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Cytovale provides rapid sepsis diagnostics for healthcare providers. It uses the Cytovale system and its flagship IntelliSep test to assess a patient's immune response from a blood sample in under 10 minutes. The system analyzes thousands of cells per second to detect disease signatures, giving clinicians quick, actionable information to diagnose sepsis and guide treatment. Unlike many diagnostics that take hours or days, IntelliSep emphasizes a simple workflow with minimal hands-on time, making it suitable for busy clinical settings. The company differentiates itself through speed, ease of use, and a focus on host-response biology to deliver fast, reliable results for sepsis diagnosis. Cytovale’s goal is to improve patient outcomes and reduce healthcare costs by providing timely diagnostic information that helps clinicians act sooner and more effectively.
Industries
Healthcare
Company Size
51-200
Company Stage
Series D
Total Funding
$216.7M
Headquarters
South San Francisco, California
Founded
2013
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Total Funding
$216.7M
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Caristo wins FDA authorization for cardiovascular risk predictor. Nick Paul Taylor Tue, August 4, 2026 at 5:00 AM PDT Dive brief: * Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week. * The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient's risk of cardiovascular mortality over 10 years. * Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease. Dive insight: CCTA images the heart and coronary arteries to detect narrowed or blocked vessels. Patients diagnosed with obstructive CAD undergo treatment to clear blockages. People with clear arteries can still suffer heart attacks and other major adverse cardiac events, or MACE. Traditional tools are unable to identify high-risk patients without obstructive CAD. A U.K. study of Caristo's technology found patients without obstructive CAD accounted for two-thirds of MACE and total cardiac deaths. The study enrolled more than 40,000 people undergoing CCTA at eight U.K. hospitals and tracked them for a median of 2.7 years. Technology from Caristo, a University of Oxford spinout, successfully differentiated patients at very high risk of cardiac mortality and MACE from people at low or medium risk. The tool combined a score based on inflammation-induced radiological changes, plaque burden and the patient's risk factors to assign individuals to one of three risk categories. The device is the first technology authorized in the U.S. to quantify coronary inflammation from routine CCTA, Caristo said. The company plans to launch the product commercially in the U.S. this quarter and expand the rollout in the fourth quarter, leveraging reimbursement codes that took effect in January. Caristo has built out its team in preparation for the launch. Stephen Deitsch joined Caristo as CEO in April, bringing experience gained as CFO of OrganOx. Terumo bought OrganOx for $1.5 billion during Deitsch's time as CFO. Last month, Caristo revealed the appointments of David Vort as chief commercial officer and Chris Louk as CFO. Vort previously worked as chief commercial officer at Cytovale and iRhythm Technologies. At Caristo, Vort will oversee commercialization of CaRi-Heart and CaRi-Plaque, which the FDA cleared last year for coronary plaque and stenosis quantification. Recommended Reading
Cytovale, a medical diagnostics company focused on early sepsis detection, has appointed Eric Khairy as Chief Marketing Officer. Khairy will lead global marketing strategy as the company scales adoption of IntelliSep, its rapid sepsis test that delivers results in eight minutes. Khairy joins from Inari Medical, where he served as Senior Vice President of Marketing and Commercial Operations, helping grow the company from $6 million to $600 million in annual revenue over seven years through its $1 billion IPO and subsequent $4.9 billion acquisition by Stryker. He previously held leadership roles at Philips, Volcano and other medical technology firms. IntelliSep is FDA-cleared and has reached over 65,000 patients. The test uses artificial intelligence and microfluidics to assess immune system response to infection.
