Bigfoot Biomedical is launching a clinical trial of its Smartloop automated insulin delivery system at medical centers in California and Colorado.
The Milpitas, Calif.-based company said it has enrolled its 1st patients in a trial of its Smartloop device that will be conducted at three sites: Stanford University School of Medicine (working with Lucile Packard Children’s Hospital Stanford and Stanford Children’s Health in Palo Alto), the William Sansum Diabetes Center in Santa Barbara, and the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, Colo.
FDA officials recently approved Bigfoot’s Investigational Device Exemption submission for the trial for a 1st clinical study of Smartloop, a device designed to treat patients with Type 1 Diabetes. Plans call for making it a closed-loop device combo that continuously monitors glucose levels and delivers insulin relying on a proprietary algorithm.
Bigfoot has gone from founding to clinical trial in less than two years. The company launched in November 2014.
At that time, Bigfoot co-founder Bryan Mazlish had made headlines by creating a closed-loop artificial pancreas for members of his family. The device operated on a Dexcom CGM, Mazhlish’s wife, Dr. Sarah Kimball, has said previously. Co-founder and CEO Jeffrey Brewer is former CEO of JDRF International.
More than 40 people now work for Bigfoot, the company said.
In January, Bigfoot raised $2.4 million in debt financing from 6 unnamed investors, and an SEC filing at the time suggested the company would plan to raise another $625,000 after that.