Beta Bionics Secures $100 Million for Artificial Pancreas Expansion Following FDA Approval

Beta Bionics, a Massachusetts-based company, has garnered a substantial infusion of funding amounting to $100 million after securing approval from the U.S. Food and Drug Administration (FDA) for its insulin pump and automated dosing software. This approval allows them to combine these elements with a Dexcom continuous glucose monitor, creating a hybrid closed-loop system for managing diabetes. The financing news comes in the wake of this regulatory milestone and was disclosed this week.

The funding round was led jointly by Sands Capital and Omega Funds, marking their debut investments in Beta Bionics. In addition to these newcomers, existing supporters and fresh contributors such as Marshall Wace, Soleus Capital, Eventide Asset Management, Farallon Capital, Perceptive Advisors, ArrowMark Partners, Pura Vida Investments, and select funds managed by RTW Investments participated in this funding endeavor.

This achievement in funding surpasses the preceding series C round that transpired in early 2022, netting $57 million. Notably, however, it falls short of the previous series B funding round, which took place in two stages and successfully generated almost $130 million over separate tranches in 2018 and 2019.

The influx of capital will not only underpin the deployment of Beta Bionics’ recently sanctioned iLet artificial pancreas technology but also propel the continuous development of further automated systems catered to individuals living with diabetes.

Distinguished by its employment of continuous glucose monitor (CGM) data, the bi-hormonal bionic pancreas technology is engineered to calculate doses of both insulin and glucagon, a hormone that raises exceptionally low glucose levels. This diverges from the insulin-only iLet system.

The iLet system combines an insulin pump with an automated dosing algorithm that uses data from a Dexcom CGM to adapt the insulin pump’s output in response to real-time glucose needs. Beta Bionics’ “bionic pancreas” distinguishes itself with its streamlined setup process. In contrast to other closed-loop systems necessitating physician input for dosing software parameters, Beta Bionics’ system only requires the user’s weight, significantly simplifying the procedure.

Moreover, the company’s technology simplifies diabetes management and insulin dosage calculations by substituting conventional mealtime carbohydrate quantifications with a multiple-choice query. Users are only required to estimate whether they intend to consume a small, medium, or large amount of carbohydrates.

Jeff Shuren, M.D., who serves as the director of the FDA’s Center for Devices and Radiological Health, acknowledged the potential implications of these streamlining measures when announcing the system’s clearance in May. He highlighted that such simplifications “will provide the Type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of [automated insulin dosing] technology.”

In light of the FDA’s approval, Beta Bionics foresees an imminent launch of the technology within the United States.

The post Beta Bionics Secures $100 Million for Artificial Pancreas Expansion Following FDA Approval appeared first on LifeSci Voice.