First patients enrolled in US trial of nerve stimulation device for IBD
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Boomerang Medical announced that the first patients have been enrolled in its U.S. clinical trial assessing the use of nerve stimulation as potential treatment for Crohn’s disease and ulcerative colitis.
The FDA granted Boomerang Medical’s bioelectronic device its breakthrough device designation earlier this year for the treatment of inflammatory bowel disease through stimulation of the parasympathetic nervous system, which is intended to reduce inflammation.
The company reported that Kansas Gastroenterology, LLC, based in Wichita, Kansas, enrolled the first patient in the trial, followed by Columbia University Irving Medical Center in New York City.
“Crohn’s disease and ulcerative colitis remain very difficult to manage, despite the numerous approved biologic therapies available,” Michael Lievens, MD, principal investigator for the Boomerang trial at Kansas Gastroenterology, LLC., said in a press release. “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 stated that the clinical trial is intended to assess safety and performance of the bioelectronic device among patients with mild to moderately severe Crohn’s disease and UC, including those who have previously been exposed to biologic therapies.
“We are thrilled to enroll the first patients in this clinical trial of our breakthrough bioelectronic device for IBD,” Heather Simonsen, CEO of Boomerang Medical, said in the release. “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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