Share on Pinterest
Bigfoot Biomedical’s Unity system

The promise of future diabetes technology can be uncertain, even in the best of times.

But there’s at least one exciting new connected system for people with diabetes that remains on course for launch in 2021 despite current economic woes, its makers claim.

It’s coming from Northern California–based Bigfoot Biomedical: an ambitious next-generation Automated Insulin Delivery (AID) system known as Bigfoot Unity.

Unlike other early “Artificial Pancreas” technologies that connect a continuous glucose monitor (CGM) and insulin pump to automate dosing, the Unity system is designed for individuals on multiple daily injection therapy.

What’s unique here is offering the decision-support and automation advantages of a connected system to a broad swath of people with diabetes who aren’t hooked up to an insulin pump — which is in fact the great majority.

Bigfoot also promises a novel business concept for a multipart automated insulin delivery system: a subscription payment model featuring regular mail-order deliveries.

“Think of it like a service, where you’re not being forced to buy each particular part of a system separately, but all of that is bundled together with a subscription cost and is delivered to your door,” said Bigfoot CEO Jeffrey Brewer. “You’re being provided with a solution, and whatever you need to use that solution (is) provided on a monthly basis.”

While they do plan to create an insulin pump version of their product later on, the first iteration based on a “smart” insulin pen will hopefully be filed for review by the Food and Drug Administration (FDA) later this year.

The company remains confident despite the current pandemic that will undoubtedly affect every industry.

Since its founding in early 2015, Bigfoot has aimed to create both an insulin pen version as well as a pump version of its AID system, allowing people with diabetes (PWDs) the choice for whatever they prefer.

In March 2019, our DiabetesMine team had the opportunity to spend time inside Bigfoot’s “lair” in the San Francisco Bay Area and get a sneak peek at the technology they’re building and company culture.

A lot has changed since then.

Bigfoot now has a new lair, after moving to a facility twice as large in a nearby town. The crew has also changed significantly, with several big names in the diabetes space leaving for other ventures.

And the priority pipeline focus has shifted to the connected smart pen version of their product in order “to serve a larger, yet lesser-served segment” of our diabetes community.

Here’s a breakdown of exactly what Bigfoot has in the works.

Bigfoot Unity (formerly Bigfoot Inject)

This system uses a “smart” digital pen cap as the base for its design, originally developed by Timesulin and acquired by Bigfoot in 2017. Yet, it goes beyond just tracking dosing data.

There will be two versions of the pen cap, one for basal (long-acting) and bolus (rapid-acting) insulin pens. Importantly, Bigfoot Unity will work with any type of insulin. The connected “smart” caps are designed to fit universally on all insulin pen models.

The caps will read CGM data directly from a future version of the Bluetooth-enabled Abbott FreeStyle Libre flash glucose monitoring sensor to make insulin dosing decisions based on those glucose readings.

Users will even be able to scan the Libre sensor using the Bigfoot Unity pen cap, in addition to current scanning with the dedicated smartphone app.

With Bigfoot Unity, users can view all the data on a mobile app but won’t need to pull out their phone to get dosing recommendations, as those will show up right on the pen cap.

This is the version Bigfoot expects to file with the FDA in fall 2020, and hopefully get approval by early 2021.

Bigfoot Autonomy (aka Bigfoot Loop)

The future insulin pump–based system is built on the Asante Solutions’ Snap pump technology and design, which Bigfoot acquired when that company went out of business in May 2015.

That two-part insulin pump has a “brains” component and disposable piece that holds the insulin cartridge, which snap together.

Bigfoot is now developing a screenless pump device with fun Bigfoot “eye” symbols (derived from its company logo). A smartphone mobile app will be the main user interface, so users won’t even have to pull out their insulin pump to operate it or see data displayed.

Users will enter carb counts for meals on the phone app, which will then recommend a dose and allow delivery without having to touch the pump at all. The timeline on this remains TBD, dependent in part on fundraising for the clinical trial work after Bigfoot Unity.

Mobile app

Both Bigfoot systems will interact directly with a mobile app, which wouldn’t even need to be opened on the user’s phone for it to connect and obtain data. The app will display data trends and transmit glucose alarms.

CGM choices

Bigfoot and Abbott Diabetes Care announced an agreement in mid-2017 to integrate a next-gen Bluetooth-enabled version of the 14-day Libre sensor with the upcoming Bigfoot AID systems.

This will be an entirely new iteration of Libre, where the CGM data stream will be continuous between pump or pen and smartphone app.

That contract with Abbott is for the first couple years of Bigfoot’s commercialization, Brewer says, and after that they’d likely collaborate with other CGM makers to offer other options to customers.

A likely candidate is Dexcom, which was an original Bigfoot partner before the Dexcom G6 “no calibration” version release. Brewer says Bigfoot is working to build a “modular system aimed at offering choice,” so it’s just a matter of time after the first generation rolls out.

Bundled subscription purchase plan

Bigfoot plans to be its own supply vendor, meaning users would order everything from them, bundled in their own branded packaging: test strips, lancets, alcohol swabs, and pen supplies or pump infusion sets (minus the needed insulin, which you’d still get the traditional way).

The idea is to require just one single prescription from a doctor to obtain your Bigfoot system supplies in a sort of “one-stop shop” that would be delivered to customers’ doorsteps each month. Training and digital learning tools would also be a part of that, Brewer says.

Share on Pinterest
Image via Bigfoot Biomedical

Like other companies, Bigfoot has had delays and pushbacks on timelines in the past, and we all know that can be frustrating.

