Bigfoot Biomedical plans to submit its smart pen system for FDA clearance this month. Photo credit: Bigfoot Biomedical

A fresh round of funding will bring Bigfoot Biomedical several steps closer to FDA clearance for its first product. The Milpitas, Calif.-based company plans to submit its application to the agency this month for a smart insulin pen cap that can help users calculate the correct dose.

For patients who rely on multiple insulin injections per day, calculating the right dose can be complicated. It includes factoring in a long-acting insulin from the morning, how many carbohydrates were eaten at mealtime, and several other factors.

The founders of Bigfoot Biomedical know this well — both have experienced it with their own children, who have type 1 diabetes.

“They’ve both been in trouble by taking the wrong amount of insulin. That is the thing we’re trying to avoid. Whatever help we can provide to make sure the person is taking a safe dose,” CEO and co-founder Jeffrey Brewer said in a phone interview.

The company’s Bigfoot Unity System would pull in information from Abbott Laboratories’ FreeStyle Libre 2 connected glucose monitor to calculate the proper dose. This information is displayed on a pen cap, along with when the last dose was taken.

Bigfoot said it had designed caps for every major brand of long-acting and rapid-acting insulin pens in the U.S.  

“You have to use it every day for the rest of your life,” Brewer said. “Not having to use your phone or open an app.  having it on this cap — it eliminates a step.”

The system is set up like a subscription model that would send users kits with connected glucose monitors, pen needles and test strips. The plan is for the kits to be covered and reimbursed by the patient’s health plan.

Abbott, which has been a recent partner for Bigfoot, led the company’s $55 million series C round. Smile Group, Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management also participated in the funding round. In January, Bigfoot shared that it had raised $45 million in the initial tranche of series C funding.

The market for insulin management solutions is a crowded one. Dexcom and Medtronic have developed “artificial pancreas” systems that pair continuous glucose monitors with insulin pumps.

But Bigfoot could prove a strong contender. The company is developing its own closed-loop insulin delivery system, which received the FDA’s Breakthrough Device designation.

Brewer’s experience in the space will also prove valuable. He helped launch the Artificial Pancreas Project before serving as Chairman and later CEO of the Juvenile Diabetes Research Foundation (JDRF), making him closely familiar with the regulatory and reimbursement landscape for launching a new device.

“When you start talking about healthcare, you have constituencies like the FDA that has to bless it, you have payers who have to reimburse it, you have clinicians who have to have confidence in it, and then you have the end user. You have this range of constituents, all who have different needs that you have to meet all at the same time,” he said.

Brewer said he plans to have a 510(k) application at the FDA’s doorstep this month. Based on that timeframe, he hopes to be able to release the system to the public next year.

“It’s a big time for us as a company,” he said. “We’re all very much looking forward to that.”

Photo credit: StockFinland, Getty Images

Correction: This article has been corrected to reflect that the $45 million raised in January was part of Bigfoot Biomedical’s series C round.