Clinical Sensors, a development-stage biotechnology company based in Research Triangle Park, is developing sensors that can detect and diagnose life-threatening infections and conditions at an early stage.

The company seeks to use its patent-pending point-of-care monitoring technology to safely and effectively monitor the levels of nitric oxide in the bloodstream, which is a involved in the progression of sepsis, an imbalance of chemicals in the body which can become life threatening if not properly diagnosed.

Clinical Sensors hopes that with the adoption of its technology by medical practices around the country, one simple blood test will be able ensure a patient’s safety and shorter hospital visits, by providing practitioners rapid recognition information they need, in a matter of seconds.

An all-to-common occurrence

Sepsis is a largely unknown word for most people, yet each year there are over 1 million reported cases in the U.S. alone.

Of these cases 25 percent end in death, with the majority of cases coming from individuals recovering from medical procedures in hospitals.

A complication of the body’s natural response to an infection, Sepsis causes chemicals released by the body into the bloodstream to become toxic, attacking vital organs and causing failure.

Onset of the condition happens very rapidly, as every hour that sepsis diagnosis is delayed, a patient’s risk of death increases by over 7 percent.

Despite the best efforts of medical professionals, many patients suffer irreversible damage from a condition, treatable with common antibiotics and fluids.

Even at UNC Hospitals, the severity and prevalence of this condition has prompted the formation of Code Sepsis, an initiative to raise awareness and provide reliable screening methods for early detection in patients.

Mark Schoenfish, distinguished professor of chemistry at UNC-Chapel Hill, wants to demonstrate the clinical capacity for his company’s point-of-care technology as a reliable screening method for sepsis.

Schoenfish founded Clinical Sensors in 2009, having previously founded Novan Therapeutics, a clinical stage company specializing in therapeutic applications of nitric oxide’s naturally occurring anti-microbial and noninflammatory mechanisms.

Schoenfish hoped to leverage the research conducted at Novan to better understand the the molecule and its role in the progression of sepsis, with hopes to develop sensing technology that could detect raising nitric oxide levels in the blood for use in diagnosis.

Supporting the cause

Support for the company came from first from within the UNC system before it gained attention at the national level.

In April 2017, the company announced that it was awarded two small business research grants by the National Institutes of Health (NIH). Together the two grants provided over $1.5 million to further support the development of the technology.

Along with these grants, the company was also awarded $1.29 million Phase 2 STTR award to further clinical studies at the Jaycee Burn Center at UNC Hospitals.

Burn victims are especially vulnerable to sepsis due to skin loss, which is the bodies first line of defense against foreign infections, making them a good candidate for the company’s trials

“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, head of research and development at Clinical Sensors. “We are honored to have Dr. Bruce Cairns, professor of surgery and director of the Jaycee Burn Unit, as co-principal investigator on the grant to lead the clinical study.”

Inciting lasting change

Currently the company is still analyzing the effectiveness of its flagship technology.

Earlier this year, progress was made into the development of prototype analyzers, which could one day serve as a primary screening method for sepsis and other blood-borne illnesses.

For Schoenfish and the rest of the team at Clinical sensors, their core focus remains on the patient.

Hoping that with the implementation of their technology, they may rest assured that their medical providers will have access to the vital, life-saving information they need, at the touch of a button.