Cytovale, Inc.

A majority (57%) of septic patients did not meet criteria for ICU level of care 30% of sepsis-associated deaths occurred in patients who did not meet the criteria of ICU level of care Cytovale's IntelliSep® host-response test was shown to be superior in both sepsis detection and prognosis when compared to a measurement of ICU level of care SAN FRANCISCO and LAS VEGAS, April 22, 2025 /PRNewswire/ -- A retrospective analysis of an observational study being presented this week at the Society of Hospital Medicine (SHM) Converge conference reveals that the need for intensive care unit (ICU)-level care in patients with suspected infection is not a definitive indicator for sepsis. "Prognostic Ability of Cellular Host Response Test in Diagnosis and Risk Stratification of Patients with Suspected Infection in Need of ICU-Level Care" details a five-year analysis of suspected infection patients at Our Lady of the Lake Regional Medical Center (OLOLRMC) in Baton Rouge, La. In comparing ICU level of care (LOC) to results of a cellular host-response test to stratify septic patients, researchers found that ruling out sepsis based on ICU level of care would have missed 57% of the patients who were ultimately diagnosed as sepsis. "Sepsis is a fast-progressing condition that mimics other diseases and can be deadly if not addressed quickly and properly," said pulmonary and critical care physician Robert Scoggins, MD, PhD at Kootenai Health. "Simply knowing that a patient is in need of ICU resources – such as ventilation, renal replacement therapy or vasopressors – tells you nothing about the cause of their condition. In fact, using emerging tools that correlate with ICU level of care likely provides limited value beyond measuring patients' lactate level. There are more accurate ways to determine risk of sepsis. Specifically, there is a U.S. Food and Drug Administration (FDA)-cleared cellular host-response test that enables clinicians to more accurately risk-stratify patients, ensuring they get the proper disease-specific treatments and ultimately improving outcomes." Accurate and timely detection requires a specific test for sepsis Sepsis is a dysregulated host immune response to infection that leads to life-threatening organ dysfunction and is the leading cause of in-hospital death. Most cases present initially to emergency departments (EDs), but symptoms, including fever, rapid heart rate and breathing, and low blood pressure, are not specific to sepsis. This makes diagnosis difficult, particularly in the early stages, which can impact patient outcomes. The risk of death increases by up to 8% for each hour that septic shock treatment is delayed, while treating non-septic patients for sepsis can result in further medical complications and death. This retrospective study compared the accuracy of ICU LOC and a cellular host-response test (IntelliSep®) to determine which risk stratification approach is most accurate in predicting sepsis using data from 730 adult patients with suspected infection who presented to the ED. Researchers demonstrated in this study that: If a provider used "no need for ICU LOC" as an indicator to rule out sepsis, 57% of patients who went on to develop sepsis would have been missed and 30% of sepsis deaths were in this subpopulation. If a provider used IntelliSep Band 1 as an indicator to rule out sepsis, only 5% of patients who went on to develop sepsis would have been missed and 0 sepsis deaths were in this subpopulation. "Doctors on the front lines need tests to aid in rapid decision making. We have these for stroke and heart attack, allowing us to quickly determine what's wrong and put patients on the right path," said Hollis "Bud" O'Neal, MD, MSc, associate professor of Medicine at Louisiana State University Health Sciences Center and medical director of research for OLOLRMC, who was one of the authors of the study. "Cellular host-response tests are filling this void for determination of sepsis, helping us accurately assess both the potential risk and severity of sepsis for patients in critical condition and determine the proper course of treatment." OLOLRMC is leveraging Cytovale®'s IntelliSep, the first and only U.S. Food and Drug Administration (FDA)-cleared cellular host response diagnostic indicated for use as an aid in the early detection of sepsis within the Emergency Department (ED). Within the first year of IntelliSep use, OLORMC reported significant clinical improvements, including improved patient outcomes with lower mortality rate for sepsis patients, faster treatment and shorter hospital stays. "Because IntelliSep provides a metric of immune dysregulation, it may provide superior and more actionable risk-stratification information for the management of potentially septic patients than using ICU LOC," said Dr. O'Neal. This study (Abstract 278) will be presented during SHM Converge on Wednesday, April 23 at 12:10 p.m., Screen F, Converge Central (Oceanside A) at the Mandalay Bay Resort and Casino in Las Vegas. About Cytovale® 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's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep®, leverages machine learning and advanced microfluidics to provide Emergency Department 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. 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 and follow Cytovale on LinkedIn and X. Media Contact Jessica Flick Cogenta Communications [email protected] SOURCE Cytovale WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Growth Equity and Late-stage Venture Capital Firm is Dedicated to Improving Patient Outcomes Through Partnerships with Best-in-Class Teams and Medical Technologies CHICAGO, April 15, 2025 /PRNewswire/ -- SPRIG Equity, a growth equity and late-stage venture capital firm focused on advancing patient care through investment in transformative medical technologies, today announced the final close of its inaugural fund, SPRIG Equity Fund I, with $50M in assets under management (AUM). With offices in the Chicago area and Orange County, CA, SPRIG Equity invests in breakthrough innovations across the medical technology sector, including medical devices, diagnostics, and tech-enabled services. "We are incredibly proud to have successfully closed our inaugural fund, especially in a year when first-time funds accounted for just 6% of total fund closures," said Evan Norton, Managing Partner and Co-Founder. "This achievement reflects the strength of our investment strategy, proprietary deal sourcing, and our team's expertise in identifying and building great companies that can transform patient care while delivering exceptional returns." SPRIG Equity is led by Managing