Devices & Diagnostics

Cytovale Snags $84M To Commercialize Early Sepsis Detection Test

Cytovale, a San Francisco-based medical diagnostics company, raised $84 million in Series C funds to advance the commercialization of its diagnostic test for early sepsis detection. Using standard blood draws, the test provides results in under 10 minutes. It is meant to detect sepsis in patients who present to hospital emergency departments.

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Sepsis kills more than 11 million people worldwide each year and contributes to 20% of all global deaths. The disease is also a leading cause of death in U.S. hospitals, and a septic patient’s risk of death increases by 8% each hour they go undiagnosed and untreated. 

Cytovale, a San Francisco-based medical diagnostics company, is seeking to tackle this issue with its early sepsis detection test. On Wednesday, the startup announced that it has raised $84 million in Series C funds to bring the test to more hospitals. The financing round, which takes Cytovale’s total funding amount to more than $122 million, was led by Norwest Venture Partners.

The company’s test for early sepsis detection, called IntelliSep, was cleared by the FDA in December and saw its first commercial placement in August. The diagnostic helps detect sepsis in patients who present to hospital emergency departments.

Using standard blood draws, the test provides results in under 10 minutes, said Cytovale CEO Ajay Shah. 

“The test uses cell morphology —or, the act of applying pressure to cells and seeing how they respond — to gain unique insights about the fundamental mechanism of sepsis, immune dysfunction,” he explained.

In other words, IntelliSep applies pressure to white blood cells and then characterizes the way these cells react, as responses differ between septic and non-septic patients. 

There are several other tests on the market that support sepsis identification or infection control across inpatient and urgent care settings, such as those made by BioFire Diagnostics, Accelerate Diagnostics and Redcliffe Labs. However, IntelliSep is the only test focused on measuring the cells’ dysregulated host response and cleared for use in the emergency department, Shah said.

With IntelliSep, each patient receives a score ranging from 0.1-10 that reflects their probability of having sepsis within the next three days. Using that score, providers are able to create better treatment plans and potentially decrease poor health outcomes from sepsis, such as death.

“IntelliSep may empower health systems to augment their current detection processes, aiming to optimize resource utilization, improve patient outcomes and ultimately save lives,” Shah declared.

Cytovale’s new capital will be used to expand IntelliSep’s commercial footprint and help the company further develop its products to optimize the user experience, he added. 

The company has partnered with early access hospitals to implement the test as part of the triage process for adults presenting to the emergency department with signs of infection. Our Lady of the Lake Regional Medical Center in Baton Rouge, which is operated by Franciscan Missionaries of Our Lady Health System, was the first to adopt IntelliSep.

“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,” said Chris Thomas, vice president and chief quality officer of Franciscan Missionaries of Our Lady Health System. “Not only are we saving lives, we are better able to channel our valuable emergency department resources in a meaningful way.”

Photo: Adam Calaitzis, Getty Images