Study Demonstrates Early Detection of Anastomotic Leaks in a Mult-Center Study
Source:
Press Release
Date:
March 30, 2023
Original Article:
Study Results to be presented at SAGES’ Next Big Thing Technology Session suggest a major breakthrough in addressing the most dreadful complication of gastro-intestinal surgeries
Or Yehuda, Israel, March 30, 2023 — Initial data from 50 patients participating in a multi-center, clinical study demonstrates that Exero Medical’s xBar has the ability to reliably detect anastomotic leaks following gastrointestinal surgery at least three days earlier than the current standard of care – a potentially life-saving early alert.
xBar clinical study operation. Photo credit: Exero Medical
“This is the first collection ever of post-operative tissue healing data sourced internally directly from the surgical location. These results are likely to reshape patient management as the system seamlessly integrated into our surgical workflow and detected leaks that the standard of care missed,” said Professor Nir Wasserberg MD, Chair of Surgery Department at Rabin Medical Center and Chair of the Israel Colorectal Society.
All of this is important as the earlier the detection, the greater the chances of circumventing hospitalization in the ICU, revision surgeries and more than ten days of added hospitalization time on average.
Participating trial sites include: Sheba Medical Center, Rabin Medical Center, Kaplan Medical Center, Soroka Medical Center, Shamir Medical Center and Ichilov Sorasky Tel Aviv Medical Center.
Initial study results will be presented for the first time by Exero Medical CMO Dr. Matan Ben David at SAGES’ Next Big Thing Technology Session in Montreal, Canada on March 31, 2023. Based on the excellent results Exero plans to commence a pivotal multi-center study in leading medical institutions in the US to obtain marketing clearance for its xBar flagship device from the FDA.
About xBar
xBar is a breakthrough technology designed to monitor surgical site healing following an operation to optimize treatment and minimize the impact of complications. The sensor is embedded in a standard surgical drain, enabling post-op monitoring without changing the surgical or patient workflows.
About Exero Medical
Exero was founded in 2018 by MEDX Xelerator, an Israeli Innovation Authority incubator, and Clalit HMO, the largest HMO in Israel. Exero Medical’s goal is to provide high quality, actionable post-surgery tissue healing that can save lives, improve prognosis and reduce cost. The company’s flagship product, xBar, which has an FDA Breakthrough Designation, is intended for the early detection of anastomotic leaks following gastrointestinal (GI) surgeries, a $2 billion market. It is currently being tested in a multi-center clinical trial.
Exero Medical is backed by seed investment from the MEDX Xelerator, Boston Scientific, MEDX Ventures, Intellectual Ventures, and CBG Group. The company is presently engaged in a series A financing round.
For more information, please visit https://www.exeromedical.com/
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