Milpitas, CA, June 15, 2021 – Bigfoot Biomedical announced today that it has acquired the intellectual property assets of Common Sensing, a Cambridge, MA-based company that develops and manufactures data-driven hardware and software solutions for people using injectable medicine, including Gocap.
“This acquisition will accelerate the innovative development work already underway at Bigfoot as we advance and expand our insulin-delivery portfolio,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “There’s tremendous momentum for smart and connected technology within the diabetes industry, and Bigfoot Biomedical is uniquely poised to deliver solutions that are simple, convenient and easy to use.”
“We’ve admired the maverick spirit of the Bigfoot Biomedical team for many years as both our companies have worked incredibly hard to develop solutions for the more than 20 million people using injectable medicine in the US and EU” said Kevin Schmid, CEO of Common Sensing. “Bigfoot has proven itself as a company that can gain regulatory approval and effectively lead a manufacturing and implementation strategy. This is important as we fully expect the number of people needing to intensify their insulin therapy with multiple daily injections to grow especially with the advent of simple and accessible technologies.”
Last month, Bigfoot received FDA clearance for its Bigfoot Unity™ Diabetes Management System featuring first-of-its-kind smart pen caps for insulin pens used to treat Type 1 and Type 2 diabetes. Integrated with Abbott’s FreeStyle® Libre 2 system, the Bigfoot Unity System is the first and only solution to translate continuously monitored glucose data into on-demand insulin dose recommendations, based on HCP instructions, displayed right on the pen-cap screen for ease of use.
“For the millions of people with insulin-requiring Type 1 and Type 2 diabetes, there’s a huge need for solutions that are accessible in terms of cost and simplicity,” said Brewer. “We’re keeping our foot firmly on the gas pedal as we look to expedite the incredible work being done currently by the Bigfoot team. Making smart acquisitions that are compatible with our mission and philosophy are key to our strategy of delivering valued innovations to the diabetes community.”
About Bigfoot Biomedical, Inc.
Bigfoot Biomedical was founded by a team of people with personal connections to Type 1 and Type 2 diabetes. We seek to change the paradigm of care for diabetes. Bigfoot is an unconventional company taking an unconventional approach. Unlike others, we’re looking at insulin therapy holistically and utilizing services, support, and novel business models. We’re partnering with health care providers 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. Follow us on Twitter @BigfootBiomed, Instagram and Facebook.
Important Safety Information for the Bigfoot Unity Diabetes Management System
The Bigfoot Unity System is indicated for management of diabetes in persons 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real-time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The system must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.
The Bigfoot Unity System requires a prescription. A health care provider must supply appropriate settings for the device based on user specific criteria. It is not intended to be used by individuals who dose insulin in ½ unit increments, take multiple daily doses of long-acting insulin or take high doses of vitamin C (more than 500 mg per day).
The system provides dose recommendations; however, the final decision on when and how to dose is up to the individual user. Failure to use the system according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury.
For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the Bigfoot Unity User Guide.
The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.
PR-400050 Rev A June 2021