Cytovale appoints Eric Khairy as Chief Marketing Officer. PR Newswire Today at 6:15am PDT Veteran MedTech commercial leader brings over two decades of operating experience to drive program-building enabled by company's rapid sepsis test SAN FRANCISCO, April 7, 2026 /PRNewswire/ - Cytovale(R), a commercial-stage medical diagnostics company focused on the early detection of sepsis, today announced the appointment of Eric Khairy as Chief Marketing Officer. In this newly created role, Khairy will lead global marketing strategy and execution as the company accelerates adoption of its IntelliSep(R) rapid sepsis test. "Eric brings deep commercial experience from high-growth top-tier MedTech organizations," said Cytovale CEO Ajay Shah. "He has successfully built and scaled teams that support product adoption and growth, and he understands how to translate clinical innovation into broad patient impact. His expertise strengthens our executive leadership team as we bring IntelliSep to more emergency departments across the nation." Khairy joins Cytovale from Inari Medical where he served as Senior Vice President of Marketing and Commercial Operations, helping to fuel the company's growth from $6 million to $600 million in annual revenue over his seven-year tenure, from startup through a $1 billion IPO and subsequent $4.9 billion acquisition by Stryker. Prior to Inari, Khairy held commercial and strategy leadership roles at Philips, Volcano, Corindus Vascular Robotics, and Minogue Medical. "Sepsis is a leading cause of in-hospital death and the most expensive condition to treat, and every hour of delayed treatment costs lives. We can do better," Khairy said. "Cytovale's IntelliSep delivers an actionable sepsis test result in 8 minutes, not days. This solution has already reached over 65,000 patients, and I'm excited to accelerate its adoption." Khairy holds an MBA from MIT, an M.A.Sc. in biomedical engineering from the University of Montreal, and a B.Eng. in computer engineering from McGill University. About IntelliSep(R) IntelliSep is Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, which leverages artificial intelligence (AI) and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep assesses the body's dysregulated immune system response to infection and provides a risk score for sepsis within approximately eight minutes using a standard blood draw. For more information, visit cytovale.com/our-solution/intellisep-sepsis-test/. About Cytovale(R) 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. Cytovale developed IntelliSep(R), the U.S. Food and Drug Administration-cleared rapid sepsis diagnostic for use with a standard blood draw in Emergency Departments to determine risk of sepsis. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit cytovale.com and follow Cytovale on LinkedIn. SOURCE Cytovale This is a paid placement. For further inquiries, please contact PR Newswire directly.
Cytovale's IntelliSep ® sepsis test highlights a new model for ED triage that's already delivering systemwide clinical and economic valueResults of real-world study with 12,000+ patients published in the journal HealthcareSAN FRANCISCO, June 12, 2025 /PRNewswire/ -- One of the largest real-world studies of a sepsis diagnostic reveals that Cytovale's IntelliSep®, a U.S. Food and Drug Administration (FDA)-cleared rapid host response diagnostic, reduced the relative rate of sepsis mortality by 39%, shortened length of hospital stay and enabled more efficient resource allocation in the emergency department (ED). The study, " Impact of a Sepsis Quality Improvement Initiative on Clinical and Operational Outcomes ," published in the peer-reviewed journal Healthcare, followed more than 12,000 patients over 12 months at Our Lady of the Lake Regional Medical Center (OLOLRMC), a 900-bed in-patient acute care facility and Level 1 trauma center in Baton Rouge, La."This is the kind of data the medical field has been waiting for and the results represent a breakthrough in sepsis care," said Dr. Christopher Thomas, study author who serves as Vice President and Chief Quality Officer at Franciscan Missionaries of Our Lady Health System (FMOLHS) and is a critical care physician at Louisiana State University Health Sciences Center. "With this small operational change, we are able to save more lives, deliver better care faster and optimize use of hospital resources. It's a pivotal step forward in how emergency departments manage sepsis
Seasoned nurse executive and health IT leader to drive expansion of nurse-driven sepsis protocol leveraging IntelliSep® rapid detection solutionSAN FRANCISCO, March 18, 2025 /PRNewswire/ -- Cytovale® , a commercial-stage medical diagnostics company, today announced the appointment of Rhonda Collins, DNP, RN, FAAN, as the company's first chief nursing officer (CNO). A former nurse, seasoned hospital executive and leader in healthcare IT, Collins will oversee Cytovale's clinical consultant team as they engage with hospital executives around the country to implement nurse-driven sepsis protocols with the company's rapid sepsis detection solution, IntelliSep® ."We've seen strong clinical improvements – including a 30% reduction in risk-adjusted mortality – when hospitals use IntelliSep as part of a nurse-driven sepsis protocol in their emergency departments. We're now looking to bring that same protocol to hospitals across the U.S.," said Ajay Shah, Cytovale co-founder and CEO. "Rhonda, with her deep understanding of nursing workflows and implementing new technologies, will be instrumental in helping more hospitals develop effective sepsis protocols that empower the nursing staff and benefit their patients."A registered nurse for over three decades, Dr. Collins was a hospital executive before continuing her evolution to become a leader in healthcare IT. She comes to Cytovale from Kontakt.io, where she served as CNO
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Industries
Healthcare
Company Size
51-200
Company Stage
Series D
Total Funding
$216.7M
Headquarters
South San Francisco, California
Founded
2013
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