Dive Brief:

• Beta Bionics has raised a private $100 million financing round to support commercialization and further development of its recently authorized automated insulin dosing (AID) system.
• The U.S. Food and Drug Administration gave 510(k) clearance to the device, iLet Bionic Pancreas, in May, positioning Beta Bionics as a challenger to Insulet, Medtronic and Tandem Diabetes Care.
• Beta Bionics is pitching the device as a simpler system that allows people with Type 1 diabetes to almost totally rely on an algorithm to make decisions about their insulin dosing. The financing will equip the company to find out if that proposition can translate into commercial success.

Dive Insight:

Beta Bionics raised a $57 million series C financing round early last year. That financing, which was co-led by a syndicate of venture capital funds with an assist from strategic partner Novo Nordisk, equipped the company to develop iLet, file for FDA clearance and prepare to commercialize the device. 

Eighteen months later, Beta Bionics has executed the strategy it outlined at the time of the series C, and persuaded investors to bankroll the next stage of its evolution. New investors Sands Capital and Omega Funds co-led the series D round. British hedge fund Marshall Wace and existing investors such as Soleus Capital, Eventide Asset Management, Farallon Capital and Perceptive Advisors also contributed cash.

The new investment “represents a powerful vote of confidence in Beta Bionics' mission,” CEO Sean Saint said in a statement on Wednesday. He added that the company is eager to expand access nationwide and “further develop and test the bi-hormonal bionic pancreas.”

Until now, hybrid closed-loop systems have involved users in the dosing process. Users have entered basal rates, insulin-sensitivity factors, carbohydrate-to-insulin ratios and other information when they start a hybrid closed-loop system, and inputted the grams of carbohydrates in each meal they eat. The systems have also empowered users to override insulin-dosing decisions.

The iLet system largely frees users from the need to enter data, limiting the initial inputs to body weight and ongoing information to a choice of three carbohydrate levels per meal. However, the system also limits the control users have, notably by preventing them from modifying doses. The approach has raised questions about whether iLet will appeal to users of rival devices, or convert people from injections.