Bigfoot Biomedical Receives FDA Clearance for Bigfoot Unity® Android App for People Living with Insulin-Requiring Diabetes

Clearance Expands Access to Bigfoot’s Connected Injection Support Technology Ahead of Expanded Commercial Rollout

Bigfoot Biomedical (Bigfoot), a leader in developing intelligent connected injection support systems, today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Android version of the Bigfoot Unity^® Mobile App, a necessary component of the Bigfoot Unity^® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices¹, this clearance enables expanded access to a large group of people with diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021.

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Bigfoot Unity® Diabetes Management System (Photo: Business Wire)

“Most Bigfoot Unity users live with type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population," said Jeffrey Brewer, CEO of Bigfoot Biomedical. “Therefore, as we prepare for our enhanced commercial rollout later this year, this clearance is key to enabling us to expand access to our comprehensive and easy-to-use solution and deliver on our goal to minimize the anxious guesswork involved with insulin dosing.”

The Bigfoot Unity System is the first and only FDA-cleared smart injection system that turns continuous glucose management (CGM) data into insulin dosing advice displayed right on the pen cap for people using multiple daily injection therapy. The system features smart pen caps compatible with a broad range of disposable insulin pens for both long-acting and rapid-acting insulin. The Bigfoot Unity Mobile App allows users to input and review healthcare professional therapy recommendations, provides a glanceable display of current glucose range, and delivers important real-time alerts. The holistic approach aims to simplify the complexities of diabetes management, so people on multiple daily injection therapy can focus on what matters most in their lives.

Once commercially launched, the Android phone application will be available via the Google Play Store. Those interested in staying apprised of Bigfoot’s Android app updates can fill out this form.

About Bigfoot Biomedical, Inc.

Bigfoot Biomedical (Bigfoot), headquartered in Milpitas, California, was founded by a team of people with personal connections to type 1 and type 2 diabetes. Bigfoot aims to free people from the burdens of living with insulin-requiring diabetes, improve access, and support health care professionals in optimizing diabetes care. Bigfoot is an unconventional company taking an unconventional approach. Unlike others, Bigfoot looks at insulin therapy holistically, and utilizes services, support, and novel business models. The company partners with health care professionals to deliver simple, connected, and comprehensive solutions for the large number of people who have been overlooked by diabetes innovation. Learn more at www.bigfootbiomedical.com and by following us on LinkedIn, Twitter, Instagram, and Facebook.

Bigfoot and Bigfoot Unity are trademarks or registered trademarks of Bigfoot Biomedical, Inc. in the United States of America and other various jurisdictions. All rights reserved.

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¹ StatCounter Global Stats: Mobile Operating System Market Share in United States Of America from Jan 2022 to Jan 2023 (https://gs.statcounter.com/os-market-share/mobile/united-states-of-america)

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