Hoping to make big tracks, Bigfoot Biomedical scores FDA clearance for smart insulin pens

A smart insulin pen may not be the rarest sighting in diabetes these days, but Bigfoot Biomedical aims to stand apart with a new FDA clearance for delivery devices that provide real-time alerts for low blood sugar and instant dosing instructions.

The company’s Unity system connects directly with Abbott’s FreeStyle Libre 2 continuous glucose monitor, and provides digitally linked insulin pen caps designed to snap on to all major U.S. brands, including fast-acting or longer-term disposables. 

After scanning the FreeStyle Libre’s sensor, the caps can display insulin dose recommendations immediately through their own tiny, built-in screens, and can track the amount of time that has passed since the user’s last injection. The pens, monitor and personal glucose levels can also be tracked through a smartphone app.

Bigfoot describes its on-demand guidance and warning engine as a one-of-a-kind option for people with Type 1 and Type 2 diabetes. “There are more than 7 million people in the U.S. on insulin therapy and many use insulin injections multiple times a day, yet there have been few advancements for this hugely underserved market,” Bigfoot CEO Jeffrey Brewer said in a statement

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The system also aims to provide training for first-time users of insulin or CGM technology, such as the FreeStyle Libre, plus connections to diabetes clinics for the 2.6 million people currently taking multiple injections per day.

Seeing a potential entry point for its own CGM system, Abbott previously backed Bigfoot’s series B and later led its series C round—both of which added $55 million apiece to its coffers.

"People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it's important to develop connected technologies that simplify the experience," said Abbott’s senior VP for diabetes care, Jared Watkin.

Bigfoot’s other investors have included Quadrant Capital Advisors, Senvest Capital, Janus Henderson, Cormorant Asset Management, Smile Group, Visionnaire Ventures, JDRF T1D Fund and T1D Exchange.

Most recently, the company raised another $57 million this past March in combined debt and equity financing from Madryn Asset Management, to help support the commercialization of its Unity pen cap system as it enters a somewhat crowded wilderness of competitors.

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Last fall, Medtronic launched the smart insulin pen that it picked up in its acquisition of Companion Medical, the InPen, which links with the medtech giant’s Guardian Connect CGM and accompanying smartphone app.

Meanwhile,  Eli Lilly & Co. recently signed international compatibility agreements for its upcoming device, to make sure it plays nicely with glucose sensors, digital health programs and other tools from Roche, Dexcom, Glooko, myDiabby Healthcare and Welldoc.

At the same time, a smart insulin pen system may just be a first step for Bigfoot. The company is also developing an automated, closed-loop infusion pump, or a type of artificial pancreas that has already received a breakthrough designation from the FDA, but requires further clinical development and regulatory approvals.