Cytovale, Inc., a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, today announced $15 million in financing to advance its technology enabling early detection of sepsis in the emergency department.

The company has 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 (WTI), who provided a venture debt facility to the company, also participated in the equity financing. Cytovale has also entered into a partnership with the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), Division of Research, Innovation, and Ventures (DRIVe) valued up to $7.6 million.

Funds will be used to advance Cytovale's technology through Good Manufacturing Practice (GMP) 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 Ajay Shah, Ph.D., co-founder and CEO of Cytovale. "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. We are excited to extend our partnership with BARDA and this esteemed group of investors to help us advance our technology for early detection of sepsis, which we believe will save and improve the lives of thousands of people."

Cytovale's rapid diagnostic is designed to measure immune cell activity associated with the dysregulated host response in sepsis in less than 10 minutes, with the goal of enabling timely and accurate triage in the emergency department. Early detection of sepsis enables early treatment, which is crucial to survival. With current approaches, sepsis remains challenging to diagnose early in a patient's journey, often consuming valuable emergency department resources and delaying care to those who need it most.

"We are thrilled to co-lead this financing of Cytovale," said Lindy Fishburne, Managing Partner at Breakout Ventures. "Cytovale's team is well-positioned to deliver on the promise of its technology to provide doctors with critical information that can reduce the global health burdens of sepsis."

"Cytovale is poised to transform the way clinicians assess patient risk for developing sepsis and improve the standard of care for this critical condition," said Philip O'Connor, Managing Partner at Blackhorn Ventures. "We are pleased to invest in this promising technology and visionary team."

The above referenced federal funds are from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 5A50119C00072.

About Cytovale, Inc.

Cytovale, based in San Francisco, Calif., is a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, and applying this first to sepsis, a condition whose early detection dramatically improves patient outcomes. For more information visit cytovale.com.