According to the World Health Organization, sepsis is the leading cause of death globally, killing 11 million people each year, many of whom are children, and crippling many more. While rapid diagnosis and treatment are critical in the fight against sepsis, the medical profession lacks a reliable and quick test for the condition.
A MedTech start-up located in San Francisco is going to change that. Cytovale, founded in 2013, is currently in the last stages of clinical testing for a novel sepsis test that produces results in less than 10 minutes.
“I grew up with pharmaceuticals that influences people’s lives at their most vulnerable times since my father was an essential care doctor and my husband is an anaesthetist,” says Ajay Shah, one of Cytovale’s three co-founders and the company’s CEO. “Right from the start, we saw the enormous need to improve early diagnosis of sepsis.”
The problem that hospitals confront across the globe is that, even though many patients present with symptoms that would indicate sepsis, the majority of them do not have the disease. Furthermore, detecting and treating sepsis is now a resource-intensive process; it isn’t a treatment approach that should be used regularly, particularly given concerns about antibiotic abuse.
Failure to detect and treat sepsis, on the other hand, is almost always fatal — delays in treatment may result in a variety of catastrophic health effects, including damage to the stomach, lungs, and other organ systems, amputations, and death. According to the latest research, the risk of mortality from sepsis increases by as much as 8% for every hour the condition is left untreated; in fact, 80 percent of sepsis fatalities might be avoided with prompt diagnosis and treatment.
In contrast to this background, early diagnosis of sepsis is a valuable tool for healthcare providers. “We want this to be a completely regular examination,” Shah explains. “It’s something the triage nurse could do when patients approach the emergency department.”
Cytovale’s “IntelliSep” test is based on technology created by Shah, his co-founders Henry Tse and Dino Di Carlo, who have worked together since a period at UCLA, and a staff that has expanded from four to about 50 people over the preceding eight years. The test requires the collection of a patient’s blood pattern, which is then processed in a tabletop apparatus created by the company to be used in hospital scientific labs. The equipment examines the mechanical characteristics of the patient’s white blood cells, which vary in sepsis patients from those who do not have the condition.
The results are available in less than 10 minutes, with the system separating patients into three groups based on their risk of sepsis. Low-risk patients are given an inexperienced rating, medium-risk patients are given a yellow rating, and high-risk patients are given a red rating. The findings provide emergency room clinicians with a clear choice on proceeding with treatment.
“About 20% of people who go into an emergency department show symptoms that might indicate sepsis, such as a high fever or an increased heartbeat, but the majority of them will not have the condition,” Shah notes. “Doctors are looking at these critical signs ahead of time to make a scientific decision, but there’s a lot more scientific work to be done to establish a prediction, and that takes time and valuable hospital resources.” In many cases, these resources are found to have been used needlessly, with sepsis being ruled out; even worse, there isn’t enough time to attend for a positive outcome in certain cases.
Given the high frequency of sepsis, its catastrophic effects, and the current lack of simple diagnostics, Cytovale’s expertise has the potential to be game-changing. Shah and his colleagues, on the other hand, have declined to rush to market. “This know-how and its functionalities have been developing since 2013, and the product has gone through a series of scientific testing,” he explains. “Now we can submit our findings to the FDA [the Food and Drug Administration, which is in charge of approving new treatments and testing in the United States].”
That would put Cytovale’s IntelliSep on the market in the first part of 2022, with Shah only beginning to think about price. “We’re quite cognizant of hospital budget limits, and we envision IntelliSep offering value that is many orders of magnitude greater than its price,” he adds. “It’s all about making sure the right patients receive the right treatment at the right time.” Aside from the obvious benefits of better outcomes for patients with sepsis, hospitals will benefit from benefits such as lower expenditure on non-sepsis patients and faster throughput of patients in the emergency department.
Shah is well aware of the scope of Cytovale’s potential opportunity. Certainly, the company has attracted several investors, raising more than $50 million in the capital. Professor Michael Atar, one of Cytovale’s original advisers and main investors, says, “It’s really exciting to see Cytovale’s technology evolving to the point where it might have a big impact on patient care; perhaps saving hundreds of lives.” “I knew I wanted to be involved with Professor DiCarlo’s lab at UCLA ever when I first heard about it.” His medical engineering lab was the birthplace of Cytovale, and I’ve always felt that their approach may provide fundamental organic discoveries. This cooperation will be revolutionary in Silicon Valley, and I’m excited that we’ll be able to have a significant impact on healthcare outcomes, both now and in the future.”
Furthermore, funding has come from venture capital firms such as Breakout Ventures, Blackhorn Ventures, Dolby Household Ventures, Western Expertise Funding, and grants and contracts from the National Science Foundation and the National Institutes of Health, and the US Department of Health and Human Services.
Regardless, the bigger picture is ultimately about saving lives. “Advancing the know-how has been both humbling and satisfying,” Shah adds. “What began as a notion from two research experts [Shah thanks his co-founders Tse and Di Carlo] has evolved into something that is set to help tens of tens of millions of people.”