Say hello to Beta Bionics, the new parent company that plans to commercialize the exciting iLet Bionic Pancreas system that administers both insulin and glucagon and was famously developed by researcher and diabetes dad Dr. Ed Damiano at Boston University.
News broke on April 1, 2016 about the establishment of this "public benefit corporation," an emerging concept that combines some aspects of non-profit and for-profit entities. This will allow the startup to prioritize benefit to our D-Community over profit for shareholders, all in the name of getting this automated system out to market and in patients' hands ASAP. Wow, what a refreshing embrace of the #PatientsOverProfit mantra! To start, Eli Lilly has pledged $5 million! (more on that below).
This unique business structure makes Beta Bionics the first of its kind in diabetes med-tech, and possibly the first public benefit corporation in the broader med-tech industry.
It's an exciting next chapter for the Bionic Pancreas, a project that Damiano kicked off a decade ago and aims to bring to market about the time his T1D son goes off to college.
Here at the 'Mine, we've been covering the Bionic Pancreas for years, especially since 2012 when 'Team Bionic' ported their system to the iPhone platform and really started setting the stage for a commercial device. Last summer at the CWD Friends For Life 2015 conference, Damiano unveiled the new iLet prototype with a slick consumer design that took this project to a whole new level of anticipation.
AP and iLet Basics
Anyone who follows the race to market for a "closed-loop" or Artificial Pancreas will know that there are a couple dozen groups (including the major Pharma players) developing these systems, which combine insulin pumping and continuous glucose monitoring (CGM) for automated glucose control. The main differences are the algorithms being developed by each group. What also sets the iLet apart is the built-in delivery of glucagon, which of course is the antidote to insulin, bringing up your blood sugar when necessary without the need to eat extra carbs and unwanted snacks (!)
The Beta Bionics team now has a third-generation prototype, or iLet 3, that Damiano showed off this past weekend at the local Friends For Life conference in Falls Church, VA. It hasn't changed significantly from the iLet design we reported on in February, but it's generating all kinds of excitement in the Diabetes Community -- from those very first people to try the iLet in its first-ever human trials, to those who've been keeping tabs on this for years.
This 'smart' system is designed to learn about a patient's needs over time, and adjust itself daily based on what it learns. The home screen will show your current blood glucose number displayed prominently on a CGM graph in the upper right, along with an clear view of how much insulin and glucagon you have on board. There will be a prominent button to easily select optional 'meal announcements' too.
“The device we showed at FFL in summer was much larger with a 4.1-inch display, and as a result it was power-hungry and burned through AAA batteries,” Damiano told us previously. “This newest one is thinner and with a much lower power display, closer to what we plan to eventually launch, and has a 3.2-inch screen with higher resolution, black and white LED display."
Of course, it will also have the Dexcom G5/G6 or future CGM generation integrated inside.
They're also working on a proprietary infusion set, which will have two needles and dual-tubing but will require only a single insertion for both glucagon and insulin delivery.
Damiano and team have been hinting that they were looking into forming a commercial company to further develop and market their system, and now here we are...
A New Business Concept?
Why set up Beta Bionics as a public benefit corporation? The idea stems from an airline magazine article that Damiano's wife, Toby Milgrome, read back in Summer 2011, he tells us.
The family was flying to London, and she noticed an article about two young women fresh out of Harvard who had started this new kind of corporation to commercialize an invention they developed in college -- a soccer ball that you could kick around during the day to store energy (roughly 30 minutes stored about three hours of energy). Depending on how much you kicked the ball around, at day’s end you could use that energy to re-charge a battery and get a full night of power for developing countries. Pretty cool!
Fascinated by both the tech and the business concept, Damiano went to meet with the ladies the following year. He learned the article was actually wrong; the women hadn’t started a public benefit corp, but had only been considering it. At the time, only two states had legal provisions for this new type of company, but Damiano was intrigued.
Now, 30 states have laws on public benefit corps. They are defined slightly differently by each state, but at the core, they have to serve a charitable purpose or offer some "public benefit" like health or education.
“This isn’t a compromise between a traditional corp and a non-profit, but is the best of both worlds and allows us to best serve the needs of the T1D community,” Damiano says.
Damiano becomes CEO and president of Beta Bionics, currently supervising seven people, including two engineers and interns.
He's brought on well-known D-Dad and Children With Diabetes founder Jeff Hitchcock from Ohio to serve as Board benefit director.
"We thought he’d be the perfect board member to make sure we’re upholding our mission and make sure the company’s being honest and faithful to it," Damiano says.
Also on the Board: Deirdre Ibsen, Lilly's global brand development director; and Ed and Serafina Raskin, whose 10-year-old son Max was diagnosed with T1D at age 7, and who serve respectively as VP/public benefit development officer/corporate strategy and VP/general counsel.
What makes Beta Bionics stand out from other diabetes and closed loop startups is, according to Damiano: "An overarching commitment that all management and board-level decisions will be made in the interest of the broader Diabetes Community, which is something that a typical corporation can’t do."
