Exero Medical has completed the enrolment phase for its US clinical trial designed to evaluate its xBar system in detecting anastomotic leaks after colorectal surgery.
The study, which enrolled the first participant in 2022, involved 222 participants across 12 medical centres in Israel and the US.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Exero Medical expects the study to support its efforts in securing the US Food and Drug Administration (FDA) clearance for the xBar system.
The system is designed for real-time monitoring of the gastrointestinal system post-surgery. The xBar application is currently restricted to investigational use in the US.
It collects electrophysiological data directly from the surgical site, enabling healthcare providers to monitor tissue healing and detect early signs of damage.
The company’s AI algorithm processes this data to facilitate timely intervention and improve patient care.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataExero Medical CEO Erez Shor said: “This milestone brings us closer to providing surgeons and patients with a reliable monitoring tool that can save lives.
“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 has received the FDA breakthrough device designation. Its sensor continuously monitors the anastomosis area to facilitate early detection of anastomotic leaks.
These leaks are a common, severe complication of gastrointestinal surgeries.
The system alerts physicians before clinical symptoms arise, to mitigate complications and support faster recovery, said Exero Medical.
Established in 2018 by MEDX Xelerator, Exero Medical is supported by investors, including the Israeli Innovation Authority and multiple venture partners.
Earlier this year, the company secured up to $12.7m in funding to complete its FDA trial and launch its xBar system in the US.
The financing round included $10m in upfront funding and additional milestone-based warrants, along with non-dilutive grants of $2.7m.
New investors Tech Council Ventures, Longevity Venture Partners and Edge Medical Ventures participated in the funding round, alongside existing investors.
