Cytovale Secures $84 Million Series C to Advance Commercialization of Transformative Sepsis Diagnostic Tool

Norwest-led Financing Will Bring FDA-Cleared IntelliSep^® Test to Hospitals Nationwide to Support Early Detection and Treatment of Serious Condition

SAN FRANCISCO, Nov. 15, 2023 /PRNewswire/ -- Cytovale^®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced it has raised $84 million in Series C funding led by Norwest Venture Partners with participation by additional new investors Sands Capital and Global Health Investment Corporation (GHIC). The financing included participation from other new and existing investors, as well as the conversion of bridge notes. Cytovale will use the proceeds to bring its recently FDA-cleared rapid sepsis diagnosis test – IntelliSep^® – to more hospital emergency departments (ED) and health systems in the United States, addressing historical diagnosis lag time that makes sepsis the leading cause of death in U.S. hospitals.

"Sepsis is a dangerous, fast-moving condition that can result in death if not identified and treated quickly," said Cytovale CEO Ajay Shah. "Our flagship diagnostic tool, IntelliSep, with a blood-to-answer time frame of under 10 minutes, helps healthcare providers recognize sepsis early and make critical, time-sensitive clinical decisions. With the support of our investors, we are now able to expand efforts to get our tool in the hands of more providers so they can address the potential deadly outcomes patients currently face."

Sepsis – A Hidden Killer
Sepsis is the leading cause of death in U.S. hospitals, with more than one-third of all in-hospital deaths attributed to the condition. About 80% of sepsis patients present to the ED, where it can be difficult to discern from ordinary infections or other conditions that can mimic sepsis. ED providers are often tasked with making triage and treatment decisions with limited information in a complex and resource-strapped environment. As a result, sepsis patients can be either underdiagnosed, resulting in rapid deterioration, risk of organ damage and need for readmission; or over-diagnosed, which can lead to increased costs, unnecessary utilization of limited hospital resources, and the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics. These errors and delays make sepsis the leading cost of hospitalization in the U.S, estimated at $62 billion annually.

Since sepsis is more prevalent in the U.S. than heart attacks and strokes combined, the related challenges are magnified because there has been no standardized care pathway to evaluate potentially septic patients. Existing ED sepsis tests and techniques are often not specific to the condition or lack the timeliness, objectivity and accuracy needed for ED use. Since the risk of death from sepsis increases by up to 8% for each hour that it goes untreated, a tool that enables providers to quickly and confidently recognize this medical emergency is urgently needed.

"Sepsis is one of the most deadly, complex and costly conditions faced by hospitals. Until now, healthcare providers have lacked a fast and reliable test to inform treatment paths," said Zack Scott, M.D., general partner at Norwest Venture Partners. "Offering the first early-detection test on the market, Cytovale has the incredible potential to dramatically improve how our healthcare system gets the right care to the right patients at the right time. We look forward to working with Cytovale as IntelliSep revolutionizes care pathways for so many patients, improving their outcomes while also helping hospitals optimize utilization and operational excellence."

IntelliSep – Fast, Actionable Diagnosis of Sepsis
IntelliSep is a transformative tool for hospital ED personnel who may suspect infection in patients. The first-of-its-kind host immune response diagnostic generates results in under 10 minutes using standard blood draws and can be seamlessly and efficiently integrated into existing care workflows.

IntelliSep takes a unique approach, assessing the body's immune response to an infection by interrogating immune cell morphology and mechanics. In simple terms, IntelliSep squeezes white blood cells and characterizes their responses – which differ between septic and non-septic patients – using cutting-edge machine learning technology.

Cytovale's rapid laboratory test provides valuable insights into potential sepsis diagnosis. The test provides a score, which categorizes a patient's probability of having or developing sepsis within the next three days. Using that score, healthcare providers can quickly determine next steps for treatment with a higher level of confidence, potentially reducing the likelihood of poor outcomes from sepsis, including death.

Cytovale is working with select early access hospitals and health systems to implement the IntelliSep test as part of triage processes for adults presenting to the ED with signs and symptoms of infection. Our Lady of the Lake Regional Medical Center was the first to implement IntelliSep, which has since enabled essential ED personnel to focus efforts on critically ill patients. In fact, IntelliSep reduced the number of all-hands-on-deck alerts in the ED by 80% relative to previous sepsis detection methods.

"The ability to detect the probability of sepsis early in patients who present to our emergency department allows us to focus our efforts and attention on our most critical patients and get them the support and interventions they need, saving precious time," said Chris Thomas, MD, vice president and chief quality officer of Franciscan Missionaries of Our Lady Health System. "Not only are we saving lives, we are better able to channel our valuable emergency department resources in a meaningful way."

TD Cowen served as financial advisor to Cytovale for this fundraising.

About Cytovale^®
Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Comprised of an extraordinary team of life scientists, engineers, clinicians and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies. Learn more about Cytovale and request to implement IntelliSep^® in your hospital or care setting through cytovale.com. For updates, follow Cytovale on LinkedIn and X.

About Norwest Venture Partners
Norwest is a leading venture and growth equity investment firm managing more than $12.5 billion in capital. Since its inception, Norwest has invested in more than 650 companies and currently partners with more than 200 companies in its venture and growth equity portfolio. The firm invests in early- to late-stage businesses across a wide range of sectors with a focus on consumer, enterprise and healthcare. The Norwest team offers a deep network of connections, operating experience, and a wide range of impactful services to help CEOs and founders scale their businesses. Norwest has offices in Menlo Park and San Francisco, with subsidiaries in India and Israel. For more information, please visit www.nvp.com.

SOURCE Cytovale