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Backed by $184M in Recent Funding, Cytovale Aims to Bring Its Sepsis Risk Test Into More ERs

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NEW YORK – With the backing of $184 million from two funding rounds, Cytovale is using the treasury it has established during the past year to support the expanded use of the firm's sepsis rapid test and forge partnerships with hospital systems across the US.

In August 2023, the San Francisco-based firm launched its IntelliSep prognostic test, after securing 510(k) clearance from the US Food and Drug Administration in late 2022, to help emergency departments stratify patients by their risk of sepsis, with results in less than 10 minutes. Cytovale CEO Ajay Shah said that the firm's benchtop testing system has been used for the evaluation of more than 7,000 patients at its leading partner hospital in Louisiana, Our Lady of the Lake Regional Medical Center, which is part of Franciscan Missionaries of Our Lady Health System. Study results from that facility show that use of the test resulted in reductions in patient length-of-stay and healthcare costs, he said.

"What we've seen in our first year of commercialization is that the test can really drive identification of sepsis in patients who might still be sitting in the waiting room and get them out of the waiting room and onto a care pathway," he said.

Cytovale announced in November 2023 that it had raised $84 million in a Series C funding round that would support the expanded commercialization of IntelliSep, and this month it announced that it had brought in another $100 million from its Series D funding round to accelerate the commercial expansion of IntelliSep into more emergency departments and health systems across the US.

Shah said that the results that Cytovale has reported from clinical use of the test have fueled demand and helped the company during conversations with large health systems. At Our Lady of the Lake, the test results are being used to save an average of one life per week, he said.

"Right now, we're focused on the US, but sepsis is certainly a global challenge," Shah said.

Cytovale announced on Wednesday that IntelliSep had become available at the emergency departments of three more Franciscan Missionaries hospitals in Mississippi and Louisiana, in addition to Our Lady of the Lake. The company also announced in August that it had inked a deal with Froedtert & the Medical College of Wisconsin regional health network for the use of IntelliSep to screen patients at the network's flagship Froedtert Hospital in Milwaukee.

Shah said that Cytovale is expanding its staff across different operations in the firm, including sales, marketing, and general and administrative, to support the company's growth and market expansion, which will result in a 65 percent increase in the firm’s workforce between January 2024 and December 2025.

Among the new hires this year is Chief Operating Officer Christopher Slachta, who previously worked as at Abbott as a divisional VP of global operations and supply chain for molecular diagnostics. Cytovale has a little more than 100 employees, Shah said.

Cytovale is also investing in more studies that will be used to collect evidence on the clinical, operational, and financial impacts of using IntelliSep as part of the effort to convince more healthcare professionals to adopt the test, Shah said.

The firm recently concluded a study with Johns Hopkins University on the impact of serial testing with IntelliSep, the results of which are expected to be published in early 2025, according to Shah, while other customer hospitals and individual investigators are conducting studies that are related to the use of IntelliSep.

IntelliSep is a blood-based semiquantitative test that uses high-speed imaging and machine learning to assess cell morphology and measure immune cell activation in emergency department patients who have signs of sepsis or who physicians suspect may have infections. The test involves the use of microfluidics and deformability cytometry to observe changes in leukocyte biophysical properties and provide a score between 0.1 and 10 of the probability of sepsis.

The results are intended for use with other clinical assessments and lab findings to aid the early detection of sepsis as well as help to determine which patients are unlikely to have sepsis.

Hollis O'Neal, medical director of research at Our Lady of the Lake and adviser for Cytovale, said the recent funding rounds have let Cytovale expand its implementation teams that advise hospitals on how to use the test and provide 24-hour technical support for emergency department customers. He noted that the money also has helped the company to increase production of the instruments and meet demand from those hospitals.

As more firms adopt the test, he hopes that the usage data from those systems will help to show the impact of IntelliSep across hospitals of different sizes and care models. He noted that while his facility has about 900 beds, other hospitals that are implementing the test have half as many beds and some have as few as 30 or 40.

O'Neal was the lead author of an article published in April in Academic Emergency Medicine that describes the use of IntelliSep with 1,002 emergency department patients who had signs or suspicion of infection. The authors performed a pooled analysis of patients from seven sites in the US and found that the test performed with 93.2 percent sensitivity, 87.0 percent specificity, and a negative predictive value of 97.5 percent.

Meanwhile, Our Lady of the Lake's parent company, the Franciscan Missionaries of Our Lady Health System, separately announced in June that the use of IntelliSep had resulted in reduced length-of-stay among patients with symptoms or suspicion of sepsis. It said that patients who were tested with IntelliSep had a 1.28-day average reduction in their length of hospitalization with O'Neal adding that this was in comparison with a baseline average of six days for similar patients.

Among ICU patients, the length of stay was reduced by an average of 2.24 days compared to a baseline average of nine days.

The hospital system also reported that the use of IntelliSep resulted in average savings of $1,429 in healthcare costs per patient tested.

O'Neal added that Our Lady of the Lake has recorded an overall decline in deaths related to sepsis while the hospital has maintained a stable expected sepsis mortality rate, which is calculated based on the number of patients with sepsis and their comorbidities and other risk factors. He said that the hospital is not ready to release those numbers, though, while he and coauthors are working on a manuscript for peer review and publication.

Shah said that Cytovale is working to spread the word about the benefits of IntelliSep to other health systems and the return on investment that Our Lady of the Lake has secured through its implementation of the test into its sepsis protocols. The firm is also in early talks with guideline-setting bodies.

Meanwhile, the sepsis testing market is becoming more crowded. Swiss firm Abionic received FDA 510(k) clearance this month for its IVD Capsule PSP immunoassay, which is used to detect in a fingerstick blood sample elevated levels of pancreatic stone protein as a marker of sepsis risk, with results in less than 10 minutes. Inflammatix also recently raised $57 million in Series E financing, which will be used to support regulatory filings and commercialization of its TriVerity Acute Infection and Sepsis Test that uses real-time RT-LAMP and a machine-learning algorithm for the differentiation of bacterial infections, viral infections, and noninfectious disease, as well as the prediction of disease progression.

Other firms active in the sepsis space include Accelerate Diagnostics, which gained 510(k) clearance this fall for a blood culture sample preparation platform designed to shorten the time to results for microbial identification tests by eliminating the need for overnight culture, as well as Immunexpress, which began the commercialization of its qPCR-based SeptiCyte Rapid assay in 2023 for the detection of two genes that are expressed in white blood cells during a cytokine cascade that indicates sepsis.

Meanwhile, Diasorin secured CE marking last year for its Liaison BRAHMS MR-proADM immunoassay to assess a biomarker that is connected with inflammatory responses and infections to stratify patients by disease severity and the risk of unfavorable outcomes.

O'Neal said that providers who have implemented IntelliSep have said that it has helped them add structure and processes to the examination of patients with suspected sepsis. Our Lady of the Lake uses the test in 20 to 30 patients daily, providing clinicians in the emergency department with objective results to guide decisions and the ability to work more efficiently while performing fewer blood cultures, he said.

O'Neal noted that residents who graduated in June and took jobs at other hospitals have called to ask how they could bring IntelliSep into those hospitals.

"Now, we're able to see a part of the biology of sepsis that we've never been able to see, and that's kind of what the game changer is," O'Neal said.