Damiano, a professor of mechanical engineering, made it his goal to make it easier to manage his young son’s condition.
Speaking on a panel at the MassMedic 2025 MedTech Symposium in Boston earlier this month, Damiano said: “I started to think about ways in which we could build the technology. I didn’t have the skill sets to engineer it before, but I thought I could lead to the problem of building an algorithm that could determine just the right amount of insulin to lower blood sugar and glucagon to raise blood sugar… for people with type one.”
Around 2001 or 2002, he began a project where he and one of his PhD students began working out what insulin delivery algorithms would look like.
By 2015, Beta Bionics was founded in Massachusetts. Beta Bionics brought its iLet bionic pancreas to market with FDA clearance in May 2023 and at the start of this year completed an IPO to become a publicly-traded company.
“We know the marketplace, Damiano said. “We really have a lot of momentum, a lot of traction out there. It’s been a very successful launch.”
About the iLet and Beta Bionics
iLet, an automated insulin delivery system streamlines diabetes management by reducing the burden on patients and physicians.
The system uses an adaptive, closed-loop algorithm. The algorithm initializes with the user’s body weight and requires no additional insulin dosing parameters. The algorithm removes the need to manually adjust insulin pump therapy settings and variables.
Beta Bionics designed iLet so that users only need to input their weight, then the system does the rest, eliminating the need for healthcare providers to determine correction factors, insulin-to-carb ratios or pre-set basal rates. The system simplifies mealtime by replacing carb counting with a meal announcement feature. Users can estimate the amount of carbs in their meals as an algorithm learns to respond to individual insulin needs.
iLet users can “go bionic,” leading to the elimination of the carb counting and insulin correction calculations. Then, iLet determines 100% of the insulin doses throughout the day.
Beta Bionics expanded its addressable patient population last year with the U.S. launch of iLet with the Dexcom G7 continuous glucose monitor (CGM). Users can select G7 or the previous-generation G6, or switch back and forth, depending on supplies. The company announced the 10,000th patient start on its iLet system in August 2024. Then, in October 2024, it announced that it launched the integration of iLet with the Abbott FreeStyle Libre 3 Plus.
What brought the company and industry to this point?
Damiano explained that consumer electronics sector’s development over the years proved significant to diabetes management.
He says pump therapy first popped up in the 1980s but didn’t move the needle in terms of improvements. But, the change from fingersticks to modern glucose monitoring technology changed the game.
“Continuous glucose monitors emerged and the accuracy of those systems was a challenge initially, but it’s not a problem anymore,” Damiano explained. “[CGMs] are essentially commoditized across Dexcom, Abbott, Medtronic’s device is now quite accurate and with Senseonics, there’s some really good sensor technologies.”
Crucially, those systems communicate with insulin pumps, too. And Damiano says pump makers couldn’t get to the point they’ve reached until CGM technology matured. The last piece of the puzzle was algorithms, developed in parallel with CGMs over the past couple of decades, to create the right dosing decisions.
Hybrid closed-loop systems — like many of the automated systems on the market — came first, then Damiano says the iLet followed as the first device that titrates all of the insulin without the user needing to make a therapeutic decision.
“This is truly an autonomous, kind of self-driving car,” Damiano said. “But, it’s the synergy that comes from those three technologies — the algorithms, the CGM and the pump — that was needed to build these little, portable, wearable devices that can automate glucose. That’s where the industry is going. Hybrid closed-loop systems are all going to move toward what the iLet is doing, which is fully automated.”
What’s next for Beta Bionics?
Beta Bionics has big plans for the funds raised through its IPO. Beta Bionics plans to use proceeds to fund the development of the bihormonal configuration of iLet through FDA submissions.
That project focuses on glucagon, which, if delivered through an automated system, could offer a dual-hormone solution to dual-hormone insufficiency. Bihormonal configuration could end up “restoring back that dysfunction,” Damiano says, while delivering the necessary insulin.
“Beta is very committed to getting a dual-hormone system out there,” Damiano said. “They’re well-resourced to do that. A large clinical trial is going to be needed. That’s on its way — a few years out — but on its way.”
The company also plans to develop a patch pump device that could rival leader Insulet and potential competitors Tandem and Medtronic, who are developing their own. Additional uses for funds include expanding sales and manufacturing infrastructure.
Beta Bionics also could follow the likes of Insulet and Tandem into type 2 — a path Medtronic is also pursuing. Damiano notes that the company has “a couple thousand” users managing their type 2 diabetes with the iLet off-label and Beta Bionics could have an indication for the population down the line, likely in the U.S. first.
“It’s exceedingly important, with the technology we have in the U.S., to get outside the U.S., and that system needs to be navigated again,” Damiano said. “It’s not something Beta can take on right now. We say a type 2 indication is probably going to come sooner in the U.S.”
