The company that reads your immune system's mechanics to catch sepsis before the clock runs out.
Sepsis is a race against time. When an infection tips the body into a runaway immune response, organs can begin to fail within hours, and it remains a leading cause of death in American hospitals. The hard part has always been the same: telling, quickly, which feverish patient in a crowded emergency department is genuinely on that path - and which is not.
Cytovale's answer is IntelliSep, a test that skips the usual hunt for a specific pathogen. Instead it examines the patient's own white blood cells and measures how they behave under mechanical stress. When the immune system is activated, those cells change - they become softer, more deformable - and that shift can be quantified. From a single blood draw, IntelliSep returns a sepsis risk band in roughly eight minutes, well before a traditional blood culture could even begin to grow.
The company was incorporated in 2013, but the science is older. The core technique - deformability cytometry - began as an academic project around 2007, rooted in work connected to UCLA and MIT. It took FDA clearance in 2022 and a commercial launch in 2023 to turn a physics idea about squeezing cells through tiny channels into a tool sitting next to an ambulance bay.
"IntelliSep analyzes the immune response to infection through the biomechanical properties of white blood cells - delivering results in approximately eight minutes."
*From a peer-reviewed quality-improvement study of 12,000+ patients at Our Lady of the Lake Regional Medical Center, Baton Rouge. Results reflect one health system and may vary.
A benchtop analyzer plus a single-use microfluidic cartridge turn a small blood sample into a probability of sepsis - using four disciplines working in sequence.
A standard blood sample is loaded into a disposable IntelliSep cartridge in the ED.
Microfluidic channels push white blood cells through a narrow flow, stressing each one.
A high-speed camera captures how far each cell deforms - a read on immune activation.
Machine learning converts the cell mechanics into a risk band for sepsis within 3 days.
The traditional sepsis workup leans on blood cultures that can take a day or more. IntelliSep aims to give clinicians an early signal while there is still time to act.
The flagship test. Aids rapid identification of sepsis in adults arriving at the ED with signs of infection, returning a risk band tied to the probability of sepsis within three days.
A benchtop instrument placed in hospitals, paired with single-use microfluidic cartridges. The recurring cartridge sales are the engine of the business.
Cytovale sells business-to-business: it places IntelliSep analyzers in hospital emergency departments and health systems, then earns recurring revenue on the disposable cartridges each test consumes. The pitch to a hospital is not only clinical - shorter stays, fewer unnecessary cultures and lower mortality also translate into operational savings, which the company backs with published data. Estimated annual revenue is in the range of $33M.
IntelliSep's users are emergency physicians, critical-care teams and hospital labs. Our Lady of the Lake Regional Medical Center in Baton Rouge - a 900-bed Level 1 trauma center - became the first US site, and adoption has since reached rural Louisiana hospitals, extending advanced diagnostics beyond big academic centers.
The competition is partly the status quo - blood cultures, lactate tests and clinical scoring - and partly a field of host-response and biomarker rivals such as Beckman Coulter's Early Sepsis Indicator (MDW), Immunexpress SeptiCyte, Prenosis' Sepsis ImmunoScore, Inflammatix and T2 Biosystems. Cytovale's differentiator is its cell-mechanics approach and its position as the first FDA-cleared cellular host-response test designed specifically for the emergency department.
CEO Ajay Shah trained in the Harvard-MIT Division of Health Sciences and Technology, working on isolating circulating tumor cells before turning to sepsis. Co-founder Henry Tse is a co-inventor of the deformability cytometry platform underpinning the technology. Today roughly 120 people - engineers, data scientists and clinical and scientific affairs staff - support the commercial rollout.
| Round | Amount | Date | Lead / Notable Investors |
|---|---|---|---|
| Series D | $100M | Oct 2024 | Sands Capital (lead), CPP Investments, Norwest, GHIC, Breakout Ventures |
| Series C | $84M | Nov 2023 | Norwest Venture Partners, GHIC, Breakout Ventures |
| Total to date | ~$224M | 2024 | Multiple institutional and strategic investors |
Figures compiled from public announcements. Valuation not disclosed.
Deformability cytometry research begins as an academic project connected to UCLA and MIT.
Ajay Shah and Henry Tse formally found the company to commercialize the cell-mechanics platform.
Cytovale gains attention for its ambition to transform sepsis care with rapid diagnostics.
IntelliSep becomes the first FDA-cleared cellular host-response sepsis test for the ED.
Commercial launch of IntelliSep alongside an $84M Series C to scale.
A round led by Sands Capital, with CPP Investments joining, funds nationwide expansion.
A published study links IntelliSep adoption to a 39% reduction in sepsis mortality.
It measures the biomechanical properties of white blood cells - how they deform under stress - as a signal of the body's immune response to infection, rather than testing for a specific pathogen.
The test returns a sepsis risk result in approximately eight minutes from a small blood sample drawn in the emergency department.
Yes. IntelliSep is described as the first and only FDA-cleared cellular host-response sepsis diagnostic for emergency department use, cleared in 2022.
Hospital emergency departments and health systems. Our Lady of the Lake Regional Medical Center in Baton Rouge was the first US site, with adoption extending to rural hospitals.
Roughly $224M in total, including an $84M Series C in 2023 and a $100M Series D in 2024 led by Sands Capital.
Profile compiled from public sources. Figures are approximate where noted.