Neurostimulator Implant Uses Bioelectronic Technology to Treat Inflammatory Bowel Disease
Posted on 28 Dec 2023
Inflammatory Bowel Disease (IBD) is a chronic, idiopathic inflammatory condition characterized by inflammation in the gastrointestinal tract, primarily manifesting as Crohn's disease and ulcerative colitis. Despite a range of biologic treatments available, effectively managing IBD remains a significant hurdle. Many patients experience non-responsiveness or diminished efficacy over time with existing therapies, leading to continued suffering and, frequently, the need for surgical intervention in severe cases. Consequently, the medical community is seeking new and more effective treatments for IBD. Now, a clinical trial is assessing the potential of sacral nerve stimulation (SNS) in treating Crohn’s disease and ulcerative colitis using a small implantable device that emits mild electrical impulses to stimulate a specific nerve pathway to reduce inflammation and improve IBD symptoms.
Boomerang Medical (Mountain View, CA, USA) is investigating the potential of SNS to activate nerve pathways to reduce inflammation and symptoms associated with Crohn’s disease and ulcerative colitis. SNS involves a small medical device implanted near the tailbone that delivers gentle electrical pulses to the sacral nerve. This method has been FDA-approved and utilized for over two decades to treat conditions like overactive bladder and fecal incontinence. Granted breakthrough device designation by the FDA in March 2023, Boomerang’s neurostimulator is designed for subcutaneous implantation via a minimally invasive procedure.
The ongoing trial aims to evaluate the safety and efficacy of this device in individuals with mild to moderate Crohn’s disease and ulcerative colitis, including those who haven't previously undergone advanced biologic therapies. This unique aspect of the study, BOOM-IBD, allows for a broader patient inclusion compared to typical IBD trials. This single-group, open-label study plans to enroll 40 adult participants diagnosed with either Crohn’s disease or ulcerative colitis and is actively recruiting at eight clinical sites across the United States. Boomerang has successfully advanced to the second stage of pilot study enrollment, examining the efficacy of its bioelectronic technology in IBD treatment.
“We are thrilled to enroll the first patients in this clinical trial of our breakthrough bioelectronic device for IBD,” said Heather Simonsen, CEO of Boomerang Medical. “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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