GRAND RAPIDS — A medical device startup will use a new $2.1 million capital investment to prepare for larger clinical trials for its new product that treats obesity.
After years of refining the Full Sense Bariatric Device’s design, Grand Rapids-based BFKW LLC wants to start trials that could position the company for regulatory approvals in global markets, CEO G. Ray Martin told MiBiz.
Studies of more than 100 obese patients in Mexico proved the device works clinically to help people lose weight, he said, noting the process led to changes in the device’s design to where it’s now ready for larger trials.
“We’ve really been in this de-risking clinically, and we think we have addressed any kinds of clinical concerns,” he said.
BFKW now needs to conduct larger clinical trials prior to pursuing the regulatory approvals required to commercialize the device, whether in the U.S., Europe or elsewhere.
On April 13, BFKW closed on the $2.1 million investment as part of a larger $10 million capital round for the company, according to a filing with securities regulators.
The company’s fundraising to date has been mostly through angel investors, most of whom are from Michigan, Martin said.
“Michigan investors have been a big part of support for the company and will continue to be as we move forward,” he said.
First conceived in 2004 by bariatric surgeon Dr. Randal Baker of Grand Health Partners in Grand Rapids, the Full Sense device is designed for temporary implantation in patients through an endoscopy procedure. The stent-like device, which is placed endoscopically within the stomach and esophagus and results in decreased hunger, represents an alternative for obese patients to invasive bariatric surgery.
Baker and his partners in BFKW have worked on the device for years with financial backing from friends, family and angel investors from Michigan, Martin said.
The device’s design has steadily evolved over 13 years as medical procedures to treat obese patients evolved, Martin said. In the last decade, there’s been a shift from laparoscopic to endoscopic approaches, he said.
“The technology has been refined on both the implant and the procedure over the course of those years,” Martin said. “Our technology has tried to integrate that wave of the future as well.”
Martin is a veteran of medical device startups who joined BFKW in March. He could not say where in the world BFKW will first seek regulatory approval to market the Full Sense device following the clinical trials.
The device remains at least two years away from final commercialization in “certain geographies, and even longer in others,” Martin said. BFKW could take the device to market on its own or through a strategic partnership for distribution.
“Right now, everything is on the table,” Martin said. “We’ll do what’s best for the sake of the business and the shareholders, but I like to think when the results come out, there’ll be knocks on the door for partnerships, whether those be in distribution, investments or whatever.”
BFKW pursues commercialization of the Full Sense device as the obesity rate in America continues to rise. As of 2016, 29.8 percent of the U.S. population was obese, according to the 2016 America’s Health Rankings report published by the United Health Foundation. That’s up from 27.8 percent four years earlier and 11.6 percent in 1990.
Michigan had an obesity incidence rate of 31.2 percent in 2016. Louisiana had the highest rate, 36.2 percent, while Colorado had the lowest, 20.2 percent.
The report from the United Health Foundation shows obesity-related health issues such as diabetes, hypertension and cardiovascular disease cost the U.S. economy $190.2 billion annually. That research offers an indication of the kind of market opportunity just in the U.S. that BFKW could tap into if the clinical trials prove successful.
“We think this is a huge opportunity in terms of just the incidence, and not just in the U.S. but globally,” Martin said.