Cytovale Inc., a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having the life-threatening condition.

The study will get underway immediately, led by Hollis O’Neal, a pulmonary disease specialist with LSU Healthcare Network Pulmonary-Critical Care, Our Lady of the Lake Regional Medical Center, in Baton Rouge, La. Early results could be available within 60 days, depending on how quickly patients are enrolled.

Large unmet need

Roughly 1.7 million Americans develop sepsis each year, and nearly 270,000 die as a result. The condition occurs when the body launches an extreme response to infection, triggering a cascade of changes that quickly can damage multiple organs, resulting in organ failure and, in many cases, death.

Ajay Shah, CEO and co-founder of Cytovale Inc.

“Mortality from sepsis increases as much as 8% for every hour that treatment is delayed,” Ajay Shah, Cytovale’s co-founder and CEO, told BioWorld, adding that as many as 80% of sepsis deaths could be prevented with early detection and treatment.

Cytovale’s system is designed to measure immune cell activity associated with the dysregulated host response in sepsis. “In less than 10 minutes, each patient’s unique signature is compared to established profiles of robustly constructed multidimensional disease signatures, reduced by machine learning techniques, to determine a diagnostic score, reportable to the clinician within minutes,” Shah explained.

By contrast, current methods can pose challenges to early diagnosis, with doctors relying on vital sign readings, blood lactate levels and other laboratory tests. Delays in care, already life-threatening, are raising new concerns with the coronavirus outbreak.

Novel coronavirus has ‘upped the ante’

“COVID-19 has upped the ante for critical care providers in terms of rapid diagnosis and has helped raise awareness among the general public about how serious infectious diseases – and the immune response to them – can be. It has also brought the issue of resource preservation to the forefront,” he said. “We are optimistic that our technology can be a part of the solution by helping providers make informed decisions quickly to treat sepsis patients who need it, spare those who don’t and, ultimately, help save lives.”

O’Neal underscored the urgency of the research in light of the current pandemic. “We are looking for any advantage over COVID-19 as Louisiana emerges as a hot spot,” he said. “We are optimistic that this system could be part of the way critically ill patients are evaluated in the short and long term.”

Cytovale plans to enroll up to 300 patients who present to the emergency department with potential respiratory infections, including SARS-CoV-2. “The goal of this study is to determine if we can diagnose sepsis quickly and accurately in potential COVID-19 patients and appropriately triage them with the Cytovale technology,” O’Neal said.

The pilot study will be followed by a larger clinical trial to support a 510(k) submission to the U.S. FDA., Shah said.

New funds follow $15M raise last fall

Last fall, Cytovale scooped up $7.4 million in an extension of series B equity financing to advance its technology. The round was co-led by Breakout Ventures and Blackhorn Ventures, with participation by Western Technology Investment.

Around the same time, the company entered a partnership with BARDA’s Division of Research, Innovation, and Ventures (DRIVe), whose core areas include early sepsis detection. The partnership, valued at up to $7.6 million, included an initial award of $3.4 million for product development work. It followed an award the prior year that supported proof-of-concept efforts.

This latest infusion represents both BARDA exercising its option to commit additional funds, as well as new funds awarded specifically for COVID-19 application, Shah said. The agency has indicated that total funding available for the company could exceed $8 million.

The $3.83 million will cover more than half of the estimated $5.9 million needed to continue developing and validating the system, including the pilot study. Cytovale will pay the remaining costs.

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*Cytovale is evaluating a test to triage patients coming to the emergency department for COVID-19 related immune activation. The test can potentially help identify patients who need the most care quickly. The company was started from the Di Carlo Lab and is licensing UCLA patents. Henry Tse, a former Di Carlo student, is their Chief Technology Officer.