Beta Bionics, a startup developing a medical device that monitors and manages blood sugar levels in diabetes patients, has closed $63 million to back late-stage clinical tests of its AI-powered technology.
The cash tops off a Series B round of funding announced last year. The Boston company, which counts diabetes drug giants Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO) among its investors and partners, says the capital will support Phase 3 studies of its device this year, and if all goes well, an application for FDA approval.
Beta Bionics’s device is designed to mimic the role of the pancreas, the organ that produces insulin and glucagon, two hormones that work together to maintain proper blood sugar levels. In type 1 diabetes, the immune system attacks the pancreatic cells that produce insulin, leading to low insulin levels and dangerously high levels of blood sugar.
Patients can manage their blood sugar with insulin therapy—self-administered injections or continuous infusions from an insulin pump. The Beta Bionics device, called iLet, is meant to replace these therapies. The system consists of a continuous glucose monitor worn on the skin that tracks glucose levels throughout the day. This monitor wirelessly sends readings to a handheld, smartphone-sized unit that houses cartridges for the hormones. This part of the device can be carried in a pocket. Like an insulin pump, the iLet administers the hormone via an infusion set that delivers its payload just below the skin. But Beta Bionics developed its technology to make all dosing decisions. After the patient’s weight is entered into the device, the algorithms take over. The company says iLet uses machine learning techniques to understand a patient’s blood sugar levels and determine when to administer hormones and how much to dose.
The iLet algorithms were licensed from Boston University, where they were developed in the lab of biomedical engineering professor Edward Damiano, the president and CEO of Beta Bionics. The company says that in earlier home-use studies in adults and children with type 1 diabetes, these algorithms showed that they can help manage patients’ blood sugar levels.
Beta Bionics isn’t the only company trying to improve upon insulin pumps. Medtronic (NYSE: MDT) won FDA approval in 2016 for MiniMed 670G, a device that uses algorithms to personalize its insulin doses. BigFoot Biomedical has developed an “artificial pancreas” technology that it says uses AI to optimize insulin dosing. The Milpitas, CA, startup’s system, which patients manage via a smartphone app, is still in clinical testing.
Beta Bionics designed its device with two chambers, one for insulin and the other for glucagon. The device can be configured to administer insulin only, glucagon only, or both. The company says glucagon-only administration could be used to treat rare, chronic, low-blood sugar conditions, such as congenital hyperinsulinism and insulinoma syndrome.
A Phase 3 study testing iLet’s insulin-only delivery is expected to begin in the second half of this year. The company says a second study testing delivery of both insulin and glucagon is expected to begin in late 2019 or early 2020.
Beta Bionics initially announced its Series B round last September, a $50 million financing that was led by Eventide Asset Management. RTW Investments joined the funding along with Novo Nordisk, which had invested in the startup’s Series A round. Other investors in Beta Bionics include Eli Lilly and Denmark-based biotech Zealand Pharma (NASDAQ: ZEAL). Beta Bionics says new investors that joined the additional funding in the Series B round include Dexcom (NASDAQ: DXCM), which is a San Diego-based maker of continuous glucose monitoring systems, and funds managed by ArrowMark Partners and LifeSci Venture Partners.