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November 15, 2023

Cytovale: A Breakthrough Tool in The Fight Against Sepsis

Norwest relentlessly pursues opportunities to improve healthcare in the U.S. by partnering with companies that improve patient outcomes while lowering costs. Our latest investment is in just such a company: Cytovale, a pioneering medical diagnostics company that’s focused on advancing early detection and treatment of sepsis. We led the company’s $84 million Series C funding, with participation from new and existing investors, to help Cytovale bring its life-saving technology to more hospitals and health systems across the U.S.


Sepsis: A Deadly and Costly Problem

Sepsis is the leading cause of death in hospitals in the U.S. – twice the number of deaths from heart attack and stroke combined, at a cost of around $62B annually.

Sepsis is defined as life-threatening organ dysfunction due to a dysregulated/inappropriate host immune response to an infection. Despite the seemingly simple definition, sepsis is very difficult to diagnose early on because it can mimic several other common medical conditions.

Around 80 percent of sepsis cases present in emergency departments (EDs), which struggle with overcrowded waiting rooms and where health practitioners simultaneously juggle multiple medical emergencies.

Worst of all, there is no fast, accurate way to determine if a patient has sepsis. Diagnosis is based on a physician’s judgment, leading to frequently missed diagnoses as well as overtreatment of patients who don’t have sepsis.

Currently, EDs run multiple tests if sepsis is suspected, but it can take hours or days to get results, adding to the number of incorrect diagnoses that lead to poorer patient outcomes and higher costs.

Rapid diagnosis and treatment of sepsis are essential. If not treated quickly, sepsis can lead to septic shock, multiple organ failure, and eventual death. Rapid administration of antibiotics is the primary approach to reduce mortality. For every hour sepsis goes untreated, the risk of death in the next 30 days increases by 8-10 percent.

The New York Times reports, “About one in three people who die in a hospital had sepsis during their time there, according to the CDC (Centers for Disease Control). About 1.7 million adults in the United States develop sepsis each year, and about 350,000 of them die or are moved to hospice.”

Recognizing the scale of the problem, the CDC recently issued a toolkit and recommendations designed to improve the diagnosis and treatment of sepsis.

In addition to the threat to patient health, hospitals also face financial risks from inconsistent diagnosis of sepsis. Capitated payments may cover only half the ED’s costs, meaning incorrect or unnecessary procedures will produce losses. In addition, incentives and penalties related to early or late diagnosis can mean a difference of millions of dollars to a hospital.


Cytovale Provides a Groundbreaking Solution

Cytovale offers IntelliSep, the first FDA-approved, rapid sepsis diagnostic test for use in EDs. Its cutting-edge, patented technology requires only 90 seconds of hands-on time by ED staff and generates results in under an hour. The IntelliSep test uses the same blood-collection tube used to perform a complete blood count or CDC (the “purple tube”), is compatible with standard ED procedures, and its single-use plastic disposable contributes to low cost.

IntelliSep’s breakthrough technology detects cellular biophysical markers of sepsis. When a patient’s inflammatory system is “overactivated” during sepsis, the white blood cells are “squishier” when compressed compared to normal white blood cells.

The IntelliSep test uses microfluidics, high-speed video, and computer algorithms to individually measure the rigidity of tens of thousands of white blood cells, looking for the “squishier” cells that may indicate sepsis.

Test results are reported in three bands corresponding to risk levels for developing sepsis within three days. ED physicians and nurses can rapidly rule out sepsis when they see results in green and prioritize high-risk patients when results appear in yellow or red.


IntelliSep Delivers Multiple Benefits

The positive impact of IntelliSep is achieved in several dimensions. It:

  • Focuses attention on the highest priorities – Fewer delays in treating high-risk patients.
  • Reduces clinical variations – Unbiased test results reduce uncertainties inherent in physician judgment.
  • Improves SEP-1 compliance – Reduced chance of penalties by payors.
  • Maximizes resources in the ED – Physicians/nurses can attend to those most at risk; fewer tests administered in favor of a single IntelliSep.
  • Potential for significant cost savings – An estimated $3.5m to $7.7m a year for an ED with 90,000 visits.

Cost savings are achieved by reducing the number of unnecessary tests or procedures and by delivering faster care to sepsis patients, which has been shown to improve outcomes and reduce the length of hospital stays.


Why Norwest is Excited About Cytovale

Cytovale is a sterling example of a company making a tangible contribution toward the goal of better patient outcomes at lower costs. IntelliSep is a straightforward, easy-to-use, and cost-effective solution that addresses a critical need that is universally recognized as a high priority.

Cytovale’s value proposition is clear and compelling: more accurate diagnoses; simple, low-cost operational requirements; and the potential for major cost savings. It also has a predictable revenue stream and a high-efficiency sales model.

It is the first sepsis diagnostic test to directly measure the core, underlying pathophysiology of sepsis (how dysregulated the patient’s immune system is). That constitutes a significant competitive differentiation of the platform technology.

The company has experienced co-founders and an impressive senior management team.

We estimate an immediate TAM of around $2B in the U.S., growing to as much as $10B worldwide.

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