Exero Medical has reached a significant milestone in its clinical study of the xBar system, which is designed to detect serious complications such as anastomotic leaks following colorectal resection surgery.

The study, which is being conducted at eleven sites across the US and Israel, aims to validate the system's safety and accuracy. The results will support Exero's application for FDA De Novo approval.

The xBar system consists of electrode sensors that are embedded in a standard surgical drain and placed near the anastomosis site. These sensors are connected to a small electronic device outside the patient’s body that records and transmits data. This data is then analysed to assess the risk of anastomotic leaks, based on the condition of tissue healing or damage.

The study began in March 2024, with the one hundredth patient enrolled at Bryan Medical Center in Lincoln, Nebraska. The patient was enrolled by Dr. Brad Olberding, a General Surgeon.

The xBar sensor is inserted using the standard surgical drain procedure, without altering the typical surgical or post-operative process. If successful, the system could help detect complications earlier, allowing surgeons to intervene before a patient’s condition worsens. This early detection may also help reduce hospital stays.

The progress of the study brings Exero closer to making the xBar technology available to prevent life-threatening complications, benefiting both patients and healthcare providers.



Source: exeromedical.com

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