Beta Bionics four-pronged mission statement is:
- To provide and to protect Beta Bionics' turnkey solutions for safe and effective autonomous glycemic control;
- To bring Beta Bionics' technology to as many people with T1D as possible in an expeditious and responsible manner;
- To continue to innovate and to offer the latest advances as expeditiously and responsibly as possible; and
- To act in the best possible interest of the T1D community in connection with fulfilling the Beta Bionics' corporate functions.
And if you’re worried that this opens the door for the iLet closed loop tech to eventually be sold to a bigger med-tech or Pharma company, Damiano says don't.
“We are not going to sell Beta Bionics. When you talk about selling a company, or ‘an exit strategy,’ that’s a euphemism for abandonment for the sake of profit-taking. We don’t abandon the T1D Community, because we are the T1D Community."
Later this year, the D-Community can expect more news on how they can get involved with Beta Bionics from the ground-floor. Expect to see details closer to the Friends For Life conference in July, Damiano says, adding: "We want people in the T1D Community to have a personal stake in this, and we want the community to help us raise awareness on this."
Lilly Diabetes Invests $5 Million
While they're not planning to sell, Beta Bionics got a huge vote of confidence from Eli Lilly, when this Pharma insulin giant recently agreed to invest $5 million into the new business. While this is a boost on top of the many millions already raised, the company needs an estimated 35 million total to complete development and prepare for market.
“My attitude in aligning with Pharma companies is that, if you really distill it down to one element of truth, the Bionic Pancreas makes a great drug even better," Damiano says. "Our technology... optimizes every last drop of insulin to give you the best possible result. That makes sense to me, that a company would want to support a platform that makes their drug the best it can possibly be."
Damiano also notes that the Lilly deal also does not pigeonhole the iLet into only using one brand of insulin, as Beta Bionics plans to work openly with various partners to develop the best possible system.
“We want to create technology that gives people as much choice as possible, and our device will be very flexible in that way,” he said.
It's clear that he hopes this will be a game-changer, revolutionizing the standard of care, as much as home glucose meters or rapid-acting insulin did when they first appeared on the scene.
But Will It Be Affordable?
One of the biggest concerns about closed-loop technology is that it will widen the gap between the privileged / well-insured and ordinary / lower socioeconomic patients in regards to diabetes care.
But Damiano says they're treating the iLet like any other diabetes device, working hard to keep costs down and negotiate insurance coverage akin to that of the existing integrated pump-CGM systems (that don't have algorithms for automation).
Setting the stage for coverage, Damiano's been making the rounds of presentations to both endocrinologists and primary care doctors to get word out about the Bionic Pancreas becoming real. Last Fall, he presented at a Congressional briefing and this summer he plans to meet with the Diabetes Caucuses in the U.S. Senate, thanks to Indiana Senator Joe Donnelly who has an adult son with type 1.
"Meetings on Capitol Hill are all about raising awareness and getting lawmakers to understand that the Bionic Pancreas is an inevitability-- a freight train that is coming and cannot be stopped.Not only is it essential that private payers reimburse it, it's just as important that CMS reimburses this technology. This is a technology that does not discriminate based on social status, gender, weight, or how well you manage diabetes under standard of care practices. This device doesn't discriminate, and neither should the reimbursement models. That's the message we need to communicate to Congress, that while CMS doesn't reimburse for CGM right now, they must reimburse for the Bionic Pancreas."
The D-Community can play a big role in helping convince doctors, policy-makers and private payers to reimburse for this tech -- if we make enough noise raising our voices online and elswhere, and even organize petitions if necessary.
OK, so when exactly is the iLet coming to market?
Damiano tells us that by year's end, the system will go through a small NIH-funded "bridging study" that will include both kids and adults at four clinical sites across the U.S. -- Massachusetts General Hospital in Boston (where this "Team Bionic" is based); Stanford University in Palo Alto, CA; Nemours inJacksonville, FL; and the Barbara Davis Center in Colorado. By mid-2017, the large pivotal study will begin for the insulin + glucagon setup as well as the comparative insulin-only version of the automated closed loop system. The plan remains to submit this to the FDA by the end of next year, with an anticipated regulatory approval for an insulin-only configuration sometime in 2019 and the full biohormonal iLet after that.
That's not really so far off, is it?
In fact, based on what other companies have said about their timeline for closed loop systems, the iLet will likely follow behind at least a few to hit market first: Medtronic's 670G hybrid closed loop planned for approval and launch in mid-2017; and the TypeZero Technologies InControl system planned for final submission in 2018; and Bigfoot Biomedical that's building an insulin-only system off the old Asante Snap device, as well as the Tandem and Insulet systems that all expect pivotal trials in 2018 or 2019.
Yep, the closed loop tech race is certainly on! And given the noble goal of improving life with diabetes, Damiano's not at all worried about the competition.
“This is a bridge to a cure, and it fits in a complimentary way with the rest of the technology that we have now and will see developed in the coming years," he said. "One gives way to the next, with the ultimate evolution ending with a biological cure that will make all of these systems obsolete.”
Amen to that.