Patient needs have always been the North Star for Heather Simonsen, CEO of Boomerang Medical Inc. This empathy stems from her early years working directly with patients in a Chicago hospital system. “Once you’ve lived that, it just stays with you,” she said.
That perspective now guides Boomerang’s work evaluating neuromodulation for people living with inflammatory bowel disease (IBD), a chronic autoimmune disease that can upend daily life. “For many, their quality of life is defined by symptoms—Can I get on a flight? Can I give a presentation?—and we want to make a difference,” she said.
Impressive funding fuels pivotal trial
Boomerang recently announced a $20 million Series B financing, co-led by Arboretum Ventures and Hatteras Venture Partners, bringing total funding to $38 million. The new capital supports BOOM-IBD2, the first pivotal study of a Class III device for neuromodulation in IBD, an area historically dominated by drug-based approaches.
Boom-IBD2, is currently enrolling patients at medical centers across the United States. It is evaluating whether sacral neuromodulation, a small, implanted device delivering gentle nerve stimulation, can help reduce symptom burden in ulcerative colitis, the most common form of IBD. Sacral neuromodulation device therapy is a well-known approach that has been used by half a million people for other conditions since 1997.
Designed with patients, for patients
To design its pivotal study, Boomerang followed the FDA’s guidance to engage people living with IBD to help shape the protocol. The company also worked with a patient advisory group, in collaboration with the Crohn’s & Colitis Foundation, to ensure the trial reflected what matters most to patients.
“In its guidance, FDA notes that incorporating patient perspectives, particularly on which endpoints are meaningful, can enhance the design and conduct of clinical studies. We took that to heart,” Simonsen said. “What really bubbled to the top from both our advisors and patients was a major gap in today’s IBD management landscape—tremendous advances have been made, yet few solutions specifically target the symptoms that disrupt daily life. As patients shared, ‘It doesn’t matter if my colon looks great if I can’t leave the house because of urgency.’”
Translating those patient perspectives into meaningful science has required bridging two very different worlds and engaging multiple subject matter experts. “There are experts in IBD, and there are experts in neuromodulation, but there are no experts in both,” she said. “With the clinical work we’ve done to date, Boomerang now has more prospective data than anyone in the world on sacral neuromodulation in IBD,” she added, referencing the company’s completed 40-patient feasibility study, which informed the design of the pivotal trial.
That growing body of work has not gone unnoticed. Earlier this year, the Crohn’s & Colitis Foundation named Boomerang its “Emerging Leader in IBD,” the first medical device company to receive that recognition. The momentum is strong. “We’re pulling 24/7 days because everybody’s very excited about the mission. It feels really good to be at this stage, operating within the rigor of a pivotal study,” Simonsen said.
Collaboration and capital discipline
Reflecting on the company’s progress to date, Simonsen credits her personal board of advisors, including the staff at Fogarty Innovation and mentors who have been CEOs themselves, with helping her recognize that when things don’t go as planned, the key is to pivot quickly rather than double down on something that isn’t working.
She also points to the strength of Boomerang’s investor partnerships. Arboretum Ventures has participated in every financing round, and managing partner Tom Shehab, MD, who is also a gastroenterologist, serves on the board. “He’s been a fantastic partner because he can wear both the investor and the GI doctor hats,” she said.
She also credits Jeff Terrell, a Boomerang board member and the second lead partner on the deal during his time at Hatteras Venture Partners, as an exceptional thought partner. “I hit the jackpot when it comes to investors and my board of directors,” she says. “They’re true partners in helping me solve the complex puzzles we encounter every day.”
In addition, Simonsen recommends startup CEOs build a strong relationship with their CFO. “Investors want to see that you understand how every dollar flows in and out of the business, and grasping that level of detail has served me very well.”
Simonsen is enthusiastic about what comes next. “We’ve got gas in the tank to get us to our next big milestone, which is commercial approval.”