Bigfoot Biomedical acquires Timesulin, giving it a connected insulin pen dose capture technology; possible launch in 2019, sold as a monthly service for insulin titration – June 9, 2017

In big news yesterday, Bigfoot Biomedical announced the acquisition of Timesulin (Patients Pending, LTD), including the company’s in-development Bluetooth-enabled insulin pen dose capture technology. Financial terms were not disclosed, but this is a major move by Bigfoot to drive insulin titration in the injection arena, in addition to automating insulin delivery with a pump. Timesulin co-founder John Sjölund (who also has type 1) has joined the Bigfoot team as of today and will lead efforts to bring insulin titration to injectors – what a coup for Bigfoot!

CEO Jeffrey Brewer told us a launch of the “Bigfoot auto-titration injection system” is possible in the ~2019 time frame. The Bluetooth-enabled insulin pen cap will not be sold as a standalone piece of hardware, but part of comprehensive Class III medical device system for optimizing MDI therapy. Clinical trials will be needed before FDA submission (no timing shared).

Consistent with Bigfoot’s business model, the auto-titration injection system will be sold as a bundled monthly service subscription model, including dose capture devices for basal and mealtime insulin (we assume two separate caps), CGM, an app for titration and data viewing, remote monitoring, etc. We love the idea of this model and look forward to seeing it scale up. How will payers perceive the value and compare it to other options?

As we covered in October when it was first announced, Timesulin’s dose capture device is a cap that fits on disposable/durable insulin pens and passively collects dose size/time and sends the data to a paired smartphone app. It was positioned as in the “final R&D” phase as of October, and a regulatory filing was previously expected this year (obviously there is more work for Bigfoot to do). The cap includes a screen with key dose information (see pictures below), uses a newly invented “novel proximity sensor” (readings within 0.5 units), does not need calibration, is expected to last “close to a year” on a replaceable battery, and can even read insulin temperature. We assume these features will carry over at Bigfoot, but of course, the product could change from the initial announcement.

This is Bigfoot’s second bold acquisition following the lightning quick purchase of Asante’s pump and assets two years ago. In addition to Bigfoot’s software/algorithm expertise, it now has a portfolio with a pump AND a dose capture device to drive better use of insulin (in combination with glucose data). Perhaps the only other company with near-term potential to do this is BD, who has its own dose capture device and a patch pump for type 2 diabetes. Of course, many other companies are working on MDI dose capture or titration alone (Companion Medical’s InPen, Sanofi MyDoseCoach, Novo Nordisk/Glooko, Common Sensing, Voluntis, etc.) or on closing the loop with pumps (see our competitive landscape). We see a lot of synergy in pursuing both at the same time.

Today’s news does not come as a surprise, as CEO Jeffrey Brewer mentioned a connected insulin pen in his January 2016 presentation at Biotech Showcase. At the time, he expected it would launch in “2017” – things always take much longer than expected! Mr. Brewer also foreshadowed this news three weeks ago when the company announced its impressive clinical advisory board (Drs. Anne Peters, Irl Hirsch, Mike Heile, and Jennifer Sherr). The recent addition of Dr. Karen Talmadge to Bigfoot’s Board of Directors also suggested a broad focus on MDI users and type 2 diabetes.

On the pump side, Bigfoot still anticipates a pivotal trial for its “first automated system” will begin in late 2017 at clinical study sites across the US. The team continues to “aggressively pursue a strategic relationship with a glucose sensor partner and looks forward to making an announcement in the near future.” As a reminder, only an R&D development agreement exists with Dexcom right now (signed in June 2015).

• Bigfoot is evaluating the future of the ~$29 original Timesulin cap, which has sold over 200,000 units in 40 countries to date (launched in 2011). The original Timesulin cap includes a screen with a basic built-in clock timer to answer the question, “When did I last take my insulin.” (It starts counting when the cap is taken off the pen and then replaced.) Said CEO Jeffrey Brewer, “While Bigfoot is proud of the legacy of the timer cap, the clear driver for this acquisition is John and the dose capture technology.” We imagine if the price point is right, most patients will far prefer the upcoming Dose Capture option that adds Bluetooth, talks to the phone, and provides titration advice.
• Our favorite quote from the press release: “Bigfoot isn’t in the pump business. And even though we are excited to add a connected dose capture technology for insulin injections, we aren't in the pen business either. Bigfoot is a solutions company developing systems that connect components into Class III medical device systems capable of supporting auto-titration for insulin dosing across a variety of glucose sensing and insulin delivery technologies. We believe integrated systems are the future of diabetes therapy and, going forward, only systems will be able to compete to improve quality of life, lower clinical delivery costs, and decrease overall healthcare costs for people with insulin-requiring diabetes.”

Close Concerns Questions

Q: How much R&D work remains on the dose capture device before it is ready for clinical trials? How difficult is the regulatory path for a Bluetooth-enabled cap vs. a reusable pen?

Q: How will MDI users evaluate the pros/cons of a reusable cap (Bigfoot/Timesulin) vs. a reusable pen (Companion Medical, Novo Nordisk/Glooko)?

Q: What clinical trials will be required for Bigfoot’s planned auto-titration service? (size, length, etc.) Will these be more or less onerous than traditional closed loop trials?

Q: How will the monthly price of this MDI titration solution compare to Bigfoot’s pump-based solution? Could MDI titration (with CGM + algorithms) be half the price of pump-based closed loop?

Q: How will payers weigh Bigfoot’s different offerings? Will there be stepwise treatment – e.g., start on MDI titration, and if things don’t go well, progress to a pump?

Q: Who will emerge as Bigfoot’s CGM partner?

Pictures of Timesulin’s Dose Capture Device (as of October 2016)

-- by Adam Brown and Kelly Close