Boomerang enrols first patient in IBD trial of nerve stimulation device

18 Apr 2023
www.nsmedicaldevices.com
Clinical StudyBreakthrough Therapy
The first patient was enrolled at Wichita, Kansas-based Kansas Gastroenterology, followed by Columbia University Irving Medical Centre in New York The study will primarily assess the safety and efficacy of the (CUIMC) in patients with Crohn’s disease and ulcerative colitis. (Credit: valelopardo from Pixabay) Bioelectronic medicine company Boomerang Medical has started enrolment of the first patients in a US clinical trial of its nerve stimulation device to treat two forms of inflammatory bowel disease (IBD). The study will evaluate the firm’s bioelectronic device as a potential treatment for Crohn’s disease and ulcerative colitis. The first patient was enrolled at Wichita, Kansas-based Kansas Gastroenterology, followed by Columbia University Irving Medical Centre (CUIMC) in New York. Earlier this year, the US-based Boomerang Medical secured breakthrough device designation from the US Food and Drug Administration (FDA) for its bioelectronic technology. The nerve stimulation device is said to apply mild electrical impulses to peripheral nerves to reduce the inflammation resulting from autoimmune disease. Kansas Gastroenterology Boomerang trial principal investigator Michael Lievens said: “Crohn’s disease and ulcerative colitis remain very difficult to manage despite the numerous approved biologic therapies available. “The Boomerang clinical trial aims to investigate a novel alternative intervention – a device to treat IBD. We are excited to be investigating this promising new treatment.” Boomerang Medical said that the study will primarily focus on the assessment of the safety and efficacy of the nerve stimulation device in patients with mild to moderately severe Crohn’s disease and ulcerative colitis, irrespective of whether they have undergone advanced therapy like biologics. Boomerang Medical CEO Heather Simonsen said: “We are thrilled to enrol the first patients in this clinical trial of our breakthrough bioelectronic device for IBD. “This trial represents a major milestone in our efforts to develop a new therapeutic approach for patients suffering from Crohn’s disease and ulcerative colitis. “We are grateful for the support of our clinical trial partners and the FDA, and we look forward to advancing this important work.”
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