Beta Bionics raises $57M to bring its artificial pancreas to the FDA

Shortly after wrapping up a pivotal trial of its device in Type 1 diabetes, Beta Bionics has secured $57 million to help complete the development of its fully automated artificial pancreas system and submit it to the FDA.

The financing is a drop from the company’s most recent funding rounds, including a two-part series B that raised separate tranches of $63 million apiece across 2018 and 2019.

Since then, Beta Bionics received a breakthrough device designation for its iLet, a pocket-sized pump designed to help control blood sugar levels without requiring the wearer to count carbohydrates, set insulin delivery rates or schedule bolus insulin for meals. The dual-chamber system only requires that users enter their body weight and employs adaptive algorithms and continuous glucose monitoring to calculate doses of insulin, glucagon or a combination of the two.

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The company’s latest series C round included backing from Soleus Capital, Perceptive Advisors, Farallon Capital Management, RTW Investments, Eventide Asset Management, Pura Vida Investments, ArrowMark Partners, LifeSci Venture Partners and Beta Bionics’ strategic partner, Novo Nordisk.

Beta Bionics’ previous clinical work tested Novo Nordisk’s fast-acting Fiasp (insulin aspart) in adults with Type 1 diabetes as well as insulin lispro and conventional insulin aspart in both adults and children. Eli Lilly and Zealand Pharma have also been touted as investors and development partners, with Zealand supplying its stable liquid glucagon analog.

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The company announced last December that its randomized, controlled trial of the iLet has gathered enough data from its participants, which included about 440 adults and children over six years with Type 1 diabetes using the device at home. It is expected to report findings in the first half of this year. The insulin-only study was funded in part by the National Institutes of Health and led by researchers at Boston University and the Jaeb Center for Health Research.

Beta Bionics also began screening and enrolling participants into a second pivotal trial testing a bihormonal configuration of the iLet, using Zealand’s dasiglucagon in a similar patient population. The study aims to support a new marketing application to the FDA for the iLet alongside a new drug application for the use of dasiglucagon in dual-chamber artificial pancreas systems.