It began as a straightforward, everyday procedure. The patient, a 34-year-old man, entered the hospital for abdominal surgery to treat his persistent colitis, a disease typified by the inflammation of the inner colon. The treatment itself was unremarkable and the patient went home shortly to recover.
But it didn’t last. Before the week was out he had returned to the hospital, complaining of ongoing diarrhea and severe abdominal pain. Upon admittance, doctors soon discovered that his core temperature was dangerously low and noted that he was slipping in and out of consciousness. His stomach was badly distended and the patient was extremely gassy.
Over time, the symptoms abated and the patient was eventually released after another week in the hospital under doctor’s care. But, for the hospital, the case became just another example of a complication that is all too common after surgery, and one that costs the industry billions every year.
Like more than 500,000 patients in the U.S. each year, this man was suffering from postoperative ileus (POI), a serious and poorly understood surgical complication that often presents within 2-6 days and leads to nausea, vomiting, and abdominal pain. In more serious cases, pulmonary aspiration is possible, which can lead to pneumonia and even death. This type of gastrointestinal impairment affects as many as 30% of all colorectal surgery patients and it can unnecessarily increase hospital stays by 4-6 days, causing readmission rates in excess of 20%. It is one of the most prevalent reasons for surgical patient readmissions.
And it’s costing us. According to some estimates, the U.S. healthcare system is wasting $10-$15 billion per year on extra resources as a direct result of this type of gastrointestinal impairment.
The power of prediction
What doctors need is a tool that can predict which patients are at risk for developing postoperative ileus with a high degree of accuracy, so that they can take appropriate action to ensure that these patients are safe and comfortable after surgery. This would also allow them to identify patients who are at low risk of developing the condition so that they can be discharged from the hospital even earlier.
Trouble is, there is currently no device or test that medical professionals can use to access this type of information. It is truly a guessing game right now as to which patients are going to suffer from postoperative ileus and how bad their symptoms are going to be. As a result, high risk patients are often treated inappropriately, while low risk patients are treated unnecessarily, impeding recovery, extending lengths of stay, increasing readmission rates and significantly increasing the cost of care.
The market for such a device is significant — more than two million patients are at risk annually in the United States, and there are similar patient numbers in Europe. In fact, for colorectal surgery alone, the addressable market is estimated to be in excess of $1 billion.
The question is how. How to offer the kind of information the doctors need to predict and treat this complication. How to ensure consistent, reliable accuracy in diagnoses. And how to deliver the technology in an affordable, handheld format that can offer quick, actionable information in the hospital.
A sonic solution
Enter Entac Medical, a Tennessee-based company that is developing noninvasive devices for the prediction and diagnosis of postoperative ileus and other medical conditions, leveraging a novel platform technology that uses audio spectral analysis to do it.
What that means is that Entac is using sound waves to diagnose patients.
Its first device, PrevisEA, is affixed to the abdomen and uses a microphone to detect biological signals that are highly correlated with gastrointestinal impairment. This is a late stage, Class II, disposable device that has been clinically proven to predict postoperative ileus in surgical patients with up to 95% accuracy.
It works by collecting imperceptible bowel sounds directly from the patient, and then analyzing that audio via its onboard microprocessor. The device’s algorithm “listens” for a very specific spectral event, dubbed MH4, which is highly correlated with the risk of developing POI. This MH4 is counted for four-minute intervals each hour over the course of 12 consecutive hours. An LED displays the number of MH4 counts from the last interval and graphical information to any changes in GI function over time. Patients can be risk stratified within minutes after surgery as being at high or low risk for developing the complication following surgery.
This information improves treatment protocols and patient outcomes while reducing readmissions and saving hospitals millions of dollars in unnecessary treatment costs.
And gastrointestinal surgeries are only the beginning. POI also occurs in 10% of gynecological surgeries, 4% of cardiovascular surgeries, and 30% of urological surgeries. Entac also believes that its current algorithm can also be used to predict potential ileus in traumatic brain injury patients, as well as potentially catastrophic bowel failures in premature infants at risk for necrotizing enterocolitis, addressing the second-leading cause of death among this population.