There has been a robust start of Exero Medical’s new, international, pivotal, multi-center study of its xBar system.
| OR YEHUDA, Israel, May 29, 2024 /PRNewswire/ -- There has been a robust start of Exero Medical’s new, international, pivotal, multi-center study of its xBar system.
xBar is an FDA breakthrough designated medical device, implementing a novel post-surgical tissue monitoring technology. It is designed to provide timely and accurate data on patients’ postoperative healing, to personalize care and expedite the detection of potential life-threatening complications following GI surgery. The study, initiated 8 weeks ago in Israel and the US, has already enrolled and has used the device to monitor more than 20 patients recovering from colorectal surgery. Ten clinical sites, in the US and Israel, will collectively enroll approximately 190 eligible subjects undergoing colorectal surgery with anastomosis. Thus far, Kaplan Medical Center, Rabin Medical Center and Soroka Medical Center in Israel and Weill Cornell/ New York-Presbyterian Hospital in the US have collectively enrolled 23 patients. “Anastomotic leaks are probably the most fretted complication that patients and their clinical team may encounter. Delays in diagnosis can lead to mortality, worsening oncological and functional outcomes and long prolonged hospitalization. Previous studies have shown the great promise this technology holds in providing advanced notice of pending complications and supporting clinical decision making, and we are looking forward to the results of the study and a potentially new gold standard in post-surgical diagnostics,” said Mehraneh Dorna Jafari, MD, Associate Professor of Surgery at Weill Cornell Medical College, Chief of Colorectal Surgery at New York-Presbyterian Brooklyn Methodist Hospital and Exero Principal Investigator. xBar collects and analyzes data from the surgical site using a sensor seamlessly embedded in a standard surgical drain. The system’s analysis software is designed to alert surgeons if the gastrointestinal tissue is not healing properly and a risk of anastomotic leak is likely to occur. Data from an interim clinical study with 50 patients showed that xBar was able to detect pending leaks, typically two-three days faster than the current standards of care. Exero Medical CEO Dr. Erez Shor said, “xBar is based on solid physiological working concepts and our excitement continues to grow as we collect data from this study, revealing the real-life performance of the system. We hope for a rapid and successful completion of the trial towards implementation of this breakthrough technology, to save lives, improve care and reduce cost.” About Exero Medical Exero Medical’s goal is to provide high-quality, actionable post-surgery tissue healing monitoring that can save lives, improve prognosis, and reduce costs. The company’s flagship product, xBar, addressing a $7B market, received FDA Breakthrough Designation and is in clinical studies towards a commercial launch in 2025. The company, founded in 2018 by MEDX Xelerator, is also backed by the Israeli Innovation Authority, Clalit Health Services, the largest HMO in Israel and Unorthodox Ventures. xBar is not approved for sale in the United States and is limited to investigational use. For more information, please visit https://www.exeromedical.com/ Follow Exero Medical on LinkedIn Press Contact: Photo: https://mma.prnewswire.com/media/2424734/Exero_s_xBar_device.jpg
SOURCE Exero Medical |
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