Undergoing major gastrointestinal (GI) surgery can be challenging enough for a patient without the worry of a grave yet common aftereffect that requires urgent corrective surgery and a lengthy hospital stay – or worse.
Israeli startup Exero Medical has come up with a way of keeping tabs on the surgical site after such a procedure, looking for a localized rupture that has hitherto been extremely difficult to detect.
Every year, millions of people undergo surgery in the digestive tract – in most cases, for the removal of a part of the digestive system due to issues such as cancer or diverticulitis, Exero CEO and co-founder Erez Shor tells NoCamels.
And even if the surgery is uneventful and successful, he says, it is difficult to fully monitor the site of the operation for any post-surgical complications.
“No one knows what’s going on in the healing process of the patient,” Shor says.
Removal of part of the digestive tract involves severing the blood supply to that section, he explains. And when the tissue is reconnected afterwards, the blood supply is not immediately fully restored.
This, combined with expected inflammation at the site of the operation, can lead to the tissue in the area becoming brittle and then perforated – posing a serious threat to the health of the patient.
“The most prevalent problem in these surgeries is called anastomotic leak,” Shor explains (the actual process of rejoining the digestive tract after surgery is called anastomosis).
“It can be a very small hole causing this leak, and this hole is usually the result of tissue being perforated,” he says.
“All of a sudden, you have actual holes in the wall of the digestive tract and then you have a leak of fecal content into the abdominal cavity – and that’s when the catastrophe starts.”
Diagnosing this occurrence in the early stages is extremely difficult as it is hard to see when the tissue is affected, he says.
“People undergo the surgery and then need to stay in hospital for a few days just to verify that they’re okay,” he explains. “[But] if they’re not doing okay, in most cases they’re diagnosed when it’s already too late.”
He explains that around 10 percent of patients who undergo digestive tract surgery develop this life-threatening complication, and up to 40 percent of those who do develop it do not survive.
“This is a huge problem with substantial impact,” he says.
Exero’s solution is xBar – a small, biocompatible sensor embedded temporarily at the surgical site. This sensor monitors healing and records any changes that could signify looming serious complications.
“Unlike other potential solutions to this problem, we thought that if we were able to actually monitor processes, [we could] identify patients who are doing well versus patients who are not,” Shor explains.
The xBar sensor is inserted alongside the standard surgical drain used in such operations. It monitors what Shor calls three “crucial” physiological processes: local inflammation, blood supply and the overall functioning of the digestive tract after surgery. The recorded data is sent to the cloud, where it is analyzed by Exero’s AI-powered platform, which in turn alerts the physicians should an issue be detected.
With his background in neural interfaces, Shor says he realized it made sense to tap into what he calls the “control mechanism” of the digestive tract to monitor its functioning.
“[The sensor] interfaces with the neural control of the digestive tract,” Shor says. “And by reading the command signals of the organ, we’re able to infer whether the patient is doing well or not.”
Identifying potential complications at an early enough stage means that any necessary intervention is less dangerous to the patient and results in a shorter stay in the intensive care unit, Shor says.
Founded in 2018, the company is part of the Or Yehuda-based MEDX Xelerator, an incubator for medtech startups in Israel. And it was a conversation with MEDX CEO Shai Policker, an old university friend, that led Shor to the development of the sensor.
Policker had posed the problem of early diagnosis of anastomotic leaks following GI surgery, with what Shor says was “a hint for a solution based on monitoring physiological processes.”
Together with a surgeon at Rabin Medical Center in Petah Tikva, they hypothesized a solution that led to the creation of xBar, and Shor partially attributes their success to modern technology.
“We have had the advantage of the recent developments in tech… comparing the state of affairs today to the state of affairs 20 years ago, with the availability of data-processing tools, computational power and AI,” he says. “Today, it’s available and it’s relatively cheap.”
According to Shor, at least one other startup has developed a diagnostic device for GI surgery sites, but he says their method is less agile and more time consuming than the Exero sensor.
The sensor has already successfully completed trials in large and small animals as well as ex vivo (removed from the body) tests of human tissue and two rounds of clinical trials with patients.
Now, Exero is about to begin a pivotal third clinical trial in the US and Israel, and its successful completion is the key to receiving US Food and Drug Administration approval to market the sensor in the United States.
At present, xBar has a breakthrough therapy designation from the FDA, which issued to therapies preliminary clinical evidence shows can treat serious or life-threatening conditions. The designation means that the device will be fast-tracked through the formal FDA approval process.
Once that milestone has been reached, the company intends to develop sensors that can monitor other potential dangers from gastrointestinal procedures.
“Monitoring for GI surgeries is a big deal,” Shor says. “The benefits we can provide, we’ll start with that.”
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