CytoVale
CytoVale is a medical technology company that developed IntelliSep, an FDA-cleared ~8-minute host-response sepsis diagnostic on its proprietary deformability cytometry analyzer, sold through enterprise field sales to U.S. hospital emergency departments and clinical laboratories.
- Company typePrivate
- Founded2013
- HeadquartersSouth San Francisco, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What CytoVale does
CytoVale is a South San Francisco-based medical technology company that develops host-response diagnostics for early detection of immune-mediated diseases, with its commercial focus on sepsis. The company was founded in 2013 and originated in academic research dating to 2007. Its core offering is the IntelliSep Sepsis Test — an FDA 510(k)-cleared in vitro diagnostic that risk-stratifies adult emergency department patients with suspected infection for probability of sepsis with organ dysfunction within three days — paired with the Cytovale System benchtop analyzer.
The IntelliSep test runs on proprietary deformability cytometry technology: a label-free approach in which a standard 100µL blood sample is processed through microfluidic channels, individual white blood cells are interrogated by ultra-high-resolution imaging and computer vision at hundreds of thousands of frames per second, and proprietary machine-learning models translate measured biomechanical features (size, deformability, stiffness, elongation, granularity, nuclear mechanics) into an IntelliSep Index score between 0.1 and 10.0, stratified into three risk bands. Results are delivered in approximately 8 minutes, with a reported 97.5-98% negative predictive value for ruling out sepsis, and the system integrates with existing hospital laboratory workflows via Ethernet to the LIS with no internet connectivity required. Real-world implementations have reported mortality reductions of 19-42% and material improvements in ED throughput and blood culture stewardship.
CytoVale sells through a direct enterprise field-sales motion targeting U.S. hospital emergency departments and laboratories, using a structured protocolized implementation program of discovery, implementation, and reassessment. Revenue is generated through placement of the Cytovale System analyzer and recurring sales of IntelliSep test cartridges (single-use), QC kits, and reagents. The company is privately held, backed primarily by Norwest Venture Partners (lead in both Series C and Series D), Sands Capital, Global Health Investment Corporation, and Breakout Ventures, with total disclosed funding of approximately $184 million across Series C ($84M, November 2023) and Series D ($100M, October 2024).
CytoVale firmographics
Firmographics- Name
- CytoVale
- Legal name
- Cytovale, Inc.
- Website
- https://cytovale.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- CytoVale is a medical technology company that developed IntelliSep, an FDA-cleared ~8-minute host-response sepsis diagnostic on its proprietary deformability cytometry analyzer, sold through enterprise field sales to U.S. hospital emergency departments and clinical laboratories.
- Ownership category
- akta.pro rank
CytoVale industry classification
Industry- Product category
- Sepsis Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Cell-Based & Potency Assays (Bioassays) (HLAGADAH)
- akta.pro secondary industry
- Microbiology & Infectious Disease Testing (Trial Support) (HLAGAEAF)
Keywords
Where CytoVale is headquartered
LocationHeadquarters
- HQ city
- South San Francisco
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
CytoVale business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Marketing or Sales, Personnel, Operations, Infrastructure
Revenue model
- IntelliSep Sepsis Test Kits and Reagents: Cytovale generates revenue through the sale of its IntelliSep test cartridges (single-use), QC kits, and related reagents to hospital laboratories. The test uses 100µL from a standard purple-top K2 EDTA blood collection tube. Reagent and consumable sales are recurring as hospitals perform tests on patients presenting to EDs with suspected sepsis.
- Cytovale System Placement: The company places its Cytovale System analyzer in hospital laboratories. Revenue is generated through associated consumables and reagents consumed with each test. The system is provided as part of the commercial relationship with health systems implementing IntelliSep.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
CytoVale product offering
Product offeringCore offering
Cytovale develops and sells IntelliSep, an FDA-cleared in vitro diagnostic test that runs on the proprietary Cytovale System benchtop analyzer to risk-stratify adult emergency department patients with signs of infection based on probability of sepsis within 3 days, delivering results in approximately 8 minutes using deformability cytometry. Revenue is generated through placement of the Cytovale System analyzer in hospital laboratories and recurring sales of IntelliSep single-use test cartridges and reagents to U.S. hospitals and health systems.
Product overview
CytoVale offers a unified portfolio centered on the IntelliSep sepsis diagnostic test and the Cytovale System medical device. The Cytovale System is the hardware platform that runs the IntelliSep test by isolating, imaging, and analyzing white blood cells via deformability cytometry, computer vision, and machine learning. IntelliSep is the single FDA-cleared in vitro diagnostic application that generates a sepsis probability score (0.1–10.0) stratified into three risk bands in approximately 8 minutes from a 100µL blood sample. IntelliSep operates exclusively on the Cytovale System, making it a tightly coupled platform-and-assay offering rather than a modular add-on architecture.
Differentiator
Problem solved
Functional benefit
Products and services
- IntelliSep Sepsis Test An FDA-cleared in vitro diagnostic test that risk-stratifies adult emergency department patients with signs and symptoms of infection based on probability of developing sepsis with organ dysfunction within 3 days. Delivers results in approximately 8 minutes using deformability cytometry to analyze biophysical properties of white blood cells, generating a score from 0.1-10.0 stratified into three discrete bands indicating probability of sepsis.
- Cytovale System Analyzer A benchtop laboratory analyzer that runs the IntelliSep test using precision microfluidics and deformability cytometry. The system isolates, images, and analyzes white blood cells via ultra-high resolution imaging, computer vision, and machine learning. Requires 4 sq ft of bench space, no calibration, no vacuum or plumbing, and integrates with hospital middleware via Ethernet connection to the LIS.
