Boomerang Medical Gets Breakthrough Device Designation

by Sharena Rice, contributing editor

March 2023 issue, BioElectRx Business Report

Boomerang Medical, in Mountain View, CA, is a startup advancing the treatment of autoimmune diseases through bioelectronic medicine. They were founded in 2021, closed a $15 million Series A funding round in late 2022, and in early 2023, they announced breakthrough device designation from the FDA for their approach to treating Crohn’s disease and ulcerative colitis, the two most common forms of inflammatory bowel disease. With a team experienced in medical devices, they have made progress quickly. Boomerang Medical’s therapy uses implanted neuromodulation to reduce inflammation and restore homeostasis. The company is women-led and headquartered on the campus of El Camino Hospital in Mountain View, CA.

inflammatory bowel disease is a chronic disease that involves chronic inflammation of the gastrointestinal tract. It has neither a cure nor well-defined causes. IBD is typically diagnosed in early adulthood. Adults with IBD tend to have worse health outcomes than those without IBD: higher rates of cardiovascular disease, liver disease, respiratory disease, cancer, arthritis, and migraine. IBD affects all aspects of life from the distinctly physical to the social and occupational. This condition is traditionally managed with biologics, pharmaceuticals, and sometimes, surgical procedures.

Boomerang is conducting their Boom-IBD clinical trial to evaluate the effectiveness of their neuromodulation therapy in treating patients with irritable bowel disease. They are evaluating responses of patients with IBD treated with neuromodulation administered at various intervals. Their clinical sites currently include Wichita, KS, New York, NY, Philadelphia, PA, Charleston, SC, and Houston, TX. They will expand to more locations.

Heather Simonsen, president and CEO of Boomerang Medical, stated, “Unfortunately, there are millions of Americans of all ages currently suffering from Crohn’s disease and ulcerative colitis. As the rate of IBD continues to increase, we are committed to generating clinical evidence for this innovative bioelectronic therapy to diversify the treatment options for IBD.”

Boomerang Medical’s therapy is an example of the potential of neuromodulation to treat digestive ailments with bioelectronic medicine. Beyond IBD, bioelectronic medicine has the potential to monitor and treat a wide range of digestive ailments. Parkinson’s disease has digestive problems as an early symptom, and the gut produces more dopamine than the brain does. As research continues to advance in this field through initiatives such as the Wyss Center’s NeuroGI project, SetPoint Medical’s developments in vagus nerve stimulation for Crohn’s disease, and Boomerang Medical’s new treatment for IBD, we can expect to see more innovations in the pipeline.

Boomerang Medical’s approach to treating digestive ailments with bioelectronic medicine through neuromodulation is a development in the field. The therapy targets the peripheral nervous system to reduce inflammation and promote healing. Clinical trials are currently underway to evaluate the effectiveness of this therapy in treating irritable bowel disease and refine intervals. Boomerang Medical is seeking to change what comes and goes around in the inflammatory pathway— developments we will need to circle back on as research results emerge and they reveal more about their device.