June 12, 2020

Bigfoot Biomedical, Inc. announced today the appointment of Dr. Jim Malone as Chief Medical Officer.

Bigfoot Biomedical notes that Dr. Jim Malone, is an endocrinologist specializing in diabetes, who spent 12 years in clinical practice and 21 years in clinical research, where he developed diabetes products and delivery devices at Eli Lilly & Company. Bigfoot Biomedical, Inc. is a medical device company dedicated to simplifying and optimizing insulin delivery and dosing decisions for people living with insulin-requiring diabetes through the use of artificial intelligence and automation.

“Jim’s blended experience in medical practice and device development brings a dynamic perspective to our team,” said Jeffrey Brewer, Chief Executive Officer of Bigfoot Biomedical. “We are laser-focused on launching Bigfoot Unity, and Jim will play a large role in the regulatory review process, payer partnerships and user experience – from the lens of the healthcare provider. Our goal is to reduce the burden on patients, healthcare providers, and payers, so Jim’s experience in these areas is immense.”

Bigfoot is finalizing product development and FDA submission for the Bigfoot Unity™ Diabetes Management Program, a real-time, dose-decision support system utilizing proprietary, smartpen caps and integrating Abbott’s continuous glucose monitoring platform. FDA 510(K) submission of Bigfoot Unity is anticipated in summer 2020 with a target launch in 2021 pending regulatory clearance.

“I’ve known Jeffrey Brewer for years, first when he served as CEO of JDRF, and admire his vision and gumption to move to the Bay Area and start this amazing company,” said Malone. “Bigfoot has also been able to attract impressive talent to the company, and with more than 25 percent of the company having a personal connection to diabetes, they are incredibly motivated.”

Last week Bigfoot announced it had raised $55 million in its Series C equity financing.

Bigfoot’s integrated system and services are being designed to address many of the challenges facing people with Type 1 and Type 2 diabetes, healthcare providers, and insurance institutions. insulin-requiring diabetes impacts over six million Americans, the vast majority of whom are not reaching clinical targets for optimal glucose levels. Now more than ever the COVID-19 pandemic has crystallized the need for telemedicine solutions like Bigfoot Unity that enable remote care, remote education & support, and home delivery of Bigfoot Unity supplies.

“I’m excited about the Bigfoot Unity system because it has broad application,” said Malone. “It’s taking full advantage of Bigfoot’s algorithmic work to apply data and support both people with diabetes and health care professionals. I’ve always been interested in the delivery aspect, and I’m excited to work with a small and nimble biotech company where I can have a bigger voice and a bigger impact.”

According to Malone, not every person with insulin-requiring diabetes is comfortable with an insulin pump and interested in moving to an automated insulin delivery system. “About 90% of people with diabetes have Type 2 and very few of them use a pump and CGM,” said Malone. “Whereas with pen devices, there’s a lot of room for innovation to make insulin therapy easier to apply. It can impact a lot of patients. Everything Bigfoot is doing is about easing the burden on health-care providers and people with diabetes. I love the direction where they are going. It is very forward-looking.”