The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), announced on Oct. 30 it will provide expertise and $3.4 million to Cytovale to develop design specifications for an early sepsis detection system and potentially an additional $4.17 million over 2.5 years for additional work.
“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 system incorporates the latest developments in microfluidics, high-speed imaging, and machine learning to identify sepsis-specific biophysical signatures of immune cells from a small volume of blood. Currently, doctors must rely on measuring vital signs, blood lactate levels and other clinical chemistry to identify sepsis. Instead, Cytovale’s system looks at biophysical properties of immune cells and measures the immune cell activity associated with body’s immune response.
“We need faster diagnostics to reduce the health burden of sepsis in our country and save lives. Like so many threats, speed of diagnosis is critical to improving outcomes for sepsis patients. Through this and other projects, our Solving Sepsis program continues to focus on catalyzing technology to address sepsis.” BARDA Director Rick Bright, Ph.D.
The cost-sharing agreement builds on work completed under a previous cost-sharing contract between Cytovale and BARDA’s Division of Research Innovation and Ventures (DRIVe). BARDA provided $749,000 under that agreement through an EZ-BAA, or Easy Broad Agency Announcement.
Cytovale also announced on Oct. 30 it 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. 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.
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.
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. Sepsis could pose an even greater health security threat in a chemical, biological, radiological or nuclear emergency, or as a complication of an influenza pandemic or other emerging infectious disease outbreak.