By Yakir Benzion, United With Israel -
The U.S. Food and Drug Administration has awarded an Israeli company the elite status of “FDA Breakthrough Designation” for developing a new system for the early detection of ‘anastomotic leaks’ – the most life-threatening complication from gastrointestinal surgery, Exero Medical reported Tuesday.
The National Institutes of Health says “Anastomotic leaks are among the most dreaded complications after colorectal surgery,” which tens of thousands of Americans undergo each year. When the intestines are sewn back together, the closure must be 100 percent, as any leakage can lead to fatal infections.
Founded in 2018, Exero Medical created a patent-pending implantable biodegradable wireless sensor designed to continuously monitor the GI tract near the surgical site, alerting physicians to potential anastomotic leakage after an operation. The system prevents complications by warning physicians of a potential leak, enabling early intervention.
The company discovered an added benefit because their device can also identify proper tissue healing that enables a healthy patient to be discharged earlier.
“In the realm of early detection of anastomotic leaks, there is currently no [other] technology that offers clinicians insights on the state of a patient’s internal tissue healing following resection surgery in the GI [tract],” said Exero Medical CEO, Erez Shor. “The time needed today to obtain definitive diagnosis of a leak often puts the patient in a critical state of health.”
“Alternatively, some surgeons order invasive interventions as a precautionary step, putting patients through often-unnecessary additional procedures,” Shor added. “Our system is designed to provide clinicians the needed data on tissue healing well before a patient reaches a catastrophic situation, enabling more precise and effective intervention, minimizing complications and potentially saving lives.”
Exero Medical demonstrated to the FDA that its smart sensor for the early detection of the potentially lethal leakage following GI surgery not only works, but also “represents a breakthrough that may demonstrate substantial improvement over any available solution.”
The FDA scrutinized the company’s pre-clinical data from its animal studies as well as clinical data collected in the first in-human feasibility trial conducted at Rabin Medical Center in Tel Aviv.
“We are thrilled to work with the FDA to optimize our regulatory process. I expect the rapid interaction with FDA will reduce our time to market,” said Shor.
