Bigfoot ready for big time

MILPITAS, Calif. – Bigfoot Biomedical is gearing up to roll out its diabetes management system to a larger market after a busy 2021 that included clearance from the U.S. Food and Drug Administration. 

Bigfoot launched its Unity Diabetes Management System in June to a handful of small clinics and in December it made three senior hires in business development, marketing and sales.  

“We are at the point where things are taking off,” said Dr. Jim Malone, chief medical officer. “We are expanding into other geographies, and down the road we are going to be approaching larger organizations.” 

Bigfoot, which launched in 2014, has deep roots in diabetes. Founder and CEO Jeffrey Brewer funded and launched the Artificial Pancreas Project, along with Juvenile Diabetes Research Foundation Intl., then served as JDRF’s CEO. Co-Founder Bryan Mazlish has focused on diabetes technology. Malone was a clinical practitioner before doing research at Eli Lilly. 

The company’s Unity system features connected smart pen caps that recommend insulin doses for people using multiple daily injections. The pen cap connects to a smart phone app and is integrated with Abbott’s FreeStyle Libre 2 continuous glucose monitoring app. Users can input carb-to-insulin ratios and correction doses to personalize recommendations, says Malone. 

“Dosing is quite variable, and it can be a challenge to determine the correct dose,” he said. “By leveraging the technology of a CGM device and connecting it with a smart phone app, it provides assistance to dose their insulin properly at the time they are ready.” 

In addition to Abbott, the pen cap works with the insulin pens from Eli Lilly, Novo Nordisk and Sanofi. Such partnerships are a necessity in advancing technology, says Malone. 

“No one company can do everything, so when companies come together and share technology, that’s when you innovate to provide better tools,” he said. 

Advances in diabetes technology, like Unity, are bringing the market one step closer to automated insulin delivery, says Malone. 

“I think it will eventually lead to where we can automate insulin delivery and be able to do that using sophisticated algorithms to do the same adjustments without going through a clinician that has to examine the data,” he said. “Eventually, it will be done in real time. That’s where we are headed."