Israeli medical device earns ‘Breakthrough Designation’ status from FDA

Israeli medical device earns ‘Breakthrough Designation’ status from FDA
The FDA Breakthrough Designation status stands reserved for medical devices who have the potential to provide more effective treatment or diagnosis of potentially life-threating conditions or disease.

By JERUSALEM POST STAFF Published: DECEMBER 18, 2020 04:21
Updated: DECEMBER 18, 2020

Israeli developer Exero Medical – whose focus centers around designing wireless systems for early detection of anastomotic leaks (AL) following gastrointestinal (GI) surgery – was granted FDA Breakthrough Designation for its AL-preventative innovation.
The FDA Breakthrough Designation status stands reserved for medical devices who have the potential to provide more effective treatment or diagnosis of potentially life-threating conditions or diseases.

“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,” said CEO of Exero Medical Erez Shor, PhD. “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.”

While Exero’s smart sensing innovation could assist the early detection of potentially lethal AL after GI surgery, the FDA criticized Exero’s pre-clinical trial data from animal studies and the clinical data collected from the human trial at Rabin Medical Center.
“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.

“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,” added CEO of MEDX Xelerator 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.”