Bay Area Bigfoot Biomedical Bags $37M Series B Financing

Amneal and Impax to Marry, Creating the 5th Larges

Amneal and Impax to Marry, Creating the 5th Larges

The round was co-led by funds managed by new investor Janus Henderson Investors.

Bigfoot Biomedical announced it had raised $37 million in the first tranche of a Series B equity round. It was co-led by funds managed by new investor Janus Henderson Investors. Existing investors also participated, including Quadrant Capital Advisors, Cormorant Asset Management, Senvest Capital, Senvest Management, Visionnaire Ventures, JDRFT1D Fund and T1D Exchange.

Bigfoot Biomedical is a medical device company focused on developing insulin-delivery systems that utilize artificial intelligence. Specifically, the company’s Bigfoot Loop and Bigfoot Inject. Bigfoot Loop is an infusion pump-based closed-loop automated insulin delivery system—a type of artificial pancreas. Bigfoot Inject is 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,” company president and chief executive officer 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.”

In July, Bigfoot and Abbott inked a deal to develop and commercialize diabetes management systems. They will integrate the Abbott FreeStyle Libre glucose-monitoring technology within Bigfoot’s insulin-delivery ecosystem. The FreeStyle Libre system launched in Europe in 2014 and is now available in more than 35 countries. It is used by more than 300,000 people with diabetes worldwide. Prior to the deal, Bigfoot was using the Dexcom Seven PLUS system.

On Nov. 3, Bigfoot presented data validating the company’s in-silico metabolic simulation engine. This software and AI package predicts how the company’s automated insulin delivery system would perform in a heterogeneous group of subjects.

“People with insulin-requiring diabetes must constantly monitor their blood glucose levels, what and when they eat, and when and how they exercise in order to make calculations and decisions about using insulin,” said Lane Desborough, Bigfoot’s chief engineer, in a statement. “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. 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.”

The data was presented at the 17th Annual Diabetes Technology Meeting in Bethesda, Maryland.

In 2016, Bigfoot raised $36 million in a Series A financing.

MobiHealthNews notes that Bigfoot isn’t the only company in this arena. “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 back of Roche.The FDA cleared the first closed-loop insulin delivery system, Medtronic’s MiniMed device, in 2016.”

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