Cytovale

Cytovale is a medical diagnostics company focused on advancing early detection technologies for diagnosing fast-moving and immune-mediated diseases like sepsis. The company has developed the IntelliSep test which uses high-speed imaging to assess cellular host response through deformability cytometry of leukocyte biophysical properties and is designed for use in patients with signs of sepsis or for those that physicians suspect may have infections. The results are used to generate a report that stratifies patients according to their risk of developing sepsis.

IntelliSep is claimed to deliver test results within a mere 10 minutes, making it a fast and valuable resource in emergency departments. It differs from traditional diagnostic methods by evaluating the host's response to infection, simplifying the process by utilizing a standard blood draw. The tool also classifies patients into three distinct categories based on their likelihood of having sepsis. Band 1 denotes a low probability, while Band 3 suggests a high likelihood of sepsis. This categorization enables healthcare providers to quickly assess a patient's condition and make informed decisions. Furthermore, it aids hospitals in aligning with the guidelines set by the Centers for Medicare & Medicaid Services (CMS) regarding timely sepsis treatment, known as SEP-1.

In January 2023, the company received US FDA 510(k) clearance for its IntelliSep test for the ~30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

Funding and Financials

In November 2023, Cytovale raised USD 84 million in a Series C funding round, with participation from Norwest Venture Partners, Sands Capital, and Global Health Investment. The funds were expected to be used to expand the use of its IntelliSep prognostic blood-based test to more hospital emergency departments and healthcare systems in the US.