Big news in the diabetes device world as it relates to future closed loop tech!
Word came on May 28 that the small but mighty startup has bought up the key assets of Asante Solutions, the California company that made the click-together and partially-disposable Snap insulin pump but announced just two weeks ago that it was closing up shop for good after being unable to secure sufficient funding.
The news of Asante's demise rocked the Diabetes Size now, catching pretty much everyone off-guard -- from current and potential pump customers, to healthcare providers and even most of Asante's own employees and sales reps.
Now, Bigfoot Biomedical, the exciting New York startup rumored to be creating one of the most ingenious closed loop systems for blood sugar control, is swooping in to buy the defunct pump maker's assets -- including the intellectual property behind the Snap pump and the manufacturing infrastructure. No, this doesn't mean Bigfoot will continue to make or sell the Snap pump, or even that Bigfoot will be involved in servicing any existing pumps out there. What it means is that the designs that make the Snap so innovative and unique -- like quick refills, missed bolus reminders, and disposable parts -- will not be lost, but rather live on in future closed loop technology!
Hey, when one door closes, another one opens, right?
If you remember, Bigfoot was first formed late last year (originally as SmartLoop), a result of the growing do-it-yourself mentality among the diabetes tech community, an initiative known as the #WeAreNotWaiting movement.
Bigfoot's new on the scene, but the people behind it are anything but newbies. The main trio of talent are all D-Dads --- Jeffrey Brewer, who became CEO of this startup after leading the JDRF as its CEO for four years up until mid-2014; , former chief engineer of insulin delivery at Medtronic Diabetes; and Bryan Mazlish, a former exec who earned the nickname "Bigfoot" by developing a homemade artificial pancreas system for his T1 wife and young son that was shrouded in mystery for over a year -- prompting a to refer to its elusive creator as "Bigfoot."
See to peruse the rest of the talent they've brought on board so far, gathering hardware and algorithm skills from all corners of the healthcare, medical device and digital tech world -- such as Medtronic Diabetes hardware and algorithm creators to the former CFO of Welldoc. It seems this ambitious outfit is adding new faces at breakneck speed!
Since the Bigfoot execs came out of the shadows earlier this year, they've been raising money to get off the ground; less than a month ago that Bigfoot had brought in $3.5 million from investors so far, with hopes to raise $10-15 million by this summer.
If all goes well, Bigfoot leaders hope to get started on pivotal clinical studies of their prototype system in 2016 and start bringing us the first generation of their device in the few years following that!
We're very proud to announce that Jeffrey Brewer (at right, with his son) will be giving a debut presentation of Bigfoot's work at our DiabetesMine D-Data Exchange event happening this Friday in conjunction with the first day of the ADA Scientific Sessions. We'll share details post-event, but in the meantime we were thrilled to connect with Jeffrey in advance for a quick Q&A about all the very cool happenings with Bigfoot. Here's what he tells us:
DM) Congrats on the exciting news about picking Asante's technology! We're bummed to see them fail of course, but glad something positive could come out of it. So what exactly did you get from them, and what will the impact be?
JB) Bigfoot Biomedical acquired all the assets of Asante Solutions. We are also hiring some former employees to support our plans. We regret that we are not in a position to support the existing Snap users at this time. However, we are thrilled that our efforts to deliver an overall automated insulin delivery system will be greatly accelerated.
Does that leave anything remaining for others to acquire?
No. Per the transaction, Bigfoot acquired all the assets of Asante Solutions.
Can you describe what the plans are at this point for using Asante Snap technology in what Bigfoot is developing?
Asante created the Snap as a simple-to-use insulin pump. We will be leveraging that as a component of our broader automated insulin delivery system. The pump body is likely to stay the same and be mated with a custom controller that will interface with other components of our system.
What does your current prototype look like now, and what can we expect to see once this is available?
I wouldn't say it's clunky, but some have used that language to describe the prototype. Those who've used it quite like it. The difference between our integrated solution and the prototype is that the prototype uses proprietary fobs and cradles to BLE (Bluetooth Low Energy) enable an off-the-shelf insulin pump and sensor. Our insulin pump will be sleeker, easier to use and talk to the other components of the system via BLE.
How will the addition of Asante tech impact your development timing and getting into regulatory review?
Having the Asante Snap platform will significantly accelerate and de-risk our pump development efforts. Our plans are to be in pivotal clinical trials in 2016.
Of course many other outfits are also working on closed loop projects. What are the challenges in moving all of these different choices forward?
I believe the only disclosed commercial closed loop development effort is by Medtronic. All the others of which I'm aware are still in the stage of "proof of concept," i.e. academic research, and are being funded by non-profit grants from the NIH, JDRF, Helmsley or individual donors.
One of the challenges is that there is a lot of misunderstanding about the difference between a commercial effort and an academic demonstration project. It will take tens of millions of dollars for us to bring our system to market. Showing something works in a small number of people is important. However, it's still just a science project until there is a funded entity that can build out the range of operational competencies required to develop, test, market and support a commercial closed loop system.
So it's pretty much a race to get the first closed loop system completed and to market?
We don't think being first is what's important. Getting it right, so that we can bring closed loop to the most people at the lowest cost is our focus.
Access to this technology and cost are huge factors... Given all of Bigfoot's collective expertise, is there any sense of how the cost of your system will compare to pumps and CGMs on the market now?
While today’s complex prototypes for “artificial pancreas” systems may strike some as a rich person’s luxury, we intend to deliver an integrated solution that costs less than the sum of all the bits of technology that people are using today. Based on our experience, we believe our system will be more cost-effective than anything else on the horizon. Plus we will lower costs while also delivering better outcomes.
By working on separate projects, aren't we just creating more closed loop "silos" that don't connect, instead of open-source platforms that can share data -- which the Diabetes Size now has been pushing on for years?
At Bigfoot we are advocates for bringing down the silos and making data available to people with T1D. However, in order to take that data and make decisions for people with T1D (such as with an automated insulin delivery system) there need to be companies that will fund development of a system and take it through clinical trials and regulatory submissions. I wish more companies were making that commitment. I think competition is healthy and that people with T1D should have choices. We plan to be one of the choices.
What about truly open-source initiatives in closed loop tech, like what Dana Lewis and Scott Leibrand are working toward with the OpenAPS initiative?
I'm not sure what happens with OpenAPS. However, I applaud those who are pushing it forward. Their efforts and advocacy are helping to educate everyone (FDA, industry, non-profits) on how desperately these technologies are needed.
Thanks for taking the time, Jeffrey -- definitely some outstanding progress being made, and we can't wait to see what materializes from Bigfoot.
** June 4, 2015 UPDATE: ** Bigfoot Biomedial announced it has signed an agreement with Dexcom allowing for CGM data sharing to be integrated into this future closed loop tech!
*** June 5, 2015 UPDATE: *** Bigfoot's CEO Jeffrey Brewer announced during the D-Data Exchange, held in conjunction with the American Diabetes Association's annual meeting, that it would be moving the startup from New York to Silicon Valley, into the 45,000 square foot former Asante building where it has a manufacturing line.