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CytoVale a 10-Minute Test for “The Biggest Threat You Never Heard Of”






The Driver: 


CytoVale Inc announced in November that it raised $84 million in a Series C funding round, led by Northwest Ventures Partners with participating investors, Sands Capital and Global Health Investments Corporation. Funds will be used to bring Ed focused FDA 510(k) Cleared IntelliSep Diagnostic Test from a simple blood draw to hospitals and health systems nationwide to support early detection and diagnosis of fast-moving diseases like Sepsis. To date, Cytovale has raised over $128.6 million in funding in over 9 rounds, with additional investments from Breakout Ventures, Blackhorn Ventures, Dolby Family Ventures, Western Technology Investments, and grants and contracts from the National Science Foundation, the National Institute of Health, and the U.S Health & Human Service Department. 


Key Takeaways: 


  • Sepsis-the body’s overwhelming life-threatening response to an infection contributes to at least 1.7 million adult hospitalizations and at least 350,000 deaths annually in the United States (MMWR, 2023)

  • Mortality rates from sepsis increase at least 8 percent for every hour that treatment is delayed and 80% of sepsis deaths could be prevented if treated in time (AAMC)

  • More than 87% of sepsis cases originate outside of the hospital, so when a patient comes into the emergency department, physicians often face a mystery to solve quickly (Mayo Clinic)

  • Sepsis was both the most frequent (2.2M stays) and the costliest ($41.5 billion in aggregate) of the 10 most common principal diagnoses for inpatient hospital stays (AHRQ)


The Story:

 

Founded in 2013, Cytovale is led by a team of scientists, engineers, former physicians, and financiers. Co-Founder and CEO, Ajay Shah, PHD is an expert in cell based diagnostic technologies and comes from a family of physicians. CytoVale, was spun out of the UCLA lab of Dino Di Carlo, the co-founder and scientific advisor to Cytovale. As noted by the San Francisco Business Times in 2014, Cytovale was one of the early recipients of funding from Peter Thiel’s Breakout Labs and has been working since inception to create a quick way to detect disease by using microfluidics to measure the physical properties of cells. Initially the company targeted biomarkers for the early diagnosis of sepsis, a potentially deadly blood infection that is difficult to spot until the infection has reached organs.


In 2019, Cytovale was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) which announced that it would give the company an initial $3.4 million, with an option for an additional $4.17 million, to advance development of the company's sepsis test, which may be able to diagnose the blood infection in less than 10 minutes. According to BARDA and the CDC, “sepsis kills about 270,000 Americans annually and occurs when there is a faulty immune response to an infection, [which] can cause tissue damage, organ failure, and even death.”  In January of 2023, Cytovale received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis in adult patients with signs and symptoms of infection who present to US emergency departments (ED). 


The Differentiators:


Patients who visit the ED with Sepsis usually present with fever and chills, low blood pressure, increased heart rate, and difficulty breathing which are caused by bacterial, viral, or fungal infections; these symptoms can mimic other conditions. Current common diagnostic testing includes Blood Tests, Urine Tests, Wound Culture Tests, Sputum Culture Tests, and X-rays, are time-consuming and have the potential to produce false negatives.

Cytovale’s IntelliSep,  a biomechanical test, rapidly assesses a patient’s immune activation state using interrogation immune cell morphology and mechanics by applying pressure to the patient’s white blood cells and characterizes their response – which differs between septic and non-septic patients, with results in under 10 minutes. IntelliSep categorizes its results into 3 categories, band 1 through 3, which is based upon the probability of a patient having or developing sepsis within the next three days, with band 3 having the highest susceptibility. Access to pertinent information in a matter of minutes gives physicians the confidence to determine treatment options and reduce poor health outcomes including death. 

As noted by the company, ”IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes. [It is a] first in a new class of ED-focused diagnostic tools that assess host response, and is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw.” Reducing the time to diagnosis is particularly important, especially with Sepsis. For example, according to a 2006 study, mortality rates from sepsis increase at least 8 percent for every hour that treatment is delayed. As explained by the Sepsis Alliance, “the condition is the body’s overwhelming life-threatening response to an infection, which triggers a chain reaction and quickly leads to tissue damage, organ failure, and death. [As a result], as many as 80 percent of sepsis deaths could be prevented with rapid diagnosis and treatment—making early detection critical to improving clinical, operational, and financial outcomes.


The Big Picture: 


In 2017, hospital costs for 35.8 million hospital stays were $434.2 billion, making hospitalization the most expensive healthcare utilization, with Septicemia being the single most costly inpatient condition at an aggregate cost of $41.5B. In addition,  Septicemia was far and away the most expensive condition with a mean cost per stay of $18,700. body’s overwhelming life-threatening response to an infection where there are difficulties distinguishing common infections or other conditions that can mimic sepsis. This can lead to errors, delays, misallocation of medical resources, and overuse of antibiotics, resulting in increased costs to the healthcare system; costs estimated at $62 billion annually on sepsis alone. “We are very aware of the cost constraints on hospitals, and we see IntelliSep offering value of many orders of magnitude greater than its costs' “, stated Shah in a 2021 Forbes interview before receiving FDA 510(K) clearance for IntelliSep. Our Lady of the Lake Regional Medical Center and its Emergency Department, located in Baton Rouge Louisiana- which has the highest rates of sepsis mortality in the United States, was among the first medical facilities to implement the IntelliSep test as its Sepsis protocol as part of a multi-center study. According to the national principal investigator, Dr. Hollis O’Neal, “the test provides hospital staff with information needed to identify and treat septic patients efficient


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