The noninvasive technology detects a biological signal that is highly correlated with the development of GII; primarily postoperative ileus, an acute paralysis of the gastrointestinal tract causing nausea and vomiting as well as abdominal distention and pain. PrevisEA, Entac’s lead device to predict GII, has demonstrated high accuracy in the risk stratification of patients with 95 percent specificity and 83 percent sensitivity in the clinical setting.
With onset occurring two to six days after surgery, GII is a common condition of many types of surgery, especially in colorectal surgery where approximately 25 percent of 2 million patients are affected annually in the United States. The inability to predict patients at risk for GII often unnecessarily increases length of hospital stay by four to six days and causes readmission rates in excess of 20 percent, making it one of the most prevalent conditions for readmissions of surgical patients. The financial impact of over-utilization of hospital resources is estimated to be $10-$15 billion per year in the United States.
“We continue to strengthen our intellectual property in the U.S. and all major global jurisdictions," said Buddy Lyons, CEO of Entac. iven that there are no devices or tests available that would enable development of a standard of care for this large, underserved patient population, Entac is moving expeditiously to complete development of PrevisEA. Based on discussions with the FDA, we believe PrevisEA could be cleared for marketing in 18-24 months.”
Entac is planning additional applications of the platform technology in gastrointestinal predictive medicine and diagnostics.
Entac Medical is a predictive analytics company developing noninvasive devices for the prediction and diagnosis of gastrointestinal and other medical conditions. The company is based in Germantown, Tenn.