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A Bionic Pancreas that Uses Machine Learning for Good

Former Vice President Al Gore was back in the news this month, raising millions for a new campaign. No, not the one crowded with 22 candidates and counting. His Generation Investment Management firm just raised $1 billion for what those who know anything about impact investing might call a do-gooder fund. Socially responsible investing, which may help you outperform the karmic cycle but not necessarily in the race to the bottom line, is estimated to account for between $250 and $500 billion in assets under management today. Companies themselves have a wide menu of certifications from which to choose their badge of socially responsible behavior. A Boston-based medical device startup not only falls into this category, but it’s developing a bionic pancreas that uses machine learning to help diabetics and others living with severe conditions involving blood-sugar management.

Click for company websiteWe recently told you about the artificial pancreas that one of our dividend-growth investing companies, Medtronic (MDT), is developing that uses artificial intelligence to keep people within a certain sweet spot on the glycemic index. Boston-based Beta Bionics has raised nearly $127 million for bringing to market a similar medical device that helps type 1 diabetics to keep their blood sugar within a healthy range. It collected $63 million earlier this year in a second Series B round only a few months after a $57.6 million round in October 2018.

The ILet bionic pancreas device for regulating insulin and glucagon.

The ILet bionic pancreas device for regulating insulin and glucagon. Credit: Beta Bionics

As you might recall from our article that explored new treatments for diabetes, the pancreas is the biological factory that churns out insulin, a type of hormone that regulates blood sugar. Type 2 diabetes is a condition where the body produces some insulin but not enough, while type 1 diabetes is more difficult to manage because the body produces no insulin at all. There are all sorts of devices that help monitor and administer insulin, which consists of two types – basal and bolus. The former replaces the background insulin that helps the body to maintain constant blood glucose levels, while the latter replaces the extra insulin the pancreas would naturally make that helps to manage the influx of additional sugars during meals or Big Gulp binges.

Bionic Pancreas that Uses Machine Learning

Like Medtronic’s FDA-approved closed-loop insulin delivery system, Beta Bionics’ iLet Bionic Pancreas System is intended to help adults and children with type 1 diabetes. The pocket-sized wearable device consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. A dosing algorithm “driven by lifelong machine learning” automatically calculates the correct dose of insulin based on data from a continuous glucose monitor. In home-use studies, the algorithms “demonstrated dramatic improvements in glycemic control relative to the standard of care,” with the results published in the New England Journal of Medicine.

2019 clinical trials for Beta Bionic's iLet Bionic Pancreas.

2019 clinical trials for Beta Bionics’ iLet Bionic Pancreas. Credit: Beta Bionics

Users initialize the iLet by simply entering their body weight. The iLet immediately and automatically controls blood-sugar levels without needing the user to count carbs, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

Yin and Yang of Blood Glucose

In addition to insulin, the device can also manage glucagon, another hormone produced by the pancreas that plays a role in regulating glucose and fats. The body releases glucagon in response to low blood glucose levels and at times when the body needs additional glucose, such as during vigorous exercise to help keep you from bonking. It’s the yang to insulin’s yin in the constant battle to maintain blood glucose homeostasis. Another way to understand it: Insulin helps tamp down high levels of blood glucose, while glucagon boosts low levels of blood glucose. The iLet can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas (insulin and glucagon). The glucagon-only configuration addresses rare and chronic low blood-sugar conditions, such as congenital hyperinsulinism and insulinoma syndrome.

A Certified B Corp

The company’s new war chest will help fund the continued development of the iLet, as well as additional clinical trials and its eventual submission of the medical device to the FDA for approval of all three iLet configurations. While Beta Bionics has its eyes on the prize, it also seems to care how it gets there: It is incorporated as both a Massachusetts public benefit corporation and certified as a B Corporation. Massachusetts public benefit corporations are legally required to consider the impact of their decisions on both shareholders and stakeholders, meaning employees and customers. Certified B Corporations are businesses that “meet the highest standards of verified social and environmental performance, public transparency, and legal accountability to balance profit and purpose.” Here are a few more tidbits:

Graph shows requirements of B Corp certification.

Looks like a lot of paperwork to us. Credit: Beta Bionics

There are nearly 2,800 B Corps in more than 60 countries and 150 industries around the world. It’s not just for startups. Companies from Danone to Kickstarter to New Belgium Brewing carry the B Corp mantle, which you can kind of think of as a way to measure what Google calls its “do no evil” mission.

Conclusion

While it’s cool that Beta Bionics is committed to taking the high road to profitability, it will probably be a rough one, considering the competition it has in a company like Medtronic. It’s impossible to say who has the superior device at this point, but we do know who has more money. As we noted in our previous story on Medtronic’s artificial pancreas, the company acquired an Israeli firm to bolster its AI-powered technologies around nutrition, which feeds directly into diabetes management. Beta Bionics may need to take on its own 800-pound gorilla to reach the market. Hopefully, it won’t be another case of the good guy finishing last.

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