Fogarty Company Blazes Through Clinical Trials of Bioelectronic Device for IBD

by | Nov 2, 2023 | Companies, Fogarty Innovation

Boomerang Medical, a women-led bioelectronic medicine company, is on the verge of completing enrollment in the second stage of its FDA-approved pilot trial studying neuromodulation as a therapeutic approach for Inflammatory Bowel Disease (IBD). The company is on a mission to expand treatment options for patients with IBD, which today, are limited to just drugs or surgery.

“Major diseases or conditions often have a variety of treatment options; it begs the question of why should IBD be any different? This disease affects millions globally and limits their life choices, hence shouldn’t the treatment landscape be just as diverse?” asks CEO Heather Simonsen.

The impressive pace of clinical trial enrollment for the company’s BOOM-IBD Clinical Trial speaks volumes about both tangible patient interest and clinical study execution. Conducted at a handful of research centers, the company saw an enrollment rate that increased by 300% from Stage 1 to Stage 2 of their pilot study. 

“There is so much interest in expanding the options for managing IBD that we have more interested sites and patients than we can accommodate,” said Simonsen. “We had to start a waiting list, which speaks to the intense need and excitement surrounding the potential of bioelectronic devices in this complex disease.”

Patients first: Impactful focus on improving quality of life

The incidence and prevalence of IBD have increased significantly worldwide over the past 15 years. Current treatment options are fairly limited to drugs or surgery. Boomerang Medical offers a potential new avenue for management that intrigues both patients and physicians.

Patients have been embracing the Boomerang device as a promising component in managing their IBD. “Bioelectronic medicine has been very appealing to patients, and we’ve seen a surge in patient-to-patient referrals in our clinical trial,” said Simonsen. “The interest is both humbling and motivating, underscoring the potential our approach has in addressing the multifaceted challenges of IBD.”

Positive physician feedback boosts interest

Boomerang is collaborating with physicians experienced in both IBD treatment and neuromodulation technologies. “Some of the top IBD experts in the world are involved in our study or advising the company,” Simonsen noted. The fact that IBD is not typically a “device-treated” population has added to the excitement among participating physicians.

Exceptional progress continues

As the second stage of the feasibility trial nears conclusion, Boomerang is gearing up for the pivotal study phase. The company’s earlier funding success provided fuel for its rapid progress via a $15 million Series A financing round supported by Arboretum Ventures and Hatteras Venture Partners, bringing the total funding raised to $18 million as of 2022. 

The company has further strengthened its team, welcoming Pharaoh Garma as COO, whose past roles at PQ Bypass (a Fogarty Innovation alumnus company) and as an FDA lead reviewer attest to her expertise. David Miller joins as Chief Technology and Innovation Officer, contributing his legacy as co-founder of multiple companies, Distinguished Scientist at Medtronic and Stanford BioDesign Fellow. Newly appointed VPs, Colleen Holthe and Lucas Payne, have also come aboard in pivotal roles as VP of clinical affairs and VP of clinical accounts and field operations, respectively.

“In the quest to widen the lens through which we view IBD treatment possibilities, we’re not just investing in research; we’re investing in people—our team, our patients and our medical partners,” concluded Simonsen.

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