Partner Evan Norton, whose proven investing track record includes leading Abbott's corporate venture group for almost a decade. He co-founded the fund alongside Rebecca Raabe, an experienced MedTech investor and operator, and Katie Arnold, the CEO and founder of SPRIG Consulting, a leading medical technology strategy and commercialization consulting firm. The team is further supported by an accomplished advisory board of industry entrepreneurs, senior executives, and thought leaders. A key differentiator for SPRIG Equity is its off-market deal flow from its exclusive relationship with SPRIG Consulting. SPRIG Equity has already demonstrated strong momentum with four portfolio investments to date: SetPoint Medical: medical device company with a first-of-its-kind neuromodulation therapy for patients living with chronic autoimmune conditions Conformal Medical: clinical-stage company developing next-generation left atrial appendage occlusion technology for stroke prevention Pi-Cardia: commercial-stage company focused on leaflet modification technologies in the structural heart market Cytovale: commercial-stage company offering rapid sepsis diagnostic technology for hospital emergency departments About SPRIG Equity SPRIG Equity is a growth equity and late-stage venture capital firm dedicated to improving patient outcomes by partnering with best-in-class teams and medical technologies. Launched in 2023, SPRIG Equity actively invests in late-stage opportunities across the medical technology sector. The team has a history of successfully backing market-shaping companies, including Affera, NeuroPace, Vertos, Endosense, Tendyne, and more. For more information, visit . SOURCE SPRIG Equity WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Company helped healthcare professionals evaluate over 15,000 patients and wins industrywide acclaim in 2024 SAN FRANCISCO, Jan. 9, 2025 /PRNewswire/ -- Cytovale®, a commercial-stage medical diagnostics company, today celebrated a monumental year that catapulted it to lead the emerging sepsis diagnostics market, driven by increased demand for IntelliSep®, the company's U.S. Food and Drug Administration (FDA)-cleared rapid sepsis detection solution. In the first full year of commercialization, Cytovale grew its customer base across three states and two health systems, demonstrated clinical improvements and financial savings for hospitals, and gained widespread industry recognition. This culminated in the company raising $100 million in Series D capital to further accelerate U.S. commercial expansion of IntelliSep in 2025. AI-enabled IntelliSep uses sophisticated high-speed cameras and microfluidics to analyze the reaction of white blood cells from a patient showing signs and symptoms of sepsis. Using a standard blood draw, IntelliSep risk-stratifies patients based on their probability of having sepsis and delivers results in about eight minutes. Sepsis, a life-threatening condition caused by a dysregulated immune response, costs the U.S. healthcare industry $62 billion each year, largely because accurate, early detection in the emergency department (ED) is lacking. Hospital demand for such a solution is driving significant growth for Cytovale's IntelliSep rapid sepsis detection solution, a first-of-its-kind technology offering clinicians the ability to see the biology of sepsis "Cytovale has applied technology and biology to develop the most comprehensive sepsis solution I've seen. The company truly partners with health systems to support the internal rollout across the hospital, providing the most state-of-the-art screening available today," said Dr. Christopher Thomas, Chief Quality Officer, Franciscan Missionaries of Our Lady Health System (FMOLHS). "IntelliSep gives providers an evidence-based protocol to either identify or rule out sepsis to get the patient on the right carepath, very similar to how providers utilize an EKG to triage a patient with chest pain for possible heart disease." Helping Hospitals Save Lives, Resources and Money IntelliSep is making a significant clinical impact across diverse populations, from small rural hospitals to Louisiana's busiest ED. IntelliSep was first deployed at Our Lady of the Lake Regional Medical Center, part of FMOLHS, in Baton Rouge, La.. In the first 12 months, providers estimate they've evaluated more than 15,000 patients with IntelliSep and reported significant clinical improvements, including: Reduced the overall risk-adjusted mortality index by 30% for sepsis patients Reduced treatment time for patients at risk of sepsis by 60 to 70 minutes Reduced hospital stays for patients tested with IntelliSep and subsequently admitted by more than a day Saved the hospital $1,429 on average per patient tested After seeing these strong clinical improvements, FMOLHS implemented IntelliSep across the health system in Louisiana and Mississippi. A second health system, the Froedtert & the Medical College of Wisconsin health network, also implemented IntelliSep in a pilot at its flagship hospital, Froedtert Hospital in Milwaukee. Novel Life-Saving Sepsis Detection Technology Wins Industry Recognition This year Cytovale's novel technology and proven clinical impact earned the company numerous health industry honors, including: Digital Health Hub Foundation's Digital Health Award winner for the Biggest Healthcare Savings Story in the Best Story Series presented at HLTH 2024 Inc.'s 2024 Best in Business in the health product category Modern Healthcare's Best in Business of 2024 winner in two categories: laboratory medicine and medical technology San Francisco Business Times Inno Award winner in the healthcare category "I am incredibly proud of our entire team, including our hospital and health system partners, for their tireless efforts this past year to roll out the industry's first solution that enables providers to accurately see sepsis with a simple blood test," said Cytovale Co-founder and CEO Ajay Shah. "Sepsis is an incredibly complex and misunderstood syndrome, and we're using technology and biological insights to help providers more accurately and quickly rule-in or rule-out this deadly condition and ultimately save lives." For more information on bringing IntelliSep to a hospital, visit our website at . About Cytovale® 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's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep®, leverages machine learning and advanced microfluidics to provide Emergency Department 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. 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 and follow Cytovale on LinkedIn and X. SOURCE Cytovale WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED