Managing insulin-dependent diabetes is no easy task. Most patients manually measure blood glucose and calculate insulin dosing using traditional multiple dose injection (MDI) therapy, a burdensome process that puts them at risk for both hypo- and hyperglycemia. Bigfoot Biomedical is working on a solution to take the guesswork out of MDI.
The Milpitas, CA-based company is developing the Bigfoot Unity Diabetes Management Program, an integrated system that helps patients dose their insulin more easily and accurately. The system consists of a mobile phone app plus proprietary insulin pen caps, pen needles, Abbott glucose sensing technology, a backup blood glucose meter, and glucose test strips. Bigfoot’s platform connects these different parts and uses algorithms to predict blood glucose levels and calculate recommended doses of insulin.
We asked Red Maxwell, Chief Marketing Officer, more about the company’s past and its role in the future of insulin management.
Medgadget: Tell me about how Bigfoot Biomedical started. What was the inspiration behind the idea and product?
Red Maxwell: Bigfoot Biomedical was started, and remains today, a very personal mission. Many of us working at the company are touched by someone with insulin-requiring diabetes — our children, spouses, other family members and friends.
The legend of Bigfoot begins with co-founder Bryan Mazlish who spent years in finance and automated stock trading before his work took an important turn when his son Sam was diagnosed with type 1 diabetes (T1D) at the age of five. Bryan’s wife had lived with T1D for many years, but it was Bryan’s handling of Sam’s care with the round-the-clock monitoring of blood glucose levels and heavy weight of worry that prompted him to pursue a new path.
Using his experience with quantitative trading algorithms, Bryan began creating models to predict future blood sugar trends which he paired with remote glucose monitoring tools and an insulin pump, effectively building the first DIY artificial pancreas device. Soon Bryan was ready to find a commercial partner and create a new paradigm of care for those with insulin-requiring diabetes.
In 2014, Bryan joined forces with former JDRF CEO Jeffrey Brewer, whose son also has T1D, and founded SmartLoop Labs. That year, Wired Magazine published a piece detailing the legendary story of someone who’d successfully hacked their own automated system, dubbing him “Bigfoot”. The name stuck and the company was renamed Bigfoot Biomedical, Inc. in February of 2015.
Today, Bigfoot and our more than 80 employees are working tirelessly on innovative solutions to simplify and optimize insulin delivery and dosing decisions for people living with insulin-requiring diabetes through the use of algorithms, artificial intelligence and automation. Our integrated system and services are designed to address many of the challenges facing people with type 1 and type 2 diabetes, health care providers, and insurance institutions. Insulin-requiring diabetes impacts over six million Americans.
Medgadget: How does the technology work? How is it different from other integrated/automated insulin pumps out there?
Maxwell: Bigfoot Unity utilizes proprietary, smart pen caps for basal and meal-time insulin dosing recommendations integrating Abbott’s FreeStyle Libre platform. The system is intended to help people using Multiple Daily Injections know when and how much insulin to inject based on their doctor’s prescribed therapy regimen.
What makes the Bigfoot Unity Diabetes Management Program different from what is currently available with smart insulin pens is that it provides real-time data to help people make insulin-dosing decisions based on their doctor’s recommendations. Determining how much insulin to take and when is one of the most burdensome and frustrating aspects for someone with insulin-requiring diabetes because glucose-levels are influenced by multiple factors and because of the inherent dangers of injecting too much or too little insulin. With Bigfoot Unity, the person with diabetes will be able to quickly and easily determine their physician recommended insulin dosage based on his or her current glucose levels and recent dosing history.
The other important aspect that makes Bigfoot Unity stand apart from others in the market is our subscription-based model. Currently, people with diabetes have to manage multiple prescriptions. Bigfoot plans to package the Unity system as a monthly subscription and will include everything the person needs — Unity’s proprietary insulin pen caps for both basal and bolus dosing, the Abbott glucose sensing technology, pen needles, backup blood glucose meter, glucose test strips and alcohol swabs. The system also includes a mobile phone app. The insulin pens will need to be obtained separately.
Bigfoot’s portfolio also includes the Bigfoot Autonomy Diabetes Management program with a closed-loop, automated insulin pump system. Bigfoot Autonomy’s insulin pump system, which received the FDA Breakthrough Device designation, will require a pivotal clinical trial and subsequent regulatory approvals.
Medgadget: At what stage is the company today? (Number of team members, stage of development and clinical studies, investment funding, etc.)
Maxwell: FDA submission of Bigfoot Unity is anticipated in 2020 with a target launch soon after clearance.
We have 80 team members and have raised $135 million in investor funding to date. Our list of investors including Abbott, JDRF, The Helmsley Trust, Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management.
Medgadget: What are some of the biggest challenges currently facing the team?
Maxwell: Our biggest challenge is time — it takes much longer to bring a product to market than any of us would like to see. The burden of insulin-requiring diabetes is tremendous and so naturally we want to see advancements like Bigfoot Unity available to those who need it as quickly as possible.
Medgadget: Looking to the next 5 years, what are some of the major goals for the company?
Maxwell: The diabetes technology industry is evolving quickly so I’m more comfortable speaking to our immediate goals which are to bring the Bigfoot Unity Diabetes Management Program to market and begin clinical trials of future generation Bigfoot Unity systems incorporating closed-loop technology for injection users.
Check out this video of Bigfoot Biomedical:
Flashback: Bigfoot Biomedical’s Diabetes Management System Going on Trial