Cytovale – a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases – recently 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 funding included participation from other new and existing investors, as well as the conversion of bridge notes.
Cytovale will use the funding 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.
Sepsis is known as a leading cause of death in U.S. hospitals, with more than one-third of all in-hospital deaths attributed to the condition. And about 80% of sepsis patients present to the ED, where it can be difficult to discern from ordinary infections or other conditions that can mimic sepsis.
ED providers are often dealing with making triage and treatment decisions with limited information in a complex and resource-strapped environment. And as a result, sepsis patients can be either underdiagnosed, resulting in rapid deterioration, risk of organ damage, and need for readmission; or over-diagnosed – which can lead to increased costs, unnecessary utilization of limited hospital resources, and the avoidable and sometimes severe health consequences of overtreating patients with broad-spectrum antibiotics. The errors and delays make sepsis the leading cost of hospitalization in the U.S., estimated at $62 billion annually.
Since sepsis is more prevalent in the U.S. than heart attacks and strokes combined – the related challenges have been magnified since there has been no standardized care pathway to evaluate potentially septic patients. And 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 every hour that it goes untreated, a tool that enables providers to quickly and confidently recognize this medical emergency is urgently needed.
IntelliSep is a transformative tool for hospital ED personnel who may suspect infection in patients. And 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 offers a unique approach, assessing the body’s immune response to an infection by interrogating immune cell morphology and mechanics. Essentially, IntelliSep squeezes white blood cells and characterizes their responses – which differ between septic and non-septic patients – using cutting-edge machine learning technology.
Cytovale’s rapid laboratory test offers valuable insights into potential sepsis diagnosis. And the test provides a score categorizing a patient’s probability of having or developing sepsis within the next three days. With 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 works 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. Plus, IntelliSep reduced the number of all-hands-on-deck alerts in the ED by 80% relative to previous sepsis detection methods.
“Sepsis is a dangerous, fast-moving condition that can result in death if not identified and treated quickly. 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.”
— Cytovale CEO Ajay Shah
“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. Offering the first early-detection test on the market, Cytovale has the incredible potential to dramatically improve 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.”
— Zack Scott, M.D., general partner at Norwest Venture Partners
“The ability to detect the probability of sepsis early in patients who present to our emergency department allows us to focus our efforts and attention on our most critical patients and get them the support and interventions they need, saving precious time. Not only are we saving lives, we are better able to channel our valuable emergency department resources in a meaningful way.”
— Chris Thomas, MD, vice president and chief quality officer of Franciscan Missionaries of Our Lady Health System