Clinical Sensors Awarded Over $1.5M in NIH Grants to Advance Nitric Oxide Diagnostic for Sepsis
By Barry Teater, NCBiotech Writer
Clinical Sensors Inc., a small diagnostic device company in Research Triangle Park, has won two grants totaling more than $1.5 million from the National Institutes of Health (NIH) to support the development of its point-of-care device that measures a patient's blood nitric oxide level within a few seconds.
Early and rapid recognition of nitric oxide is critical to life-saving care for sepsis, a life-threatening illness commonly known as “blood poisoning,” caused by the body's overwhelming response to infection.
"These two awards will help us demonstrate the clinical impact of our technology, which is designed to directly measure nitric oxide and related metabolites from biological fluids," said Philippe Chemla, Ph.D., CEO of Clinical Sensors. "Our device requires a single blood sample at bedside to quickly deliver this information."
A $1.29 million Phase 2 Small Business Technology Transfer grant will extend this work, including a clinical study at the North Carolina Jaycee Burn Center’s intensive care unit (ICU) at UNC Health Care in Chapel Hill, the company said in a news release. Patients with severe burns often develop sepsis, leading to prolonged hospital stays, increased costs and a higher risk of death.
"This NIH-supported study will use our device to follow 120 patients during their ICU stays and demonstrate the dynamic nature of nitric oxide in these patients," said Jon McDunn, Ph.D., head of research and development at Clinical Sensors.
Dr. Bruce Cairns, professor of surgery and director of the Jaycee Burn Unit will be a co-principal investigator on the grant and will lead the clinical study, McDunn said.
Clinical Sensors also won a $215,000 Phase 1 Small Business Innovation Research grant to add the measurement of low molecular weight S-nitrosothiols to its sensor platform. S-nitrosothiols are important compounds that store nitric oxide in the body. Currently, there is no reliable method to measure these compounds to better assess their role in sepsis and other diseases, the company said.
Clinical Sensors has been awarded $3.8 million in NIH grants since 2014.
Its latest federal support follows a $250,000 Small Business Research Loan from the North Carolina Biotechnology Center in late 2016 that will also support development of the nitric oxide diagnostic device. NCBiotech also awarded the company $3,000 in 2014 to support a business intern.
Sepsis is a common occurrence in hospitals, with over 1.6 million patients diagnosed annually in the United States. For every hour that sepsis diagnosis is delayed, a patient's risk of death increases by over 7 percent.
Delayed treatment is believed to play a significant role in many of the 250,000-plus deaths that occur each year from sepsis, according to Clinical Sensors.