Of course, the company has adopted a work-from-home (WFH) policy in reaction to the COVID-19 outbreak.

But Bigfoot’s Chief Marketing Officer Red Maxwell says they’re making business adjustments to maintain the “aggressive timeline” for FDA filing of Bigfoot Unity by this fall.

“It’s been a challenge, but the entire company is committed to get it in the hands of our community as soon as possible. The pandemic has only crystallized the need for medical solutions like ours that enable remote care, remote support, and home delivery,” he said.

In the past year or so, Brewer says their conversations with payers (aka insurers) and healthcare providers pushed them to focus first on the pen version of their product.

That’s because people using injections make up a majority of insulin-dependent PWDs, yet this larger group is underserved when it comes to diabetes tech options.

“This has popped to top of mind for insurance companies and large healthcare delivery systems that realize there must be a better way,” Brewer said.

“We’re not looking at CGM as just a way to provide data to people. Rather, we’re providing advice,” he said. “We want to take those CGM readings and turn that into specific advice on how much insulin to take… and when.”

Bigfoot cites Seagrove Partners market research showing that an estimated 6.6 million Americans are dependent on insulin as of 2019. Meanwhile, T1D ExChange data shows that across the board, people with T1D aren’t achieving optimal health outcomes (largely based on non-optimal A1C results).

And with more T2s being diagnosed and put on insulin, experts are sensing a growing need to offer the same kind of cutting-edge, data-driven treatment for all.

That is what Bigfoot hopes to address, using a “blue ocean strategy” to tap the vast, unmet demand of both T1s and T2s who may not be the most typical tech-savvy engaged users.

That’s a business concept that involves “the simultaneous pursuit of differentiation and low cost to open up a new market space and create new demand.”

“The endocrinologists aren’t going to be able to support all the patients who need insulin therapy. So whatever comes, it needs to be simple and self-training, be able to lower the burden on the clinician profoundly, and be easily prescribed and be able to support itself. That’s what we are developing here,” Brewer said.

He acknowledges that access is important, i.e., it’s critical that clinicians be able to prescribe this easily, that it be reimbursed by payers, and be affordable for anyone who needs it.

“Removing the bottlenecks is critical: price, complexity, doctor familiarly, etc.,” Brewer said.

“To us, it’s not either pen or pumps — it’s both. That is still a novel idea in the industry. I think we’re saying no one thing is the best. There needs to be choice, and it needs to encompass both injections and infusion pumps and probably patch and tethered pumps too.

“These all have a place in the marketplace because they’re preferred by certain people, and the customer may change their mind over time for any variety of reason. We need that flexibility,” Brewer said.

Don’t forget this startup is named after the Bigfoot creature that was historically so elusive — did he exist or not?

In early 2014, rumors began to spread within the diabetes community about a guy out there somewhere who had hacked into his diabetes devices to create a so-called Artificial Pancreas… but no one would publicly confirm his existence or real name.

That changed in late 2014, when this diabetes tech-savvy “Bigfoot” outed himself and finally shared his family’s story with the world.

It turned out to be D-Dad Bryan Mazlish from New York, whose wife and son live with T1D. He had managed to crack the code on a CGM and insulin pump to create the first homemade closed loop — years before anyone else was openly doing this.

For the formation of the company Bigfoot Biomedical, Mazlish partnered with a trio of other diabetes dads also anxious to build best-in-class technology for their loved ones:

  • Brewer, known as the “Father of the Artificial Pancreas,” as he’d been CEO of JDRF for 4 years and helped pave the pathway for closed loop technology
  • former Medtronic Chief Engineer Lane Desborough, who had helped create the data-sharing game changer known as Nightscout
  • Jon Brilliant, who had served as chief financial officer of WellDoc after co-founding the company years earlier

Recently, their employee count has dipped from 100+ to 80+, but they are bringing new faces on board.

Notably, co-founder Desborough is one of those employees who has moved on to other ventures, along with big names like Timesulin founder John Sjolund, Stanford closed loop expert and diabetes educator Jen Block, and longtime patient advocate Melissa Lee.

“The organization has evolved and is becoming more mature, and as a company we’re moving out of the development stage into a commercialization stage. It’s a different challenge and requires different talent. There will be a time when Bigfoot outgrows me as well,” said CEO Brewer.

“It’s still as driven in the DNA by people who understand and are committed to alleviating challenges of life with insulin-requiring diabetes. (Change) is a function of our success in getting to this stage,” he said.

Despite those fluctuations, the company has marked some important wins and remains optimistic.

Late last year, Abbott led a series C round of financing that brought in $45 million and sped the startup along the path of being able to finalize its first-gen product development.

They’ve also been focused this past year on talking with payers to secure as much insurance coverage as possible in advance of their planned market launch in 2021.

The company has struck up numerous partnerships to optimize this in-development system, including one with Pennsylvania-based Allegheny Health Network, allowing their endocrinologists and primary care doctors to help refine the provider-facing features for best-case use on the clinical side.

“We’ve chosen to turn the traditional logic on its end, not just asking if someone is ‘complying or adhering,’ but what is preventing them from doing that?” Brewer noted.

“Usually, if you look closely enough, it’s because (diabetes management) is too much a pain in the ass or requires too much attention, or there’s some aspect that is getting in the way. It’s not that people don’t want to be healthy. The fundamental design of diabetes care is flawed, and from the beginning that’s been our key insight and driving impetus in doing this,” he said.