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Closing the Loop, One Bigfoot Step at a Time

Bigfoot system on striped background with investigational watermark

 

We all want to get our hands on the latest and greatest technology in type 1 diabetes, and it appears a closed-loop system is on the horizon. With several players in the race to bring artificial pancreas technology to market, one company to watch is Bigfoot Biomedical. We recently connected with Founder & CEO Jeffrey Brewer to learn more about the timeline of their product in development, and to ask what we, the Glu Community, can do to help.

What is the meaning behind the name “Bigfoot Biomedical?”

In late 2014, Wired Magazine published an article by Dan Hurley about patients who were “hacking their way toward” an artificial pancreas. He spoke of his quest to track down a person who was rumored to have been using a homemade system for a couple of years, referring to this mystery man as “Bigfoot.”

“Bigfoot” was actually Bryan Mazlish, a Wall Street quantitative trader who had designed a solution for his family (Bryan’s wife Sarah Kimball, a longtime T1 and pediatrician, began using his first prototype system in February 2013. Their son Sam started using the system that summer.). Wanting to see his solution be made available to more people with T1D and encountering a lack of understanding from those he approached in industry, Mazlish launched a new company with myself and fellow D-dads Lane Desborough (former chief engineer of Medtronic Diabetes and father of Nightscout), and Jon Brilliant (former CFO and founding board member of WellDoc, the first FDA-approved mobile prescription therapy). An uncommon company born of the #wearenotwaiting mindset, we thought an uncommon name was perfect and embraced “Bigfoot” as the name of our endeavor.

What about your closed-loop system should people affected by type 1 be most excited about and why?

The community has been promised a closed-loop system for many years and has grown increasingly frustrated at the pace of development. The technology is here. The tools are here. Why don’t we have this? And most importantly, will it bring us the relief that we imagine it will bring?

After using this closed-loop system for three straight years, the Mazlish family’s prototype has served as the inspiration for the system we’ve designed in anticipation of our first clinical trial —a system that has now logged over 100 million simulated patient days in the cloud.

We have been able to subject our “virtual” patients to scenarios that were pulled directly from their real world experiences with T1D that are outside the carefully measured meals and controlled conditions of a trial setting. We now look forward to working with the FDA to validate our work in a human trial.

Their experience serves as evidence that a control algorithm can take data from a continuous glucose monitor and safely dose insulin in the right amount at the right time. A system like this really is possible, and more than that, their experience reflects that daily life with automated insulin delivery is as we hope it could be – less stressful, more consistent, providing more peace of mind! It’s a little like looking into a crystal ball and glimpsing the world of T1D a few years from now and seeing that life will get better.

The Bigfoot system, built on Mazlish’s early prototype, will offer not just automated insulin delivery, but also a complete service in managing T1D. We hope to draw a circle around everything that it takes to manage this disease – talking to your doctor, managing your prescriptions, automating your insulin – and ease the whole burden. On top of that, we want to see our technology accessible to a broader population. If it’s not at a cost that is accessible to average people with average insurance, it’s not going to reach the people who need it.

How is this product different from other developing systems anticipated to come to market?

Thanks to the tremendous work of organizations such as the JDRF, the Helmsley Charitable Trust, T1D Exchange and the NIH in advancing the field of Artificial Pancreas research and development, there are multiple commercial and academic efforts pursuing the goal of automating insulin delivery. Competition is good. It raises the bar for everyone and it helps raise awareness and build momentum. We need more innovative and breakthrough thinking – that’s why we started Bigfoot – we felt the industry could, and should, be doing more and delivering on it faster.

What sets Bigfoot apart is that we believe our solution is robust and ready. We are heading into our first series of clinical trials this quarter with a goal of being on the market near the end of 2018. For a company that just started sixteen months ago, that is light speed!

We feel that the perspective we bring as we are making system design decisions differs from our competitors, too. We were founded by people who live with and intimately understand T1D, so we know the ways that T1D is a burden emotionally, mentally, physically, and financially. We aren’t beholden to clunky, legacy technology and are able to move forward quickly and with agility. And we don’t see insulin delivery automation as just another bell or whistle to add to a pump; we see it as an entirely different way of living.

Where is Bigfoot Biomedical in the process of clinical trials and FDA approval?

Our growing team is 100% focused on preparing for our first trial, our Clinical Research Center trial, which we will announce soon. In 2017, we plan to launch a longer-duration outpatient pivotal trial, which is a trial of the system that we hope we can submit to FDA for approval to offer the system to the market. We have been working alongside FDA throughout the development to ensure that the solution we are designing will meet their high standards for safety and efficacy. They’ve been an excellent partner and facilitator to enable smart companies like ours to advance product candidates through the regulatory process as quickly as possible.

Are you currently facing or anticipating any hurdles as the company moves towards marketability?

We’re happy to report that, no, we don’t anticipate significant hurdles. Time and again, we find ourselves with unparalleled opportunity. Our acquisition of the Asante Snap pump assets in 2015 catapulted us forward, providing us with a 510(k)-approved insulin pump platform, a full manufacturing line and quality system, a portfolio of nearly 125 patents and patent applications, and a 45,000 square foot facility located in the heart of Silicon Valley. Partnerships with best-in-class technologies like Dexcom have given us the benefit of state-of-the-art continuous glucose sensor technology. And our investors share our vision for how revolutionary this technology will be. In terms of our team, we’ve recruited top talent across a variety of fields and are confident that we will have the capacity to tackle challenges as they arise.

What can families and people affected by type 1 (like the Glu Community) do to help fast-track a device like this?

We have been incredibly grateful for the support we’ve received from the greater community – the members of Glu, the team at T1D Exchange, our fans and followers across social media, bloggers, podcasters, and community leaders. We are moving as quickly as we can toward regulatory approval, and we are lifted by the wave of excitement. The community can continue to spread the word about who we are and what we are building and you can follow us on Facebook, Twitter, LinkedIn, and Instagram to catch the latest Bigfoot sightings, news, and updates. We came from this community and we want to deliver on the things we’ve promised. #BigfootisReal and it’s coming.

GluAnna (Anna Floreen)

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