Cytovale Inc., a San Francisco-based medical technology company, has picked up $15 million in financing to advance its technology that enables the early detection of sepsis in the emergency department.

Specifically, the company raised $7.4 million in an extension of series B equity financing, co-led by existing investors Breakout Ventures and Blackhorn Ventures. Western Technology Investment also participated, providing a venture debt facility to the company.

Cytovale also entered a partnership with the U.S. Department of Health and Human Services's Biomedical Advanced Research and Development Authority (BARDA), Division of Research, Innovation, and Ventures (DRIVe) valued at up to $7.6 million.

Ajay Shah, co-founder and CEO of the company, told BioWorld MedTech that about a year and a half ago, BARDA launched DRIVe, which is focused on the early detection of sepsis as one of its core areas. He noted that the company got a first award from the division last year that helped the company with its proof-of-concept work.

Now, this latest award, coupled with the financing, will help advance Cytovale's technology through good manufacturing practice and conduct clinical studies needed to pursue regulatory clearance of the Cytovale test.

"Sepsis is a life-threatening condition triggered by an infection that can suddenly overwhelm the body and lead to septic shock and death," said Shah. "It has traditionally been difficult to quickly and accurately diagnose sepsis, making it the leading cause of death in U.S. hospitals, with 270,000 lives lost to the condition each year."

Biomechanical properties

Cytovale's diagnostic is designed to measure immune cell activity associated with the dysregulated host response in sepsis in less than 10 minutes. With current approaches, sepsis remains challenging to diagnose early, delaying care to those who need it most.

Doctors must rely on measuring vital signs, blood lactate levels and other clinical chemistry to identify sepsis.

"Cytovale's core technology was developed by our academic co-founder Dino Di Carlo [from] UCLA," Shah said. "And what we have here is a really cool way to look at the biomechanical properties of single cells at high throughput."

That is accomplished by using innovations across microfluidics and ultra-high speed imaging, adding a layer of computer vision and machine learning. As a result, tens of thousands of cells can be studied in only a few seconds.

For now, the company is focuses on kicking off studies next year ahead of an FDA submission. And while it is concentrating on the U.S. in the near term, it is interested in exploring Europe and beyond.

The company started with early detection of sepsis in the emergency department because it is an area of acute need. "I think this is a really broader platform technology and we're focused on using it to unlock immune diagnostics in real time," Shah said. "We're excited to bring this product to the market in the coming years, but are also actively thinking about and beginning to explore additional areas."

Other players

There are other players that have teamed up with BARDA, including Beckman Coulter Inc., a Danaher company. Brea, Calif.-based Beckman Coulter reported this week that it had won a contract of $1.25 million, with potential to be awarded an additional $6.5 million if all contract options are exercised, from the DRIVe. As a result, Beckman Coulter, in collaboration with Oakland, Calif.-based Dascena Inc., will work on a machine learning-based sepsis detection algorithm.

The solution combines clinical data from laboratory tests and patient data from electronic health records in a predictive machine learning algorithm, with the goal of detecting sepsis early. It builds on Beckman Coulter's existing Early Sepsis Indicator, which was cleared in April.

Last month, the Rory Staunton Foundation for Sepsis Prevention, of New York, won a contract intended to better understand and combat maternal sepsis. That initiative also will be funded in part by DRIVe and look at the risk factors associated with maternal sepsis, including the demographic characteristics, co-morbidities and obstetric procedures that place some women at higher risk of developing the condition.

In September, T2 Biosystems Inc., of Lexington, Mass., reported that it had scored a contract with BARDA. (See BioWorld MedTech, Sept. 16, 2019.) The company is looking to advance its pipeline of diagnostic tests for sepsis-causing pathogens and antibiotic-resistance genes. The cost-sharing agreement, which is worth up to $69 million, includes an initial phase valued at $6 million and seven option phases that BARDA can act upon, valued between $5 million and $10 million.