BOSTON - BioDirection, Inc., a privately held medical device company developing rapid, whole blood based point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced that the company has obtained an exclusive worldwide license for the use of the Tbit™ System to diagnose and monitor sepsis.
The Centers for Disease Control and Prevention (CDC) states, "Sepsis is a complication caused by the body's overwhelming and life-threatening response to infection. It can lead to tissue damage, organ failure and death. Sepsis is a medical emergency. Time matters. When sepsis is quickly recognized and treated, lives are saved." Additionally, it is reported that sepsis is the most expensive condition treated in U.S. hospitals, costing nearly $27 billion in 2018.
"Our Tbit System is ultrasensitive and provides actionable results within minutes," said Brian McGlynn, founder and chief technology officer of BioDirection. "Healthcare professionals need to identify a sepsis infection quickly and cannot wait days or even hours to begin effective medical treatment. Whether the patient presents with symptoms in the emergency room or acquires the infection during a hospital stay, our flexible platform is uniquely positioned to provide actionable information to support patient management and help improve chances of survival."
The company's Tbit System is based on proprietary nanowire technology and a biosensor that is capable of rapidly detecting and accurately measuring the presence and concentration of specific biomarker molecules from any bodily fluid, including inflammatory biomarkers associated with sepsis. The Tbit System is a portable platform designed to provide answers within minutes, which is critically important at the first sign of sepsis.
"The Tbit System is a truly disruptive technology with a broad range of potential applications," said James Wylie, executive chairman of BioDirection. "BioDirection is currently focused on commercializing the Tbit System for the diagnosis of concussion and other pathologies resulting from acquired brain injury. As a result, we are currently seeking a partner to support the co-development of a Tbit diagnostic platform for sepsis and to accelerate commercialization of this exciting new worldwide license."
According to the World Health Organization (WHO), sepsis is estimated to affect more than 30 million people worldwide, potentially leading to 6 million deaths with the highest burden in low- and middle-income countries. Anyone affected by an infection can progress to sepsis conditions, but there are more vulnerable groups including seniors, pregnant women, cancer patients, neonates and hospitalized patients to name a few. It is estimated that mortality rates in the U.S. range from 15-30% if no organ failure has occurred at the time of diagnosis, and rise to 40-60% in severe cases with sepsis shock. According to the CDC, 1.5 million people in the U.S. develop sepsis leading to more than 250,000 deaths each year. Approximately one-third of hospital deaths each year are the result of sepsis. Rapid identification of the bloodborne bacterial infection is vitally important for treatment and patient survival.