnostic cost constraints.

For Cytovale’s investors and prospective provider customers, these data support a business case that combines clinical outcome gains with measurable operational and economic benefits, potentially accelerating health‑system adoption and recurring test utilization. Backed by venture investors including Norwest Venture Partners, Sands Capital, and Global Health Investment Corporation, Cytovale is building an early detection platform around immune activation, with IntelliSep as its lead commercial asset and a beachhead in the large emergency care sepsis market.