Vail Scientific has redesigned its VSNO sepsis screening device with the help of contract development and manufacturing organization
Minnetronix Medical
.
VSNO is a noninvasive, handheld breath test that measures exhaled nitric oxide (NO) for faster, earlier diagnosis of sepsis. Sepsis is a top cause of mortality globally and the leading cause of death inside hospitals, but Bloomington, Minnesota-based Vail Scientific said up to 80% of sepsis deaths could be prevented with faster diagnosis and treatment.
The CDC estimates at least 1.7 million adults in America develop sepsis each year from infections such as flu, RSV and Covid-19, leading to at least 350,000 annual deaths. Almost half of the nearly 50 million global sepsis patients each year are children, according to the World Health Organization.
“With sepsis, speed and accuracy can help save lives,” Vail Scientific Chair, CEO and co-founder Tom Burke said in a statement shared ahead of the official announcement.
“The Minnetronix team helped make our technology viable in a device designed for use at the triage stage of a patient workflow,” he continued. “They understood the science and brought their integrated electronics, hardware, and software expertise to the challenge of making VSNO into a better way to address the global issue of sepsis.”
Minnetronix Medical Engineering Director Kera West said the team used design-for-manufacturing principles for efficient production and scaling to meet anticipated demand for the devices.
“Sepsis hasn’t seen innovation in more than a decade,” she said. “This is such purpose-driven work, and we can’t wait for the new standard-setting sepsis testing process to be in the market.”
The VSNO system is now 75% smaller for improved portability and can be mounted on an IV pole. It also has what Vail Scientific describes as an easy-to-use handle to collect the patient’s breath for analysis.
The VSNO device’s portability and ease of use will allow for sepsis tests during triage in an emergency room, urgent care or even an ambulance within two minutes. A standard sepsis test requires a blood draw, and results can take up to eight hours from the time when a patient arrives at a hospital.
Vail Scientific said it has
completed two clinical trials
with the University of Minnesota and HealthPartners (through the emergency departments at the healthcare provider’s Regions and Methodist hospitals).
St. Paul, Minnesota-based Minnetronix has manufactured enough devices for a verification study planned for this year, followed by a final definitive clinical trial and an application for FDA 510(k) clearance.
Vail Scientific also announced a $2 million investment this week from Sioux Falls, South Dakota-based investment firm Exit 156.
Vail Scientific’s “innovative and groundbreaking approach to rapid sepsis screening is set to be the new standard of care, and we’re confident this investment will significantly enhance patient care,” Exit 156 Managing Partner Josh Robinson said in a news release.
