Exero Medical, developer of a wireless sensor for the early detection of leaks following gastrointestinal surgery procedures, has completed the first human implantation of its sensor as part of a clinical trial.
The implant procedure was part an ongoing clinical trial conducted at the Rabin Medical Center led by Prof. Nir Wasserberg, director of the center’s colorectal surgery division and chairman of the Israel Society of Colon and Rectal Surgery.
The study team reported the successful placement of the sensor and data collection during low anterior resection surgery for rectal cancer, the company said in a statement on Monday.
Following gastrointestinal surgery, there is a 6-10 percent chance of a side effect called “anastomotic leak,” a leak that develops where two tracts of the intestine are reattached following a gastrointestinal resection, in which part of the bowel is removed.
These leaks carry a serious risk of death. Exero says it has created a monitoring implantable biodegradable wireless sensor to address this problem. The sensor is designed to continuously monitor the area and alert physicians to potential issues, enabling early intervention before complications can become life-threatening, the statement said.
“The initiation of clinical data collection is a critical step towards providing a reliable detection tool for surgeons, said Wasserberg in the statement. “The fear of anastomotic leak is the one that keeps gastrointestinal surgeons up at night and one that represents a true clinical need. Exero’s sensor is designed to provide surgeons with insight on patients’ healing processes so they can determine the best course of action and improve clinical outcomes.”
The first-time use of the device in an operating room is “a significant milestone for Exero Medical,” said Erez Shor, the CEO of the startup. “We look forward to developing a reliable anastomotic leak detection system, that will save lives, reduce suffering and address a challenge currently costing billions of dollars for payers and providers.”
There is a $2 billion market for Exero’s solution, the company said.
The surgeons involved in the trial said that they were able to implant the sensor as part of their ongoing operating procedures, with “minimal added time and negligible added risk to the patient,” the statement said.
Or Yehuda, Israel-based Exero Medical was founded in 2018 by the MEDX Xelerator, an Israeli Innovation Authority incubator, and Clalit HMO, the largest HMO in Israel.