MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Boomerang Medical, a women-led bioelectronic medicine company, has announced the enrollment of the first patients in its U.S. clinical trial evaluating the use of nerve stimulation as a potential treatment for Crohn’s disease and ulcerative colitis, the two most common forms of Inflammatory Bowel Disease (IBD). This study marks a significant milestone for the company, which was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) earlier this year for its bioelectronic technology targeting the treatment of IBD.
The trial will primarily examine the safety and performance of the device in patients with mild to moderately severe Crohn’s disease and ulcerative colitis, regardless of whether they have previously undergone advanced therapy such as biologics. Kansas Gastroenterology, LLC in Wichita, Kansas, enrolled the first patient in the study, followed by Columbia University Irving Medical Center in New York, NY.
“Crohn’s disease and ulcerative colitis remain very difficult to manage, despite the numerous approved biologic therapies available,” said Michael Lievens, M.D., principal investigator for the Boomerang trial at Kansas Gastroenterology, LLC. “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.”
“The most fascinating aspect of this study is the possibility of managing IBD simply by stimulating the patient’s autonomic system to release anti-inflammatory mediators,” said Marco Zoccali, M.D., FACS, principal investigator for the Boomerang trial at Columbia University Irving Medical Center.
“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.”
Inflammatory Bowel Disease (IBD) is a chronic, idiopathic inflammatory condition affecting the gastrointestinal tract. The two most common forms of IBD are Crohn's disease and ulcerative colitis. Despite the availability of several approved biologic therapies, managing IBD remains a significant challenge. Non-response or loss of response to therapy is common, leaving patients to suffer from disease symptoms. In addition, surgical intervention is often required for medically refractory disease. As a result, there is a clear need for additional therapeutic options for IBD.
For more information about the clinical trial and Boomerang Medical’s bioelectronic technology, please visit www.boomerangmedical.com.
About Columbia University Irving Medical Center
Columbia University Irving Medical Center (CUIMC) is a leader in providing comprehensive patient care and offers a range of general and specialized medical, dental, and nursing services. We have more than 1,800 physicians, surgeons, dentists, and nurses in locations throughout the New York City metro area. Our knowledge of innovative treatments is enhanced by our compassion for patients and their families and a devotion to maintaining the highest standard of care.
For more information about Columbia University Irving Medical Center, visit https://www.cuimc.columbia.edu/.
For information about our Colorectal and IBD Care Programs, please visit https://columbiasurgery.org/colorectal.
About Kansas Gastroenterology, LLC
Kansas Gastroenterology, LLC is a physician-owned practice where our priority is to deliver high quality efficient, compassionate, and patient-centered care. Our five physicians, six physician assistants, and staff are dedicated to providing the individual attention all patients deserve. We look forward to seeing patients for an office consultation, for a procedure in our Ambulatory Surgery Center, or in our new Infusion Center. Our Research department is continually reviewing opportunities to include patients in exciting and beneficial clinical trials.
About Boomerang Medical, Inc.
Boomerang Medical is a women-led bioelectronic medicine company on a mission to disrupt how we treat autoimmune diseases. Our innovative technology, granted Breakthrough Device Designation by the Food and Drug Administration (FDA), applies mild electrical impulses to peripheral nerves intended to decrease the inflammation caused by autoimmune disease. Headquartered in the heart of Silicon Valley on the campus of El Camino Hospital, Boomerang is a Company-In-Residence at the prestigious Fogarty Innovation incubator – the only healthcare-focused incubator/accelerator of its kind in the U.S. – giving us access to the brightest minds and expertise in the medical technology industry.