Accelerated Demand for Cytovale's FDA-Cleared Sepsis Detection Solution, IntelliSep®, to Drive Growth in 2025

Company helped healthcare professionals evaluate over 15,000 patients and wins industrywide acclaim in 2024

SAN FRANCISCO, Jan. 9, 2025 /PRNewswire/ -- Cytovale^®, a commercial-stage medical diagnostics company, today celebrated a monumental year that catapulted it to lead the emerging sepsis diagnostics market, driven by increased demand for IntelliSep^®, the company's U.S. Food and Drug Administration (FDA)-cleared rapid sepsis detection solution. In the first full year of commercialization, Cytovale grew its customer base across three states and two health systems, demonstrated clinical improvements and financial savings for hospitals, and gained widespread industry recognition. This culminated in the company raising $100 million in Series D capital to further accelerate U.S. commercial expansion of IntelliSep in 2025.

AI-enabled IntelliSep uses sophisticated high-speed cameras and microfluidics to analyze the reaction of white blood cells from a patient showing signs and symptoms of sepsis. Using a standard blood draw, IntelliSep risk-stratifies patients based on their probability of having sepsis and delivers results in about eight minutes.

Sepsis, a life-threatening condition caused by a dysregulated immune response, costs the U.S. healthcare industry $62 billion each year, largely because accurate, early detection in the emergency department (ED) is lacking. Hospital demand for such a solution is driving significant growth for Cytovale's IntelliSep rapid sepsis detection solution, a first-of-its-kind technology offering clinicians the ability to see the biology of sepsis

"Cytovale has applied technology and biology to develop the most comprehensive sepsis solution I've seen. The company truly partners with health systems to support the internal rollout across the hospital, providing the most state-of-the-art screening available today," said Dr. Christopher Thomas, Chief Quality Officer, Franciscan Missionaries of Our Lady Health System (FMOLHS). "IntelliSep gives providers an evidence-based protocol to either identify or rule out sepsis to get the patient on the right carepath, very similar to how providers utilize an EKG to triage a patient with chest pain for possible heart disease."

Helping Hospitals Save Lives, Resources and Money
IntelliSep is making a significant clinical impact across diverse populations, from small rural hospitals to Louisiana's busiest ED. IntelliSep was first deployed at Our Lady of the Lake Regional Medical Center, part of FMOLHS, in Baton Rouge, La.. In the first 12 months, providers estimate they've evaluated more than 15,000 patients with IntelliSep and reported significant clinical improvements, including:

• Reduced the overall risk-adjusted mortality index by 30% for sepsis patients
• Reduced treatment time for patients at risk of sepsis by 60 to 70 minutes
• Reduced hospital stays for patients tested with IntelliSep and subsequently admitted by more than a day
• Saved the hospital $1,429 on average per patient tested

After seeing these strong clinical improvements, FMOLHS implemented IntelliSep across the health system in Louisiana and Mississippi. A second health system, the Froedtert & the Medical College of Wisconsin health network, also implemented IntelliSep in a pilot at its flagship hospital, Froedtert Hospital in Milwaukee.

Novel Life-Saving Sepsis Detection Technology Wins Industry Recognition
This year Cytovale's novel technology and proven clinical impact earned the company numerous health industry honors, including:

• Digital Health Hub Foundation's Digital Health Award winner for the Biggest Healthcare Savings Story in the Best Story Series presented at HLTH 2024
• Inc.'s 2024 Best in Business in the health product category
• Modern Healthcare's Best in Business of 2024 winner in two categories: laboratory medicine and medical technology
• San Francisco Business Times Inno Award winner in the healthcare category

"I am incredibly proud of our entire team, including our hospital and health system partners, for their tireless efforts this past year to roll out the industry's first solution that enables providers to accurately see sepsis with a simple blood test," said Cytovale Co-founder and CEO Ajay Shah. "Sepsis is an incredibly complex and misunderstood syndrome, and we're using technology and biological insights to help providers more accurately and quickly rule-in or rule-out this deadly condition and ultimately save lives."

For more information on bringing IntelliSep to a hospital, visit our website at www.cytovale.com. 

About Cytovale^®
Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep^®, leverages machine learning and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit www.cytovale.com and follow Cytovale on LinkedIn and X.

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SOURCE Cytovale