GHIC Invests in Cytovale’s Series C Financing

SAN FRANCISCO, CA / NEW YORK, NY, 15 November 2023: Cytovale®, a pioneering 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 new investor Norwest Venture Partners with participation by 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 time lags that make sepsis the leading cause of death in U.S. hospitals.

“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 healthcare providers so they can address the potential deadly outcomes patients currently face.”

Sepsis – A Hidden Killer

Sepsis is the leading cause of death in U.S. hospitals, with more than one-third of all in-hospital deaths attributed to the condition. Approximately 80% of sepsis patients present to the emergency department (ED), where it can be difficult to discern from ordinary infections or other conditions that can mimic sepsis. ED providers are often tasked with making triage and treatment decisions with limited information in a complex and resource-strapped environment. As a result, sepsis patients can be either underdiagnosed, resulting in rapid deterioration, risk of organ damage and need for readmission; or over-diagnosed, leading to increased costs and unnecessary utilization of limited hospital resources. These errors and delays make sepsis the leading cost of hospitalization in the U.S., estimated to be $62 billion annually.

Sepsis is more prevalent in the U.S. than heart attacks and strokes combined, and the related challenges are magnified because there is not highly reliable early warning system for patients at risk of sepsis. Existing ED sepsis tests and techniques are often not specific to the condition or lack the timeliness, objectivity and accuracy needed for ED use. Since the risk of death from sepsis increases by up to 8% for each hour that it goes untreated, a tool is urgently needed that enables providers to quickly and confidently recognize this medical emergency.

IntelliSep – Fast, Actionable Diagnosis of Sepsis

IntelliSep is a transformative tool for hospital and ED personnel who may suspect severe infection in patients. The first-of-its-kind host immune response diagnostic generates results in under 10 minutes using standard blood draws and can be seamlessly and efficiently integrated into existing care workflows.

IntelliSep takes a unique approach, assessing the body’s immune response to an infection using immune cell morphology, the act of interrogating cells and observing their reaction. In simple terms, IntelliSep applies pressure on white blood cells – which differ between septic and non-septic patients – and characterizes their responses using cutting-edge machine learning technology.

Cytovale’s rapid laboratory test provides valuable insights into potential sepsis diagnosis. The test provides a score, which categorizes a patient's probability of developing sepsis within the next three days. Using that score, healthcare providers can quickly determine next steps for treatment with a higher level of confidence, potentially reducing the likelihood of poor outcomes from sepsis, including death.

Cytovale is working with select early access hospitals and health systems to implement the IntelliSep test as part of triage processes for adults presenting to the ED with signs and symptoms of infection. Our Lady of the Lake Regional Medical Center was the first to implement IntelliSep, which has since enabled essential ED personnel to focus efforts on critically ill patients. In fact, IntelliSep reduced the number of all hands on deck alerts in the ED by 80% relative to previous sepsis detection methods.

“Sepsis is one of the most deadly, complex and costly conditions faced by hospitals. Until now healthcare providers have lacked a fast and reliable test to inform treatment paths,” said Zack Scott, M.D., general partner at Norwest Venture Partners. “Offering the first early-detection test on the market, Cytovale has the incredible potential to revolutionize how our healthcare system gets the right care to the right patients at the right time. We look forward to working with Cytovale as IntelliSep revolutionizes care pathways for so many patients, improving their outcomes, while also helping hospitals optimize utilization and operational excellence.”

About Cytovale®

Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Comprised of an extraordinary team of life scientists, engineers, clinicians, and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies. Learn more about Cytovale and request to implement IntelliSep® in your hospital or care setting through cytovale.com. For updates, follow Cytovale on LinkedIn and X.

About Global Health Investment Corporation (GHIC)

A pioneer of investing in global health, GHIC has been supporting high-impact biomedical innovations for nearly a decade. GHIC's Global Health Investment Fund (GHIF) financed the development of products to combat public health challenges that disproportionately affect people living in low- and middle-income countries. In 2021, GHIC entered a 10-year venture investment partnership with the Biomedical Advanced Research and Development Authority (BARDA) focused on global health security.