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Summary: PercuSense aims to improve outcomes and reduce the cost of sepsis. Sepsis is a life-threatening condition that occurs when the body’s response to an infection injures its own tissues and organs. Every year, this medical emergency is the primary diagnosis in more than 1.2 million hospitalizations in the US. Despite the use of the latest treatments, sepsis mortality persists. Recent studies show sepsis mortality of 20-30% independent of treatment protocols. As sepsis progresses, the associated mortality rate increases dramatically. Mortality in cases of septic shock is 36.4 percent, more than six times that of early sepsis. The key to improving outcomes is earlier identification and treatment to prevent sepsis progression. SIRSDx is a low-cost and easy to use minimally invasive sensor that continuously measures lactate, glucose, tissue oxygenation, tissue perfusion and temperature to assess sepsis risk for earlier and optimized treatment. The innovative sensor supports accurate, multi-parameter sensing on a single implanted probe. The device can be placed on at-risk patients not only in the hospital, but also in ambulatory care center or ambulances for early monitoring and diagnosis of sepsis risk. The continuous nature of the tool enables rapid feedback for therapy optimization in a disease where time is critical, thus improving sepsis mortality and saving lives.
Need: The economic burden of sepsis is significant. And those who survive sepsis may never completely recover, resulting in even greater indirect costs. However, there are effective treatments for sepsis, when it is detected. Rivers demonstrated that EGDT (a treatment approach using IV fluids and vasopressors) administered for six hours following diagnosis resulted in a significant reduction of in-hospital mortality. The Surviving Sepsis Campaign has created a recommended 3-Hour Resuscitation Bundle, which is effective when started immediately after onset. However, sepsis remains difficult to diagnose and is often caught late or misdiagnosed leading to unnecessary deaths, complications, and costs.
Value: SIRSDx continuously measures lactate, glucose, tissue oxygen, tissue perfusion and temperature. The measurements are converted into a pathophysiology-derived risk score to alert providers of SIRS and sepsis progression. The unique placement in the microcirculation provides tissue oxygen and perfusion values that provide a direct measurement of tissue perfusion, the primary endpoint in fluid resuscitation in the treatment of sepsis. PercuSense has the only sensor design that can support calibration-free, multi-analyte sensing on a single implanted probe. And importantly, due to the unique PercuSense design, manufacturing is low cost and low capital with a resulting sensor LBM under $4.