Anastomotic (AI) leak is a common, life threatening complication of gastrointestinal (GI) surgeries such as colorectal and bariatric. Early detection before clinical manifestation of AI leak is key to a favorable outcome, but diagnosis at this stage is difficult. Now, a tissue monitoring and diagnostic system is being studied for the early detection of AI leaks following low anterior resection GI surgery.

Exero Medical’s (Or Yehuda, Israel) xBar tissue monitoring and diagnostic system is a sensor designed to track tissue healing internally from the surgical site following an operation. The biodegradable wireless sensor aims to prevent complications by warning physicians of a potential leak, enabling early intervention. Exero’s system intended benefits are better patient recovery, prevention of serious complications in case of a postoperative leak, generation of new real time data on patient recovery, cost reduction and shorter hospitalization.

Exero has enrolled the first patient in its multi-center safety and feasibility study of xBar. The data collected will be used to refine the system's machine-learning algorithms and evaluate the system against the institutional standard of leak diagnosis. Exero’s system targets an addressable market of millions of procedures annually with over USD 2 billion of potential revenues.

"An anastomotic leak is the most fretted complication of colorectal surgery. Of the more than five million patients undergoing GI surgery every year, as many as 10% percent could develop this devastating complication," said Professor Nir Wasserberg, M.D., Chair of the Israel Colorectal Society and Director, Division of Colorectal Surgery, Department of Surgery, Beilinson Campus, Rabin Medical Center. "Of those, up to 40%, will need multiple revision surgeries, longer hospitalization stays in terms of weeks and, frankly some won't make it. Mortality depends on how early a leak is detected and how quickly intervention begins. The diagnostic monitoring system developed by Exero Medical is intended to provide timely intervention that could save lives and improve the prognosis of hundreds of thousands of patients as well as save the healthcare system billions of dollars every year."

"The severe complications associated with AI leaks cost the healthcare system in excess of USD 7 billion annually," said Exero Medical CEO Dr. Erez Shor. "It's important to understand that these complications can be avoided by detecting such leaks early. Exero Medical's breakthrough technology is designed to directly monitor the healing of the surgical site so that post-op complications can be circumvented." 

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