electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Reduce Ileus After Major Colorectal Surgery - Seite 2

The study established the safety, treatment compliance, and usability of self-administered nVNS in patients undergoing major colorectal surgery. Patients were able to self-administer nVNS consistently before and after surgery with infrequent, non-serious, and similar adverse events across both Active and Sham groups, indicating a satisfactory safety profile. While the study was not powered to demonstrate statistically significant improvement in any clinical measure, the group using nVNS showed a greater improvement in several clinically important endpoints, including time to first flatus, tolerance of solid diets and a composite measure of bowel function (GI-3) compared to the Sham group. Benefits were most prominent in subjects who had right-sided surgeries, which may be related to increased manipulation of the duodenum and small bowel in these surgeries. In this population (n=8) there was also a 25.6% decrease in the consumption of oral morphine equivalents in the three days post-surgery between the Active and Sham arms (96 mg vs. 129 mg).

Dr. Stephen Chapman, NIHR Doctoral Research Fellow at University of Leeds and lead investigator of the study, commented, “We are pleased that our study demonstrates the safety and practicality of nVNS for treating ileus. The potential for nVNS to decrease recovery time could represent an important new way to improve the outcomes for patients undergoing major colorectal surgery. Our results clearly support additional work to further understand the potential for nVNS in this indication.”

“We congratulate and thank Dr. Chapman, the clinical team and the patients and families that participated in this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “We are pleased that Dr. Chapman is continuing his research through the TRANSIT study (ISRCTN62033341), which plans to recruit 140 patients in England at St. James’s University Hospital and Bradford Royal Infirmary, to provide further data to understand the potential for nVNS to improve patients’ recovery.”

Dr. Lesley Booth, Director of Research and Patient & Public Integration at Bowel Research UK commented “Recovering after bowel surgery can be an ordeal for patients, so we are really pleased to have been able to fund work that could help them recover in comfort and get people back to what they love doing more quickly. We are really pleased to see this important work published and hope it leads to significant patient benefit in the future.”