What You Should Know:
- Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced it has raised $84 million in Series C funding led by Norwest Venture Partners with participation by additional new investors Sands Capital and Global Health Investment Corporation (GHIC).
- The financing included participation from other new and existing investors, as well as the conversion of bridge notes. Cytovale will use the proceeds to bring its recently FDA-cleared rapid sepsis diagnosis test – IntelliSep® – to more hospital emergency departments (ED) and health systems in the United States, addressing historical diagnosis lag time that makes sepsis the leading cause of death in U.S. hospitals.
Bringing Rapid Sepsis Diagnosis Test to Health Systems in the US
Sepsis, responsible for over one-third of in-hospital deaths in the U.S., poses a significant challenge in emergency departments (EDs). Approximately 80% of sepsis cases are presented in the ED, where distinguishing it from regular infections or similar conditions is challenging. ED providers must make crucial triage decisions in a resource-constrained environment, leading to potential underdiagnosis or overdiagnosis of sepsis. This can result in rapid deterioration, organ damage, readmissions, increased costs, and unnecessary resource utilization. Sepsis, costing an estimated $62 billion annually, surpasses heart attacks and strokes combined in prevalence. The absence of a standardized care pathway for sepsis evaluation in EDs, coupled with non-specific tests, contributes to errors and delays. Given that the risk of death from sepsis rises by 8% for each untreated hour, there is an urgent need for a timely and accurate tool to aid providers in recognizing this medical emergency.
IntelliSep is a revolutionary diagnostic tool for Emergency Department (ED) personnel, providing rapid infection assessments within 10 minutes using standard blood draws. It analyzes the immune response by studying white blood cell morphology and mechanics, distinguishing between septic and non-septic patients with advanced machine learning. The test produces a numerical score indicating a patient’s sepsis probability within three days, aiding healthcare providers in making confident and timely treatment decisions. Cytovale’s collaboration with early access hospitals, such as Our Lady of the Lake Regional Medical Center, has shown significant benefits, reducing ED alerts by 80% compared to previous sepsis detection methods.
“Sepsis is a dangerous, fast-moving condition that can result in death if not identified and treated quickly,” said Cytovale CEO Ajay Shah. “Our flagship diagnostic tool, IntelliSep, with a blood-to-answer time frame of under 10 minutes, helps healthcare providers recognize sepsis early and make critical, time-sensitive clinical decisions. With the support of our investors, we are now able to expand efforts to get our tool in the hands of more providers so they can address the potential deadly outcomes patients currently face.”