Bigfoot Biomedical acquires Asante’s assets and IP, giving it a market-ready pump – May 28, 2015

Bigfoot Biomedical has just acquired all of pump-maker Asante’s assets, including the intellectual property behind the Snap and the associated manufacturing line. The move is a bold one – Asante shut its doors just 14 days ago! – and yet, unsurprising given Bigfoot’s recent momentum and desire to have an automated insulin delivery system in a pivotal trial by the end of 2016. The deal gives Bigfoot its own FDA-approved pump to use, meaning it will not have to build its own from scratch or license from an established player – it’s a major de-risk as the startup advances to market. Deal terms were not disclosed. [For context, Asante’s total assets at the time of the IPO filing last December were ~$25 million (per its balance sheet) – it’s of course very challenging to even begin to know how much was paid based on this number alone.]

Bigfoot plans to use the existing Asante pump body (disposable) and mate it with a new custom built, durable, Bluetooth-enabled controller that includes a control algorithm. Given Bigfoot’s focus on simplicity and broad accessibility, we think the fit is an outstanding one – Asante’s Snap has many desirable characteristics, including pre-filled reservoirs, auto-priming, and low upfront cost. (See diaTribe’s test drive.) The Snap’s modular architecture could also allow Bigfoot to swap out controllers over time without having to change the underlying pump body manufacturing, enabling faster iteration, more customized controllers (e.g., one for super engaged patients and another for those who don’t want to push any buttons), and improved profitability.

Bigfoot intends to use the Snap’s existing manufacturing line (small at this point, as Asante had ~1,000 users), and plans to hire back some of Asante’s engineering and manufacturing employees. In line with our debut February interview, Bigfoot hopes to be in a pivotal trial of its automated insulin delivery system by the end of 2016.

While it was disheartening to see Asante come and go so fast (in recent weeks, the IPO filing in December to shutting its doors two weeks ago), this story is not over if Bigfoot uses the legacy Asante technology. We were very glad to see today’s news, not only because it stands to benefit patients through a faster time to market and greater industry competition, but because it means much of Asante’s hard work will be leveraged going forward.

• Just two weeks ago, Bigfoot Biomedical raised $3.5 million from eight undisclosed investors (see the SEC Filing). The team is working to solidify agreements with institutional investors for a follow-on Series A round of financing – this is likely to close by the end of summer, and we could imagine it happening sooner. Investors here are likely to be very, very smart.
• Bigfoot Biomedical now has eight full-time employees, including spectacular new hires (since our February interview) Jon Brilliant as CFO (formerly of WellDoc) and powerhouse educator Jen Block as Director of Clinical Innovation – both are major votes of confidence. The company also includes CEO Jeffrey Brewer (former CEO of JDRF), CTO Bryan Mazlish (type 1 dad/partner and Wall Street wiz), Chief Engineer Lane Desborough (type 1 dad and formerly of Medtronic), Director of Hardware Development George Crothall, Director of Business Development Bethany Salmon (formerly of JDRF), and Ross Naylor (co-developer of Nightscout).
• CEO Jeffrey Brewer will give a keynote at Diabetes Mine’s D-Data Exchange next Friday. This is an invite-only event, though we will be in attendance and plan to cover broadly in Closer Look.

Automated Insulin Delivery Competitive Landscape

• See below for an overview of the automated insulin delivery landscape, as far as we aware. We acknowledge this list may be incomplete, as they are likely other stealth startups or academic group working to commercialize closed-loop technology.

Close Concerns Questions Related to Commercializing Automated Insulin Delivery Technology

Q: What do patients, clinicians, and payers expect out of closed-loop systems?

Q: How do we appropriately manage sky high patient expectations?

Q: How will patients tradeoff nighttime vs. 24-hour use of closed-loop systems? Will this impact design at all? See diaTribe’s test drive of the UVa DiAs system for more perspective on this point.

Q: How much extra will patients be willing to pay out of pocket to use closed-loop systems? Does it even matter?

Q: What patients will be best suited for closed-loop systems? What patients will not be suited for closed-loop systems?

Q: Will closed-loop systems make clinicians lives easier or harder in the short-term? How long will it take for such systems to reduce the burden on clinicians?

Q: Should the field worry about “de-skilling” once patients are on closed-loop systems? (i.e., when things “break”, patients won’t have any idea how to manage their diabetes)

Q: How should we balance customization with the ability to keep things simple? One could imagine a closed-loop system where every parameter can be tweaked vs. one with little customization. Both have pros and cons. Which would patients prefer? Which would clinicians prefer? Which is easier from a regulatory perspective?

Q: What advice would payers give manufacturers in terms of designing artificial pancreas pivotal studies?

Q: What efficacy data do closed-loop trials need to show for payers to reimburse at a premium vs. sensor-augmented pumps? (e.g., what reduction in A1c, what reduction in hypo, etc.)

Q: If a closed-loop system does not change A1c, but reduces hypoglycemia by 50%, will payers pay a premium vs. sensor-augmented pump therapy? 

Q: Pivotal studies might not show a very critical benefit of closed-loop systems: reductions in severe hypoglycemia. How can we gather this data in a real-world setting? 

-- by Adam Brown and Kelly Close