Cytovale Collects $100 Million in Series D Funding

Cytovale is $100 million in the black, having closed a Series D funding round led by Sands Capital. New support came from Canada Pension Plan Investment Board (CPP Investments) and existing backers—Norwest Venture Partners, Global Health Investment Corporation, and Breakout Ventures.

Cytovale will use the money to build upon its early clinical success and accelerate the expansion of IntelliSep to U.S.hospital emergency departments (ED) and health systems.

“Sepsis is the largest single condition presenting to the Emergency Department where there hasn’t been an effective diagnostic to quickly and effectively triage patients. Cytovale’s IntelliSep test has now been demonstrated, prospectively, to help save lives and money by doing just that,” Sands Capital Partner Parker Cassidy said. “We’re excited to lead this financing and help accelerate Cytovale’s commercial launch.”

IntelliSep is touted as the first and only U.S. Food and Drug Administration (FDA)-cleared cellular host diagnostic indicated for use in the ED, where more than 80% of sepsis cases present. The eight-minute test provides clinicians a first-ever look into the biology that causes sepsis, enabling care teams to quickly and confidently identify the proper diagnosis and deliver appropriate, patient-centered care.

“Seeing sepsis is a major breakthrough; IntelliSep allows our care teams in the Emergency Department to quickly and accurately triage and diagnose suspected infection patients and put them on the right path for treatment,” said Dr. Christopher Thomas, chief quality officer, Franciscan Missionaries of Our Lady Health System. “The clinical, operational and financial benefits we have experienced have led us to implement IntelliSep across all major hospitals in our health system.”

IntelliSep launched in August 2023 at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. As a result of an IntelliSep-driven screening process, patients with occult sepsis were detected earlier and had treatment initiated more than 60 minutes faster, the hospital reported. The facility also experienced a 30% decrease in the risk-adjusted mortality index for sepsis patients. From an operational and financial perspective, patients tested with IntelliSep spent 1.28 fewer days in the hospital, and realized a savings of $1,400 per patient.

“Sepsis has historically been one of the most challenging and costly conditions for hospitals to manage due to the lack of rapid, objective diagnostic tools. Thankfully, that’s finally changing with IntelliSep, which holds the potential to transform sepsis care in the same way troponin tests did for cardiac care and rapid CT scans did for stroke diagnosis,” Cytovale CEO Ajay Shah, Ph.D., stated. “Cytovale is growing at an astounding pace to meet demand from other health systems looking to tackle this deadly condition. The additional investment will enable us to quickly scale across the U.S. with greater agility to serve health systems and their patients.”

San Francisco-based Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. The company’s FDA-cleared rapid sepsis diagnostic, IntelliSep, leverages machine learning and advanced microfluidics to provide ED clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw.