Bigfoot Biomedical's automated insulin delivery systems attract $37M in Series B funding

By Dave Muoio

Milpitas, California-based diabetes management device maker Bigfoot Biomedical has raised $37 million in Series B funding in a round co-led by funds from Janus Henderson Investors and Quadrant Capital Advisors. Additional participants included Cormorant Asset Management, Senvest Capital Inc., Senvest Management LLC, Visionnaire Ventures, JDRF T1D Fund, and T1D Exchange.

Bigfoot previously announced a $35.5 million round in 2016, bringing the company’s total announced funding to $72.5 million.

According to the company’s release, this latest funding will be used to support development and clinical trials for Bigfoot’s AI-driven insulin delivery systems. These include the Bigfoot Loop, an infusion pump-based closed loop automated insulin delivery system, and the Bigfoot Inject, an auto-titrating connected insulin pen-based system.

“Bigfoot Biomedical is made up of people who have a direct connection to insulin-requiring diabetes and we are working diligently to bring this technology to people who need it,” President and CEO Jeffrey Brewer told MobiHealthNews. “This new funding will help us advance our clinical development for the Bigfoot Loop and Bigfoot Inject systems, and we look forward to initiating our pivotal trial in 2018.”

Last month, Bigfoot presented feasibility trial data for its investigational automated system at the Annual Diabetes Technology Meeting in Bethesda, Maryland. These findings suggested that the company’s system was effective for Type 1 diabetes patients coming from both injection and infusion pump therapies, and supported prior data that Bigfoot generated from modeling a metabolic simulation engine for their algorithms.

“Algorithms for automating insulin delivery must be safe and effective for a diverse group of people and account for significant variations in meals, stress, exercise, and illness,” Lane Desborough, Bigfoot’s chief engineer, said in a statement last month. “Our innovative virtual clinic provides critical insights into how our technology is anticipated to function in these real-world situations. The agreement between our predicted results and our study data validates and supports our use of modeling and simulation to hone our algorithms and predict clinical outcomes.”

In July, Bigfoot and Abbott announced a deal to develop and commercialize diabetes management systems that would integrate Abbott’s FreeStyle Libre glucose sensing technology with Bigfoot’s automated delivery system.

Bigfoot was created based on a personal connection to one of the cofounders. In 2011, Bigfoot cofounder and Chief Technology Officer Bryan Mazlish’s 5-year-old son was diagnosed with Type 1 diabetes. In 2014, Mazlish developed his own insulin delivery system by hacking into an off-the-shelf insulin pump and continuous glucose monitor, then writing an algorithm to automatically dose insulin. He then created a companion app to bring it all together. Bigfoot was founded shortly thereafter with Brewer, Lane Desborough and Jon Brilliant, and within two years they acquired the assets of diabetes equipment supplier Asante Solutions, and established partnerships with glucose monitoring companies.

However, Bigfoot has some competition in the race for better insulin delivery. In the past few weeks, Eli Lilly and Company announced that the first Type 1 diabetes patient has been dosed in a feasibility study of its own investigational Automated Insulin Delivery (AID) system. Earlier this year, Tandem Diabetes launched a new trial for its insulin pump with a predictive low glucose suspend (PLGS) algorithm, while Senseonics and TypeZero’s artificial pancreas R&D partnership gained the backing of Roche. The FDA cleared the first closed-loop insulin delivery system, Medtronic’s MiniMed device, in 2016.