Quantifiable outcome
- 39% relative risk reduction in 30-day sepsis-associated mortality
- +11 more outcomes
Companies that use CytoVale
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles3 records
CytoVale technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature4 records
CytoVale partnerships and signals
Strategic signalScale indicators9 records
Recent moves6 records
Expansion highlights6 records
CytoVale competitors and assessment
Company assessmentDirect peers
- Inflammatix: Inflammatix is a direct host-response diagnostics peer developing rapid blood-based immune-transcriptional tests (HostDx) for acute infection and sepsis. It targets the same unmet need as IntelliSep—an ED-friendly, pathogen-agnostic sepsis rule-out—and competes head-to-head for hospital lab adoption.
- T2 Biosystems: T2 Biosystems is a direct competitor in rapid sepsis diagnostics with FDA-cleared T2Bacteria and T2Candida panels run on the T2Dx instrument. Like Cytovale, it offers hospital-lab rapid diagnostics for bloodstream infections and competes for the same ED/ICU sepsis decision point.
- MeMed Diagnostics: MeMed is a direct host-response diagnostic peer with FDA-cleared MeMed BV (bacterial vs. viral) and developing immune-based tests. It uses host immune signatures to differentiate infection etiologies at the point of care, sharing IntelliSep's 'read the immune response, not the pathogen' approach.
- Accelerate Diagnostics: Accelerate Diagnostics provides rapid antimicrobial susceptibility testing (AST) and identification directly from positive blood cultures via the Pheno system. It addresses the same bloodstream infection/sepsis clinical pathway as Cytovale, though at a later step in the diagnostic workflow.
Emerging players
- Prenosis (formerly Dascena): Prenosis is an emerging AI-driven sepsis diagnostics company, with FDA-authorized InSight platform combining EHR data and biomarkers to predict sepsis. It overlaps with IntelliSep's ED sepsis decision support use case, though it is software/EHR-based rather than a lab analyzer.
Broad incumbents
- bioMérieux: bioMérieux is a broad incumbent in clinical microbiology and sepsis diagnostics (BACT/ALERT blood culture, VITEK MS, BIOFIRE Blood Culture Identification panels). It competes in the same hospital lab sepsis workflow and represents the established standard against which IntelliSep must displace or layer.
- Roche Diagnostics: Roche Diagnostics is a broad incumbent offering the cobas platform and sepsis-relevant biomarkers (procalcitonin, lactate). It is referenced in Cytovale's own materials as a comparator and represents the large, entrenched diagnostic infrastructure that IntelliSep must integrate with or differentiate against in U.S. hospital labs.
- Beckman Coulter (Danaher): Beckman Coulter is a broad incumbent in hospital clinical chemistry, immunoassay, and hematology diagnostics, including sepsis-related biomarkers run on the DxH and Access platforms. It competes for the same hospital lab budget and workflow integration as Cytovale's IntelliSep on the Cytovale System.
- Abbott Diagnostics: Abbott Diagnostics is a broad incumbent in point-of-care and central-lab diagnostics, including the i-STAT platform commonly used in EDs for lactate and other sepsis-relevant markers. It is referenced in Cytovale's content marketing as a comparator and competes for the same ED sepsis triage workflow.
- QuidelOrtho: QuidelOrtho is a broad incumbent in clinical diagnostics, including rapid immunoassays and Triage products used in hospital and point-of-care settings. It competes for hospital lab and ED testing share, with overlap in the rapid infectious-disease and biomarker testing space where IntelliSep is deployed.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
CytoVale social profiles
Digital presenceCytoVale compliance and trust
Trust signalCompliance3 records
CytoVale financial estimates
Financial estimateRevenue estimate
Valuation estimate
CytoVale leadership team
Management profileNumber of profiles
Profiles14 records
CytoVale funding detail
Funding detailFunding overview
Funding rounds11 records
Investors15 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CytoVale M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CytoVale
What does CytoVale do?
Cytovale develops and sells IntelliSep, an FDA-cleared in vitro diagnostic test that runs on the proprietary Cytovale System benchtop analyzer to risk-stratify adult emergency department patients with signs of infection based on probability of sepsis within 3 days, delivering results in approximately 8 minutes using deformability cytometry. Revenue is generated through placement of the Cytovale System analyzer in hospital laboratories and recurring sales of IntelliSep single-use test cartridges and reagents to U.S. hospitals and health systems.
Is CytoVale a public or private company?
CytoVale is a private company. It is classified as venture growth investor backed and is currently operating.
When was CytoVale founded?
CytoVale was founded in 2013. It employs 11 to 50 people.
Where is CytoVale based?
CytoVale is headquartered in South San Francisco, United States, in the North America region.
How does CytoVale make money?
Two revenue lines are on record. IntelliSep Sepsis Test Kits and Reagents are the primary driver. The others are cytovale System Placement.
Who are CytoVale's main competitors?
Direct peers on record are Inflammatix, T2 Biosystems, MeMed Diagnostics and Accelerate Diagnostics. Prenosis (formerly Dascena) is listed as an emerging player. Broad incumbents are bioMérieux, Roche Diagnostics, Beckman Coulter (Danaher), Abbott Diagnostics and QuidelOrtho.
Does CytoVale have an API?
No public API is recorded for CytoVale.
What industry is CytoVale in?
CytoVale's product category is Sepsis Diagnostics. Its primary akta.pro industry code is HLAGADAH, Cell-Based & Potency Assays (Bioassays), with a secondary code of HLAGAEAF, Microbiology & Infectious Disease Testing (Trial Support). Its NAICS code is 325413 and its SIC code is 2835.