UC San Diego-Incubated Startup Awarded Up to $3.9M to Advance Personalized Care for Critically Ill

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• Mika Ono - [email protected]

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A startup incubated in the University of California San Diego Qualcomm Institute (QI) will track the immune responses of more than 200 sepsis patients in real time in the largest trial yet for the company's wearable sensor. The work is part of a federal initiative to personalize treatment for critical illness.

The startup, InflammaSense, will use its VITAL^x-patch, a noninvasive device smaller than a business card, to read immune activity from magnetic and electrical signals in nerves in the neck, then feed the information into its algorithm to sort patients by immune trajectory.

"This is an unprecedented testbed for our device," said Imanuel Lerman, MD, CEO and co-founder of InflammaSense and head of the Lerman Lab of UC San Diego's Qualcomm Institute and School of Medicine. "Since the project includes an adaptive clinical trial and many collaborating groups, the results will be especially helpful in determining whether we can improve patient outcomes."

The subaward to InflammaSense, worth up to $3.9 million, is part of a contract of up to $38 million over as many as five years from the Advanced Research Projects Agency for Health (ARPA-H) to the University of Vermont (UVM). The UVM-led project, ReSCUED (Reprogramming Severe Critical Illness Using Extensible Digital Twins), is part of ARPA-H's Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) program.

Addressing a lethal problem

The ReSCUED project seeks to address one of medicine's most persistent challenges: the disordered immune response associated with critical conditions such as severe trauma, burns and sepsis.

A central focus of the ReSCUED research, and of InflammaSense's role in it, is sepsis, a life-threatening condition that occurs when the body's response to an infection triggers widespread inflammation. That inflammation can damage healthy tissues and rapidly lead to organ failure. Sepsis requires urgent hospital treatment, which may include intravenous fluids, medications to support blood pressure, antibiotics, ventilation or dialysis.

Each year, about 1.7 million adults in the U.S. develop sepsis, and at least 350,000 die during hospitalization or are discharged to hospice, according to the Centers for Disease Control and Prevention.

"Sepsis is a huge health care problem, and one that will only get bigger as the population gets older and we get better at keeping people alive," said Gary An, MD, a University of Vermont trauma surgeon, researcher at UVM's Larner College of Medicine and ReSCUED principal investigator. "In the past, before ICUs [intensive care units], people simply died. Today, with advances in organ support technologies, we can keep people alive longer in the ICU, but often their bodies can't get out of the immune dysfunction hole, and we don't know how to help them out of it. The multidimensional dynamics of immune dysfunction is too complex for a person, even an expert, to comprehend. But we can train a computational model to do that."

Under the ReSCUED approach, researchers will measure a critically ill patient's immune and inflammatory state through frequent blood samples and physiological monitoring - including through InflammaSense's device, developed with UC San Diego-licensed technology.

The team will then create a digital twin that models the patient's condition and simulate how the patient might respond to different FDA-approved medications. The goal is to provide clinicians with an individualized tool that can help them understand how a patient's illness is evolving and use that information to guide care.

Core technology from UC San Diego

Lerman, who is a clinical professor of anesthesiology at UC San Diego School of Medicine, co-founded InflammaSense to address a problem he encountered while studying the vagus nerve, which helps regulate inflammation: Patients receiving the same treatment can respond very differently. His research suggested that differences in people's immune and nervous-system activity might help explain why a treatment benefits one patient but not another.

That insight led Lerman and his collaborators to pursue a new approach to precision medicine. Rather than rely on intermittent blood tests or give every patient the same treatment, they envisioned continuously monitoring signals from the vagus nerve to determine how an individual's immune response is changing - and which treatment might help at a particular moment.

"Why are we treating everybody with the same Phillips screwdriver when they may need a flathead?" Lerman said. "It's the wrong tool for the wrong patient, and it has to be given at the right time."

Beginning in 2019, support from the Biomedical Advanced Research and Development Authority (BARDA) enabled Lerman and colleagues to test whether nerve activity recorded from the neck could reveal the body's response to inflammation. In a controlled study of healthy volunteers, they found that changes in nerve activity tracked changes in inflammatory proteins in the blood. The findings, published in Communications Biology in 2024, showed that the signals could be detected noninvasively and might provide an early indication of infection or harmful inflammation.

At InflammaSense's headquarters in the UC San Diego Qualcomm Institute Innovation Space, where employees take advantage of the institute's specialized facilities, such as the Nano3 cleanroom, the magnetically shielded magnetoencephalography room, the startup has since worked to turn that discovery into a practical hospital device, shrinking the technology from laboratory equipment to a wearable sensor the size of a credit card.

According to Lerman, approximately $4.5 million in previous support from BARDA, the Defense Advanced Research Projects Agency and the National Institutes of Health, together with a recent $1.4 million seed investment, has brought the company's technology to the stage where a large clinical trial is the logical next step.

"The CIRCLE initiative is focused on what we've always been working on at InflammaSense," Lerman said. "Longer-term, we hope to move beyond sepsis because this technology has the potential to address many other conditions in and out of the hospital."

This research was, in part, funded by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the United States Government.

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