Startup company Exero Medical announced today that the FDA has granted breakthrough device designation for its wireless system designed for early detection of potentially lethal anastomotic leaks (AL) following gastrointestinal surgery.
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, according to Or Yehuda, Israel-based Exero.
“In the realm of early detection of AL, there is currently no technology that offers clinicians insights on the state of a patient’s internal tissue healing following resection surgery in the GI,” explained Exero Medical CEO Erez Shor in a news release. “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.
“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,” Shor said. “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.”
Exero Medical is a portfolio company of MEDX Xelerator, a medical device and digital health-focused incubator based in Israel, formed as a partnership between Boston Scientific, MEDX Ventures and Sheba Medical Center.
“Erez and his team have developed a life-saving technology using a multi-disciplinary approach to medical device development that will have a significant impact on the GI surgical market,” said MEDX Xelerator CEO Shai Policker. “Achieving the FDA’s breakthrough designation at this stage attests to the quality of their initial R&D and the urgent need for this technology to reach the hands of clinicians.”