Bigfoot Biomedical has a lot going for it. It’s got intrigue (read the story about its co-founder Bryan Mazlish in Wired); it has respected industry executives (co-founder Jeffrey Brewer was the president of JDRF for four years); and it has guts (to grapple with getting FDA approval for a brand new concept––the artificial pancreas––well, that takes a lot of guts).
After two and a half years of development, during which the company has raised over $40M in funding, the company has rejected one of the most respected names in diabetes tools––Dexcom––to partner with Abbott Laboratories for its initial launch. It’s not easy to make technology changes but Brewer, the CEO of Bigfoot, felt the switch was crucial. The difference in the two products came down to calibration and accuracy.
“A lot of people calibrate the sensor with the sensor,” says Brewer. “Our data says this happens a lot. If you can take the calibration step out, you don’t have the risk of a bad number,” says Brewer. He also found the insertion process of the FreeStyle® Libre, which has only one unit, to be elegant. “It’s consistent with our product vision,” says the CEO. “We picked the thing that will work best for Bigfoot. Dexcom makes a good sensor, but competition drives innovation.”
Jared Watkin, divisional vice president of R&D at Abbott, was thrilled to have the partnership come together. While many outside regarded the move (announced on July 13th) as a validation for Libre, Watkin already had it. “The 300,000 people using Libre around the world is our clear sign,” he says. “Were we pleased? Of course.” But the team at Abbott was already convinced that Libre was the right technology. While Bigfoot knew it wanted to switch, there were still some concerns that Abbott, which has 74,000 employees to Bigfoot’s 50, wouldn’t be able to move fast enough for the intrepid startup, but Watkin assured them it could.
While Abbott is still working to get FDA approval in the U.S. for its FreeStyle Libre, the team is also working on next generations––think real-time communications with alarms––and this is what it will deliver to Bigfoot for the clinical trials, which are targeted for late 2018, a date that has bumped out a bit because of this shift in technology.
According to Brewer, there will be about a dozen sites across the country hosting clinical trials. Because the company aims for wide adoption, the study will also include doctors and people who aren’t pump savvy. “It needs to be simple and work in an environment where you don’t have an endocrinologist,” says Brewer. “That’s never been done before. Whenever trials have been done they only use the most savvy individuals. But that’s not the real world.” Keep your eyes on clinicaltrials.gov for the chance to sign up.
Like many, Brewer got pulled into the diabetes world because his son was diagnosed with Type 1 in 2002. We won’t tell you how challenging it is to be a child or a teenager or a young adult with diabetes, but it’s from watching his own son struggle with managing his own care (and tools that failed) that Brewer honed in on what the diabetes community needs. (I was diagnosed when I was twelve.) Bigfoot’s goals are simple: to build solutions that will blend into our lives with ease and be simple enough to prescribe and operate that they could be accessible to a broad population.
“My son doesn’t want to be reminded that he has type one diabetes,” says Brewer. “He needs something simpler and easier––a consumer product, not a medical device. He needs Bigfoot.” Let’s hope with this new collaboration that the Bigfoot team is one step closer to the prize.