Exero Medical Completes Enrollment of 222-Patient U.S. Pivotal Study for Early Detection of Post-Operative Gastrointestinal Surgery Complications

Enrollment milestone advances Exero Medical toward FDA clearance of its breakthrough xBar system for early anastomotic leak detection.

JERSEY CITY, N.J. and OR YEHUDA, Israel, Sept. 16, 2025 /PRNewswire/ -- Exero Medical, a medical technology company developing advanced monitoring solutions for early detection of major post-operative complications, announced the completion of patient enrollment in its pivotal U.S. clinical trial. The study, designed to validate the safety and effectiveness of the xBar system for early detection of anastomotic leaks following colorectal surgery, enrolled 222 patients across 12 top medical centers in the U.S. and Israel.

"This milestone brings us closer to providing surgeons and patients with a reliable monitoring tool that can save lives," comments Dr. Erez Shor, CEO of Exero Medical. "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

The xBar system is the first and only technology to provide real-time monitoring of the gastrointestinal system 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 detect early signs of tissue damage, 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" adds Dr. Mehraneh Dorna Jafari, Associate Professor of Surgery at Weill Cornell Medicine. "The xBar system's potential for early detection could enable timely, planned reoperation only if a leak is present, rather than reactive interventions after a patient's condition has deteriorated." 

About Exero Medical

Exero Medical's mission is to empower healthcare providers with high-quality, actionable post-operative tissue healing data that can save lives, improve prognosis, and reduce cost of care. The company's flagship product, the xBar system, has been granted Breakthrough Device Designation by the FDA. Exero Medical was founded in 2018 at the MEDX Xelerator venture studio 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 not yet approved for sale in the United States and is currently limited to investigational use.

For more information, visit https://exeromedical.com.

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SOURCE Exero Medical