Bigfoot Biomedical Enrolls Clinical Trial of Automated Insulin Delivery System

“Life with T1D using today’s tools is unreasonable,” according to Jeffrey Brewer, founder & chief executive officer of Bigfoot Biomedical. “Therapies are too expensive, too complex, and require intense focus and attention with little support. Also, healthcare providers are overwhelmed, with too many hurdles blocking them from helping their patients. The smartloop™ automated insulin delivery system has the potential to change people’s lives. It is designed to deliver better health with greater ease of use, making life simpler for both the patient and the clinicians who treat them, ultimately lowering cost of treatment.”

Motivated by a desire to improve the lives of their children, Jeffrey Brewer, former CEO of JDRF International, and Bryan Mazlish, the mysterious “Bigfoot” in Dan Hurley’s piece for Wired Magazine, founded Bigfoot Biomedical in November 2014. Moving with unprecedented speed in medical device development, over the past 20 months they’ve assembled a team of 40 people and are driving toward commercialization of a cutting edge approach to improving the lives of people with T1D.



Bigfoot recently received approval by the FDA of its Investigational Device Exemption (IDE) submission for a first clinical study of the smartloop™ automated insulin delivery system. The trial is slated to take place at three sites, each of which is a global leader in closed-loop insulin delivery research. Bigfoot is collaborating with Stanford University School of Medicine in coordination with Lucile Packard Children's Hospital Stanford and Stanford Children's Health in Palo Alto, CA, the William Sansum Diabetes Center in Santa Barbara, CA, and the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, CO.

A press release can be found from Bigfoot Biomedical website.