Enrollment Complete in Anastomotic Leak Early Detection Trial

More than 200 patients have been enrolled and completed a 30-day follow-up period in Exero Medical’s pivotal U.S. study of the xBar system, designed for early detection of anastomotic leaks after colorectal surgery. The trial enrolled 222 patients at 12 U.S. and Israeli medical centers.

“This milestone brings us closer to providing surgeons and patients with a reliable monitoring tool that can save lives,” Exero Medical CEO Dr. Erez Shor stated. “We extend our deepest gratitude to the patients, investigators, and clinical teams whose dedication and commitment have made this study a success.”

The xBar system is touted as the first and only technology to provide real-time gastrointestinal system monitoring after surgery, enabling timely, personalized care to support faster recovery. By collecting electrophysiological data directly from the surgical site, the system provides clinicians with clear insights into tissue healing. Exero’s proprietary AI algorithm analyzes this data to monitor recovery and detects early signs of colorectal anastomotic leaks, allowing for earlier intervention when necessary and improved patient outcomes.

“Anastomotic leaks are among the most severe post-operative complications, often leading to extended hospital stays, additional surgeries, and higher mortality rates. Early detection is critical to improving patient safety and reducing healthcare costs” said Dr. Mehraneh Dorna Jafari, associate professor of Surgery at Weill Cornell Medicine. “The xBar system’s potential for early detection of colorectal anastomotic leaks could enable timely, planned reoperation only if a leak is present, rather than reactive interventions after a patient’s condition has deteriorated.”

Exero Medical empowers healthcare providers with high-quality, actionable post-operative tissue healing data that can save lives, improve prognosis, and reduce healthcare costs. The company’s flagship product, the xBar system, has been granted U.S. Food and Drug Administration Breakthrough Device Designation. Exero Medical was founded in 2018 by MEDX Xelerator, a medtech incubator, and is backed by the Israeli Innovation Authority, Tech Council Ventures, Longevity Venture Partners, Edge Medical Ventures, Consensus Business Group (CBG), Unorthodox Ventures, and Clalit Health Services – Israel’s largest HMO.

The xBar system is limited to investigational use only and is not for sale in the United States.