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The trial enrolled patients with Crohn’s disease and ulcerative colitis at multiple U.S. locations.
March 11, 2024
By: Michael Barbella
Managing Editor
Boomerang Medical Inc. has completed the second stage 2 its U.S. Food and Drug Administration (FDA)-approved pilot study. The milestone marks a significant advance in the company’s research as it progresses towards its pivotal study. The BOOM-IBD Clinical Trial is the first prospective, multicenter study of its kind in the United States to explore the use of a bioelectronic technology designated as an FDA Breakthrough Device for inflammatory bowel disease (IBD). The clinical trial has successfully enrolled patients with Crohn’s disease and ulcerative colitis—the two most common forms of IBD—at multiple U.S. locations, including renowned research institutions like Mount Sinai, Columbia Irving Medical Center, and the University of Pennsylvania. The Comprehensive Digestive Institute of Nevada enrolled the last study patient. “This study represents a promising step forward in the quest for expanding the armamentarium for managing IBD. Our participation underscores our dedication to advancing patient care, and we are eager to contribute valuable insights that could advance the future management of IBD,” said Christian Stone, M.D., principal investigator at the Comprehensive Digestive Institute of Nevada. IBD is one of the most debilitating autoimmune diseases, affecting millions globally. Living with ulcerative colitis or Crohn’s disease impacts not just physical health but also work, relationships, and well-being. While existing therapies have made significant strides in managing IBD, the complexity of the condition means that there is always room for innovative approaches. “Successfully completing the Stage 2 enrollment for our BOOM-IBD Clinical Trial is a significant step in our research trajectory. Our heartfelt appreciation goes to the BOOM-IBD investigational sites for their dedicated efforts in this critical research,” Boomerang Medical CEO Heather Simonsen stated. Comprehensive Digestive Institute of Nevada provides personalized, empathetic patient care—from consultations, testing, care plan, procedures, to continual care as needed. The facility develops and enhances methods to improve each patient’s experience. Some of its services include colonoscopy, endoscopy, treating abdominal pain, and treating diarrhea and constipation. Boomerang Medical is a women-led bioelectronic medicine company on a mission to disrupt autoimmune disease treatment. The company is developing a bioelectric neuromodulation technology, which has been granted FDA Breakthrough Device Designation for treating Crohn’s disease and ulcerative colitis. Boomerang Medical is headquartered on the campus of El Camino Hospital in Mountain View, Calif. Boomerang Medical is a Company–In-Residence at the Fogarty Innovation incubator—the only healthcare-focused U.S. incubator. Current investors in the company include Arboretum Ventures and Hatteras Venture Partners.
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